IOQ - AUT-10202-CAM-03

Installation and Operational Qualification Protocol for AUT-

10202-CAM-03
Workspace : Facility, Utility, and Equipment Validation (CAM)
Document No : IOQ - AUT-10202-CAM-03
Document Title : Installation and Operational Qualification Protocol for AUT-10202-CAM-03
Version : 1.0

This is a representation of an electronic record that was signed electronically and this page is a
manifestation of the electronic signature. The electronic signatures for this document are maintained in
the Kneat system.

Pre-Approval
Signed By Signatory Capacity User Group Date
Parry, John Engineering Approval Engineering 20-Jan-2020 (UTC)
Signatory
Kent, Amy Validation Approval Signatory Validation 20-Jan-2020 (UTC)
Beyer, Jessica Manufacturing Approval Manufacturing 20-Jan-2020 (UTC)
Signatory
Isabelle, Richard Quality Assurance Approval QA 20-Jan-2020 (UTC)
Signatory

Post-Approval
Signed By Signatory Capacity User Group Date
Parry, John Engineering Approval Engineering 19-Mar-2020 (UTC)
Signatory
Kent, Amy Validation Approval Signatory Validation 19-Mar-2020 (UTC)
Waldmann, Lars Manufacturing Approval Manufacturing 19-Mar-2020 (UTC)
Signatory
Isabelle, Richard Quality Assurance Approval QA 19-Mar-2020 (UTC)
Signatory
 INSTALLATION AND OPERATIONAL QUALIFICATION (IOQ)
PROTOCOL
Initial

 System Name  Key Fill Finish Autoclave 

 System ID  AUT-10202 
 Protocol #  IOQ - AUT-10202-CAM-03 
 Protocol Revision  1.0 
 Project / Product  Project Key 
 Driver #  CC-19-296, MAN-000017 
  Document Number:  IOQ - AUT-10202-CAM-03 
 Document Version:  1.0 
 Equipment ID:  AUT-10202 
 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Table of Contents
1 Purpose.................................................................................................................................... 6
2 Scope of Validation................................................................................................................... 7
2.1 Testing Strategies.............................................................................................................. 8
3 System Description.................................................................................................................38
4 References............................................................................................................................. 39
5 General Protocol Requirements..............................................................................................41
6 Protocol and SOP Training.....................................................................................................42
7 IQ Prerequisites...................................................................................................................... 44
7.1 Drawing Prerequisite........................................................................................................45
8 IQ Test Case List.................................................................................................................... 47
9 IQ Test Cases......................................................................................................................... 48
9.1 System Walkdown Verification (IOQ - AUT-10202-CAM-03-01).......................................49
9.1.1 Field Execution - System Walkdown Verification (IOQ - AUT-10202-CAM-03-01).....50
9.2 Supporting Utility Verification (IOQ - AUT-10202-CAM-03-02).........................................59
9.2.1 Field Execution - Supporting Utility Verification (IOQ - AUT-10202-CAM-03-02).......60
9.3 System Drawing Verification (IOQ - AUT-10202-CAM-03-03)..........................................62
9.3.1 Field Execution - System Drawing Verification (IOQ - AUT-10202-CAM-03-03)........62
9.4 System Component Verification (IOQ - AUT-10202-CAM-03-04).....................................64
9.4.1 Field Execution - System Component Verification (IOQ - AUT-10202-CAM-03-04)...65
9.5 Materials of Construction Verification (IOQ - AUT-10202-CAM-03-05).............................70
9.5.1 Field Execution - Materials of Construction Verification (IOQ - AUT-10202-CAM-03-
05)...................................................................................................................................... 71
9.6 System Calibration Verification (IOQ - AUT-10202-CAM-03-06)......................................73
9.6.1 Field Execution - System Calibration Verification (IOQ - AUT-10202-CAM-03-06)....73
9.7 Technical Supporting Documentation Verification (IOQ - AUT-10202-CAM-03-07)..........76
9.7.1 Field Execution - Technical Supporting Documentation Review (IOQ - AUT-10202-
CAM-03-07)........................................................................................................................ 76
9.8 Maintenance System Registration Verification (IOQ - AUT-10202-CAM-03-08)...............78
9.8.1 Field Execution - Maintenance System Registration Verification (IOQ - AUT-10202-
CAM-03-08)........................................................................................................................ 78

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9.9 Embedded Software Verification (IOQ - AUT-10202-CAM-03-09)....................................80

9.9.1 Field Execution - Embedded Software Verification (IOQ - AUT-10202-CAM-03-09). .80
10 OQ Prerequisites..................................................................................................................83
10.1 Standard Operating Procedure Review..........................................................................84
10.2 Automation Prerequisites...............................................................................................85
11 OQ Test Case List................................................................................................................87
12 OQ Test Cases..................................................................................................................... 88
12.1 Test Equipment Calibration Verification (IOQ - AUT-10202-CAM-03-10).......................89
12.1.1 Field Execution - Kaye Validator Calibration Verification (IOQ - AUT-10202-CAM-03-
10)...................................................................................................................................... 89
12.1.2 Field Execution - Stand-Alone Test Equipment Calibration Verification (IOQ - AUT-
10202-CAM-03-10).............................................................................................................91
12.2 Alarm and Interlock Testing (IOQ - AUT-10202-CAM-03-11).........................................93
12.2.1 Field Execution - Alarm and Interlock Testing (IOQ - AUT-10202-CAM-03-11).......94
12.3 Power Backup Testing (IOQ - AUT-10202-CAM-03-12)...............................................101
12.3.1 Field Execution - Power Backup Testing (IOQ - AUT-10202-CAM-03-12).............101
12.4 Set Point Verification (IOQ - AUT-10202-CAM-03-13)..................................................104
12.4.1 Field Execution - Pre-Execution Set Point Verification (IOQ - AUT-10202-CAM-03-
13).................................................................................................................................... 105
12.4.2 Field Execution - Post-Execution Set Point Verification (IOQ - AUT-10202-CAM-03-
13).................................................................................................................................... 119
12.5 Filter Integrity Test Certification Verification (IOQ - AUT-10202-CAM-03-14)...............134
12.5.1 Field Execution - Filter Integrity Test Certification Verification (IOQ - AUT-10202-
CAM-03-14)...................................................................................................................... 134
12.6 Sequence of Operations Verification (IOQ - AUT-10202-CAM-03-15)..........................136
12.6.1 Field Execution - Sequence of Operations Verification (IOQ - AUT-10202-CAM-03-
15).................................................................................................................................... 142
12.7 Automated Valve Actuation Testing (IOQ - AUT-10202-CAM-03-16)...........................144
12.7.1 Field Execution - Automated Valve Actuation Testing (IOQ - AUT-10202-CAM-03-
16).................................................................................................................................... 144
12.8 Autoclave Sterilization (Empty Chamber Mapping) (IOQ - AUT-10202-CAM-03-17)....148
12.8.1 Field Execution - Autoclave Sterilization (Empty Chamber) - TMDs Setup (IOQ -
AUT-10202-CAM-03-17)...................................................................................................152

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12.8.2 Field Execution - Autoclave Sterilization (Empty Chamber) - Test Run (IOQ - AUT-
10202-CAM-03-17)...........................................................................................................153
12.8.3 Field Execution - Autoclave Sterilization (Empty Chamber) - Test Results (IOQ -
AUT-10202-CAM-03-17)...................................................................................................154
12.9 Access Rights Testing (IOQ - AUT-10202-CAM-03-18)...............................................157
12.9.1 Field Execution - Access Rights Testing (IOQ - AUT-10202-CAM-03-18)..............160
12.10 Steam Quality Test (IOQ - AUT-10202-CAM-03-19)..................................................173
12.10.1 Field Execution - Steam Quality Test (IOQ - AUT-10202-CAM-03-19).................173
12.11 Leak Test (IOQ - AUT-10202-CAM-03-20).................................................................175
12.11.1 Field Execution - Leak Test (IOQ - AUT-10202-CAM-03-20)...............................176
12.12 Air Removal Test (IOQ - AUT-10202-CAM-03-21).....................................................179
12.12.1 Field Execution - Air Removal Test (IOQ - AUT-10202-CAM-03-21)...................183
13 System Instruments Calibration Verification........................................................................186
14 UR Traceability Matrix.........................................................................................................190
15 Protocol Deviations.............................................................................................................193
16 Attachments........................................................................................................................ 195

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1 Purpose

This Installation and Operational Qualification (IOQ) protocol will provide documented evidence that the Key Fill
Finish Autoclave (ID# AUT-10202) in Room 175 is installed and operates as required per Brammer Bio User
Requirements, manufacturer's design specifications, and cGMP requirements.

This IOQ protocol will define all testing needed and outline the strategy to meet the installation and operational
qualification requirements defined per CC-19-296, MAN-000017.

Comments
# Comments Performed By Date
1 No comments. Coane, John 11-Feb-2020 (UTC)
2      
3      
Note: If there are no comments in the "Comments" table above, type "No Comments" in the first line. The
remaining empty rows will be considered "N/A". Otherwise, "N/A" all unused rows.

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 Document Name: Installation and Operational Qualification Protocol for AUT-10202

2 Scope of Validation

The scope of this IOQ protocol applies to the installation and operation of the system at Thermo Fisher Scientific,
Brammer Bio in Cambridge, MA. All required testing per CC-19-296, MAN-000017 will be performed in
this protocol unless listed and justified in Table 1 below.

Table 1: Test Cases Out of Scope

Test Case Justification / Rationale
Loop Verification Loop Verification will not be performed for this unit. System Calibration Verification, Sequence of
Operations, and Automated Valve Actuation meets all test objectives required to confirm that all
components of the system are wired and installed correctly.

Acceptance criteria required per SOP-000600 are satisfied by the test cases specified above.

 
# Comments Performed By Date
1  No comments Coane, John 11-Feb-2020 (UTC)
2      
3      
Note: If there are no comments in the "Comments" table above, type "No Comments" in the first line. The
remaining empty rows will be considered "N/A". Otherwise, "N/A" all unused rows.

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2.1 Testing Strategies

The test strategies that will be followed for all IQ and OQ test cases in this protocol for AUT-10202 are listed in the below sections. Some of the testing
was completed during the commissioning (see CTP-AUT-10202-CAM-01) to satisfy qualification requirements. Any applicable test cases are
documented in this section.

System Walkdown Verification

Verify all GURs and SURs from the system UR meet required specifications.

Supporting Utility Verification

Supporting utilities will be verified to be connected and meet required specifications.

System Drawing Verification

The system P&IDs will be verified to reflect the installed state of the system.

System Component Verification

Equipment, instruments, and components of the system will be verified to be present and installed.

System Calibration Verification

Instrument Impact Assessments (IIAs) will be verified to have been performed for system instruments. 

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Technical Supporting Documentation Verification

Supporting documentation for the system will be verified to have been received and stored.

Maintenance System Registration Verification

The system and critical records associated with the system will be verified to be recorded in the CMMS. This includes the equipment record, system
impact assessments, and maintenance plans.

Embedded Software Verification

This test shall verify the current firmware and/or software version on the system and that a back-up version has been archived.

Test Equipment Calibration Verification

Any independent test instruments used during the execution of this protocol will be documented and verified to be with their calibration interval during
testing.

Alarm and Interlock Testing

This test will verify that all alarms and interlocks identified in Table 1 are configured correctly and function as designed. All alarms have previously been
tested by the manufacturer during Site Acceptance Testing (SAT) with a Brammer Bio representative present. The manufacturer's testing will be attached
to this test case to support that all alarms function as designed. The vendor documentation (SAT) was pre-approved by ENG/CQV and post-approved by
ENG, CQV, and QAV.

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Table 1: Alarm Testing

# Alarm ID # Alarm Description
1 AlarmProg1 Manual step change

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Table 1: Alarm Testing

# Alarm ID # Alarm Description
2 AlarmProg2 Program abort
3 AlarmProg3 Machine is in hold state
4 AlarmProg4 Sterilized product isn't discharged
5 AlarmProg5 Door open, program start not possible
6 AlarmProg10 Recipe couldn't be loaded, program start not possible
7 AlarmProg11 Autostart not successful
8 AlarmProg15 Maximum step time exceeded
9 AlarmProg16 PLC has an error
10 AlarmProg28 Data program start not recorded
11 AlarmProg29 Data program end not recorded
12 AlarmProg30 Data batch release not recorded
13 AlarmProg31 No communication between PLC and HMI
14 AlarmFc1 Door unlocked without reaching the release
15 AlarmFc10 Supply pressure heating steam too low
16 AlarmFc11 Supply pressure steam too low
17 AlarmFc12 Difference between steam supply pressure and maximum process pressure too small
18 AlarmFc13 Air detector test not passed
19 AlarmFc16 A not configured temperature control sensor is used
20 AlarmFc17 Monitoring of temperature control sensor deactivated due to sensor fault
21 AlarmFc18 No control sensor available
22 AlarmFc19 Temperature control sensor 1 faulty
23 AlarmFc20 Temperature control sensor 2 faulty
24 AlarmFc21 Temperature difference between control sensors too large
25 AlarmFc23 Failure monitoring sensor
26 AlarmFc25 A not configured product sensor is used

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Table 1: Alarm Testing

# Alarm ID # Alarm Description
27 AlarmFc31 Timeout overtemperature sensor T1
28 AlarmFc32 Timeout overtemperature sensor T2
29 AlarmFc33 Timeout overtemperature sensor T3
30 AlarmFc34 Timeout overtemperature sensor T4
31 AlarmFc35 Timeout overtemperature sensor T5
32 AlarmFc40 Timeout overtemperature sensor T10
33 AlarmFc41 Timeout overtemperature sensor T11
34 AlarmFc42 Timeout overtemperature sensor T12
35 AlarmFc47 Timeout undertemperature sensor T1
36 AlarmFc48 Timeout undertemperature sensor T2
37 AlarmFc49 Timeout undertemperature sensor T3
38 AlarmFc50 Timeout undertemperature sensor T4
39 AlarmFc51 Timeout undertemperature sensor T5
40 AlarmFc54 Timeout undertemperature sensor T8
41 AlarmFc56 Timeout undertemperature sensor T10
42 AlarmFc57 Timeout undertemperature sensor T11
43 AlarmFc58 Timeout undertemperature sensor T12
44 AlarmFc79 Overtemperature sensor T1
45 AlarmFc80 Overtemperature sensor T2
46 AlarmFc81 Overtemperature sensor T3
47 AlarmFc82 Overtemperature sensor T4
48 AlarmFc83 Overtemperature sensor T5
49 AlarmFc86 Overtemperature sensor T8
50 AlarmFc88 Overtemperature sensor T10
51 AlarmFc89 Overtemperature sensor T11

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Table 1: Alarm Testing

# Alarm ID # Alarm Description
52 AlarmFc90 Overtemperature sensor T12
53 AlarmFc95 Correlation - Chamber pressure in relation to chamber temperature too high
54 AlarmFc96 Undertemperature T1
55 AlarmFc97 Undertemperature T2
56 AlarmFc98 Undertemperature T3
57 AlarmFc99 Undertemperature T4
58 AlarmFc100 Undertemperature T5
59 AlarmFc103 Undertemperature T8
60 AlarmFc105 Undertemperature T10
61 AlarmFc106 Undertemperature T11
62 AlarmFc107 Undertemperature T12
63 AlarmFc112 Correlation - Chamber pressure in relation to chamber temperature too small
64 AlarmFc116 No monitoring sensor parameterized
65 AlarmFc117 Too short sterilization time or too low sterilization temperature to parameterized
66 AlarmFc118 Temperature difference between monitoring sensors is too large
67 AlarmFc119 Temperature monitoring sensor during sterilization too low
68 AlarmFc126 Failure chamber pressure sensor P1
69 AlarmFc127 Failure chamber pressure sensor P1 and P2
70 AlarmFc128 Difference between chamber pressure sensors too large
71 AlarmFc129 Maximum chamber pressure exceeded
72 AlarmFc130 Maximum jacket pressure exceeded
73 AlarmFc131 Deviation from theoretical ambient pressure too large
74 AlarmFc136 Timeout during closing door 1
75 AlarmFc137 Timeout during opening door 1
76 AlarmFc138 Door 1 has opened without permission

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Table 1: Alarm Testing

# Alarm ID # Alarm Description
77 AlarmFc139 Safety bar has been actuated during closing door 1
78 AlarmFc140 Timeout pressing on door seal 1
79 AlarmFc141 Timeout releasing door seal 1
80 AlarmFc151 Door 1 does not move due to missing release
81 AlarmFc153 Process was not sterile
82 AlarmFc154 Door release type requires both doors
83 AlarmFc155 Both doors open
84 AlarmFc167 Leakage test not passed
85 AlarmFc183 Circulation container, timeout overtemperature
86 AlarmFc185 Circulation container, overtemperature
87 AlarmFc186 Jacket, timeout under pressure
88 AlarmHw1 Emergency stop active
89 AlarmHw2 Forcing active
90 AlarmHw21 Breakdown power supply
91 AlarmHw22 Breakdown power supply, with active motors
92 AlarmHw23 24 VDC, fuse tripped
93 AlarmHw24 Breakdown power supply, timeout internal UPS
94 AlarmHw25 Internal UPS, failure state
95 AlarmHw29 Overtemperature control cabinet
96 AlarmHw35 Service door side 1 open, door 1 can not move
97 AlarmHw37 Service switch side 1 is switched, door 1 can not move
98 AlarmHw41 Door drive side 1, fuse tripped
99 AlarmHw45 Vacuum pump, fuse tripped
100 AlarmHw47 Fan 1, fuse tripped
101 AlarmHw55 Power supply unit control, fuse tripped

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Table 1: Alarm Testing

# Alarm ID # Alarm Description
102 AlarmHw56 Power supply unit power, fuse tripped
103 AlarmHw57 LED lighting, fuse tripped
104 AlarmHw58 Phase monitoring, fuse tripped
105 AlarmHw110 Sensor chamber pressure P1, input value under limit or exceeded limit
106 AlarmHw112 Sensor chamber pressure P2, input value under limit or exceeded limit
107 AlarmHw114 Sensor jacket pressure P3, input value under limit or exceeded limit
108 AlarmHw116 Sensor steam supply pressure P4, input value under limit or exceeded limit
109 AlarmHw130 Sensor chamber temperature T1, input value under limit or exceeded limit
110 AlarmHw132 Sensor chamber temperature exit T2, input value under limit or exceeded limit
111 AlarmHw134 Sensor product temperature 1 T3, input value under limit or exceeded limit
112 AlarmHw136 Sensor chamber temperature 2 T4, input value under limit or exceeded limit
113 AlarmHw138 Sensor areation filter temperature T5, input value under limit or exceeded limit
114 AlarmHw144 Sensor air detector temperature T8, input value under limit or exceeded limit
115 AlarmHw148 Sensor cooling temperature backflow T10, input value under limit or exceeded limit
116 AlarmHw150 Sensor condensator temperature T11, input value under limit or exceeded limit
117 AlarmHw152 Sensor circulation container temperature T12, input value under limit or exceeded limit
118 AlarmHmi1 Automatic creation of report at end of batch failed
119 AlarmHmi2 Automatic print of report at end of batch failed
120 AlarmHmi3 Automatic export of report as PDF at end of batch failed

Power Backup Testing

The power backup test will verify that the HMI retains all system settings and parameters in the event of a power loss to the unit.  A power failure
condition will be simulated for at least 15 minutes. Upon restoration of power to the HMI, all system settings and parameters, including user accounts and
programs, will be verified to be unchanged. Power Backup Testing shall be performed concurrently with Set Point Verification. 

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Set Point Verification 

The equipment settings and set points (refer to Tables 2 - 5 below) will be verified and documented prior to any OQ test execution. This verification will
serve as the record of the settings that were used when the autoclave sterilization mapping activities took place. Following completion of all testing,
equipment, and/or control settings that were found to be acceptable during the validation will be documented. Set Point Verification shall be performed
concurrently with Power Backup Testing. 

Table 2: Wrapped Goods Parameter List

Parameter Parameter Value
Jacket pressure  2150 mbar
Liquid sterilization program  not active
Temperature monitoring pre-  Active Sensor 1, Sensor 2
Treatment
Pos. temperature hysteresis   5.0 °C
Neg. temperature hysteresis   1.0 °C
Air detector   not active
Temperature monitoring Active Sensor 1, Sensor 2
sterilization
Correlation monitoring  not active
Differential monitoring of control  active
sensors
F0 value calculation   not active
Pos. temperature hysteresis   3.0°C
Neg. temperature hysteresis   0.0°C
Temperature monitoring Post  Active Sensor 1, Sensor 2
Treatment
Pos. temperature hysteresis   3.0°C

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Table 2: Wrapped Goods Parameter List

Parameter Parameter Value
Neg. temperature hysteresis   3.0°C
Ventilation filter FIS active   not active
Ventilation filter FIF active   not active
Basic time interval for recording   5 sec.
Batch Report  Temp: Active Sensor 1, Sensor 2, Sensor 3
StemFract Program Parameters 
Number of fractions  4
Jacket heating  active
Fan  not active
Evacuation target value  60 mbar
Evacuation ramp  500 mbar/min
Additional value evacuation  60 mba
Additional time evacuation  60 sec
Steam target value  2010 mbar
Steam ramp  400 mbar/min
Steam monitoring temperature  0.0 °C
Additional value steam  2010 mbar
Additional time steam  60 sec
Report filter value  6
SteamFract Program Parameters 
Number of fractions   1
Jacket heating   active
Fan   active
Evacuation target value  1013 mbar
Evacuation ramp  400 mbar/min

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Table 2: Wrapped Goods Parameter List

Parameter Parameter Value
Additional value evacuation  1013 mbar
Additional time evacuation  0 sec
Steam target value  2220 mbar
Steam ramp  70 mbar/min
Steam monitoring temperature  0.0 °C
Additional value steam  2242 mbar
Additional time steam  0 sec
Report filter value  6
SteriPres  Program Parameters 
Support pressure   not active
Jacket heating   active
Fan   not active
Steam target value   2242 mbar
Steam ramp  1000 mbar/min
Sterilization monitoring 123.2 °C
temperature 
Sterilization time   1800 sec
Report filter value  6
AirFract Program Parameters
Number of fractions   2
Jacket heating   active
Fan   active
Evacuation target value  100 mbar
Evacuation ramp  1000 mbar/min
Additional value evacuation  100 mbar
Additional time evacuation  600 sec

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Table 2: Wrapped Goods Parameter List

Parameter Parameter Value
Ventilation target value  800 mbar
Ventilation ramp  1000 mbar/min
Additional value ventilation  800 mbar
Additional time ventilation  90 sec
Report filter value  6
AirFract Program Parameters
Number of fractions   1
Jacket heating   active
Fan   not active
Evacuation target value  100 mbar
Evacuation ramp  1000 mbar/min
Additional value evacuation  100 mbar
Additional time evacuation  0 sec
Ventilation target value  800 mbar
Ventilation ramp  1000 mbar/min
Additional value ventilation  800 mbar
Additional time ventilation  90 sec
Report filter value  6
LastAirFract Program Parameters
Jacket heating   active
Fan   not active
Evacuation target value  100 mbar
Evacuation ramp  1000 mbar/min
Additional value evacuation  100 mbar
Additional time evacuation  0 sec

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Table 2: Wrapped Goods Parameter List

Parameter Parameter Value
Ventilation ramp  1000 mbar/min
Report filter value  6

Table 3: Bowie Dick Test Parameters

Parameter Parameter Value
Jacket pressure  2064 mbar
Liquid sterilization program  not active
Temperature monitoring Pre  Active Sensor 1, Sensor 2
Treatment
Pos. temperature hysteresis   5.0 °C
Neg. temperature hysteresis   1.0 °C
Air detector   not active
Correlation monitoring  active
Differential monitoring of control  active
sensors
F0 value calculation   not active
Temperature monitoring  Active Sensor 1, Sensor 2
sterilization 
Pos. temperature hysteresis   3.0°C
Neg. temperature hysteresis   0.0°C
Temperature monitoring Post  None
Treatment
Pos. temperature hysteresis   0.0°C
Neg. temperature hysteresis   0.0°C
 Ventilation filter FIS active  not active

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Table 3: Bowie Dick Test Parameters

Parameter Parameter Value
 Ventilation filter FIS active  not
Basic time interval for recording   10 sec.
Batch Report Sensors  Active Sensor 1, Sensor 2
StemFract Program Parameters 
Number of fractions   4
Jacket heating   active
Fan   not active
Evacuation target value   60 mbar
Evacuation ramp   500 mbar/min
Additional value evacuation   60 mbar
Additional time evacuation   60 sec
Steam target value  2010 mbar
Steam ramp  400 mbar/min
Steam monitoring temperature  0.0 °C
Additional value steam  2010 mbar
Additional time steam  60 sec
Report filter value  6 **
StemFract Program Parameters 
Number of fractions   1
Jacket heating   active
Fan   active
Evacuation target value   1013 mbar
Evacuation ramp   400 mbar/min
Additional value evacuation   1013 mbar
Additional time evacuation   0 sec

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Table 3: Bowie Dick Test Parameters

Parameter Parameter Value
Steam target value  2113 mbar
Steam ramp  70 mbar/min
Steam monitoring temperature  0.0 °C
Additional value steam  2113 mbar
Additional time steam  0 sec
Report filter value  6
SteriPres  Program Parameters 
Support pressure   not active
Jacket heating   active
Fan   not active
Steam target value   2113 mbar
Steam ramp  300 mbar/min
Sterilization monitoring 121.0 °C
temperature 
Sterilization time   480 sec
Report filter value  6
AirFract Program Parameters
Number of fractions   1
Jacket heating   active
Fan   not active
Evacuation target value  100 mbar
Evacuation ramp  2000 mbar/min
Additional value evacuation  10 mbar
Additional time evacuation  300 sec
Ventilation target value  800 mbar
Ventilation ramp  1000 mbar/min

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Table 3: Bowie Dick Test Parameters

Parameter Parameter Value
Additional value ventilation  800 mbar
Additional time ventilation  0 sec
Report filter value  6
AirFract Program Parameters
Number of fractions   1
Jacket heating   active
Fan   not active
Evacuation target value  100 mbar
Evacuation ramp  2000 mbar/min
Additional value evacuation  10 mbar
Additional time evacuation  30 sec
Ventilation target value  800 mbar
Ventilation ramp  1000 mbar/min
Additional value ventilation  800 mbar
Additional time ventilation  0 sec
Report filter value  6
LastAirFract Program Parameters
Jacket heating   active
Fan   not active
Evacuation target value  100 mbar
Evacuation ramp  2000 mbar/min
Additional value evacuation  10 mbar
Additional time evacuation  0 sec
Ventilation target value  0 mbar
Ventilation ramp  1000 mbar/min

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Table 3: Bowie Dick Test Parameters

Parameter Parameter Value
Report filter value  6

Table 4: Leak Test Parameters

Parameter Parameter Value
Jacket pressure  2050 mbar
Liquid sterilization program  not active
Temperature monitoring pre- None
Treatment
Pos. temperature hysteresis   0.0 °C
Neg. temperature hysteresis   0.0 °C
Air detector   not active
Temperature monitoring  None
sterilization 
Correlation monitoring  not active
Differential monitoring of control  not active
sensors
F0 value calculation   not active
Temperature monitoring Post  None
Treatment
Pos. temperature hysteresis   0.0°C
Neg. temperature hysteresis   0.0°C
Ventilation filter FIS active   active
Ventilation filter FIF active   not active
Basic time interval for recording   10 sec.
Temperature monitoring   Active Sensor 1
 VacLeakTest  Program Values

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Table 4: Leak Test Parameters

Parameter Parameter Value
Jacket heating   active
Fan   not active
Evacuation target value  70 mbar
Evacuation ramp  2000 mbar/min
Stabilization time  300 sec
Test time   600 sec
Ventilation ramp   1000 mbar/min
Report filter value   6

Table 5: Filter Inline Sterilization Parameters

Parameter Parameter Value
Jacket pressure  2150 mbar
Liquid sterilization program  not active
Temperature monitoring pre-  Active Sensor 1, Sensor 2
Treatment
Pos. temperature hysteresis   5.0 °C
Neg. temperature hysteresis   1.0 °C
Air detector   not active
Temperature monitoring Active Sensor 1, Sensor 2
sterilization
Correlation monitoring  not active
Differential monitoring of control  active
sensors
F0 value calculation   not active
Pos. temperature hysteresis   3.0°C
Neg. temperature hysteresis   0.0°C

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Table 5: Filter Inline Sterilization Parameters

Parameter Parameter Value
Temperature monitoring Post  Active Sensor 1, Sensor 2
Treatment
Pos. temperature hysteresis   3.0°C
Neg. temperature hysteresis   3.0°C
Ventilation filter FIS active   active
Ventilation filter FIF active   not active
Basic time interval for recording   5 sec.
Batch report  Temp: Active Sensor 1, Sensor 2, Sensor 3
StemFract Program Parameters 
Number of fractions  4
Jacket heating  active
Fan  not active
Evacuation target value  60 mbar
Evacuation ramp  500 mbar/min
Additional value evacuation  60 mba
Additional time evacuation  60 sec
Steam target value  2010 mbar
Steam ramp  400 mbar/min
Steam monitoring temperature  0.0 °C
Additional value steam  2010 mbar
Additional time steam  60 sec
Report filter value  6
SteamFract Program Parameters 
Number of fractions   1
Jacket heating   active
Fan   active

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Table 5: Filter Inline Sterilization Parameters

Parameter Parameter Value
Evacuation target value  1013 mbar
Evacuation ramp  400 mbar/min
Additional value evacuation  1013 mbar
Additional time evacuation  0 sec
Steam target value  2220 mbar
Steam ramp  70 mbar/min
Steam monitoring temperature  0.0 °C
Additional value steam  2242 mbar
Additional time steam  0 sec
Report filter value  6
SteriPres  Program Parameters 
Support pressure   not active
Jacket heating   active
Fan   not active
Steam target value   2242 mbar
Steam ramp  1000 mbar/min
Sterilization monitoring 123.2 °C
temperature 
Sterilization time   1800 sec
Report filter value  6
AirFract Program Parameters
Number of fractions   2
Jacket heating   active
Fan   active
Evacuation target value  100 mbar
Evacuation ramp  1000 mbar/min

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Table 5: Filter Inline Sterilization Parameters

Parameter Parameter Value
Additional value evacuation  100 mbar
Additional time evacuation  600 sec
Ventilation target value  800 mbar
Ventilation ramp  1000 mbar/min
Additional value ventilation  800 mbar
Additional time ventilation  90 sec
Report filter value  6
AirFract Program Parameters
Number of fractions   1
Jacket heating   active
Fan   not active
Evacuation target value  100 mbar
Evacuation ramp  1000 mbar/min
Additional value evacuation  100 mbar
Additional time evacuation  0 sec
Ventilation target value  800 mbar
Ventilation ramp  1000 mbar/min
Additional value ventilation  800 mbar
Additional time ventilation  90 sec
Report filter value  6
LastAirFract Program Parameters
Jacket heating   active
Fan   not active
Evacuation target value  100 mbar
Evacuation ramp  1000 mbar/min

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Table 5: Filter Inline Sterilization Parameters

Parameter Parameter Value
Additional value evacuation  100 mbar
Additional time evacuation  0 sec
Ventilation ramp  1000 mbar/min
Report filter value  6

Filter Integrity Test Certification Verification

Any filter installed as part of this validation execution will be integrity tested prior to and after validation testing. Verifying filter integrity following validation
activities confirms the filter flow through properties were representative of normal operating conditions and confirms the process being validated didn’t
negatively impact the filter integrity.  Filter Integrity Certification documentation will be included as part of this protocol execution. 

Sequence of Operations Verification

This test will verify that all system recipes, prompts, and system functions progress as intended. One run will be performed for every cycle programmed
(refer to Tables 2 - 5). Testing can be completely concurrently with other operational tests.

Automated Valve Actuation Testing

This test will confirm that all valves are capable of opening and closing properly when controlled manually through the local HMI. One run will be
performed for each automatic valve on the system as listed in Table 6. Results of the test will be visually verified by confirming that each valve moves to
the proper position when prompted by the control system. The valve numbers provided in this test case are Belimed-specific numbers which are hard
coded into the GUI (Graphics User Interface).

Table 6: Automated Valves in AUT-10202

# Automate Valve ID  Manufacturer ID Valve Description from GUI
1  Sampling  650 8D6040 5A10T1 1508 Steam Sampling 

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Table 6: Automated Valves in AUT-10202

# Automate Valve ID  Manufacturer ID Valve Description from GUI
2  K307 (see Note)  555 15D91C2 5P12G1 1903 F Press on Seal 1 (confirm existence, do not activate) 
3  K307 (see Note)  555 15D91C2 5P12G1 1903 F Release Door Seal 1 (confirm existence, do not activate) 
4  G904 (see Note)  650 15D6040 5211T1 1508  Vacuum injector door seal (confirm existence, do not activate) 
5  Q4003  550 10D6034 511G1 Cooling valve circulation tank 
6  Q4004  550 20D6034 512G1 Cooling unit valve return flow
7  Q3001  650 20D8240 5E12T1 1508 Air Valve Chamber 
8  Q3202  550 8D6040 510G1 Air Valve ventilation filter
9  Q3203  CA2096 Condensate valve ventilation filter
10  Q1101  555 15D91C2 5P12G1 1903 F Steam valve jacket
11  Q1001  555 20D82C2 5P12G1 RS804 Steam valve chamber
1903 F
12  Q1601  550 40D6034 514G1  Vacuum valve vacuum unit
13  Q1602  550 10D6034 511G1  Pressure relief valve vacuum unit
14  Q4001  550 8D6040 510G1  Cooling valve circulation tank
15  Q4002  550 20D6034 512G1  Cooling valve condenser
16  Q2001  650 40D6040 5E13T1 1508  Shut off valve chamber
17  Q2002  650 15D6040 5211T1 1508  Condensate valve chamber
18  Q2003  550 15D6034 511G1  Drain valve vacuum line

Note: The door valves/releases will be implicitly tested by the opening and closing the system door. The door release and door close sequence can
damage the door seal if performed incorrectly. Therefore, only the programmed automated open/close buttons will be used to challenge the valves and
not manual forcing functions.

Testing was performed as part of the SAT and witnessed by Brammer (Thermo-Fisher) personnel. Therefore, this testing does not need to be repeated
and the original acceptable testing results are referenced.

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Autoclave Sterilization (Empty Chamber Mapping)

The Autoclave sterilization programs are made up of three main phases: pre-treatment, sterilization, and post-treatment. The only applicable program
used to process GMP materials will be performed under empty chamber conditions for the Wrapped Goods cycle. One successful run will be required for
each cycle per SOP-000601. The empty chamber mapping will be conducted with the autoclave rack/cart in place. 
 
Note that the Bowie Dick Test cycle has been programmed with an identical pre-conditioning phase as the Wrapped Goods cycle. This shall ensure that
any sterilized materials under the Wrapped Goods program can successfully remove air prior to the sterilization phase and therefore does not require
empty chamber mapping. Additionally, the Filter Inline Sterilization cycle will not be challenged in this test case. This program will not be used to sterilize
materials in the chamber and is strictly limited to sterilizing the air filter.

Pre-Treatment
The pre-treatment phase consists of a number of pressure variations following a certain pattern which removes air from the chamber and load items. As
steam enters it and comes in contact with cooler surface of chamber or load items and condenses resulting into condensation boundary. When the steam
valve is closed and the dram valve is opened during pre-treatment the pressure drops quickly. Due to pressure drops the air expands quickly and
moisture from the condensation boundary evaporates and pushes out air. Similarly a subsequent pre-vacuum pulse reduces the air from chamber and
produces the moisture required in the later phase of sterilization. Air removal when autoclaving aqueous solutions in open containers is made by a single
pre-vacuum or flowing steam in order to avoid that the liquid comes to boiling during the decompression periods in a pulsating procedure.

Sterilization
The sterilizing time starts (counting down) when the chamber temperature transducer signals a temperature equal to or higher than the chamber
temperature set point. Count down of the sterilizing time stops at temperatures below this threshold temperature.

Post-Treatment
The post-treatment is intended to normalize the temperature and moisture content of the goods. All types of goods except liquids therefore are exposed
to a deep vacuum for a certain period of time. The post-treatment of aqueous solutions sterilized in open or vented containers consists of a period of
natural cooling while pressure and temperature are lowered slowly until the temperature of the liquid is safely below its boiling point This process
increased by applying a slight vacuum to the chamber when its pressure approaches atmospheric.The sterilizer door will remain sealed by its gasket until
atmospheric pressure prevails in the chamber.

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Temperature Monitoring Devices (TMDs) will be placed throughout the chamber to verify heat distribution and elucidate cold spots. Heat
distribution studies determine whether the temperature is uniform throughout the empty chamber.  A pre-approved TMD Placement Map will show the
TMD locations in the chamber. The Temperature Mapping Run data will be reviewed by Engineering/CQV to ensure it meets temperature
requirements in all locations.

Per SOP-000601, the following criteria must met for the acceptable sterilization cycle:
- The base temperature criteria during exposure must be 121.1°C. Lethality calculations must be performed using the data.
-- All TMDs must remain over 121.1°C accumulating an F0 greater than or equal to 12 minutes (during exposure).

For validation exercise purposes an “overkill” approach will be used with a sterilization set point of 123.5ºC. A full cycle will be performed during the
empty chamber for each program.

A theoretical F0 calculation (lethality) will be included for information only for empty chamber sterilization testing (no microorganism (BIs) will be used
during this phase). F0 calculation formula will be as follows:

   

Since a theoretical calculation will be performed the following assumptions will be taken in consideration:

 Sterilization Temperature of 123.5ºC will be used (based on the overkill approach)

 Average Z value (Z = 10 deg C) for “Geobacillus Stearothermopilus” at 121ºC with a 12 log reduction (use as a reference point to perform the F0
calculation to determine our limit value)

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Therefore, the F0 theoretical criteria should be greater than or equal to 12 minutes. 

This OQ protocol testing (empty chamber temperature mapping) will be performed to confirm uniform distribution of the heat throughout the chamber. It
also confirms that all the TMDs installed per mapping diagram are achieving specified temperature setpoint for the duration of the exposure period. 
Biological indicators are only used in PQ protocols (with a defined load pattern) to prove the sterilization cycle parameters are effective to kill BI
organisms.

Access Rights Testing

Autoclave  AUT-10202 have 5 different default levels, listed in Table 7. One user account from each security level will be tested to verify that the proper
functions and restrictions are assigned to each user group based on their security level. The selected accounts will also be tested to ensure that the
default password is correct and that incorrect passwords do not grant access to the user account (refer to Table 8).

Note: A subset of access permissions is bracketed by default for each access level.

Table 7: Autoclave Access Levels/Rights

# Navigation Operator Supervisor Validator Access Maintenance Administrator
Access Rights Description Access Access Access  Access
1  Menu: Allowed   Allowed  Allowed  Allowed  Allowed
 Displaying the menu
2  Menu  Allowed  Allowed   Allowed   Allowed   Allowed 
Program parameters: Reading program parameters 
3  Menu - Program parameters:   Not Allowed  Not Allowed   Allowed   Allowed   Allowed 
 Creating/modifying program parameters, incl. process 
direction, monitoring sensors, program export/import 
4  Menu - Calibrate temperature / pressure sensors  Not Allowed  Allowed   Allowed   Allowed   Allowed 
 Reading temperature and pressure sensor’s calibration
5  Menu - Calibrate temperature / pressure sensors  Not Allowed  Not Allowed  Not Allowed Allowed   Allowed 
Calibrating temperature and pressure sensors
6  Menu - Align temperature / pressure sensors Not Allowed  Allowed   Allowed   Allowed   Allowed 

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Table 7: Autoclave Access Levels/Rights

# Navigation Operator Supervisor Validator Access Maintenance Administrator
Access Rights Description Access Access Access  Access
Reading temperature and pressure sensor’s
alignment 
7  Menu - Calibrate temperature / pressure sensors Not Allowed  Not Allowed   Allowed   Allowed   Allowed 
 Aligning temperature and pressure sensors
8  Menu - Settings - Machine configuration  Not Allowed  Allowed  Not Allowed  Allowed  Allowed
Reading machine configuration 
9  Menu - Settings - General settings Not Allowed  Allowed   Allowed   Allowed   Allowed 
 Reading machine parameters 
10 Menu - Settings - General settings  Not Allowed  Not Allowed   Allowed   Allowed   Allowed
Setting machine parameters
11  Menu - Settings - Process settings Not Allowed  Allowed   Allowed   Allowed   Allowed
 Reading the machine settings 
12  Menu - Settings - Process settings Not Allowed  Not Allowed   Allowed   Allowed   Allowed
 Setting the machine settings
13  Menu - Automatic mode / Time I Date Not Allowed  Allowed   Allowed   Allowed   Allowed
 Reading system settings
14  Menu - Automatic mode Not Allowed  Allowed  Not Allowed  Allowed  Allowed
Setting the system settings
15  Menu - Time I Date Not Allowed  Allowed  Not Allowed  Allowed  Allowed
Setting date, time and displaying format
16  Menu - Automatic mode Not Allowed  Allowed  Not Allowed  Allowed  Allowed
 Setting automatic mode and operation start/stop
17  Menu - Automatic mode Not Allowed  Allowed  Not Allowed  Allowed  Allowed
Setting automatic start program
18  Menu – User management Not Allowed  Allowed  Not Allowed  Not Allowed  Allowed
Administrating users
19  Menu – Group management Not Allowed  Allowed  Not Allowed  Not Allowed  Allowed
Administrating user group (and authorizations)
20  Menu - Maintenance / Door seal / Force actuators  Not Allowed  Not Allowed  Not Allowed Allowed  Allowed
Performing maintenance work and acknowledging
maintenance messages. Controlling door seal, actuators
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Table 7: Autoclave Access Levels/Rights

# Navigation Operator Supervisor Validator Access Maintenance Administrator
Access Rights Description Access Access Access  Access
and sensors
21  Process  Allowed   Allowed  Allowed  Allowed  Allowed
Change unloading side (before process start /
only if sterilizer has two doors)
22  Process - Control Allowed   Allowed  Allowed  Allowed  Allowed
Selecting a program, entering batch data, starting the batch
(also after an error)
23  Process - Control Not Allowed   Allowed  Allowed  Allowed  Allowed
Perform a manual step change
24  Lock a batch (at the end of a batch with alarms)  Allowed   Allowed  Allowed  Allowed  Allowed
25  Release a batch (at the end of a batch with Not Allowed   Allowed  Allowed  Allowed  Allowed
alarms)
26  Alarm history Allowed   Allowed  Allowed  Allowed  Allowed
Acknowledging all alarms
27  Shutdown GUI program (Show Windows Desktop) Not Allowed   Allowed  Not Allowed  Allowed  Allowed

Table 8: Autoclave User Accounts*

# Access Rights User Log On Name Default Password
Description
1  Maintenance mcqv  3142
2  Operator ocqv  3142
3  Supervisor scqv  3142
4  Validator vcqv  3142
5  admin acqv  3142
*The user accounts in Table 7 will be created in order to complete the Access Rights test case and then will be deleted following test completion.

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Steam Quality Test 

Steam Quality Testing for this unit has previously been completed by an outside vendor with a Brammer Bio representative present. The vendor's test
report will be attached to this test case to support that all acceptance criteria were met.

The steam entering the Material Prep Autoclave  AUT-10202 will be tested for steam quality in alignment with EN285 requirements; test acceptance
criteria is detailed in Table 9 below.

The steam dryness measures the fraction of steam relative to water that reaches the autoclave. Wet steam does not deliver as much energy to the load
dry steam and results in less sterilizing capabilities. 

The non-condensable gas test measures the amount of air relative to steam that reaches the autoclave. More air in the mixture will result in less energy
transferred and less sterilizing power. The percentage of non-condensable gases is required to be less than or equal to 3.5% by volume.

The superheat test measures the amount of moisture in the steam relative to the saturation limit of the steam at the working temperature at atmospheric
pressure. If the moisture content is the lower than the saturation limit, the energy in the steam is too high and can damage goods in the autoclave. The
amount of superheat present in the steam should be no more than 25 Kelvin at atmospheric pressure.

Table 9: Steam Quality Test Acceptance Criteria

Test Acceptance Criteria Additional Information
 Steam Dryness  >= 0.95 w/w The acceptance criterion for steam dryness (the fraction of steam relative to water – 1.0 = all steam, no water) is at
least 0.95, or 95% by weight, steam below this value is considered to be wet steam.
 Non-Condensable Gases  <= 3.5% v/v  Non-condensable gases are generally air and air is a poor sterilant compared to steam.
 Superheat  <= 25k When the moisture content is lower than saturation for the temperature, the condition is called superheat. In
superheat, the steam is too dry and its energy content is too high. When the steam condenses on the load, the
energy released is enough to melt plastic packaging and actually char paper packaging.

   

Leak Test 

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The purpose of this test is to determine the integrity of an autoclave chamber. The autoclave is equipped with a program for automatic leak test of the
autoclave chamber. This test exposes the autoclave to vacuum conditions and measures how much vacuum depth was lost over a given period of time. 
The program parameters are listed in Tables 2 - 5 above a leak test shall be performed with an empty chamber. The test run that will be performed for
sequence timer testing will be utilized to verify the leak test. The pressure rise shall be not greater than 1.3 mbar/min during the test.

Air Removal Test 

The purpose of this test is to detect any leaks and inadequate air removal. The Bowie Dick Test Pack (I50246/SPEC 7664) is used to perform this
testing. Sterilizer vacuum performance is acceptable if the sheet inside the test pack shows a uniform color change. Entrapped air will cause a spot to
appear on the test sheet due to the inability of the steam to reach the chemical indicator.

The test pack will be placed horizontally on the lowest shelf above the drain and a Bowie Dick cycle  will be initiated. The test pack will be placed
during the sequence/timer testing for the Bowie Dick Test cycle and results will be documented.

The pattern of the Bowie Dick indicator paper shows same saturation with color (Dark Purple) all over its surface after complete sterilization. The cycle
fails if the indicator paper color is light yellow.

Comments
# Comments Performed By Date
1  No comments Coane, John 11-Mar-2020 (UTC)
2      
3      
Note: If there are no comments in the "Comments" table above, type "No Comments" in the first line. The remaining empty rows will be considered
"N/A". Otherwise, "N/A" all unused rows.

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3 System Description 

AUT-10202 is a Belimed model 10-6-10 HS1 BST 6050/6060 series autoclave with the following features:

• Installed via recession through walls and inspection door mounted in extended fascia
• Single door
• Chamber Internal Dimensions:  1.149m H x 0.669m W x 1.050m L
• Chamber volume is approximately 807 L.
• 480V, 3 phase 60 Hz power supply
• Steam supply has a condensate return
• Stainless steel sanitary process piping and jacket piping
• Equipped with an Allen Bradley Versa View 5400 control panel / system
• Stainless steel electrical cabinet, rated NEMA 4XSS
• System is networked to a HP M553 series printer (S/N JPCCM9K47H) and can print batch reports following
completion of a run cycle.
• System is connected to PI historian with probes continuously monitoring system status.

The PLC control unit is fully programmed to provide sterilization using central steam supply. Programmed cycles
use pre-vacuum pulses, positive pulses, and gravity displacement for non-condensable gas removal. Saturated
clean steam is used to sterilize both wrapped and liquid components.

Comments
# Comment Performed By Date
1  No comments Coane, John 11-Feb-2020 (UTC)
2      
3      
Note: If there are no comments in the "Comments" table above, type "No Comments" in the first line. The
remaining empty rows will be considered "N/A". Otherwise, "N/A" all unused rows.

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4 References

The following documents are referenced and/or used for generation of the protocol. 
 

References
# Document Number Title Version #
1 SOP-000344 Kneat Protocol Execution 1.0
2 SOP-000345 Kneat Protocol Development 2.0
3 SOP-000452 Manufacturing Automation Systems Validation 1.0
4 SOP-000518 Manual Operation of Filter Integrity Testers 4.0
5 SOP-000600 Installation Qualification (IQ) Validation of Utilities and Equipment Systems 2.0
6 SOP-000601 Operational Qualification (OQ) Validation of Utilities and Equipment Systems 2.0
7 SOP-000603 Facility, Utility, and Equipment Validation Protocol Deviations 2.0
8 SOP-000608 Risk Assessment for Validation of Facilities, Utilities and Equipment Systems 4.0
9 SOP-000609 Validation Documentation Guidelines and Requirements for Facility, Utility, and Equipment Systems 1.0
10 SOP-000629 Good Documentation Practices (GDP) Procedure 5.0
11 SOP-000651 Electronic Record and Electronic Signature 1.0
12 SOP-000447 Cambridge Metrology Program 3.0
13 SOP-000457 Preventative Maintenance Program 2.0
14 SOP-000439 Facilities and Engineering Activities for New Systems or Modified Direct Impact Systems 3.0
15 SOP-001252 Operation and Maintenance of Belimed Autoclave (Key) 1.0
16 DC-000452 cGMP Autoclave 3.0
17 CC-19-296 Project Key:  New Autoclave (AUT-10202) N/A
18 MAN-000017 Project Key Validation Project Plan 1.0
19 EN285 Sterilization - Steam Sterilizers - Large Sterilizers 2015
Edition
20 ISO17665 International Standard: Sterilization of Health Products – Moist Heat First
Edition
 

Comments
# Comment Performed By Date
1  No comments Coane, John 11-Feb-2020 (UTC)
2      
3      
Note: If there are no comments in the "Comments" table above, type "No Comments" in the first line. The
remaining empty rows will be considered "N/A". Otherwise, "N/A" all unused rows.

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5 General Protocol Requirements

1. The qualification entries must be completed in compliance with SOP-000629, Good Documentation Practices (GDP) Procedure, and SOP-
000651, Electronic Record and Electronic Signatures. 
2. Perform all of the steps outlined in the test tables for each of the required Test Case subsections.
3. Record the information required by the step and attach any supporting documentation as requested. Refer to Attachments section for attaching
documentation.
4. Where requested, record "Pass" in the Pass/Fail column, if the Actual Results met the Expected Results. Otherwise, record "Fail" and generate a
protocol deviation per SOP-000344 and/or SOP-000603. Refer to Deviations section for generation of deviations.
5. Electronically sign for each step at the time the activity is performed.
6. The Test Case will be considered complete once all of the step rows have been signed and all deviations have been approved. 

Comments
# Comments Performed By Date
1  No comments Coane, John 11-Feb-2020 (UTC)
2      
3      
Note: If there are no comments in the "Comments" table above, type "No Comments" in the first line. The remaining empty rows will be considered
"N/A". Otherwise, "N/A" all unused rows.

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6 Protocol and SOP Training

The CQV Department will ensure that training is performed and documented prior to execution of the protocol. All other personnel must be trained on
applicable operational procedures and on this protocol prior to performing any execution activities.

A person is considered trained on the protocol if they authored or pre-approved the protocol. All other personnel performing testing are required to sign
the training log in Table 1 below. The trainee's electronic signature below signifies that the trainee:

1. Is trained on SOP-000344: Kneat Protocol Execution.

2. Has read the protocol and understands the testing purpose(s), objective(s), and requirements.

All trainee signatures must be accompanied by a trainer signature. Any personnel that have been trained or are considered trained on this protocol are
able to train additional personnel.

Table 1: Protocol Training Log

# Trainee Signature Trainer Signature
1 Coane, John Amy.Kent (05-Mar-2020 (UTC))
2    
3    
4    
5    
6    
Note: This table is designed to contain electronic signatures only. Unused rows are considered to be "N/A".

All personnel performing execution activities must be trained on all relevant and applicable SOPs. Prior to executing any testing that is governed by an
SOP, personnel must record the SOP title, the SOP effective date, and the training date in Table 2 below. If draft versions of SOPs will be used to
execute this protocol, a formal training date may not be applicable. Attach the draft version of the SOP(s) in Section 15.

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Table 2: SOP Training Log

# Personnel Name SOP(s) Trained On Effective Date(s) Training Date(s) Trained on Most Performed By Date
Effective Version?
(Yes / No / N/A)
1 John Coane SOP-001252 14 Feb 2020 10 Mar 2020 Yes Coane, John 11-Mar-2020 (UTC)
2  N/A  N/A  N/A  N/A N/A Coane, John 11-Mar-2020 (UTC)
3  N/A  N/A  N/A  N/A N/A Coane, John 11-Mar-2020 (UTC)
4  N/A  N/A  N/A  N/A N/A Coane, John 11-Mar-2020 (UTC)
5  N/A  N/A  N/A  N/A N/A Coane, John 11-Mar-2020 (UTC)
6  N/A  N/A  N/A  N/A N/A Coane, John 11-Mar-2020 (UTC)
7  N/A  N/A  N/A  N/A N/A Coane, John 11-Mar-2020 (UTC)
8  N/A  N/A  N/A  N/A N/A Coane, John 11-Mar-2020 (UTC)

Comments
# Comments Performed By Date
1 See Deviation  IOQ-IOQ-AUT-10202-CAM-03-DEV-03 in Section 15 "Protocol Deviations" for details. Coane, John 11-Mar-2020 (UTC)
2  N/A Coane, John 11-Mar-2020 (UTC)
3  N/A Coane, John 11-Mar-2020 (UTC)
Note: If there are no comments in the "Comments" table above, type "No Comments" in the first line. The remaining empty rows will be considered
"N/A". Otherwise, "N/A" all unused rows.

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7 IQ Prerequisites

Verify each prerequisite condition has been met prior to executing the IQ validation tests contained in this
protocol. If a prerequisite has not been satisfied, provide a documented rationale including the impact, if any, to
testing. The information documented below has been assessed and the signature for each prerequisite indicates
requirement completion and the permission to proceed to execution. 

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7.1 Drawing Prerequisite

P&IDs used during the execution of this protocol are identified below and must be, at a minimum, in draft version prior to the execution of the test case(s)
that use the P&ID as a reference.
 
 

Table 1: Drawing Prerequisites Verification

# Drawing # Drawing Title Version Performed By Date
1 250-D3-10202 P&ID:  Bio-2, Key Area Autoclave (AUT-10202)  A Coane, John 11-Feb-2020 (UTC)
 

Table 2: Additional Drawing Prerequisites Verification

# Drawing # Drawing Title Version Performed By Date
1  N/A  N/A  N/A Coane, John 11-Feb-2020 (UTC)
2   N/A   N/A   N/A Coane, John 11-Feb-2020 (UTC)
3   N/A   N/A   N/A Coane, John 11-Feb-2020 (UTC)
 Note: If there are items identified during the execution of this test that are necessary for verification but are not included in Table 1, record those items
and capture the results of the verification in  Table 2. "N/A" all unused rows in  Table 2.

Comments
# Comments: Performed By Date
1 No comments Coane, John 05-Mar-2020
(UTC)
2      
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Comments
# Comments: Performed By Date
3      
Note: If there are no comments in the "Additional Comments" table above, type "No Comments" in the first line. The remaining empty rows will be
considered "N/A". Otherwise, "N/A" all unused rows. 

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8 IQ Test Case List

Test Case List

Test Case Number Test Case Name
IOQ - AUT-10202-CAM-03-01 System Walkdown Verification
IOQ - AUT-10202-CAM-03-02 Supporting Utility Verification
IOQ - AUT-10202-CAM-03-03 System Drawing Verification
IOQ - AUT-10202-CAM-03-04 System Component Verification
IOQ - AUT-10202-CAM-03-05 Materials of Construction Verification
IOQ - AUT-10202-CAM-03-06 System Calibration Verification.
IOQ - AUT-10202-CAM-03-07 Technical Supporting Documentation Verification
IOQ - AUT-10202-CAM-03-08 Maintenance System Registration Verification
IOQ - AUT-10202-CAM-03-09 Embedded Software Verification
 

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9 IQ Test Cases

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9.1 System Walkdown Verification (IOQ - AUT-10202-CAM-03-01)

1. Objective

Verify and confirm that the system has been properly installed and ready for use.

2. Scope

The scope of this test is to verify that system applicable requirements are met and will ensure that the system
has been properly installed and operates/performs properly. 

3. Acceptance Criteria

• All GURs and SURs from the associated system UR have been verified.

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9.1.1 Field Execution - System Walkdown Verification (IOQ - AUT-10202-CAM-03-01)

Procedure:

1. Perform a walkdown/visual inspection verification for each GUR/SUR item listed under the current autoclave user requirements document (DC-
000452 version 3) in Table 1.
2. Verify that each item is found to be acceptable.
3. Attach a copy of any supporting document, if necessary/applicable. 

Table 1: Verification Checklist

# UR # Item Verification Requirement Comments Attachment Performed By Date
Found
Acceptable?
1 3.1.3 Autoclaves must be capable of being isolated from Yes System door is pressure N/A Coane, John 11-Feb-2020
potentially contaminating environments when not in use. sealed, preventing potential (UTC)
contaminating environments
when system is not in use.
Verified during Site
Acceptance Testing (SAT) in
Section 9.7.1 of this protocol.
Refer to Section IQ-03.01 of
the SAT.
2 3.1.4 Welds shall be ground flush and smooth with no rough Yes  Visual verification N/A Coane, John 11-Feb-2020
edges, cracks, and discoloration. (UTC)
3 3.1.5 Autoclave can be single-door front loading or double door Yes System is single-door front N/A Coane, John 11-Feb-2020
pass-through. loading unit. (UTC)
4 3.1.6 Exposed surfaces shall be constructed of 304 or higher Yes  Verified during Site N/A Coane, John 11-Feb-2020
grade stainless steel. Acceptance Testing (SAT) in (UTC)
Section 9.7.1 of this protocol.
Refer to Section IQ-02.02 of
the SAT.
5 3.1.7 Autoclave chamber and piping shall be sloped to facilitate Yes  Verified during Site N/A Coane, John 11-Feb-2020
draining. Acceptance Testing (SAT) in (UTC)
Section 9.7.1 of this protocol.
Refer to Section IQ-02.02 of

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Table 1: Verification Checklist

# UR # Item Verification Requirement Comments Attachment Performed By Date
Found
Acceptable?
the SAT.
6 3.1.8 Chamber drains shall be fitted with screens to trap debris. Yes  Visual verification. Verified N/A Coane, John 11-Feb-2020
during Site Acceptance (UTC)
Testing (SAT) in Section 9.7.1
of this protocol. Refer to
Section IQ-03.01 of the SAT.
7 3.1.9 Autoclave chamber and jacket shall be pressure rated to full Yes  Verified during Site N/A Coane, John 11-Feb-2020
vacuum. Acceptance Testing (SAT) in (UTC)
Section 9.7.1 of this protocol.
Refer to Section IQ-02.02 of
the SAT.
8 3.1.10 If required, autoclave shall have an integral clean steam N/A Not applicable to this system. N/A Coane, John 11-Feb-2020
generator. (UTC)
9 3.1.12 Autoclave shall have a validation test port. Yes  Visual verification.  Verified N/A Coane, John 11-Feb-2020
during Site Acceptance (UTC)
Testing (SAT) in Section 9.7.1
of this protocol. Refer to
Section IQ-03.02 of the SAT.
10 3.1.13 Autoclave shall have an accessible port for clean steam Yes  Visual verification.  Verified N/A Coane, John 11-Feb-2020
quality testing. during Site Acceptance (UTC)
Testing (SAT) in Section 9.7.1
of this protocol. Refer to
Section IQ-03.03 of the SAT.
11 3.1.14 Autoclave shall be equipped with carts, racks, baskets to Yes  Visual verification.  Verified N/A Coane, John 11-Feb-2020
accommodate all the desired loads. during Site Acceptance (UTC)
Testing (SAT) in Section 9.7.1
of this protocol. Refer to
Section IQ-03.04 of the SAT.
12 3.1.16 If required, autoclave shall include a bio-seal to isolate from Yes Autoclave has bio-seal. Installation_&_Prepar Coane, John 11-Feb-2020
the surrounding environment. Vendor installation & ation_Drawing.pdf (UTC)
preparation drawing attached.
This document is included in
the system ETOP in Section
9.7.

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Table 1: Verification Checklist

# UR # Item Verification Requirement Comments Attachment Performed By Date
Found
Acceptable?
13 3.1.20 Autoclave shall include remote monitoring, trending and Yes  Visual verification.  Verified N/A Coane, John 11-Feb-2020
historian capabilities. during Site Acceptance (UTC)
Testing (SAT) in Section 9.7.1
of this protocol. Refer to
Section IQ-02.02 of the SAT.
14  3.1.21 All control cabinets shall be built to meet NEMA 4X or IP-65 Yes Control cabinets verified to be N/A Coane, John 11-Feb-2020
standards and UL listed.  NEMA 4X and UL listed. (UTC)
15  3.1.22 Control and electrical panels shall be suitable for area Yes Visual verification N/A Coane, John 11-Feb-2020
electrical classification.  (UTC)
16 3.1.23 High voltage electrical feeds (208 - 480V) should be Yes   Verified during Site N/A Coane, John 11-Feb-2020
separated from lower voltages (120V) which will be powered Acceptance Testing (SAT) in (UTC)
by site UPS system. Section 9.7.1 of this protocol.
Refer to Section IQ-02.02 of
the SAT.
17 3.1.24 Autoclave shall be equipped with a load probe for use during Yes  Visual verification.  Verified N/A Coane, John 11-Feb-2020
liquid cycles. Use of load probe during liquid processing shall during Site Acceptance (UTC)
be assessed upon load qualification. Probe shall not impede Testing (SAT) in Section 9.7.1
autoclave operation when not in use. of this protocol. Refer to
Section IQ-02.02 of the SAT.
18 3.2.1 Autoclave shall have, at a minimum, automatic cycles for Yes  Cycles are user configurable. N/A Coane, John 11-Feb-2020
sterilization, leak test, and air filter sterilization. Cycles shall Automatic cycles for (UTC)
be user-configurable. sterilization, leak test, and air
filter sterilization were
configured and verified during
commissioning (CTP-AUT-
10202-CAM-01).
19 3.2.7 System shall be capable of achieving the user-defined cool Yes  Verified during cycle N/A Coane, John 11-Feb-2020
down temperature at the end of the cycle. development (CTP-AUT- (UTC)
10202-CAM-02).
20 3.2.8 System shall monitor temperature at the jacket, chamber, Yes  Visual verification on the HMI. N/A Coane, John 11-Feb-2020
and air filter. (UTC)
21 3.2.9 System is capable of a leak rate less than or equal to Yes   Verified during N/A Coane, John 11-Feb-2020
manufacturer's recommended leak rate. commissioning (CTP-AUT- (UTC)

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Table 1: Verification Checklist

# UR # Item Verification Requirement Comments Attachment Performed By Date
Found
Acceptable?
10202-CAM-01).
22 3.2.10 System shall monitor pressure at the chamber, jacket, clean Yes  Verified during Site N/A Coane, John 11-Feb-2020
steam supply, glycol, process condenser water supply, and Acceptance Testing (SAT) in (UTC)
clean compressed air supply. Section 9.7.1 of this protocol.
Refer to Sections IQ-02.02
and OQ-07 of the SAT.
23 3.2.11 Autoclave shall achieve the desired dryness of the sterilized Yes  Verified during cycle N/A Coane, John 11-Feb-2020
goods at the end of the cycle. development (CTP-AUT- (UTC)
10202-CAM-02).
24 3.2.16 Max temperature during pre-conditioning (all TMDs) ≤ 135ºC Yes  Verified during cycle N/A Coane, John 11-Feb-2020
development (CTP-AUT- (UTC)
10202-CAM-02).
25 3.4.1 The control system shall perform multiphase cycles from Yes Verified during commissioning N/A Coane, John 11-Feb-2020
start to finish with no operator interaction required after the (CTP-AUT-10202-CAM-01). (UTC)
cycle is properly initiated.
26 3.4.2 All process parameters shall be user configurable. Yes   Cycles are user configurable. N/A Coane, John 11-Feb-2020
Automatic cycles for (UTC)
sterilization, leak test, and air
filter sterilization were
configured and verified during
commissioning (CTP-AUT-
10202-CAM-01).
27 3.4.5 The control system shall not initiate the cycle until the doors Yes  Verified during Site N/A Coane, John 11-Feb-2020
are closed and locked. Acceptance Testing (SAT) in (UTC)
Section 9.7.1 of this protocol.
Refer to Section IQ-06.07 of
the SAT.
28 3.4.6 The control system shall interlock door(s) when the cycle is Yes  Verified during Site N/A Coane, John 11-Feb-2020
in progress. Acceptance Testing (SAT) in (UTC)
Section 9.7.1 of this protocol.
Refer to Section IQ-06.07 of
the SAT.
29 3.4.7 Door(s) is allowed to open only when the cool-down Yes  Verified during Site N/A Coane, John 11-Feb-2020

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Table 1: Verification Checklist

# UR # Item Verification Requirement Comments Attachment Performed By Date
Found
Acceptable?
temperature and/or pressure are achieved. Acceptance Testing (SAT) in (UTC)
Section 9.7.1 of this protocol.
Refer to Section IQ-06.07 of
the SAT.
30 3.4.8 System OIT shall provide user-friendly graphic screens with Yes  Verified during Site N/A Coane, John 11-Feb-2020
full functionalities for setup, calibration, operation, alarms, Acceptance Testing (SAT) in (UTC)
and process trending. Section 9.7.1 of this protocol.
Refer to Section IQ-02.02 of
the SAT.
31 3.4.9 If autoclave is a pass-through, OIT shall be installed on both N/A  System is not a pass-through. N/A Coane, John 11-Feb-2020
loading and unloading sides. (UTC)
32 3.4.10 System shall have integrated communication access for data Yes  Verified during Site N/A Coane, John 11-Feb-2020
collection and alarm statuses. Acceptance Testing (SAT) in (UTC)
Section 9.7.1 of this protocol.
Refer to Section IQ-02.02 of
the SAT.
33 3.4.11 System control software shall be compliant with 21CFR Part Yes Verified during Site N/A Coane, John 11-Feb-2020
11. Acceptance Testing (SAT) in (UTC)
Section 9.7.1 of this protocol.
Refer to Section IQ-02.02 of
the SAT.
34 3.4.12 The control system shall include multi-level security control Yes  Verified during Site N/A Coane, John 11-Feb-2020
access. Acceptance Testing (SAT) in (UTC)
Section 9.7.1 of this protocol.
Refer to Section IQ-02.02 of
the SAT.
35  3.5.1 Exposed exterior surfaces within the cGMP production suites Yes Exposed surfaces verified to Steris VHP Guide.pdf Coane, John 11-Feb-2020
shall be resistant to cleaning and sanitizing chemicals such be minimum 300 series (UTC)
as mild detergents, Spor-Klenz, and vaporized hydrogen stainless or greater. Refer to
peroxide (VHP).  ETOP in section 9.7.1. VHP
compatibility provided in
attachment.
36 3.6.1 Autoclave shall be installed with sufficient clearance for Yes  Visual verification. Verified N/A Coane, John 11-Feb-2020
maintenance and accessible to utilities. during Site Acceptance (UTC)

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Table 1: Verification Checklist

# UR # Item Verification Requirement Comments Attachment Performed By Date
Found
Acceptable?
Testing (SAT) in Section 9.7.1
of this protocol. Refer to
Section IQ-02.02 of the SAT.
37 3.6.2 Maintenance and utility access for the autoclave shall be Yes  Visual verification. Verified N/A Coane, John 11-Feb-2020
from a mechanical chase. during Site Acceptance (UTC)
Testing (SAT) in Section 9.7.1
of this protocol. Refer to
Section IQ-02.02 of the SAT.
38 3.6.3 Autoclave shall be floor mounted. Yes  Visual verification N/A Coane, John 11-Feb-2020
(UTC)
39 3.7.1 All components shall be capable of being removed from the Yes  Visual verification N/A Coane, John 11-Feb-2020
system for maintenance, calibration, and visual inspection. (UTC)
40 3.7.2 All instruments, valves, etc. shall be easily accessible to Yes  Visual verification N/A Coane, John 11-Feb-2020
allow safe operation and maintenance. (UTC)
41 3.7.3 A recommended spare parts list shall be provided. Yes  Verified during Site N/A Coane, John 11-Feb-2020
Acceptance Testing (SAT) in (UTC)
Section 9.7.1 of this protocol.
Refer to Section IQ-03.01 of
the SAT.
42 3.8.1 All moving parts shall have safety guards. Yes  Verified during Site N/A Coane, John 11-Feb-2020
Acceptance Testing (SAT) in (UTC)
Section 9.7.1 of this protocol.
Refer to Section IQ-02.02 of
the SAT.
43 3.8.2 All energizing utilities to the system shall have means of Yes  Visual verification N/A Coane, John 11-Feb-2020
Lock Out / Tag Out (LOTO). (UTC)
44 3.8.3 Autoclave and associated chilled water piping shall have Yes  Verified during Site N/A Coane, John 11-Feb-2020
pressure relief for thermal expansion. Acceptance Testing (SAT) in (UTC)
Section 9.7.1 of this protocol.
Refer to Section IQ-02.02 of
the SAT.
45 3.8.4 Chamber and jacket vents and relief shall be routed to safe Yes  Visual verification. Verified N/A Coane, John 11-Feb-2020
locations. during Site Acceptance (UTC)
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Table 1: Verification Checklist

# UR # Item Verification Requirement Comments Attachment Performed By Date
Found
Acceptable?
Testing (SAT) in Section 9.7.1
of this protocol. Refer to
Section IQ-02.02 of the SAT.
46  3.8.5 Power failure shall place the autoclave in the fail-safe de- Yes  Visual verification N/A Coane, John 11-Feb-2020
energized state.  (UTC)
47  3.8.6 Potential hot surfaces shall be insulated with warning labels Yes  Visual verification N/A Coane, John 11-Feb-2020
to prevent any burn hazards. (UTC)
48  3.8.7 Noise level shall be <85dBa under normal operating Yes Noise level recorded during N/A Coane, John 11-Feb-2020
conditions. (Operations side and Mechanical side measured vacuum leak test. Measured (UTC)
separately)   using sound level meter 97-
DM-001. Levels on
loading/unloading side of
system:  55 dBa; Levels on
mechanical side of system: 82
dBa
49 3.8.8 Autoclave shall have an emergency stop (Estop) button to Yes  Verified during Site N/A Coane, John 11-Feb-2020
de-energize energy sources and moving parts. Acceptance Testing (SAT) in (UTC)
Section 9.7.1 of this protocol.
Refer to Section IQ-02.02 of
the SAT.
50 3.8.9 If the autoclave is a pass-through, Estop button shall be N/A  N/A. System is a single door N/A Coane, John 11-Feb-2020
installed on both loading and unloading sides. unit. (UTC)
51 3.8.10 Door should not open if pressure in chamber is ≥ 200 mbar. Yes   Verified during Site N/A Coane, John 11-Feb-2020
Acceptance Testing (SAT) in (UTC)
Section 9.7.1 of this protocol.
Refer to Section IQ-06.07 of
the SAT.
52 3.9.1 Autoclave shall have visual and audible alarms. Yes Verified during Site N/A Coane, John 11-Feb-2020
Acceptance Testing (SAT) in (UTC)
Section 9.7.1 of this protocol.
Refer to Section OQ-04.01 of
the SAT.
53 3.9.2 The control system shall have customizable alarms for Yes  Verified during cycle N/A Coane, John 11-Feb-2020

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Table 1: Verification Checklist

# UR # Item Verification Requirement Comments Attachment Performed By Date
Found
Acceptable?
process monitoring. development (CTP-AUT- (UTC)
10202-CAM-02).
54 3.9.3 Autoclave shall alarm if the cycle fails. Yes Verified during Site N/A Coane, John 11-Feb-2020
Acceptance Testing (SAT) in (UTC)
Section 9.7.1 of this protocol.
Refer to Section OQ-04.01 of
the SAT.
55 3.9.4 Alarms shall be acknowledged and cleared from the OIT. Yes Verified during Site N/A Coane, John 11-Feb-2020
Acceptance Testing (SAT) in (UTC)
Section 9.7.1 of this protocol.
Refer to Section OQ-04.01 of
the SAT.
56  3.9.6  The control system shall log all of the alarm conditions. Yes Visual verification. All alarm N/A Coane, John 11-Feb-2020
conditions are tracked in (UTC)
system audit trail.
57  3.10.2 The control system shall have user definable PID controller Yes   Verified during cycle N/A Coane, John 11-Feb-2020
settings for loops tuning. development (refer to (UTC)
Attachment 8 in CTP-AUT-
10202-CAM-01).

Comments
# Comments: Performed By Date
1 No comments Coane, John 02-Mar-2020
(UTC)
2      
3      
Note: If there are no comments in the "Additional  Comments" table above, type "No Comments" in the first line. The remaining empty rows will be
considered "N/A". Otherwise, "N/A" all unused rows.

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9.2 Supporting Utility Verification (IOQ - AUT-10202-CAM-03-02)

1. Objective

Verify that all supporting utilities are supplied to the system in accordance with manufacturer specifications.

2. Scope

The scope of this test is to verify that system applicable requirements are met and will ensure that the system
has been properly installed and operates/performs properly. 

3. Acceptance Criteria

• All supporting utilities are connected and meet required specifications.

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9.2.1 Field Execution - Supporting Utility Verification (IOQ - AUT-10202-CAM-03-02)

Procedure:

1. Identify all supporting utilities for System # AUT-10202.

2. Identify all manufacturer and design specification requirements (voltage, pressure, temperature, etc.) for each supporting utility.
3. Ensure each supporting utility meets the defined requirements. Attach or reference any required documentation. 

Table 1: Verification Checklist

# Supporting Utility Utility Requirements Actual Utility Result(s) Supporting Utility Meets Attachment Performed By Date
Requirements?
(Yes / No / N/A)
1  3-Phase Power  3 Leg (3 phase) 480V +/- 10% at 60Hz  3 Leg (3 phase) 480V +/- 10% at Yes Multimeter and Clamp Meter Cal Coane, John 02-Mar-2020 (UTC)
60Hz. Verified using calibrated Certificates.pdf
multimeter 44980065. Frequency
verified using clamp meter
41130725WS. Calibration certificates
attached for reference.
2  Single Phase Power  2 Leg (single phase) 120V +/- 10% at 60Hz 2 Leg (single phase) 120V +/- 10% at Yes N/A Coane, John 31-Jan-2020 (UTC)
60Hz. Multimeter and clamp meter
used is same as referenced in line 1
above. Refer to line 1 attachment for
calibration certificate.
3 Clean Steam Supply Pressure  NLT 30 psig (static) 37 psig from 64-PG-012. Yes N/A Coane, John 31-Jan-2020 (UTC)
4 Compressed Air Supply  5.0-7.0 barg (75-100psig) 92 psig from PI-10202-002. Yes N/A Coane, John 31-Jan-2020 (UTC)
5 Glycol Supply  2.0-5.0 barg (40-75 psig) 68 psig from PG-10202-008. Yes N/A Coane, John 31-Jan-2020 (UTC)
6 Cold Water  2.0-5.0 barg (40-75 psig) 50 psig from PG-10202-007. Yes N/A Coane, John 31-Jan-2020 (UTC)

Comments
# Comments: Performed By Date
1 No comments Coane, John 05-Mar-2020 (UTC)

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Comments
# Comments: Performed By Date
2      
3      
Note: If there are no comments in the "Additional Comments" table above, type "No Comments" in the first line. The remaining empty rows will be considered "N/A". Otherwise, "N/A" all unused rows. 

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9.3 System Drawing Verification (IOQ - AUT-10202-CAM-03-03)

1. Test Objective

Ensure that each system drawing exists and have been verified to accurately reflect the system installed.

2. Scope

All components and piping within the system’s boundary for System # AUT-10202 on all the applicable drawings will be verified in this test case.  
Verification will consist at a minimum:

• P&IDs are field verified

• Slope Verification, where applicable, as noted on drawings
• System has been verified to be free of dead legs

3. Acceptance Criteria

• System P&IDs have been verified against the installed system and any redlines have been submitted for revision. 

9.3.1 Field Execution - System Drawing Verification (IOQ - AUT-10202-CAM-03-03)

Procedure:

1. Obtain a copy of the current version of the applicable system drawing(s) and perform a visual verification (drawing walk-down).
2. Record the Revision # in the table.
3. Verify that the “as-built” drawing represents the system installed.
4. Highlight accurate system drawing confirmations during walk-down with yellow highlighter. If the drawing does not accurately represent the
installed equipment/system, overlay corrections with redlines on the as-built drawing. 
5. If the drawing walk-down verifies the accuracy of the as-built drawing, comment "Walk-Down Complete without corrections", initial and date.
6. Attach a copy of the drawing verified. 

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7. If a drawing did not accurately represent the installed equipment/system, reference the SAP order that contains the drawing redline and drives
the drawing revision.

Table 1: System Drawings Verification

# Drawing Number Drawing Title Revision # Drawing System Free of Drawing SAP Order Number Performed By Date
Accurate? Dead Legs? Attachment (if applicable)
(Yes / No / N/A) (Yes / No / N/A)
1 250-D3-10202 P&ID:  Bio-2, Key Area Autoclave  1.0 Yes Yes 250-D2- 4030371 Coane, John 05-Mar-2020
(AUT-10202) 10202.pdf (UTC)

Table 2: Additional System Drawings Verification

# Drawing Number Drawing Title Revision # Drawing System Free of Drawing SAP Order Number Performed By Date
Accurate? Dead Legs? Attachment (if applicable)
(Yes / No / N/A) (Yes / No / N/A)
1  N/A  N/A  N/A N/A N/A N/A  N/A Coane, John 11-Feb-2020
(UTC)
2  N/A  N/A  N/A N/A N/A N/A  N/A Coane, John 11-Feb-2020
(UTC)
3  N/A  N/A  N/A N/A N/A N/A  N/A Coane, John 11-Feb-2020
(UTC)
Note: If there are pieces of equipment identified during the execution of this test that are necessary for verification but are not included in Table 1, record
those pieces of equipment and capture the results of the verification in Table 2. "N/A" all unused rows in Table 2.

Comments
# Comments: Performed By Date
1 Protocol generation error. Drawing Number column in Table 1 was incorrectly documented during protocol draft. Drawing Number should be '250- Coane, John 11-Feb-2020
D2-10202' instead of '250-D3-10202'. (UTC)
2 See Deviation #4 in section 15 "Protocol Deviations" for details. Coane, John 11-Mar-2020
(UTC)
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Comments
# Comments: Performed By Date
3  N/A Coane, John 06-Mar-2020
(UTC)
Note: If there are no comments in the "Comments" table above, type "No Comments" in the first line. The remaining empty rows will be considered
"N/A". Otherwise, "N/A" all unused rows.

9.4 System Component Verification (IOQ - AUT-10202-CAM-03-04)

1. Test Objective

Confirm that all equipment, instruments, and/or components within the system boundary are installed and meet engineering and manufacturer
specifications.

2. Scope

All equipment components identified as having direct impact on product quality within the System # AUT-10202 boundary will be verified in this test case.

3. Acceptance Criteria

• All equipment, instruments, and/or components have been physically verified to be installed correctly.

• All equipment, instruments, and/or components meet the required engineering and manufacturer acceptance criteria.

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9.4.1 Field Execution - System Component Verification (IOQ - AUT-10202-CAM-03-04)

Procedure:

1. In Table 1, record the make, model number, and serial number (if available) of each piece of equipment and component identified in the table.
2. "N/A" cells if verification is not applicable to the listed component.

Table 1: System Component Verification

# Instrument Technical Instrument Description Manufacturer / Model# (if applicable) As-Found Serial Number  Manufacturer / Model# Met? Performed by Date
ID (if applicable) (Yes / No / N/A)
1 AUT-10202 Autoclave BeliMed / 10-6-10 HS1 BST 6050/6060 2007811 Yes Coane, John 31-Jan-2020 (UTC)
2 PG-10202-001 Pressure Gauge  Wika / PGT21.050  CH055173 Yes Coane, John 31-Jan-2020 (UTC)
3 PG-10202-002 Pressure Gauge  Wika / 232.50.063 N/A Yes Coane, John 31-Jan-2020 (UTC)
4 PG-10202-003 Pressure Gauge  Wika / 232.50.063 N/A Yes Coane, John 31-Jan-2020 (UTC)
5 PG-10202-006  Pressure Gauge  SMC /K8-10-40 N/A Yes Coane, John 31-Jan-2020 (UTC)
6 PG-10202-007  Pressure Gauge  Wika / 213.53.100 N/A Yes Coane, John 31-Jan-2020 (UTC)
7 PG-10202-008  Pressure Gauge  Wika / 213.53.100 N/A Yes Coane, John 31-Jan-2020 (UTC)
8 PI-10202-001  Pressure Indicator  Ashcroft / 351009SW04LXNH100# N/A Yes Coane, John 31-Jan-2020 (UTC)
9 PI-10202-002  Pressure Indicator  Ashcroft / 351009SW04LXNH160# N/A Yes Coane, John 31-Jan-2020 (UTC)
10 PI-10202-003  Pressure Indicator  Ashcroft / 351009SW04LXNH100# N/A Yes Coane, John 31-Jan-2020 (UTC)
11 PI-10202-006  Pressure Indicator  Ashcroft / 351009SW04LXNH100# N/A Yes Coane, John 31-Jan-2020 (UTC)
12 PIT-10202-001  Pressure Transmitter  SMC / ISE40A-01-Y-X531 N/A Yes Coane, John 31-Jan-2020 (UTC)
13  PR-10202-001  Pressure Regulator  SMC / AR40-F03BE N/A Yes Coane, John 31-Jan-2020 (UTC)
14  PT-10202-001  Pressure Transmitter  Baumer / PBMH25B19AA1448F02000C01 2.19.102252844.3 Yes Coane, John 31-Jan-2020 (UTC)
15  PT-10202-002  Pressure Transmitter  Baumer / PBMH25B19AA1448F02000C01 N/A Yes Coane, John 31-Jan-2020 (UTC)
16  PT-10202-003  Pressure Transmitter  Wika / PGT21.050 N/A Yes Coane, John 31-Jan-2020 (UTC)
17  PT-10202-004  Pressure Transmitter  Baumer / PBMH25B19AA1448F02000C01 N/A Yes Coane, John 31-Jan-2020 (UTC)

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Table 1: System Component Verification

# Instrument Technical Instrument Description Manufacturer / Model# (if applicable) As-Found Serial Number  Manufacturer / Model# Met? Performed by Date
ID (if applicable) (Yes / No / N/A)
18 TE-10202-002  Temperature Element   Sawi / SW100-5-80-2PH4-K-V-TED-ST N/A Yes Coane, John 31-Jan-2020 (UTC)
19 TE-10202-005  Temperature Element  Sawi / SW100-5-55-2PH4-K-V2-TED-ST N/A Yes Coane, John 31-Jan-2020 (UTC)
20 TE-10202-008  Temperature Element  Sawi / SW100-5-55-2PH4-K-V2-TED-ST N/A Yes Coane, John 31-Jan-2020 (UTC)
21 TE-10202-010   Temperature Element  Sawi / SW138-6-75-IPH4-P-V4-BST-160 N/A Yes Coane, John 31-Jan-2020 (UTC)
22 TE-10202-011   Temperature Element  Sawi / SW138-6-75-IPH4-P-V4-BST-160 N/A Yes Coane, John 31-Jan-2020 (UTC)
23 TE-10202-012   Temperature Element  Sawi / SW38-8-75-IPH4-P-V4-BST-160 N/A Yes Coane, John 31-Jan-2020 (UTC)
24 TI-10202-004  Temperature Indicator  Ashcroft / 30-EI-60E-040-50/50C-XNHSG N/A Yes Coane, John 31-Jan-2020 (UTC)
25 TI-10202-007  Temperature Indicator  Ashcroft / 30-EI-60E-040-50/50C-XNHSG N/A Yes Coane, John 31-Jan-2020 (UTC)
26 TIT-10202-001  Temperature Transmitter  Sawi / SW161-5-130-2PH4-K-V-TED-ST N/A Yes Coane, John 31-Jan-2020 (UTC)
27  TIT-10202-003  Temperature Transmitter  Sawi / SW161-5-130-2PH4-K-V-TED-ST N/A Yes Coane, John 31-Jan-2020 (UTC)
28  TIT-10202-004  Temperature Transmitter  Sawi / SW161-5-130-2PH4-K-V4-TED-ST N/A Yes Coane, John 31-Jan-2020 (UTC)
29 F0301 Safety Valve Spence / 0041EDA-40  N/A Yes Coane, John 31-Jan-2020 (UTC)
30 F1001 Safety Valve  LESER / 4834/DN40/DO/DO I73I17/I74A17  N/A Yes Coane, John 31-Jan-2020 (UTC)
31 Q1001 Slanted seat valve PID  GEMÜ / 555 20D82C2 5P12G1 RS804 1903 F 99088683-117105674 Yes Coane, John 31-Jan-2020 (UTC)
regulated
32 Q1001 Slanted seat valve PID  GEMÜ / 1434 000Z1A142A001030  99088683-117105674 Yes Coane, John 31-Jan-2020 (UTC)
regulated
33 R1501 Nonreturn valve  SMC / AKM2000-F02-A  N/A Yes Coane, John 31-Jan-2020 (UTC)
34 Q1601 Pneumatic valve 2p  GEMÜ / 550 40D6034 514G1  88246792-10940678 Yes Coane, John 31-Jan-2020 (UTC)
regulated
35 Q1602 Pneumatic valve 2p  GEMÜ / 550 10D6034 511G1  88301838-11140045 Yes Coane, John 31-Jan-2020 (UTC)
regulated
36 Q2001 Pneumatic valve 2p  GEMÜ / 650 40D6040 5E13T1 1508 88320122-10675351 Yes Coane, John 31-Jan-2020 (UTC)
regulated
37 Q2002 Pneumatic valve 2p  GEMÜ / 650 15D6040 5211T1 1508  88227428-11689098 Yes Coane, John 31-Jan-2020 (UTC)
regulated
38  Q2003 Pneumatic valve 2p  GEMÜ / 550 15D6034 511G1 88245715-11625808 Yes Coane, John 31-Jan-2020 (UTC)

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Table 1: System Component Verification

# Instrument Technical Instrument Description Manufacturer / Model# (if applicable) As-Found Serial Number  Manufacturer / Model# Met? Performed by Date
ID (if applicable) (Yes / No / N/A)
regulated
39 Q3001 Pneumatic valve 2p  GEMÜ / 650 20D8240 5E12T1 1508  88123531-11216821 Yes Coane, John 31-Jan-2020 (UTC)
regulated
40 R3102 Nonreturn valve  Mondeo / Idrja-FKM-1/2" N/A Yes Coane, John 31-Jan-2020 (UTC)
41 R3103 Nonreturn valve  Mondeo / Small-FKM-1/4" N/A Yes Coane, John 31-Jan-2020 (UTC)
42 Q3202 Pneumatic valve 2p  GEMÜ / 550 15D6034 511G1  88245715-10426472 Yes Coane, John 31-Jan-2020 (UTC)
regulated
43 Q3203 Pneumatic valve 2p  GEMÜ / 550 8D6040 510G1  88257372-11490453 Yes Coane, John 31-Jan-2020 (UTC)
regulated
44 R4001 Nonreturn valve  TLV / LV21C CF3M (316L) 1/2" N/A Yes Coane, John 31-Jan-2020 (UTC)
45 Q4001 Pneumatic valve 2p  GEMÜ / 550 8D6040 510G1  88257372-11162739 Yes Coane, John 31-Jan-2020 (UTC)
regulated
46 Q4002 Pneumatic valve 2p  GEMÜ / 550 20D6034 512G1  88245725-1182566 Yes Coane, John 31-Jan-2020 (UTC)
regulated
47 Q4003 Pneumatic valve 2p  GEMÜ / 550 10D6034 511G1  88301838-11518578 Yes Coane, John 31-Jan-2020 (UTC)
regulated
48 Q4004 Pneumatic valve 2p  GEMÜ / 550 20D6034 512G1  88245725-11518576 Yes Coane, John 31-Jan-2020 (UTC)
regulated
49 F4401 Standard safety valve 10  Herose / 133RG000015-17  N/A Yes Coane, John 31-Jan-2020 (UTC)
bar
50 Q5001 Pneumatic valve 2p  GEMÜ / 650 8D6040 5A10T1 1508  88500768-11625504 Yes Coane, John 31-Jan-2020 (UTC)
regulated
51 Q5002 Pneumatic valve 2p  GEMÜ / 550 15D6034 511G1 88245715-11625508 Yes Coane, John 31-Jan-2020 (UTC)
regulated
52 Q5003 Diaphragm valve manual  GEMÜ / 602 8D6040 5A00TM 1508 88291758-11710819 Yes Coane, John 31-Jan-2020 (UTC)
53 Q5301 Pneumatic valve 2p  GEMÜ / 650 8D6040 5A10T1 1508 88324747-11710820 Yes Coane, John 31-Jan-2020 (UTC)
regulated
54 Q5302 Diaphragm valve manual  GEMÜ / 602 8D6040 5A00TM 1508  N/A Yes Coane, John 31-Jan-2020 (UTC)
55 R5302 Nonreturn valve  Mondeo / Small 1/4" FKM N/A Yes Coane, John 31-Jan-2020 (UTC)

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Table 1: System Component Verification

# Instrument Technical Instrument Description Manufacturer / Model# (if applicable) As-Found Serial Number  Manufacturer / Model# Met? Performed by Date
ID (if applicable) (Yes / No / N/A)
56 Q5303 Needle valve  Swagelock / SS-6L-MM  N/A Yes Coane, John 31-Jan-2020 (UTC)

Table 2: Additional System Component Verification

# Equipment Equipment Manufacturer / Model # As-Found Serial Number  Manufacturer / Model # Installed per Engineering SAP Record Attachment Performed By Date
Number Description (If Applicable) (If Applicable) Met? Specifications?
(Yes / No / N/A) (Yes / No / N/A)
1  N/A  N/A  N/A  N/A N/A N/A N/A Coane, John 11-Feb-2020
(UTC)
2  N/A  N/A  N/A  N/A N/A N/A N/A Coane, John 11-Feb-2020
(UTC)
3  N/A  N/A  N/A  N/A N/A N/A N/A Coane, John 11-Feb-2020
(UTC)
4  N/A  N/A  N/A  N/A N/A N/A N/A Coane, John 11-Feb-2020
(UTC)
5  N/A  N/A  N/A  N/A N/A N/A N/A Coane, John 11-Feb-2020
(UTC)
6  N/A  N/A  N/A  N/A N/A N/A N/A Coane, John 11-Feb-2020
(UTC)
7  N/A  N/A  N/A  N/A N/A N/A N/A Coane, John 11-Feb-2020
(UTC)
8  N/A  N/A  N/A  N/A N/A N/A N/A Coane, John 11-Feb-2020
(UTC)
Note: If there are pieces of equipment identified during the execution of this test that are necessary for verification but are not included in Table 1, record those pieces of equipment and capture the
results of the verification in Table 2. "N/A" all unused rows in Table 2.

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Comments
# Comments Performed By Date
1 SAP records for all components are attached in Section 16, line 1. Coane, John 11-Feb-2020 (UTC)
2 Q1001 is in two parts and each part has a unique model number but the same serial number Coane, John 11-Mar-2020 (UTC)
3  N/A Coane, John 06-Mar-2020 (UTC)
Note: If there are no comments in the "Comments" table above, type "No Comments" in the first line. The remaining empty rows will be considered "N/A". Otherwise, "N/A" all unused rows.

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9.5 Materials of Construction Verification (IOQ - AUT-10202-CAM-03-05)

1. Test Objective

Verify that proper documentation is available to prove that all product or process contact components meet or
exceed engineering requirements.

2. Scope

All equipment and/or components that have been identified as having direct product contact or direct impact on
product quality within System #  AUT-10202  boundary will be verified in this test case.

Note: Including line components (e.g. piping, major components, valves, and product-contact instrumentation)

3. Acceptance Criteria

• All product or process contact components on the system meet or exceed the material and surface finish
requirements per GEP-ST-007.

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9.5.1 Field Execution - Materials of Construction Verification (IOQ - AUT-10202-CAM-03-05)

Procedure:

1. Verify the “Specified" Data and ensure the specifications outlined in GEP-ST-007 are met. If the material is acceptable, record “Yes” in the "Met
Specifications?" Column. Otherwise, record “No”.
2. Attach the supporting document in Table 1.

Table 1: Materials of Construction Verification

# Item and/or Component ID Specified Material Specified Electropolishing Materials of Construction, Surface Attachment Recorded By Date
of Construction Surface Finish Required? Finish, and Electropolishing Met
(Max Ra) (Yes / No) Specifications? (Yes / No / N/A)
1  Autoclave Cart 316L SS  25 Ra  No Yes FAT Scan for Coane, John 11-Mar-2020
IOQ.pdf (UTC)
2  Autoclave Chamber 316L SS  25 Ra  No Yes N/A Coane, John 31-Jan-2020
(UTC)
3  Steam Supply Piping 316L SS  25 Ra  No Yes N/A Coane, John 31-Jan-2020
(UTC)
4  Chamber Probe T1 (Well) 316L SS  25 Ra  No Yes N/A Coane, John 31-Jan-2020
(UTC)
5  Chamber Probe T2 (Well) 316L SS  25 Ra  No Yes N/A Coane, John 31-Jan-2020
(UTC)
6  Chamber Probe T4 (Well) 316L SS  25 Ra  No Yes N/A Coane, John 31-Jan-2020
(UTC)
7  Fan/Blower 316 or 316L SS  N/A  No Yes N/A Coane, John 31-Jan-2020
(UTC)
8  Filter Housing 316L SS  25 Ra  No  Yes N/A Coane, John 31-Jan-2020
(UTC)

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Table 2: Additional Materials of Construction Verification

# Item and/or Component ID Specified Material Specified Electropolishing Materials of Construction, Surface Attachment Recorded By Date
of Construction Surface Finish Required? Finish, and Electropolishing Met
(Max Ra) (Yes / No / N/A) Specifications? (Yes / No / N/A)
1  N/A  N/A  N/A N/A N/A N/A Coane, John 11-Feb-2020
(UTC)
2  N/A  N/A  N/A N/A N/A N/A Coane, John 11-Feb-2020
(UTC)
3  N/A  N/A  N/A N/A N/A N/A Coane, John 11-Feb-2020
(UTC)
4  N/A  N/A  N/A N/A N/A N/A Coane, John 11-Feb-2020
(UTC)
5  N/A  N/A  N/A N/A N/A N/A Coane, John 11-Feb-2020
(UTC)
Note: If there are pieces of equipment identified during the execution of this test that are necessary for verification but are not included in Table 1,
record those pieces of equipment and capture the results of the verification in Table 2. "N/A" all unused rows in Table 2.

Comments
# Comments: Recorded By Date
1 Documents are in the ETOP in the cut sheets, mechanical drawings, and component list. See section 9.7. Materials of construction were verified Coane, John 05-Mar-2020
in the FAT and confirmed in CTP-AUT-10202-CAM-01 (Commissioning). (UTC)
2  N/A Coane, John 05-Mar-2020
(UTC)
3  N/A Coane, John 05-Mar-2020
(UTC)
Note: If there are no comments in the "Comments" table above, type "No Comments" in the first line. The remaining empty rows will be considered
"N/A". Otherwise, "N/A" all unused rows.

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9.6 System Calibration Verification (IOQ - AUT-10202-CAM-03-06)

1. Test Objective

Ensure that all instruments in the system have been assessed for calibration per SOP-000439.

2. Scope

All instruments in the system # AUT-10202 will be covered by this test.

3. Acceptance Criteria

• Instrument Impact Assessments (IIAs) were performed for all system instruments per SOP-000439.

9.6.1 Field Execution - System Calibration Verification (IOQ - AUT-10202-CAM-03-06)

Procedure:

1. For each of the instruments identified as requiring calibration, verify that an IIA has been approved and the instrument has been registered in the
Cambridge Metrology Program.
2. Attach or reference the storage location of the approved IIA.
3. If the instrument has been assessed, record "Yes" in the "Meets Requirements?" column, otherwise record "No".

Table 1: System Calibration Verification

# Instrument Technical Instrument Description IIA Storage Location Attachment Meets Requirements? Performed by Date
ID (if not attached)
(Yes / No / N/A)
1 PG-10202-001 Pressure Gauge  See attached. PG-10202-001 IIA.pdf Yes Coane, John 23-Jan-2020 (UTC)
2 PG-10202-002 Pressure Gauge  See attached. PG-10202-002 & -003 Yes Coane, John 23-Jan-2020 (UTC)
IIA.pdf

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Table 1: System Calibration Verification

# Instrument Technical Instrument Description IIA Storage Location Attachment Meets Requirements? Performed by Date
ID (if not attached)
(Yes / No / N/A)
3 PG-10202-003 Pressure Gauge  See attached. PG-10202-002 & -003 Yes Coane, John 23-Jan-2020 (UTC)
IIA.pdf
4  PG-10202-006  Pressure Gauge  See attached. PG-10202-006 IIA.pdf Yes Coane, John 23-Jan-2020 (UTC)
5  PG-10202-007  Pressure Gauge  See attached. PG-10202-007 & -008 Yes Coane, John 23-Jan-2020 (UTC)
IIA.pdf
6  PG-10202-008  Pressure Gauge  See attached. PG-10202-007 & -008 Yes Coane, John 23-Jan-2020 (UTC)
IIA.pdf
7  PI-10202-001  Pressure Indicator   See attached. PI-10202-001, -003, - Yes Coane, John 23-Jan-2020 (UTC)
006 IIA.pdf
8  PI-10202-002 Pressure Indicator   See attached. PI-10202-002 IIA.pdf Yes Coane, John 23-Jan-2020 (UTC)
9  PI-10202-003  Pressure Indicator   See attached. PI-10202-001, -003, - Yes Coane, John 23-Jan-2020 (UTC)
006 IIA.pdf
10  PI-10202-006  Pressure Indicator   See attached. PI-10202-001, -003, - Yes Coane, John 23-Jan-2020 (UTC)
006 IIA.pdf
11  PIT-10202-001  Pressure Transmitter   See attached. PIT-10202-001 Yes Coane, John 23-Jan-2020 (UTC)
IIA_18Oct19.pdf
12  PR-10202-001  Pressure Regulator See attached. PR-10202-001 IIA.pdf Yes Coane, John 23-Jan-2020 (UTC)
13  PT-10202-001  Pressure Transmitter   See attached. PT-10202-001 & -002 Yes Coane, John 23-Jan-2020 (UTC)
IIA_18Oct19.pdf
14  PT-10202-002  Pressure Transmitter   See attached. PT-10202-001 & -002 Yes Coane, John 23-Jan-2020 (UTC)
IIA_18Oct19.pdf
15  PT-10202-003  Pressure Transmitter   See attached. PT-10202-003 & -004 Yes Coane, John 23-Jan-2020 (UTC)
IIA_18Oct19.pdf
16  PT-10202-004  Pressure Transmitter   See attached. PT-10202-003 & -004 Yes Coane, John 23-Jan-2020 (UTC)
IIA_18Oct19.pdf
17 TE-10202-002  Temperature Element    See attached. TE-10202-002 IIA.pdf Yes Coane, John 23-Jan-2020 (UTC)
18 TE-10202-005  Temperature Element   See attached. TE-10202-005 IIA.pdf Yes Coane, John 23-Jan-2020 (UTC)
19 TE-10202-008  Temperature Element   See attached. TE-10202-008 IIA.pdf Yes Coane, John 23-Jan-2020 (UTC)

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Table 1: System Calibration Verification

# Instrument Technical Instrument Description IIA Storage Location Attachment Meets Requirements? Performed by Date
ID (if not attached)
(Yes / No / N/A)
20 TE-10202-010   Temperature Element   See attached. TE-10202-010 IIA.pdf Yes Coane, John 23-Jan-2020 (UTC)
21 TE-10202-011   Temperature Element   See attached. TE-10202-011 & -012 Yes Coane, John 23-Jan-2020 (UTC)
IIA.pdf
22 TE-10202-012   Temperature Element   See attached. TE-10202-011 & -012 Yes Coane, John 23-Jan-2020 (UTC)
IIA.pdf
23 TI-10202-004  Temperature Indicator   See attached. TI-10202-004 & -007 Yes Coane, John 23-Jan-2020 (UTC)
IIA.pdf
24 TI-10202-007  Temperature Indicator   See attached. TI-10202-004 & -007 Yes Coane, John 23-Jan-2020 (UTC)
IIA.pdf
25 TIT-10202-001  Temperature Transmitter   See attached. TIT-10202-001, -003, Yes Coane, John 23-Jan-2020 (UTC)
-004 IIA.pdf
26 TIT-10202-003  Temperature Transmitter   See attached. TIT-10202-001, -003, Yes Coane, John 23-Jan-2020 (UTC)
-004 IIA.pdf
27 TIT-10202-004 Temperature Transmitter   See attached. TIT-10202-001, -003, Yes Coane, John 23-Jan-2020 (UTC)
-004 IIA.pdf
 

Table 2: Additional System Calibration Verification

# Instrument Instrument Description IIA Storage Location Attachment Meets Requirements? Performed by Date
Technical ID  (if not attached) (Yes / No / N/A)
1   N/A   N/A   N/A N/A N/A Coane, John 11-Feb-2020 (UTC)
2   N/A   N/A   N/A N/A N/A Coane, John 11-Feb-2020 (UTC)
3   N/A   N/A   N/A N/A N/A Coane, John 11-Feb-2020 (UTC)
4   N/A   N/A   N/A N/A N/A Coane, John 11-Feb-2020 (UTC)
5  N/A   N/A   N/A N/A N/A Coane, John 11-Feb-2020 (UTC)
Note: If there are pieces of equipment identified during the execution of this test that are necessary for verification but are not included in Table 1,
record those pieces of equipment and capture the results of the verification in Table 2. "N/A" all unused rows in Table 2.

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 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Comments
# Comments: Performed By Date
1  No Comments Coane, John 11-Feb-2020 (UTC)
2      
3      
Note: If there are no comments in the "Comments" table above, type "No Comments" in the first line. The remaining empty rows will be considered
"N/A". Otherwise, "N/A" all unused rows.

9.7 Technical Supporting Documentation Verification (IOQ - AUT-10202-CAM-03-07)

1. Objective

Ensure that the required supporting documentation for this system has been received and the storage location is documented.

2. Scope

All required technical supporting documentation for System # AUT-10202 will be verified in this test case.

3. Acceptance Criteria

• Required supporting documentation for this system has been received and the storage location is documented.

9.7.1 Field Execution - Technical Supporting Documentation Review (IOQ - AUT-10202-CAM-03-07)

Procedure

1. Verify and locate the listed documents in Table 1 for this system.
2. Attach the document or record the document location in Table 1.
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3. If the document has been received and it has either been attached to the protocol or is stored in an acceptable location, record "Yes" in the
"Documentation Acceptable?" column. Otherwise record "No".

Table 1: Technical Supporting Documentation Verification

# Documentation Type Document Title Document Location Documentation Attachment Performed By Date
Acceptable?
(Yes / No / N/A)
1 Engineering Turn Over Package (ETOP) Engineering Turn-Over    TOP-AUT-10202-01 (1.0 Yes N/A Coane, John 31-Jan-2020
Package for AUT-10202 App)   (UTC)
2 Factory Acceptance Testing (FAT) Qualification FAT; Available in Brammer Bio Yes N/A Coane, John 31-Jan-2020
Equipment:  2007811 intranet drive S:\_Shared\ (UTC)
CQV\Autoclaves\Key
3 Site Acceptance Testing (SAT) Qualification SAT;  CTP-AUT-10202-CAM-01 Yes N/A Coane, John 31-Jan-2020
Equipment:  2007811 (UTC)

Table 2: Additional Technical Supporting Documentation Verification

# Documentation Type Document Title Document Location Documentation Attachment Performed  By Date
Acceptable?
(Yes / No / N/A)
1  N/A  N/A  N/A N/A N/A Coane, John 11-Feb-2020
(UTC)
2  N/A  N/A  N/A N/A N/A Coane, John 11-Feb-2020
(UTC)
3  N/A  N/A  N/A N/A N/A Coane, John 11-Feb-2020
(UTC)
Note: If there are pieces of equipment identified during the execution of this test that are necessary for verification but are not included in Table 1,
record those pieces of equipment and capture the results of the verification in Table 2. "N/A" all unused rows in Table 2.

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Comments
# Comments Performed By Date
1 ETOP is hyperlinked in Table 1 line 1 in the Document Location column. Coane, John 05-Mar-2020 (UTC)
2  N/A Coane, John 06-Mar-2020 (UTC)
3  N/A Coane, John 06-Mar-2020 (UTC)
Note: If there are no comments in the "Comments" table above, type "No Comments" in the first line. The remaining empty rows will be considered
"N/A". Otherwise, "N/A" all unused rows.

9.8 Maintenance System Registration Verification (IOQ - AUT-10202-CAM-03-08)

1. Objective

Verify that the system has been registered in the Brammer Bio Maintenance System per SOP-000439 and SOP-000457.

2. Scope

All critical records associated with System # AUT-10202 will be verified to be recorded in the Brammer Bio maintenance system. Critical records include
the equipment record, impact assessments, maintenance plans, and task lists.

3. Acceptance Criteria

• The system and all required components have been registered in the CMMS per SOP-000439 and SOP-000457.

9.8.1 Field Execution - Maintenance System Registration Verification (IOQ - AUT-10202-CAM-03-08)

Procedure:

1. Obtain access to the Brammer Bio maintenance system.

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2. Locate the equipment record for AUT-10202. Verify that all system information (manufacturer, model, S/N, etc.) in the equipment record is
accurate.
3. Verify that equipment records have been created for all applicable components within the system. Verify that all components have been assigned
as subordinate equipment to System #  AUT-10202.
4. Verify that a System Impact Assessment for the system has been completed per SOP-000439 and SOP-000457. Verify that a copy of the SIA
has been attached to the equipment record.
5. Verify that the correct designation has been assigned to the "System Impact Assessment" field in the equipment record.
6. Ensure that Engineering has created all necessary maintenance plans in the maintenance system.

Table 1: Maintenance System Registration Verification

# Expected Result Meets Requirement? Justification (If Applicable) Attachment Performed by Date
(Yes / No / N/A)
1 All system information in the Yes  See attached. AUT-10202.PNG Coane, John 31-Jan-2020 (UTC)
equipment record is accurate.
2 All system components have Yes  See attached AUT-10202 & Coane, John 31-Jan-2020 (UTC)
equipment records and are listed as components.PNG
subordinate equipment to the system.
3 System Impact Assessment has been Yes  See attached. AUT-10202 SIA.PNG Coane, John 31-Jan-2020 (UTC)
completed and is attached to the
equipment record.
4 The correct designation has been Yes  See attached. AUT-10202 SIA Coane, John 31-Jan-2020 (UTC)
assigned to the "System Impact designation.PNG
Assessment" field in the equipment
record.
5 All necessary maintenance plans Yes  See attached. AUT-10202 Maintenance Coane, John 31-Jan-2020 (UTC)
have been created. Plan.PNG
 
 

Comments
# Comments: Performed By Date
1  No Comments Coane, John 11-Feb-2020
(UTC)

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Comments
# Comments: Performed By Date
2      
3      
Note: If there are no comments in the "Comments" table above, type "No Comments" in the first line. The remaining empty rows will be considered
"N/A". Otherwise, "N/A" all unused rows.

9.9 Embedded Software Verification (IOQ - AUT-10202-CAM-03-09)

1. Objective

Ensure that embedded software for the operation of the system is recorded and has been appropriately backed up and archived.

2. Scope

Embedded software for System # AUT-10202 and all applicable components will be verified in this test case.

3. Acceptance Criteria

• The current firmware or software version on the system has been documented.

• A back-up of the current firmware or software version has been archived.

9.9.1 Field Execution - Embedded Software Verification (IOQ - AUT-10202-CAM-03-09)

Procedure:

1. Record the File Name, Version No. and Date of the embedded software in Table 1.
2. Verify that a software backed up has been performed by recording the back-up storage location in Table 1.

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Table 1: Embedded Software Verification

# Equipment Number File Name (If Applicable) Version No. Version Date Backup Location Attachment Performed by Date
1 AUT-10202 PLC N/A 2007811_11 19 Mar 19  FactoryTalk N/A Coane, John 11-Feb-2020
(UTC)
2 AUT-10202 GUI   N/A V1.3.4.1 28 Mar 19  FactoryTalk N/A Coane, John 11-Feb-2020
(UTC)

Table 2: Additional Embedded Software Verification

# Equipment Number File Name (If Applicable) Version No. Version Date Backup Location Attachment Performed by Date
1 AUT-10202 Operating 1.2.4.1 First 28.03.19 Factory Talk N/A Coane, John 31-Jan-2020
Windows System: Windows 10 loT revision (UTC)
Enterprise 2016 (Win is Windows
activated, 02219-066-783- settings: Time
540, zone "(UTC -
X21-19905) (local Win 05:00)
administrator Eastern Time"
(name/password): (with Day-
autologon I autologon) light-saving
time change)
2   N/A   N/A   N/A   N/A   N/A N/A Coane, John 11-Feb-2020
(UTC)
3   N/A   N/A   N/A   N/A   N/A N/A Coane, John 11-Feb-2020
(UTC)
4   N/A   N/A   N/A   N/A   N/A N/A Coane, John 11-Feb-2020
(UTC)
5   N/A   N/A   N/A   N/A  N/A N/A Coane, John 11-Feb-2020
(UTC)
Note: If there are pieces of equipment identified during the execution of this test that are necessary for verification but are not included in Table 1, record
those pieces of equipment and capture the results of the verification in Table 2. "N/A" all unused rows in Table 2.

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Comments
# Comments: Performed By Date
1  No comments Coane, John 11-Feb-2020 (UTC)
2      
3      
Note: If there are no comments in the "Comments" table above, type "No Comments" in the first line. The remaining empty rows will be considered
"N/A". Otherwise, "N/A" all unused rows.

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10 OQ Prerequisites

Verify each installation prerequisite condition has been met prior to executing the operational validation tests contained in this protocol. If a prerequisite
has not been satisfied, provide a documented rationale including the impact, if any, to operational testing.
The information documented below has been assessed and the approval signature below indicates the permission to proceed to OQ execution. 

Operational Qualification Prerequisites Verification Table

# Instructions Yes / No/ N/A If No, add Justification / Impact IQ Document Number Performed By Date
1 Verify that IQ test cases have been No The following test cases were not  IOQ-AUT-10202-CAM-03 Coane, John 05-Mar-2020 (UTC)
completed and deviations requiring re-testing completed prior to the start of OQ
have been closed. testing:  Drawing Prerequisite, System
Walkdown Verification, System
Drawing Verification, and Embedded
Software Verification. Impact to
qualification is considered minimal.
Refer to Deviation 1 in Section 15.
 

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Comments
# Comments Performed By Date
1  No comments Coane, John 02-Mar-2020 (UTC)
2      
3      
Note: If there are no comments in the "Comments" table above, type "No Comments" in the first line. The remaining empty rows will be considered
"N/A". Otherwise, "N/A" all unused rows.

10.1 Standard Operating Procedure Review

Standard Operating Procedures (SOPs) for the operation of the system are identified below and must be, at a minimum, in draft prior to the execution of
the test case(s) that use the operational SOP to perform the test.
 

Table 1: Standard Operating Procedure Review Verification

# SOP # SOP Title Version Performed By Date
1 SOP-000518 Manual Operation of Filter Integrity Testers   4.0 Coane, John 11-Feb-2020 (UTC)
2 SOP-001252 Operation and Maintenance of Belimed Autoclave (Key)  2.0 Coane, John 11-Feb-2020 (UTC)
  
  

Table 2: Additional Standard Operating Procedure Review Verification

# SOP # SOP Title Version Performed By Date
1  N/A  N/A  N/A Coane, John 11-Feb-2020 (UTC)
2  N/A  N/A  N/A Coane, John 11-Feb-2020 (UTC)
3  N/A  N/A  N/A Coane, John 11-Feb-2020 (UTC)
Note: If there are items identified during the execution of this test that are necessary for verification but are not included in Table 1, record those items
and capture the results of the verification in  Table 2. "N/A" all unused rows in  Table 2.
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 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Comments
# Comment Performed By Date
1  No Comments Coane, John 11-Feb-2020 (UTC)
2      
3      
Note: If there are no comments in the "Comments" table above, type "No Comments" in the first line. The remaining empty rows will be considered
"N/A". Otherwise, "N/A" all unused rows.

10.2 Automation Prerequisites

Automation Prerequisites Verification Table

# Instructions Automation Testing Status If Required Testing Was Not Performed, Automation Testing Performed By Date
Provide Justification / Impact Document #
1 Record the status of the automation The required automation testing N/A  ATS-CC-19-296-001 Coane, John 11-Feb-2020
testing on the system that is was executed. (UTC)
outside the scope of this protocol.
 

Comments
# Comments Performed By Date
1  No Comments Coane, John 11-Feb-2020 (UTC)
2      

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Comments
# Comments Performed By Date
3      
Note: If there are no comments in the "Comments" table above, type "No Comments" in the first line. The remaining empty rows will be considered
"N/A". Otherwise, "N/A" all unused rows.

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11 OQ Test Case List

Test Case List

Test Case Number Test Case Name
IOQ - AUT-10202-CAM-03-10 Test Equipment Calibration Verification
IOQ - AUT-10202-CAM-03-11 Alarm and Interlock Testing
IOQ - AUT-10202-CAM-03-12 Power Backup Testing 
IOQ - AUT-10202-CAM-03-13 Set Point Verification
IOQ - AUT-10202-CAM-03-14 Filter Integrity Test / Certification
IOQ - AUT-10202-CAM-03-15 Sequence of Operations Verification
IOQ - AUT-10202-CAM-03-16 Automated Valve Actuation Verification
IOQ - AUT-10202-CAM-03-17 Autoclave Sterilization (Empty Chamber)
IOQ - AUT-10202-CAM-03-18 Access Rights Testing
IOQ - AUT-10202-CAM-03-19 Steam Quality Testing 
IOQ - AUT-10202-CAM-03-20 Leak Test 
IOQ - AUT-10202-CAM-03-21 Air Removal Test 
 

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12 OQ Test Cases

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12.1 Test Equipment Calibration Verification (IOQ - AUT-10202-CAM-03-10)

1. Test Objective

Confirm that the test equipment used during testing has been calibrated and is verified to be within the calibration frequency.

2. Scope

This test will apply to any test equipment and/or instruments used within the execution of the protocol.

3. Acceptance Criteria

• All test instruments used during qualification were properly calibrated.  

12.1.1 Field Execution - Kaye Validator Calibration Verification (IOQ - AUT-10202-CAM-03-10)

Procedure:

1. Setup the Kaye loggers for pre-calibration per SOP-000604 using the recommendations in Attachment 3 of SOP-000601.
2. Record the required pre-calibration information in Table 1.
3. Attach the pre-calibration report in Table 2. If any loggers fail pre-calibration, substitute the failed loggers and repeat pre-calibration.
4. Perform execution in this protocol as necessary with the Kaye loggers.
5. When all execution with the Kaye loggers is complete, perform a post-calibration check of the loggers.
6. Perform the post-calibration using the recommended setpoints, tolerances, and stabilities in Attachment 3 of SOP-000601.
7. Record the required post-calibration information in Table 3.
8. Attach the post-calibration report in Table 4. If any loggers fail post-calibration, perform an assessment per the instructions in Attachment
3 of SOP-000601 to determine the impact to the test(s) in this protocol.

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Table 1: Kaye Pre-Calibration Verification

# Parameter Value Used Meets Recommendations in Performed By Date
SOP-000601?
(Yes / No / N/A)
1 Calibration Check Setpoint Yes Coane, John 05-Mar-2020 (UTC)
123.5 °C
2 Calibration Low Setpoint  100 °C Yes Coane, John 05-Mar-2020 (UTC)
3 Calibration High Setpoint 140 °C Yes Coane, John 05-Mar-2020 (UTC)
4 Logger Stabilization Requirement  0.50 °C for 3 minutes Yes Coane, John 05-Mar-2020 (UTC)
5 Reference Stabilization Requirement 0.012  °C for 5 minutes Yes Coane, John 05-Mar-2020 (UTC)
6 Deviation Criteria Uncalibrated:  1.00 °C Yes Coane, John 05-Mar-2020 (UTC)
Calibrated:  0.50 °C

Table 2: Kaye Pre-Calibration Report

# Document Attachment Pre-Calibration Results Performed By Date
1 Pre-Execution Kaye Cal In Report.pdf All loggers passed post-calibration Coane, John 05-Mar-2020 (UTC)
Calibration Report

Table 3: Kaye Post-Calibration Verification

# Parameter Value Used Meets Recommendations in Performed By Date
SOP-000601?
(Yes / No / N/A)
1 Calibration Check Setpoint 123.5 °C Yes Coane, John 05-Mar-2020 (UTC)
2 Logger Stabilization Requirement 0.50 °C for 3 minutes Yes Coane, John 05-Mar-2020 (UTC)
3 Reference Stabilization Requirement  0.012 °C for 5 minutes Yes Coane, John 05-Mar-2020 (UTC)
4 Deviation Criteria  Calibrated: 0.50 °C Yes Coane, John 05-Mar-2020 (UTC)
 

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Table 4: Kaye Post-Calibration Report

# Document Attachment Post-Calibration Results If any loggers failed, perform Performed By Date
assessment and specify required action
1 Post-Calibration Kaye Cal Out Report.pdf All loggers passed post-calibration N/A Coane, John 05-Mar-2020 (UTC)
Report

Comments
# Comments Performed by Date
1  Kaye Setup Report is attached in Section 16. Coane, John 05-Mar-2020
(UTC)
2 loggers in the study are TCs Coane, John 05-Mar-2020
(UTC)
3 N/A Coane, John 06-Mar-2020
(UTC)
Note: If there are no comments in the "Comments" table above, type "No Comments" in the first line. The remaining empty rows will be considered
"N/A". Otherwise, "N/A" all unused rows.

12.1.2 Field Execution - Stand-Alone Test Equipment Calibration Verification (IOQ - AUT-10202-CAM-03-10)

List the test equipment below used for the execution of this protocol.

Table 5: Test Equipment List and Calibration Records Verification

# Equipment / Equipment / Instrument Calibration Due Date Test Equipment remained in a Attachment Performed By Date
Instrument Number Description (DDMMMYY) calibrated state for the duration
of qualification execution?
(Yes / No / N/A)
1  11619  Validator 31Mar20 Yes Validator Cal Cert.pdf Coane, John 05-Mar-2020 (UTC)
2 09399 Sensor Input Module  31Mar20 Yes SIM 1 Cal Cert.pdf Coane, John 05-Mar-2020 (UTC)
(SIM)

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Table 5: Test Equipment List and Calibration Records Verification

# Equipment / Equipment / Instrument Calibration Due Date Test Equipment remained in a Attachment Performed By Date
Instrument Number Description (DDMMMYY) calibrated state for the duration
of qualification execution?
(Yes / No / N/A)
3 09408 Sensor Input Module 31Mar20 Yes SIM 2 Cal Cert.pdf Coane, John 05-Mar-2020 (UTC)
(SIM)
4 11174  Intelligent RTD  31Mar20 Yes IRTD Cal Cert.pdf Coane, John 05-Mar-2020 (UTC)
5 BPI-225 Dual Input Thermometer 23 Sep 20 Yes BPI225 2019.pdf Coane, John 11-Mar-2020 (UTC)
(Steam Quality)
6  N/A  N/A  N/A N/A N/A Coane, John 11-Mar-2020 (UTC)
7  N/A  N/A  N/A N/A N/A Coane, John 11-Mar-2020 (UTC)
8  N/A  N/A  N/A N/A N/A Coane, John 11-Mar-2020 (UTC)
 

Test Review (To be completed by Validation)

# Summary (Yes / No / N/A) Performed By Date
1 Were all test instruments used during qualification properly calibrated? Yes Coane, John 11-Mar-2020
(UTC)
2 Deviation(s) required? No Coane, John 11-Mar-2020
(UTC)
3 Deviation(s) resolved and referenced, if applicable? N/A Coane, John 11-Mar-2020
(UTC)

Comments
# Comments: Performed By Date
1  No comments Coane, John 11-Mar-2020
(UTC)

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Comments
# Comments: Performed By Date
2      
3      
Note: If there are no comments in the "Comments" table above, type "No Comments" in the first line. The remaining empty rows will be considered
"N/A". Otherwise, "N/A" all unused rows.

12.2 Alarm and Interlock Testing (IOQ - AUT-10202-CAM-03-11)

1. Test Objective

Provide evidence that critical alarms activate correctly and interlocks occur as designed.

This test will verify that all alarms and interlocks identified in Table 1 of Section 2.1 are configured correctly and function as designed. All alarms have
previously been tested by the manufacturer during Site Acceptance Testing (SAT) with a Brammer Bio representative present. The manufacturer's testing
will be attached to this test case to support that all alarms function as designed. The vendor documentation (SAT) was pre-approved by ENG/CQV and
post-approved by ENG, CQV, and QAV.

2. Scope

This test case covers the critical Alarms and Interlocks associated with System #  AUT-10202 identified in Table 1 of Section 2.1.
 

3. Acceptance Criteria

• All critical alarms and interlocks associated with the system function as designed.

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12.2.1 Field Execution - Alarm and Interlock Testing (IOQ - AUT-10202-CAM-03-11)

Procedure:

1. Confirm in Table 1 that each alarm was successfully tested and confirm to function as designed during the manufacturer's testing.
2. Attach a copy of the manufacturer's alarm testing in Table 2.

Table 1: Alarm and Interlock Testing

# Alarm ID # Alarm Description Alarm / Interlock Condition Met? Performed By Date
(Yes / No)
1 AlarmProg1 Manual step change Yes Coane, John 02-Mar-2020 (UTC)
2 AlarmProg2 Program abort Yes Coane, John 02-Mar-2020 (UTC)
3 AlarmProg3 Alarm is in hold state Yes Coane, John 02-Mar-2020 (UTC)
4 AlarmProg4 Sterilized product isn't discharged Yes Coane, John 02-Mar-2020 (UTC)
5 AlarmProg5 Door open, program start not possible Yes Coane, John 02-Mar-2020 (UTC)
6 AlarmProg10 Recipe couldn't be loaded, program start not possible Yes Coane, John 02-Mar-2020 (UTC)
7 AlarmProg11 Autostart not successful Yes Coane, John 02-Mar-2020 (UTC)
8 AlarmProg15 Maximum step time exceeded Yes Coane, John 02-Mar-2020 (UTC)
9 AlarmProg16 PLC has an error Yes Coane, John 02-Mar-2020 (UTC)
10 AlarmProg28 Data program start not recorded Yes Coane, John 02-Mar-2020 (UTC)
11 AlarmProg29 Data program end not recorded Yes Coane, John 02-Mar-2020 (UTC)
12 AlarmProg30 Data batch release not recorded Yes Coane, John 02-Mar-2020 (UTC)
13 AlarmProg31 No communication between PLC and HMI Yes Coane, John 02-Mar-2020 (UTC)
14 AlarmFc1 Door unlocked without reaching the release Yes Coane, John 02-Mar-2020 (UTC)
15 AlarmFc10 Supply pressure heating steam too low Yes Coane, John 02-Mar-2020 (UTC)

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Table 1: Alarm and Interlock Testing

# Alarm ID # Alarm Description Alarm / Interlock Condition Met? Performed By Date
(Yes / No)
16 AlarmFc11 Supply pressure steam too low Yes Coane, John 02-Mar-2020 (UTC)
17 AlarmFc12 Difference between steam supply pressure and maximum process Yes Coane, John 02-Mar-2020 (UTC)
pressure too small
18 AlarmFc13 Air detector test not passed Yes Coane, John 02-Mar-2020 (UTC)
19 AlarmFc16 A not configured temperature control sensor is used Yes Coane, John 02-Mar-2020 (UTC)
20 AlarmFc17 Monitoring of temperature control sensor deactivated due to sensor Yes Coane, John 02-Mar-2020 (UTC)
fault
21 AlarmFc18 No control sensor available Yes Coane, John 02-Mar-2020 (UTC)
22 AlarmFc19 Temperature control sensor 1 faulty Yes Coane, John 02-Mar-2020 (UTC)
23 AlarmFc20 Temperature control sensor 2 faulty Yes Coane, John 02-Mar-2020 (UTC)
24 AlarmFc21 Temperature difference between control sensors too large Yes Coane, John 02-Mar-2020 (UTC)
25 AlarmFc23 Failure monitoring sensor Yes Coane, John 02-Mar-2020 (UTC)
26 AlarmFc25 A not configured product sensor is used Yes Coane, John 02-Mar-2020 (UTC)
27 AlarmFc31 Timeout overtemperature sensor T1 Yes Coane, John 02-Mar-2020 (UTC)
28 AlarmFc32 Timeout overtemperature sensor T2 Yes Coane, John 02-Mar-2020 (UTC)
29 AlarmFc33 Timeout overtemperature sensor T3 Yes Coane, John 02-Mar-2020 (UTC)
30 AlarmFc34 Timeout overtemperature sensor T4 Yes Coane, John 02-Mar-2020 (UTC)
31 AlarmFc35 Timeout overtemperature sensor T5 Yes Coane, John 02-Mar-2020 (UTC)
32 AlarmFc40 Timeout overtemperature sensor T10 Yes Coane, John 02-Mar-2020 (UTC)
33 AlarmFc41 Timeout overtemperature sensor T11 Yes Coane, John 02-Mar-2020 (UTC)
34 AlarmFc42 Timeout overtemperature sensor T12 Yes Coane, John 02-Mar-2020 (UTC)
35 AlarmFc47 Timeout undertemperature sensor T1 Yes Coane, John 02-Mar-2020 (UTC)
36 AlarmFc48 Timeout undertemperature sensor T2 Yes Coane, John 02-Mar-2020 (UTC)
37 AlarmFc49 Timeout undertemperature sensor T3 Yes Coane, John 02-Mar-2020 (UTC)
38 AlarmFc50 Timeout undertemperature sensor T4 Yes Coane, John 02-Mar-2020 (UTC)

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Table 1: Alarm and Interlock Testing

# Alarm ID # Alarm Description Alarm / Interlock Condition Met? Performed By Date
(Yes / No)
39 AlarmFc51 Timeout undertemperature sensor T5 Yes Coane, John 02-Mar-2020 (UTC)
40 AlarmFc54 Timeout undertemperature sensor T8 Yes Coane, John 02-Mar-2020 (UTC)
41 AlarmFc56 Timeout undertemperature sensor T10 Yes Coane, John 02-Mar-2020 (UTC)
42 AlarmFc57 Timeout undertemperature sensor T11 Yes Coane, John 02-Mar-2020 (UTC)
43 AlarmFc58 Timeout undertemperature sensor T12 Yes Coane, John 02-Mar-2020 (UTC)
44 AlarmFc79 Overtemperature sensor T1 Yes Coane, John 02-Mar-2020 (UTC)
45 AlarmFc80 Overtemperature sensor T2 Yes Coane, John 02-Mar-2020 (UTC)
46 AlarmFc81 Overtemperature sensor T3 Yes Coane, John 02-Mar-2020 (UTC)
47 AlarmFc82 Overtemperature sensor T4 Yes Coane, John 02-Mar-2020 (UTC)
48 AlarmFc83 Overtemperature sensor T5 Yes Coane, John 02-Mar-2020 (UTC)
49 AlarmFc86 Overtemperature sensor T8 Yes Coane, John 02-Mar-2020 (UTC)
50 AlarmFc88 Overtemperature sensor T10 Yes Coane, John 02-Mar-2020 (UTC)
51 AlarmFc89 Overtemperature sensor T11 Yes Coane, John 02-Mar-2020 (UTC)
52 AlarmFc90 Overtemperature sensor T12 Yes Coane, John 02-Mar-2020 (UTC)

53 AlarmFc95 Correlation - Chamber pressure in relation to chamber temperature too Yes Coane, John 02-Mar-2020 (UTC)
high
54 AlarmFc96 Undertemperature T1 Yes Coane, John 02-Mar-2020 (UTC)
55 AlarmFc97 Undertemperature T2 Yes Coane, John 02-Mar-2020 (UTC)
56 AlarmFc98 Undertemperature T3 Yes Coane, John 02-Mar-2020 (UTC)
57 AlarmFc99 Undertemperature T4 Yes Coane, John 02-Mar-2020 (UTC)
58 AlarmFc100 Undertemperature T5 Yes Coane, John 02-Mar-2020 (UTC)
59 AlarmFc103 Undertemperature T8 Yes Coane, John 02-Mar-2020 (UTC)
60 AlarmFc105 Undertemperature T10 Yes Coane, John 02-Mar-2020 (UTC)
61 AlarmFc106 Undertemperature T11 Yes Coane, John 02-Mar-2020 (UTC)

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Table 1: Alarm and Interlock Testing

# Alarm ID # Alarm Description Alarm / Interlock Condition Met? Performed By Date
(Yes / No)
62 AlarmFc107 Undertemperature T12 Yes Coane, John 02-Mar-2020 (UTC)
63 AlarmFc112 Correlation - Chamber pressure in relation to chamber temperature too Yes Coane, John 02-Mar-2020 (UTC)
small
64 AlarmFc116 No monitoring sensor parameterized Yes Coane, John 02-Mar-2020 (UTC)
65 AlarmFc117 Too short sterilization time or too low sterilization temperature to Yes Coane, John 02-Mar-2020 (UTC)
parameterized
66 AlarmFc118 Temperature difference between monitoring sensors is too large Yes Coane, John 02-Mar-2020 (UTC)
67 AlarmFc119 Temperature monitoring sensor during sterilization too low Yes Coane, John 02-Mar-2020 (UTC)
68 AlarmFc126 Failure chamber pressure sensor P1 Yes Coane, John 02-Mar-2020 (UTC)
69 AlarmFc127 Failure chamber pressure sensor P1 and P2 Yes Coane, John 02-Mar-2020 (UTC)
70 AlarmFc128 Difference between chamber pressure sensors too large Yes Coane, John 02-Mar-2020 (UTC)
71 AlarmFc129 Maximum chamber pressure exceeded Yes Coane, John 02-Mar-2020 (UTC)
72 AlarmFc130 Maximum jacket pressure exceeded Yes Coane, John 02-Mar-2020 (UTC)
73 AlarmFc131 Deviation from theoretical ambient pressure too large Yes Coane, John 02-Mar-2020 (UTC)
74 AlarmFc136 Timeout during closing door 1 Yes Coane, John 02-Mar-2020 (UTC)
75 AlarmFc137 Timeout during opening door 1 Yes Coane, John 02-Mar-2020 (UTC)
76 AlarmFc138 Door 1 has opened without permission Yes Coane, John 02-Mar-2020 (UTC)
77 AlarmFc139 Safety bar has been actuated during closing door 1 Yes Coane, John 02-Mar-2020 (UTC)
78 AlarmFc140 Timeout pressing on door seal 1 Yes Coane, John 02-Mar-2020 (UTC)
79 AlarmFc141 Timeout releasing door seal 1 Yes Coane, John 02-Mar-2020 (UTC)
80 AlarmFc151 Door 1 does not move due to missing release Yes Coane, John 02-Mar-2020 (UTC)
81 AlarmFc153 Process was not sterile Yes Coane, John 02-Mar-2020 (UTC)
82 AlarmFc154 Door release type requires both doors N/A Coane, John 02-Mar-2020 (UTC)
83 AlarmFc155 Both doors open N/A Coane, John 02-Mar-2020 (UTC)
84 AlarmFc167 Leakage test not passed Yes Coane, John 02-Mar-2020 (UTC)

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Table 1: Alarm and Interlock Testing

# Alarm ID # Alarm Description Alarm / Interlock Condition Met? Performed By Date
(Yes / No)
85 AlarmFc183 Circulation container, timeout overtemperature Yes Coane, John 02-Mar-2020 (UTC)
86 AlarmFc185 Circulation container, overtemperature Yes Coane, John 02-Mar-2020 (UTC)
87 AlarmFc186 Jacket, timeout under pressure Yes Coane, John 02-Mar-2020 (UTC)
88 AlarmHw1 Emergency stop active Yes Coane, John 02-Mar-2020 (UTC)
89 AlarmHw2 Forcing active Yes Coane, John 02-Mar-2020 (UTC)
90 AlarmHw21 Breakdown power supply Yes Coane, John 02-Mar-2020 (UTC)
91 AlarmHw22 Breakdown power supply, with active motors Yes Coane, John 02-Mar-2020 (UTC)
92 AlarmHw23 24 VDC, fuse tripped Yes Coane, John 02-Mar-2020 (UTC)
93 AlarmHw24 Breakdown power supply, timeout internal UPS Yes Coane, John 02-Mar-2020 (UTC)
94 AlarmHw25 Internal UPS, failure state Yes Coane, John 02-Mar-2020 (UTC)
95 AlarmHw29 Overtemperature control cabinet Yes Coane, John 02-Mar-2020 (UTC)
96 AlarmHw35 Service door side 1 open, door 1 can not move Yes Coane, John 02-Mar-2020 (UTC)
97 AlarmHw37 Service switch side 1 is switched, door 1 can not move N/A Coane, John 02-Mar-2020 (UTC)
98 AlarmHw41 Door drive side 1, fuse tripped Yes Coane, John 02-Mar-2020 (UTC)
99 AlarmHw45 Vacuum pump, fuse tripped Yes Coane, John 02-Mar-2020 (UTC)
100 AlarmHw47 Fan 1, fuse tripped Yes Coane, John 02-Mar-2020 (UTC)
101 AlarmHw55 Power supply unit control, fuse tripped Yes Coane, John 02-Mar-2020 (UTC)
102 AlarmHw56 Power supply unit power, fuse tripped Yes Coane, John 02-Mar-2020 (UTC)
103 AlarmHw57 LED lighting, fuse tripped Yes Coane, John 02-Mar-2020 (UTC)
104 AlarmHw58 Phase monitoring, fuse tripped Yes Coane, John 02-Mar-2020 (UTC)
105 AlarmHw110 Sensor chamber pressure P1, input value under limit or exceeded limit Yes Coane, John 02-Mar-2020 (UTC)
106 AlarmHw112 Sensor chamber pressure P2, input value under limit or exceeded limit Yes Coane, John 02-Mar-2020 (UTC)
107 AlarmHw114 Sensor jacket pressure P3, input value under limit or exceeded limit Yes Coane, John 02-Mar-2020 (UTC)
108 AlarmHw116 Sensor steam supply pressure P4, input value under limit or exceeded Yes Coane, John 02-Mar-2020 (UTC)
limit

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Table 1: Alarm and Interlock Testing

# Alarm ID # Alarm Description Alarm / Interlock Condition Met? Performed By Date
(Yes / No)
109 AlarmHw130 Sensor chamber temperature T1, input value under limit or exceeded Yes Coane, John 02-Mar-2020 (UTC)
limit
110 AlarmHw132 Sensor chamber temperature exit T2, input value under limit or Yes Coane, John 02-Mar-2020 (UTC)
exceeded limit
111 AlarmHw134 Sensor product temperature 1 T3, input value under limit or exceeded Yes Coane, John 02-Mar-2020 (UTC)
limit
112 AlarmHw136 Sensor chamber temperature 2 T4, input value under limit or exceeded Yes Coane, John 02-Mar-2020 (UTC)
limit
113 AlarmHw138 Sensor areation filter temperature T5, input value under limit or Yes Coane, John 02-Mar-2020 (UTC)
exceeded limit

114 AlarmHw144 Sensor air detector temperature T8, input value under limit or Yes Coane, John 02-Mar-2020 (UTC)
exceeded limit
115 AlarmHw148 Sensor cooling temperature backflow T10, input value under limit or Yes Coane, John 02-Mar-2020 (UTC)
exceeded limit
116 AlarmHw150 Sensor condensator temperature T11, input value under limit or Yes Coane, John 02-Mar-2020 (UTC)
exceeded limit
117 AlarmHw152 Sensor circulation container temperature T12, input value under limit or Yes Coane, John 02-Mar-2020 (UTC)
exceeded limit
118 AlarmHmi1 Automatic creation of report at end of batch failed Yes Coane, John 02-Mar-2020 (UTC)
119 AlarmHmi2 Automatic print of report at end of batch failed Yes Coane, John 02-Mar-2020 (UTC)
120 AlarmHmi3 Automatic export of report as PDF at end of batch failed Yes Coane, John 02-Mar-2020 (UTC)

Table 2:  Alarm Testing Attachment

Attachment Description Attachment Performed By Date
Manufacturer's Alarm Testing Alarm Verification_SAT.pdf Coane, John 02-Mar-2020 (UTC)

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Test Review (To be completed by Validation)

# Summary (Yes / No / N/A) Performed By Date
1 All critical alarms and interlocks associated with the system functioned as designed? Yes Coane, John 02-Mar-2020 (UTC)
2 Deviation(s) required? No Coane, John 02-Mar-2020 (UTC)
3 Deviation(s) resolved and referenced, if applicable? N/A Coane, John 02-Mar-2020 (UTC)

Comments
# Comments Performed By Date
1 No comments Coane, John 02-Mar-2020 (UTC)
2      
3      
Note: If there are no comments in the "Comments" table above, type "No Comments" in the first line. The remaining empty rows will be considered "N/A". Otherwise, "N/A" all unused rows.

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12.3 Power Backup Testing (IOQ - AUT-10202-CAM-03-12)

1. Test Objective

Provide evidence that the unit's internal backup power system is functional and restores critical system functionality after a primary power loss.

2. Scope

This section is only applicable to test the internal back-up power of System #  AUT-10202 and is not applicable to systems with no user requirement for
backup power.

3. Acceptance Criteria

• The system maintained the current equipment settings and operating parameters after a primary power loss.

• The system successfully reconnected to all control and/or monitoring systems.

12.3.1 Field Execution - Power Backup Testing (IOQ - AUT-10202-CAM-03-12)

Table 1: Power Backup Testing (see Note 1)

# Procedure Expected Result Actual Result Pass / Fail Performed By Date
1 Verify all As-Found parameters of All As-Found parameters of the  All As-Found parameters of the Pass Coane, John 07-Feb-2020
every programmed recipe have programmed recipes have been programmed recipes have been (UTC)
been documented in Section documented in Section 12.4.1. documented in Section 12.4.1.
12.4.1.
2  Start a Wrapped Goods cycle. Wrapped goods cycle has begun.  Wrapped goods cycle started at Pass Coane, John 07-Feb-2020
1413 07Feb20 (UTC)
3  Simulate a power failure during Power failure is simulated during the cycle.  Power failure was simulated Pass Coane, John 07-Feb-2020
the cycle. Document date and time Date and time of failure is documented. during the cycle at 2:35pm (UTC)
of failure initiation. 07Feb20

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Table 1: Power Backup Testing (see Note 1)

# Procedure Expected Result Actual Result Pass / Fail Performed By Date
4  Attempt to open the autoclave  Autoclave doors remain closed and  Autoclave doors remained closed Pass Coane, John 07-Feb-2020
doors. locked.  and locked and could not be (UTC)
opened during the power failure.
5  Allow a minimum of 15 minutes to  A minimum of 15 minutes has lapsed. The  Power restored at 1453 07Feb20. Pass Coane, John 07-Feb-2020
lapse prior to restoring power to total lapsed time is recorded. This is an lapsed time of 18 (UTC)
the system. minutes.
6  Restore power and attempt to  Power is restored and a failure alarm is  Power is restored and a failure Pass Coane, John 07-Feb-2020
continue running the cycle. Verify present. HMI shows power failure. Cycle alarm is present. HMI shows (UTC)
cycle is aborted. abort is verified. power failure. Cycle abort is
verified.
7  Verify that all As-Found All As-Found parameters documented in  All As-Found parameters Pass Coane, John 13-Feb-2020
parameters documented in Section Section 12.4.1 remain unchanged following documented in Section 12.4.1 (UTC)
12.4.1 remain unchanged following power failure. remain unchanged following
power failure. power failure.
Note 1:  Power Backup Testing shall be performed concurrently with Set Point Verification. 

Test Review (To be completed by Validation)

# Summary (Yes / No / N/A) Performed By Date
1 System maintained the current settings and parameters after a primary power loss? Yes Coane, John 13-Feb-2020
(UTC)
2 System reconnected to all control and monitoring systems after primary power was restored? Yes Coane, John 13-Feb-2020
(UTC)
3 Deviation(s) required? No Coane, John 02-Mar-2020
(UTC)
4 Deviation(s) resolved and referenced, if applicable? N/A Coane, John 02-Mar-2020
(UTC)

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Comments
# Comments: Performed By Date
1 Table 1 line 6 the batch report for this cycle was corrupted and could not be printed as the system did not properly shutdown. The Batch Coane, John 06-Mar-2020
Number is 221 (Wrapped Goods Cycle). (UTC)
2  N/A Coane, John 06-Mar-2020
(UTC)
3  N/A Coane, John 06-Mar-2020
(UTC)
Note: If there are no comments in the "Comments" table above, type "No Comments" in the first line. The remaining empty rows will be considered
"N/A". Otherwise, "N/A" all unused rows.

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 Document Name: Installation and Operational Qualification Protocol for AUT-10202

12.4 Set Point Verification (IOQ - AUT-10202-CAM-03-13)

1. Test Objective

Record the as-found and as-left critical system settings and setpoints.

2. Scope

This test section will cover the System #  AUT-10202 settings. The verification will consist on documenting the
settings as found on the system prior to OQ Qualification testing and a confirmation of the as-left equipment and
control settings.

3.  Acceptance Criteria

• The as-found settings and/or setpoints on the system were recorded prior to qualification testing.

• The as-left settings and/or setpoints on the system were recorded at the conclusion of all testing.  

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12.4.1 Field Execution - Pre-Execution Set Point Verification (IOQ - AUT-10202-CAM-03-13)

Procedure:

1. Record the as-found settings, parameters, and/or set points on the system in Table 1, Table 2, Table 3, and Table 4.
2. This test case shall be performed concurrently with Power Backup Testing.

 
Table 1: As-Found Wrapped Goods Parameter Verification
Parameter Expected Parameter Value As-Found Parameter Value Parameter Value Acceptable? Performed By Date
(Yes / No)
Jacket pressure  2150 mbar  2150 mbar Yes Coane, John 02-Mar-2020 (UTC)
Liquid sterilization program  not active  not active Yes Coane, John 06-Feb-2020 (UTC)
Temperature monitoring pre-  Active Sensor 1, Sensor 2   Active Sensor 1, Sensor 2 Yes Coane, John 06-Feb-2020 (UTC)
Treatment
Pos. temperature hysteresis   5.0 °C  5.0 °C Yes Coane, John 06-Feb-2020 (UTC)
Neg. temperature hysteresis   1.0 °C  1.0 °C Yes Coane, John 06-Feb-2020 (UTC)
Air detector   not active  not active Yes Coane, John 06-Feb-2020 (UTC)
Temperature monitoring Active Sensor 1, Sensor 2  Active Sensor 1, Sensor 2 Yes Coane, John 06-Feb-2020 (UTC)
sterilization
Correlation monitoring  not active  not active Yes Coane, John 06-Feb-2020 (UTC)
Differential monitoring of control  active  active Yes Coane, John 06-Feb-2020 (UTC)
sensors
F0 value calculation   not active  not active Yes Coane, John 06-Feb-2020 (UTC)
Pos. temperature hysteresis   3.0°C  3.0°C Yes Coane, John 06-Feb-2020 (UTC)
Neg. temperature hysteresis   0.0°C  0.0°C Yes Coane, John 06-Feb-2020 (UTC)
Temperature monitoring Post  Active Sensor 1, Sensor 2  Active Sensor 1, Sensor 2 Yes Coane, John 06-Feb-2020 (UTC)
Treatment

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 Equipment ID:  AUT-10202 
 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Table 1: As-Found Wrapped Goods Parameter Verification

Parameter Expected Parameter Value As-Found Parameter Value Parameter Value Acceptable? Performed By Date
(Yes / No)
Pos. temperature hysteresis   3.0°C  3.0°C Yes Coane, John 06-Feb-2020 (UTC)
Neg. temperature hysteresis   3.0°C  3.0°C Yes Coane, John 06-Feb-2020 (UTC)
Ventilation filter FIS active   not active  not active Yes Coane, John 06-Feb-2020 (UTC)
Ventilation filter FIF active   not active  not active Yes Coane, John 06-Feb-2020 (UTC)
Basic time interval for recording   5 sec.  5 sec. Yes Coane, John 06-Feb-2020 (UTC)
Batch Report  Temp: Active Sensor 1, Sensor 2, Sensor 3  Active Sensor 1, Sensor 2, Sensor 3 Yes Coane, John 06-Feb-2020 (UTC)
StemFract Program Parameters   Program Parameters Yes Coane, John 06-Feb-2020 (UTC)
Number of fractions  4  4 Yes Coane, John 06-Feb-2020 (UTC)
Jacket heating  active  active Yes Coane, John 06-Feb-2020 (UTC)
Fan  not active  not active Yes Coane, John 06-Feb-2020 (UTC)
Evacuation target value  60 mbar  60 mbar Yes Coane, John 06-Feb-2020 (UTC)
Evacuation ramp  500 mbar/min  500 mbar/min Yes Coane, John 06-Feb-2020 (UTC)
Additional value evacuation  60 mba  60 mbar Yes Coane, John 06-Feb-2020 (UTC)
Additional time evacuation  60 sec  60 sec Yes Coane, John 06-Feb-2020 (UTC)
Steam target value  2010 mbar  2010 mbar Yes Coane, John 06-Feb-2020 (UTC)
Steam ramp  400 mbar/min  400 mbar/min Yes Coane, John 06-Feb-2020 (UTC)
Steam monitoring temperature  0.0 °C  0.0 °C Yes Coane, John 06-Feb-2020 (UTC)
Additional value steam  2010 mbar  2010 mbar Yes Coane, John 06-Feb-2020 (UTC)
Additional time steam  60 sec  60 sec Yes Coane, John 06-Feb-2020 (UTC)
Report filter value  6  6 Yes Coane, John 06-Feb-2020 (UTC)
SteamFract Program Parameters   Program Parameters Yes Coane, John 06-Feb-2020 (UTC)
Number of fractions   1  1 Yes Coane, John 06-Feb-2020 (UTC)
Jacket heating   active  active Yes Coane, John 06-Feb-2020 (UTC)
Fan   active  active Yes Coane, John 06-Feb-2020 (UTC)
Evacuation target value  1013 mbar  1013 mbar Yes Coane, John 06-Feb-2020 (UTC)

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Table 1: As-Found Wrapped Goods Parameter Verification

Parameter Expected Parameter Value As-Found Parameter Value Parameter Value Acceptable? Performed By Date
(Yes / No)
Evacuation ramp  400 mbar/min  400 mbar/min Yes Coane, John 06-Feb-2020 (UTC)
Additional value evacuation  1013 mbar  1013 mbar Yes Coane, John 06-Feb-2020 (UTC)
Additional time evacuation  0 sec  0 sec Yes Coane, John 06-Feb-2020 (UTC)
Steam target value  2220 mbar  2220 mbar Yes Coane, John 06-Feb-2020 (UTC)
Steam ramp  70 mbar/min  70 mbar/min Yes Coane, John 06-Feb-2020 (UTC)
Steam monitoring temperature  0.0 °C  0.0 °C Yes Coane, John 06-Feb-2020 (UTC)
Additional value steam  2242 mbar  2242 mbar Yes Coane, John 06-Feb-2020 (UTC)
Additional time steam  0 sec  0 sec Yes Coane, John 06-Feb-2020 (UTC)
Report filter value  6  6 Yes Coane, John 06-Feb-2020 (UTC)
SteriPres  Program Parameters   Program Parameters Yes Coane, John 06-Feb-2020 (UTC)
Support pressure   not active  not active Yes Coane, John 06-Feb-2020 (UTC)
Jacket heating   active  active Yes Coane, John 06-Feb-2020 (UTC)
Fan   not active  not active Yes Coane, John 06-Feb-2020 (UTC)
Steam target value   2242 mbar  2242 mbar Yes Coane, John 06-Feb-2020 (UTC)
Steam ramp  1000 mbar/min  1000 mbar/min Yes Coane, John 06-Feb-2020 (UTC)
Sterilization monitoring 123.2 °C  123.2 °C Yes Coane, John 06-Feb-2020 (UTC)
temperature 
Sterilization time   1800 sec  1800 sec Yes Coane, John 06-Feb-2020 (UTC)
Report filter value  6  6 Yes Coane, John 06-Feb-2020 (UTC)
AirFract Program Parameters  Program Parameters Yes Coane, John 06-Feb-2020 (UTC)
Number of fractions   2  2 Yes Coane, John 06-Feb-2020 (UTC)
Jacket heating   active  active Yes Coane, John 06-Feb-2020 (UTC)
Fan   active  active Yes Coane, John 06-Feb-2020 (UTC)
Evacuation target value  100 mbar  100 mbar Yes Coane, John 06-Feb-2020 (UTC)
Evacuation ramp  1000 mbar/min  1000 mbar/min Yes Coane, John 06-Feb-2020 (UTC)

Page 106 of 196 01-Mar-2023 (UTC)

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 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Table 1: As-Found Wrapped Goods Parameter Verification

Parameter Expected Parameter Value As-Found Parameter Value Parameter Value Acceptable? Performed By Date
(Yes / No)
Additional value evacuation  100 mbar  100 mbar Yes Coane, John 06-Feb-2020 (UTC)
Additional time evacuation  600 sec  60 sec No Coane, John 06-Feb-2020 (UTC)
Ventilation target value  800 mbar  800 mbar Yes Coane, John 06-Feb-2020 (UTC)
Ventilation ramp  1000 mbar/min  1000 mbar/min Yes Coane, John 06-Feb-2020 (UTC)
Additional value ventilation  800 mbar  800 mbar Yes Coane, John 06-Feb-2020 (UTC)
Additional time ventilation  90 sec  90 sec Yes Coane, John 06-Feb-2020 (UTC)
Report filter value  6  6 Yes Coane, John 06-Feb-2020 (UTC)
AirFract Program Parameters  Program Parameters Yes Coane, John 06-Feb-2020 (UTC)
Number of fractions   1  1 Yes Coane, John 06-Feb-2020 (UTC)
Jacket heating   active  active Yes Coane, John 06-Feb-2020 (UTC)
Fan   not active  not active Yes Coane, John 06-Feb-2020 (UTC)
Evacuation target value  100 mbar  100 mbar Yes Coane, John 06-Feb-2020 (UTC)
Evacuation ramp  1000 mbar/min  1000 mbar/min Yes Coane, John 06-Feb-2020 (UTC)
Additional value evacuation  100 mbar  100 mbar Yes Coane, John 06-Feb-2020 (UTC)
Additional time evacuation  0 sec  0 sec Yes Coane, John 06-Feb-2020 (UTC)
Ventilation target value  800 mbar  800 mbar Yes Coane, John 06-Feb-2020 (UTC)
Ventilation ramp  1000 mbar/min  1000 mbar/min Yes Coane, John 02-Mar-2020 (UTC)
Additional value ventilation  800 mbar  800 mbar Yes Coane, John 06-Feb-2020 (UTC)
Additional time ventilation  90 sec  90 sec Yes Coane, John 06-Feb-2020 (UTC)
Report filter value  6  6 Yes Coane, John 06-Feb-2020 (UTC)
LastAirFract Program Parameters  Program Parameters Yes Coane, John 06-Feb-2020 (UTC)
Jacket heating   active  active Yes Coane, John 06-Feb-2020 (UTC)
Fan   not active  not active Yes Coane, John 06-Feb-2020 (UTC)
Evacuation target value  100 mbar  100 mbar Yes Coane, John 06-Feb-2020 (UTC)
Evacuation ramp  1000 mbar/min  1000 mbar/min Yes Coane, John 06-Feb-2020 (UTC)

Page 107 of 196 01-Mar-2023 (UTC)

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 Equipment ID:  AUT-10202 
 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Table 1: As-Found Wrapped Goods Parameter Verification

Parameter Expected Parameter Value As-Found Parameter Value Parameter Value Acceptable? Performed By Date
(Yes / No)
Additional value evacuation  100 mbar  100 mbar Yes Coane, John 06-Feb-2020 (UTC)
Additional time evacuation  0 sec  0 sec Yes Coane, John 06-Feb-2020 (UTC)
Ventilation ramp  1000 mbar/min  1000 mbar/min Yes Coane, John 06-Feb-2020 (UTC)
Report filter value  6  6 Yes Coane, John 06-Feb-2020 (UTC)
 

Table 2: As-Found Bowie Dick Test Parameter Verification

Parameter Expected Parameter Value As-Found Parameter Value Parameter Values Performed By Date
Acceptable? (Yes / No)
Jacket pressure  2064 mbar  2064 mbar Yes Coane, John 06-Feb-2020 (UTC)
Liquid sterilization program  not active  not active Yes Coane, John 06-Feb-2020 (UTC)
Temperature monitoring Pre  Active Sensor 1, Sensor 2  Active Sensor 1, Sensor 2 Yes Coane, John 06-Feb-2020 (UTC)
Treatment
Pos. temperature hysteresis   5.0 °C  5.0 °C Yes Coane, John 06-Feb-2020 (UTC)
Neg. temperature hysteresis   1.0 °C  1.0 °C Yes Coane, John 06-Feb-2020 (UTC)
Air detector   not active  not active Yes Coane, John 06-Feb-2020 (UTC)
Correlation monitoring  active  active Yes Coane, John 06-Feb-2020 (UTC)
Differential monitoring of control  active  active Yes Coane, John 06-Feb-2020 (UTC)
sensors
F0 value calculation   not active  not active Yes Coane, John 06-Feb-2020 (UTC)
Temperature monitoring  Active Sensor 1, Sensor 2  Active Sensor 1, Sensor 2 Yes Coane, John 06-Feb-2020 (UTC)
sterilization 
Pos. temperature hysteresis   3.0°C  3.0°C Yes Coane, John 06-Feb-2020 (UTC)
Neg. temperature hysteresis   0.0°C  0.0°C Yes Coane, John 06-Feb-2020 (UTC)
Temperature monitoring Post  None  None Yes Coane, John 06-Feb-2020 (UTC)
Treatment
Pos. temperature hysteresis   0.0°C  0.0°C Yes Coane, John 06-Feb-2020 (UTC)

Page 108 of 196 01-Mar-2023 (UTC)

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 Equipment ID:  AUT-10202 
 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Table 2: As-Found Bowie Dick Test Parameter Verification

Parameter Expected Parameter Value As-Found Parameter Value Parameter Values Performed By Date
Acceptable? (Yes / No)
Neg. temperature hysteresis   0.0°C  0.0°C Yes Coane, John 06-Feb-2020 (UTC)
 Ventilation filter FIS active  not active   not active Yes Coane, John 06-Feb-2020 (UTC)
 Ventilation filter FIS active  not   not active Yes Coane, John 06-Feb-2020 (UTC)
Basic time interval for recording   10 sec.  10 sec. Yes Coane, John 06-Feb-2020 (UTC)
Batch Report Sensors  Active Sensor 1, Sensor 2  Active Sensor 1, Sensor 2 Yes Coane, John 06-Feb-2020 (UTC)
StemFract Program Parameters   Program Parameters Yes Coane, John 06-Feb-2020 (UTC)
Number of fractions   4  4 Yes Coane, John 06-Feb-2020 (UTC)
Jacket heating   active  active Yes Coane, John 06-Feb-2020 (UTC)
Fan   not active  not active Yes Coane, John 06-Feb-2020 (UTC)
Evacuation target value   60 mbar  60 mbar Yes Coane, John 06-Feb-2020 (UTC)
Evacuation ramp   500 mbar/min  500 mbar/min Yes Coane, John 06-Feb-2020 (UTC)
Additional value evacuation   60 mbar  60 mbar Yes Coane, John 06-Feb-2020 (UTC)
Additional time evacuation   60 sec  60 sec Yes Coane, John 06-Feb-2020 (UTC)
Steam target value  2010 mbar  2010 mbar Yes Coane, John 06-Feb-2020 (UTC)
Steam ramp  400 mbar/min  400 mbar/min Yes Coane, John 06-Feb-2020 (UTC)
Steam monitoring temperature  0.0 °C  0.0 °C Yes Coane, John 06-Feb-2020 (UTC)
Additional value steam  2010 mbar  2010 mbar Yes Coane, John 06-Feb-2020 (UTC)
Additional time steam  60 sec  60 sec Yes Coane, John 06-Feb-2020 (UTC)
Report filter value  6 **  6  Yes Coane, John 06-Mar-2020 (UTC)
StemFract Program Parameters   Program Parameters Yes Coane, John 06-Feb-2020 (UTC)
Number of fractions   1  1 Yes Coane, John 06-Feb-2020 (UTC)
Jacket heating   active  active Yes Coane, John 06-Feb-2020 (UTC)
Fan   active  active Yes Coane, John 06-Feb-2020 (UTC)
Evacuation target value   1013 mbar  1013 mbar Yes Coane, John 06-Feb-2020 (UTC)
Evacuation ramp   400 mbar/min  400 mbar/min Yes Coane, John 06-Feb-2020 (UTC)

Page 109 of 196 01-Mar-2023 (UTC)

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 Equipment ID:  AUT-10202 
 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Table 2: As-Found Bowie Dick Test Parameter Verification

Parameter Expected Parameter Value As-Found Parameter Value Parameter Values Performed By Date
Acceptable? (Yes / No)
Additional value evacuation   1013 mbar  1013 mbar Yes Coane, John 06-Feb-2020 (UTC)
Additional time evacuation   0 sec  0 sec Yes Coane, John 06-Feb-2020 (UTC)
Steam target value  2113 mbar  2113 mbar Yes Coane, John 06-Feb-2020 (UTC)
Steam ramp  70 mbar/min  70 mbar/min Yes Coane, John 06-Feb-2020 (UTC)
Steam monitoring temperature  0.0 °C  0.0 °C Yes Coane, John 06-Feb-2020 (UTC)
Additional value steam  2113 mbar  2113 mbar Yes Coane, John 06-Feb-2020 (UTC)
Additional time steam  0 sec  0 sec Yes Coane, John 06-Feb-2020 (UTC)
Report filter value  6  6 Yes Coane, John 06-Feb-2020 (UTC)
SteriPres  Program Parameters   Program Parameters Yes Coane, John 06-Feb-2020 (UTC)
Support pressure   not active  not active Yes Coane, John 06-Feb-2020 (UTC)
Jacket heating   active  active Yes Coane, John 06-Feb-2020 (UTC)
Fan   not active  not active Yes Coane, John 06-Feb-2020 (UTC)
Steam target value   2113 mbar  2113 mbar Yes Coane, John 06-Feb-2020 (UTC)
Steam ramp  300 mbar/min  300 mbar/min Yes Coane, John 06-Feb-2020 (UTC)
Sterilization monitoring 121.0 °C  121.0 °C Yes Coane, John 06-Feb-2020 (UTC)
temperature 
Sterilization time   480 sec  480 sec Yes Coane, John 06-Feb-2020 (UTC)
Report filter value  6  6 Yes Coane, John 06-Feb-2020 (UTC)
AirFract Program Parameters  Program Parameters Yes Coane, John 06-Feb-2020 (UTC)
Number of fractions   1  1 Yes Coane, John 06-Feb-2020 (UTC)
Jacket heating   active  active Yes Coane, John 07-Feb-2020 (UTC)
Fan   not active  not active Yes Coane, John 07-Feb-2020 (UTC)
Evacuation target value  100 mbar  100 mbar Yes Coane, John 07-Feb-2020 (UTC)
Evacuation ramp  2000 mbar/min  2000 mbar/min Yes Coane, John 07-Feb-2020 (UTC)
Additional value evacuation  10 mbar  10mbar Yes Coane, John 07-Feb-2020 (UTC)

Page 110 of 196 01-Mar-2023 (UTC)

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 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Table 2: As-Found Bowie Dick Test Parameter Verification

Parameter Expected Parameter Value As-Found Parameter Value Parameter Values Performed By Date
Acceptable? (Yes / No)
Additional time evacuation  300 sec  300 sec Yes Coane, John 07-Feb-2020 (UTC)
Ventilation target value  800 mbar  800 mbar Yes Coane, John 07-Feb-2020 (UTC)
Ventilation ramp  1000 mbar/min  1000 mbar/min Yes Coane, John 07-Feb-2020 (UTC)
Additional value ventilation  800 mbar  800 mbar Yes Coane, John 07-Feb-2020 (UTC)
Additional time ventilation  0 sec  0 sec Yes Coane, John 07-Feb-2020 (UTC)
Report filter value  6  6 Yes Coane, John 07-Feb-2020 (UTC)
AirFract Program Parameters  Program Parameters Yes Coane, John 07-Feb-2020 (UTC)
Number of fractions   1  1 Yes Coane, John 07-Feb-2020 (UTC)
Jacket heating   active  active Yes Coane, John 07-Feb-2020 (UTC)
Fan   not active  not active Yes Coane, John 07-Feb-2020 (UTC)
Evacuation target value  100 mbar  100 mbar Yes Coane, John 07-Feb-2020 (UTC)
Evacuation ramp  2000 mbar/min  2000 mbar/min Yes Coane, John 07-Feb-2020 (UTC)
Additional value evacuation  10 mbar  10 mbar Yes Coane, John 07-Feb-2020 (UTC)
Additional time evacuation  30 sec  30 sec Yes Coane, John 07-Feb-2020 (UTC)
Ventilation target value  800 mbar  800 mbar Yes Coane, John 07-Feb-2020 (UTC)
Ventilation ramp  1000 mbar/min  1000 mbar/min Yes Coane, John 07-Feb-2020 (UTC)
Additional value ventilation  800 mbar  800 mbar Yes Coane, John 07-Feb-2020 (UTC)
Additional time ventilation  0 sec  0 sec Yes Coane, John 07-Feb-2020 (UTC)
Report filter value  6  6 Yes Coane, John 07-Feb-2020 (UTC)
LastAirFract Program Parameters  Program Parameters Yes Coane, John 07-Feb-2020 (UTC)
Jacket heating   active  active Yes Coane, John 07-Feb-2020 (UTC)
Fan   not active  not active Yes Coane, John 07-Feb-2020 (UTC)
Evacuation target value  100 mbar  100 mbar Yes Coane, John 07-Feb-2020 (UTC)
Evacuation ramp  2000 mbar/min  2000 mbar/min Yes Coane, John 07-Feb-2020 (UTC)
Additional value evacuation  10 mbar  10 mbar Yes Coane, John 07-Feb-2020 (UTC)

Page 111 of 196 01-Mar-2023 (UTC)

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 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Table 2: As-Found Bowie Dick Test Parameter Verification

Parameter Expected Parameter Value As-Found Parameter Value Parameter Values Performed By Date
Acceptable? (Yes / No)
Additional time evacuation  0 sec  0 sec Yes Coane, John 07-Feb-2020 (UTC)
Ventilation target value  0 mbar  0 mbar Yes Coane, John 07-Feb-2020 (UTC)
Ventilation ramp  1000 mbar/min  1000 mbar/min Yes Coane, John 07-Feb-2020 (UTC)
Report filter value  6  6 Yes Coane, John 07-Feb-2020 (UTC)

Table 3: As-Found Leak Test Parameter Verification

Parameter Expected Parameter Value As-Found Parameter Value Parameter Values Acceptable? Performed By Date
(Yes / No)
Jacket pressure  2050 mbar  2050 mbar Yes Coane, John 07-Feb-2020 (UTC)
Liquid sterilization program  not active  not active Yes Coane, John 07-Feb-2020 (UTC)
Temperature monitoring pre- None  None Yes Coane, John 07-Feb-2020 (UTC)
Treatment
Pos. temperature hysteresis   0.0 °C  0.0 °C Yes Coane, John 07-Feb-2020 (UTC)
Neg. temperature hysteresis   0.0 °C  0.0 °C Yes Coane, John 07-Feb-2020 (UTC)
Air detector   not active  not active Yes Coane, John 07-Feb-2020 (UTC)
Temperature monitoring  None  None Yes Coane, John 07-Feb-2020 (UTC)
sterilization 
Correlation monitoring  not active  not active Yes Coane, John 07-Feb-2020 (UTC)
Differential monitoring of control  not active  not active Yes Coane, John 07-Feb-2020 (UTC)
sensors
F0 value calculation   not active  not active Yes Coane, John 07-Feb-2020 (UTC)
Temperature monitoring Post  None  None Yes Coane, John 07-Feb-2020 (UTC)
Treatment
Pos. temperature hysteresis   0.0°C  0.0°C Yes Coane, John 07-Feb-2020 (UTC)

Page 112 of 196 01-Mar-2023 (UTC)

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 Document Version:  1.0 
 Equipment ID:  AUT-10202 
 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Table 3: As-Found Leak Test Parameter Verification

Parameter Expected Parameter Value As-Found Parameter Value Parameter Values Acceptable? Performed By Date
(Yes / No)
Neg. temperature hysteresis   0.0°C  0.0°C Yes Coane, John 07-Feb-2020 (UTC)
Ventilation filter FIS active   active  active Yes Coane, John 07-Feb-2020 (UTC)
Ventilation filter FIF active   not active  not active Yes Coane, John 07-Feb-2020 (UTC)
Basic time interval for recording   10 sec.  10 sec. Yes Coane, John 07-Feb-2020 (UTC)
Temperature monitoring   Active Sensor 1  Active Sensor 1 Yes Coane, John 07-Feb-2020 (UTC)
 VacLeakTest  Program Values  Program Values Yes Coane, John 07-Feb-2020 (UTC)
Jacket heating   active  active Yes Coane, John 07-Feb-2020 (UTC)
Fan   not active  not active Yes Coane, John 07-Feb-2020 (UTC)
Evacuation target value  70 mbar  70 mbar Yes Coane, John 07-Feb-2020 (UTC)
Evacuation ramp  2000 mbar/min  2000 mbar/min Yes Coane, John 07-Feb-2020 (UTC)
Stabilization time  300 sec  300 sec Yes Coane, John 07-Feb-2020 (UTC)
Test time   600 sec  600 sec Yes Coane, John 07-Feb-2020 (UTC)
Ventilation ramp   1000 mbar/min  1000 mbar/min Yes Coane, John 07-Feb-2020 (UTC)
Report filter value   6  6 Yes Coane, John 07-Feb-2020 (UTC)

Table 4: As-Found Filter Inline Sterilization Parameter Verification

Parameter Expected Parameter Value As-Found Parameter Value Parameter Values Acceptable? Performed By Date
(Yes / No)
Jacket pressure  2150 mbar  2150 mbar Yes Coane, John 07-Feb-2020 (UTC)
Liquid sterilization program  not active  not active Yes Coane, John 07-Feb-2020 (UTC)
Temperature monitoring pre-  Active Sensor 1, Sensor 2  Active Sensor 1, Sensor 2 Yes Coane, John 07-Feb-2020 (UTC)
Treatment
Pos. temperature hysteresis   5.0 °C  5.0 °C Yes Coane, John 07-Feb-2020 (UTC)
Neg. temperature hysteresis   1.0 °C  1.0 °C Yes Coane, John 07-Feb-2020 (UTC)

Page 113 of 196 01-Mar-2023 (UTC)

  Document Number:  IOQ - AUT-10202-CAM-03 
 Document Version:  1.0 
 Equipment ID:  AUT-10202 
 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Table 4: As-Found Filter Inline Sterilization Parameter Verification

Parameter Expected Parameter Value As-Found Parameter Value Parameter Values Acceptable? Performed By Date
(Yes / No)
Air detector   not active  not active Yes Coane, John 07-Feb-2020 (UTC)
Temperature monitoring Active Sensor 1, Sensor 2  Active Sensor 1, Sensor 2 Yes Coane, John 07-Feb-2020 (UTC)
sterilization
Correlation monitoring  not active  not active Yes Coane, John 07-Feb-2020 (UTC)
Differential monitoring of control  active  active Yes Coane, John 07-Feb-2020 (UTC)
sensors
F0 value calculation   not active  not active Yes Coane, John 07-Feb-2020 (UTC)
Pos. temperature hysteresis   3.0°C  3.0°C Yes Coane, John 07-Feb-2020 (UTC)
Neg. temperature hysteresis   0.0°C  0.0°C Yes Coane, John 07-Feb-2020 (UTC)
Temperature monitoring Post  Active Sensor 1, Sensor 2  Active Sensor 1, Sensor 2 Yes Coane, John 07-Feb-2020 (UTC)
Treatment
Pos. temperature hysteresis   3.0°C  3.0°C Yes Coane, John 07-Feb-2020 (UTC)
Neg. temperature hysteresis   3.0°C  3.0°C Yes Coane, John 07-Feb-2020 (UTC)
Ventilation filter FIS active   active  active Yes Coane, John 07-Feb-2020 (UTC)
Ventilation filter FIF active   not active  not active Yes Coane, John 07-Feb-2020 (UTC)
Basic time interval for recording   5 sec.  5 sec. Yes Coane, John 07-Feb-2020 (UTC)
Batch report  Temp: Active Sensor 1, Sensor 2, Sensor 3  Temp: Active Sensor 1, Sensor 2, Sensor 3 Yes Coane, John 07-Feb-2020 (UTC)
StemFract Program Parameters   Program Parameters Yes Coane, John 07-Feb-2020 (UTC)
Number of fractions  4  4 Yes Coane, John 07-Feb-2020 (UTC)
Jacket heating  active  active Yes Coane, John 07-Feb-2020 (UTC)
Fan  not active  not active Yes Coane, John 07-Feb-2020 (UTC)
Evacuation target value  60 mbar  60 mbar Yes Coane, John 07-Feb-2020 (UTC)
Evacuation ramp  500 mbar/min  500 mbar/min Yes Coane, John 07-Feb-2020 (UTC)
Additional value evacuation  60 mba  60 mbar Yes Coane, John 07-Feb-2020 (UTC)
Additional time evacuation  60 sec  60 sec Yes Coane, John 07-Feb-2020 (UTC)
Steam target value  2010 mbar  2010 mbar Yes Coane, John 07-Feb-2020 (UTC)

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Table 4: As-Found Filter Inline Sterilization Parameter Verification

Parameter Expected Parameter Value As-Found Parameter Value Parameter Values Acceptable? Performed By Date
(Yes / No)
Steam ramp  400 mbar/min  400 mbar/min Yes Coane, John 07-Feb-2020 (UTC)
Steam monitoring temperature  0.0 °C  0.0 °C Yes Coane, John 07-Feb-2020 (UTC)
Additional value steam  2010 mbar  2010 mbar Yes Coane, John 07-Feb-2020 (UTC)
Additional time steam  60 sec  60 sec Yes Coane, John 07-Feb-2020 (UTC)
Report filter value  6  6 Yes Coane, John 07-Feb-2020 (UTC)
SteamFract Program Parameters   Program Parameters Yes Coane, John 07-Feb-2020 (UTC)
Number of fractions   1  1 Yes Coane, John 07-Feb-2020 (UTC)
Jacket heating   active  active Yes Coane, John 07-Feb-2020 (UTC)
Fan   active  active Yes Coane, John 07-Feb-2020 (UTC)
Evacuation target value  1013 mbar  1013 mbar Yes Coane, John 07-Feb-2020 (UTC)
Evacuation ramp  400 mbar/min  400 mbar/min Yes Coane, John 07-Feb-2020 (UTC)
Additional value evacuation  1013 mbar  1013 mbar Yes Coane, John 07-Feb-2020 (UTC)
Additional time evacuation  0 sec  0 sec Yes Coane, John 07-Feb-2020 (UTC)
Steam target value  2220 mbar  2220 mbar Yes Coane, John 07-Feb-2020 (UTC)
Steam ramp  70 mbar/min  70 mbar/min Yes Coane, John 07-Feb-2020 (UTC)
Steam monitoring temperature  0.0 °C  0.0 °C Yes Coane, John 07-Feb-2020 (UTC)
Additional value steam  2242 mbar  2242 mbar Yes Coane, John 07-Feb-2020 (UTC)
Additional time steam  0 sec  0 sec Yes Coane, John 07-Feb-2020 (UTC)
Report filter value  6  6 Yes Coane, John 07-Feb-2020 (UTC)
SteriPres  Program Parameters   Program Parameters Yes Coane, John 07-Feb-2020 (UTC)
Support pressure   not active  not active Yes Coane, John 07-Feb-2020 (UTC)
Jacket heating   active  active Yes Coane, John 07-Feb-2020 (UTC)
Fan   not active  not active Yes Coane, John 07-Feb-2020 (UTC)
Steam target value   2242 mbar  2242 mbar Yes Coane, John 07-Feb-2020 (UTC)
Steam ramp  1000 mbar/min  1000 mbar/min Yes Coane, John 07-Feb-2020 (UTC)

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 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Table 4: As-Found Filter Inline Sterilization Parameter Verification

Parameter Expected Parameter Value As-Found Parameter Value Parameter Values Acceptable? Performed By Date
(Yes / No)
Sterilization monitoring 123.2 °C  123.2 °C Yes Coane, John 07-Feb-2020 (UTC)
temperature 
Sterilization time   1800 sec  1800 sec Yes Coane, John 07-Feb-2020 (UTC)
Report filter value  6  6 Yes Coane, John 07-Feb-2020 (UTC)
AirFract Program Parameters  Program Parameters Yes Coane, John 07-Feb-2020 (UTC)
Number of fractions   2  2 Yes Coane, John 07-Feb-2020 (UTC)
Jacket heating   active  active Yes Coane, John 07-Feb-2020 (UTC)
Fan   active  active Yes Coane, John 07-Feb-2020 (UTC)
Evacuation target value  100 mbar  100 mbar Yes Coane, John 07-Feb-2020 (UTC)
Evacuation ramp  1000 mbar/min  1000 mbar/min Yes Coane, John 07-Feb-2020 (UTC)
Additional value evacuation  100 mbar  100 mbar Yes Coane, John 07-Feb-2020 (UTC)
Additional time evacuation  600 sec  60 sec No Coane, John 11-Mar-2020 (UTC)
Ventilation target value  800 mbar  800 mbar Yes Coane, John 07-Feb-2020 (UTC)
Ventilation ramp  1000 mbar/min  1000 mbar/min Yes Coane, John 07-Feb-2020 (UTC)
Additional value ventilation  800 mbar  800 mbar Yes Coane, John 07-Feb-2020 (UTC)
Additional time ventilation  90 sec  90 sec Yes Coane, John 07-Feb-2020 (UTC)
Report filter value  6  6 Yes Coane, John 07-Feb-2020 (UTC)
AirFract Program Parameters  Program Parameters Yes Coane, John 07-Feb-2020 (UTC)
Number of fractions   1  1 Yes Coane, John 07-Feb-2020 (UTC)
Jacket heating   active  active Yes Coane, John 07-Feb-2020 (UTC)
Fan   not active  not active Yes Coane, John 07-Feb-2020 (UTC)
Evacuation target value  100 mbar  100 mbar Yes Coane, John 07-Feb-2020 (UTC)
Evacuation ramp  1000 mbar/min  1000 mbar/min Yes Coane, John 07-Feb-2020 (UTC)
Additional value evacuation  100 mbar  100 mbar Yes Coane, John 07-Feb-2020 (UTC)
Additional time evacuation  0 sec  0 sec Yes Coane, John 07-Feb-2020 (UTC)

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 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Table 4: As-Found Filter Inline Sterilization Parameter Verification

Parameter Expected Parameter Value As-Found Parameter Value Parameter Values Acceptable? Performed By Date
(Yes / No)
Ventilation target value  800 mbar  800 mbar Yes Coane, John 07-Feb-2020 (UTC)
Ventilation ramp  1000 mbar/min  1000 mbar/min Yes Coane, John 07-Feb-2020 (UTC)
Additional value ventilation  800 mbar  800 mbar Yes Coane, John 07-Feb-2020 (UTC)
Additional time ventilation  90 sec  90 sec Yes Coane, John 07-Feb-2020 (UTC)
Report filter value  6  6 Yes Coane, John 07-Feb-2020 (UTC)
LastAirFract Program Parameters  Program Parameters Yes Coane, John 07-Feb-2020 (UTC)
Jacket heating   active  active Yes Coane, John 07-Feb-2020 (UTC)
Fan   not active  not active Yes Coane, John 07-Feb-2020 (UTC)
Evacuation target value  100 mbar  100 mbar Yes Coane, John 07-Feb-2020 (UTC)
Evacuation ramp  1000 mbar/min  1000 mbar/min Yes Coane, John 07-Feb-2020 (UTC)
Additional value evacuation  100 mbar  100 mbar Yes Coane, John 07-Feb-2020 (UTC)
Additional time evacuation  0 sec  0 sec Yes Coane, John 07-Feb-2020 (UTC)
Ventilation ramp  1000 mbar/min  1000 mbar/min Yes Coane, John 07-Feb-2020 (UTC)
Report filter value  6  6 Yes Coane, John 07-Feb-2020 (UTC)

Comments
# Comments Performed By Date
1 Tables 1 and 4 have an expected parameter value of 600 seconds for "Additional time evacuation" during the post-treatment phase. This was Coane, John 02-Mar-2020
due to a protocol generation error. The correct value should be 60 seconds as documented during execution. Refer to Deviation #2 in Section (UTC)
15.
2 Table 2 "Report filter value 6 **" in the SteamFrac is recorded as "6" as field only accepts numerical values. This was a protocol generation Coane, John 06-Mar-2020
error. (UTC)

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 Equipment ID:  AUT-10202 
 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Comments
# Comments Performed By Date
3  N/A Coane, John 06-Mar-2020
(UTC)
Note: If there are no comments in the "Comments" table above, type "No Comments" in the first line. The remaining empty rows will be considered "N/A". Otherwise,"N/A" all unused rows.

12.4.2 Field Execution - Post-Execution Set Point Verification (IOQ - AUT-10202-CAM-03-13)

Procedure:

1. Record the as-left settings and/or set points on the system in Table 5, Table 6, Table 7, and Table 8.

Table 5: As-Left Wrapped Goods Parameters Verification

Parameter Expected Parameter Value As-Found Parameter Value Parameter Value Acceptable? Performed By Date
(Yes / No)
Jacket pressure  2150 mbar  2150 mbar Yes Coane, John 12-Feb-2020 (UTC)
Liquid sterilization program  not active  not active Yes Coane, John 12-Feb-2020 (UTC)
Temperature monitoring pre-  Active Sensor 1, Sensor 2  Active Sensor 1, Sensor 2 Yes Coane, John 12-Feb-2020 (UTC)
Treatment
Pos. temperature hysteresis   5.0 °C  5.0 °C Yes Coane, John 12-Feb-2020 (UTC)
Neg. temperature hysteresis   1.0 °C  1.0 °C Yes Coane, John 12-Feb-2020 (UTC)
Air detector   not active  not active Yes Coane, John 12-Feb-2020 (UTC)
Temperature monitoring Active Sensor 1, Sensor 2  Active Sensor 1, Sensor 2 Yes Coane, John 12-Feb-2020 (UTC)
sterilization
Correlation monitoring  not active  not active Yes Coane, John 12-Feb-2020 (UTC)
Differential monitoring of control  active  active Yes Coane, John 12-Feb-2020 (UTC)
sensors
F0 value calculation   not active  not active Yes Coane, John 12-Feb-2020 (UTC)
Pos. temperature hysteresis   3.0°C  3.0°C Yes Coane, John 12-Feb-2020 (UTC)

Page 118 of 196 01-Mar-2023 (UTC)

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 Equipment ID:  AUT-10202 
 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Table 5: As-Left Wrapped Goods Parameters Verification

Parameter Expected Parameter Value As-Found Parameter Value Parameter Value Acceptable? Performed By Date
(Yes / No)
Neg. temperature hysteresis   0.0°C  0.0°C Yes Coane, John 12-Feb-2020 (UTC)
Temperature monitoring Post  Active Sensor 1, Sensor 2  Active Sensor 1, Sensor 2 Yes Coane, John 12-Feb-2020 (UTC)
Treatment
Pos. temperature hysteresis   3.0°C  3.0°C Yes Coane, John 12-Feb-2020 (UTC)
Neg. temperature hysteresis   3.0°C  0.0°C Yes Coane, John 12-Feb-2020 (UTC)
Ventilation filter FIS active   not active  not active Yes Coane, John 12-Feb-2020 (UTC)
Ventilation filter FIF active   not active  not active Yes Coane, John 12-Feb-2020 (UTC)
Basic time interval for recording   5 sec.  5 sec. Yes Coane, John 12-Feb-2020 (UTC)
Temperature monitoring Post  Temp: Active Sensor 1, Sensor 2, Sensor 3  Temp: Active Sensor 1, Sensor 2, Sensor 3 Yes Coane, John 12-Feb-2020 (UTC)
Treatment
StemFract Program Parameters   Program Parameters Yes Coane, John 12-Feb-2020 (UTC)
Number of fractions  4  4 Yes Coane, John 12-Feb-2020 (UTC)
Jacket heating  active  active Yes Coane, John 12-Feb-2020 (UTC)
Fan  not active  not active Yes Coane, John 12-Feb-2020 (UTC)
Evacuation target value  60 mbar  60 mbar Yes Coane, John 12-Feb-2020 (UTC)
Evacuation ramp  500 mbar/min  500 mbar/min Yes Coane, John 12-Feb-2020 (UTC)
Additional value evacuation  60 mba  60 mbar Yes Coane, John 12-Feb-2020 (UTC)
Additional time evacuation  60 sec  60 sec Yes Coane, John 12-Feb-2020 (UTC)
Steam target value  2010 mbar  2010 mbar Yes Coane, John 12-Feb-2020 (UTC)
Steam ramp  400 mbar/min  400 mbar/min Yes Coane, John 12-Feb-2020 (UTC)
Steam monitoring temperature  0.0 °C  0.0 °C Yes Coane, John 12-Feb-2020 (UTC)
Additional value steam  2010 mbar  2010 mbar Yes Coane, John 12-Feb-2020 (UTC)
Additional time steam  60 sec  60 sec Yes Coane, John 12-Feb-2020 (UTC)
Report filter value  6  6 Yes Coane, John 12-Feb-2020 (UTC)
SteamFract Program Parameters   Program Parameters Yes Coane, John 12-Feb-2020 (UTC)

Page 119 of 196 01-Mar-2023 (UTC)

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 Equipment ID:  AUT-10202 
 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Table 5: As-Left Wrapped Goods Parameters Verification

Parameter Expected Parameter Value As-Found Parameter Value Parameter Value Acceptable? Performed By Date
(Yes / No)
Number of fractions   1  1 Yes Coane, John 12-Feb-2020 (UTC)
Jacket heating   active  active Yes Coane, John 12-Feb-2020 (UTC)
Fan   active  active Yes Coane, John 12-Feb-2020 (UTC)
Evacuation target value  1013 mbar  1013 mbar Yes Coane, John 12-Feb-2020 (UTC)
Evacuation ramp  400 mbar/min  400 mbar/min Yes Coane, John 12-Feb-2020 (UTC)
Additional value evacuation  1013 mbar  1013 mbar Yes Coane, John 12-Feb-2020 (UTC)
Additional time evacuation  0 sec  0 sec Yes Coane, John 12-Feb-2020 (UTC)
Steam target value  2220 mbar  2220 mbar Yes Coane, John 12-Feb-2020 (UTC)
Steam ramp  70 mbar/min  70 mbar/min Yes Coane, John 12-Feb-2020 (UTC)
Steam monitoring temperature  0.0 °C  0.0 °C Yes Coane, John 12-Feb-2020 (UTC)
Additional value steam  2242 mbar  2242 mbar Yes Coane, John 12-Feb-2020 (UTC)
Additional time steam  0 sec  0 sec Yes Coane, John 12-Feb-2020 (UTC)
Report filter value  6  6 Yes Coane, John 12-Feb-2020 (UTC)
SteriPres  Program Parameters    Program Parameters Yes Coane, John 12-Feb-2020 (UTC)
Support pressure   not active  not active Yes Coane, John 12-Feb-2020 (UTC)
Jacket heating   active  active Yes Coane, John 12-Feb-2020 (UTC)
Fan   not active  not active Yes Coane, John 12-Feb-2020 (UTC)
Steam target value   2242 mbar  2242 mbar Yes Coane, John 12-Feb-2020 (UTC)
Steam ramp  1000 mbar/min  1000 mbar/min Yes Coane, John 12-Feb-2020 (UTC)
Sterilization monitoring 123.2 °C  123.2 °C Yes Coane, John 12-Feb-2020 (UTC)
temperature 
Sterilization time   1800 sec  1800 sec Yes Coane, John 12-Feb-2020 (UTC)
Report filter value  6  6 Yes Coane, John 12-Feb-2020 (UTC)
AirFract Program Parameters  Program Parameters Yes Coane, John 12-Feb-2020 (UTC)
Number of fractions   2  2 Yes Coane, John 12-Feb-2020 (UTC)

Page 120 of 196 01-Mar-2023 (UTC)

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 Equipment ID:  AUT-10202 
 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Table 5: As-Left Wrapped Goods Parameters Verification

Parameter Expected Parameter Value As-Found Parameter Value Parameter Value Acceptable? Performed By Date
(Yes / No)
Jacket heating   active  active Yes Coane, John 12-Feb-2020 (UTC)
Fan   active  active Yes Coane, John 12-Feb-2020 (UTC)
Evacuation target value  100 mbar  100 mbar Yes Coane, John 12-Feb-2020 (UTC)
Evacuation ramp  1000 mbar/min  1000 mbar/min Yes Coane, John 12-Feb-2020 (UTC)
Additional value evacuation  100 mbar  100 mbar Yes Coane, John 12-Feb-2020 (UTC)
Additional time evacuation  600 sec  60 sec No Coane, John 12-Feb-2020 (UTC)
Ventilation target value  800 mbar  800 mbar Yes Coane, John 12-Feb-2020 (UTC)
Ventilation ramp  1000 mbar/min  1000 mbar/min Yes Coane, John 12-Feb-2020 (UTC)
Additional value ventilation  800 mbar  800 mbar Yes Coane, John 12-Feb-2020 (UTC)
Additional time ventilation  90 sec  90 sec Yes Coane, John 12-Feb-2020 (UTC)
Report filter value  6  6 Yes Coane, John 12-Feb-2020 (UTC)
AirFract Program Parameters  Program Parameters Yes Coane, John 12-Feb-2020 (UTC)
Number of fractions   1  1 Yes Coane, John 12-Feb-2020 (UTC)
Jacket heating   active  active Yes Coane, John 12-Feb-2020 (UTC)
Fan   not active  not active Yes Coane, John 12-Feb-2020 (UTC)
Evacuation target value  100 mbar  100 mbar Yes Coane, John 12-Feb-2020 (UTC)
Evacuation ramp  1000 mbar/min  1000 mbar/min Yes Coane, John 12-Feb-2020 (UTC)
Additional value evacuation  100 mbar  100 mbar Yes Coane, John 12-Feb-2020 (UTC)
Additional time evacuation  0 sec  0 sec Yes Coane, John 12-Feb-2020 (UTC)
Ventilation target value  800 mbar  800 mbar Yes Coane, John 12-Feb-2020 (UTC)
Ventilation ramp  1000 mbar/min  1000 mbar/min Yes Coane, John 13-Feb-2020 (UTC)
Additional value ventilation  800 mbar  800 mbar Yes Coane, John 13-Feb-2020 (UTC)
Additional time ventilation  90 sec  90 sec Yes Coane, John 13-Feb-2020 (UTC)
Report filter value  6  6 Yes Coane, John 13-Feb-2020 (UTC)
LastAirFract Program Parameters  Program Parameters Yes Coane, John 13-Feb-2020 (UTC)

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 Equipment ID:  AUT-10202 
 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Table 5: As-Left Wrapped Goods Parameters Verification

Parameter Expected Parameter Value As-Found Parameter Value Parameter Value Acceptable? Performed By Date
(Yes / No)
Jacket heating   active  active Yes Coane, John 13-Feb-2020 (UTC)
Fan   not active  not active Yes Coane, John 13-Feb-2020 (UTC)
Evacuation target value  100 mbar  100 mbar Yes Coane, John 13-Feb-2020 (UTC)
Evacuation ramp  1000 mbar/min  1000 mbar/min Yes Coane, John 13-Feb-2020 (UTC)
Additional value evacuation  100 mbar  100 mbar Yes Coane, John 13-Feb-2020 (UTC)
Additional time evacuation  0 sec  0 sec Yes Coane, John 13-Feb-2020 (UTC)
Ventilation ramp  1000 mbar/min  1000 mbar/min Yes Coane, John 13-Feb-2020 (UTC)
Report filter value  6  6 Yes Coane, John 13-Feb-2020 (UTC)

Table 6: As-Left Bowie Dick Test Parameters Verification

Parameter Expected Parameter Value As-Found Parameter Value Parameter Values Performed By Date
Acceptable? (Yes / No)
Jacket pressure  2064 mbar  2064 mbar Yes Coane, John 13-Feb-2020 (UTC)
Liquid sterilization program  not active  not active Yes Coane, John 13-Feb-2020 (UTC)
Temperature monitoring Pre  Active Sensor 1, Sensor 2  Active Sensor 1, Sensor 2 Yes Coane, John 13-Feb-2020 (UTC)
Treatment
Pos. temperature hysteresis   5.0 °C  5.0 °C Yes Coane, John 13-Feb-2020 (UTC)
Neg. temperature hysteresis   1.0 °C  1.0 °C Yes Coane, John 13-Feb-2020 (UTC)
Air detector   not active  not active Yes Coane, John 13-Feb-2020 (UTC)
Correlation monitoring  active  active Yes Coane, John 13-Feb-2020 (UTC)
Differential monitoring of control  active  active Yes Coane, John 13-Feb-2020 (UTC)
sensors
F0 value calculation   not active  not active Yes Coane, John 13-Feb-2020 (UTC)
Temperature monitoring  Active Sensor 1, Sensor 2  Active Sensor 1, Sensor 2 Yes Coane, John 13-Feb-2020 (UTC)
sterilization 
Pos. temperature hysteresis   3.0°C  3.0°C Yes Coane, John 13-Feb-2020 (UTC)

Page 122 of 196 01-Mar-2023 (UTC)

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 Equipment ID:  AUT-10202 
 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Table 6: As-Left Bowie Dick Test Parameters Verification

Parameter Expected Parameter Value As-Found Parameter Value Parameter Values Performed By Date
Acceptable? (Yes / No)
Neg. temperature hysteresis   0.0°C  0.0°C Yes Coane, John 13-Feb-2020 (UTC)
Temperature monitoring Post  None  None Yes Coane, John 13-Feb-2020 (UTC)
Treatment
Pos. temperature hysteresis   0.0°C  0.0°C Yes Coane, John 13-Feb-2020 (UTC)
Neg. temperature hysteresis   0.0°C  0.0°C Yes Coane, John 13-Feb-2020 (UTC)
 Ventilation filter FIS active  not active  not active Yes Coane, John 13-Feb-2020 (UTC)
 Ventilation filter FIS active  not  not active Yes Coane, John 13-Feb-2020 (UTC)
Basic time interval for recording   10 sec.  10 sec. Yes Coane, John 13-Feb-2020 (UTC)
Batch Report Sensors  Active Sensor 1, Sensor 2  Active Sensor 1, Sensor 2 Yes Coane, John 13-Feb-2020 (UTC)
StemFract Program Parameters   Program Parameters Yes Coane, John 13-Feb-2020 (UTC)
Number of fractions   4  4 Yes Coane, John 13-Feb-2020 (UTC)
Jacket heating   active  active Yes Coane, John 13-Feb-2020 (UTC)
Fan   not active  not active Yes Coane, John 13-Feb-2020 (UTC)
Evacuation target value   60 mbar  60 mbar Yes Coane, John 13-Feb-2020 (UTC)
Evacuation ramp   500 mbar/min  500 mbar/min Yes Coane, John 13-Feb-2020 (UTC)
Additional value evacuation   60 mbar  60 mbar Yes Coane, John 13-Feb-2020 (UTC)
Additional time evacuation   60 sec  60 sec Yes Coane, John 13-Feb-2020 (UTC)
Steam target value  2010 mbar  2010 mbar Yes Coane, John 13-Feb-2020 (UTC)
Steam ramp  400 mbar/min  400 mbar/min Yes Coane, John 13-Feb-2020 (UTC)
Steam monitoring temperature  0.0 °C  0.0 °C Yes Coane, John 13-Feb-2020 (UTC)
Additional value steam  2010 mbar  2010 mbar Yes Coane, John 13-Feb-2020 (UTC)
Additional time steam  60 sec  60 sec Yes Coane, John 13-Feb-2020 (UTC)
Report filter value  6 **  6 Yes Coane, John 13-Feb-2020 (UTC)
StemFract Program Parameters   Program Parameters Yes Coane, John 13-Feb-2020 (UTC)
Number of fractions   1  1 Yes Coane, John 13-Feb-2020 (UTC)

Page 123 of 196 01-Mar-2023 (UTC)

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 Document Version:  1.0 
 Equipment ID:  AUT-10202 
 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Table 6: As-Left Bowie Dick Test Parameters Verification

Parameter Expected Parameter Value As-Found Parameter Value Parameter Values Performed By Date
Acceptable? (Yes / No)
Jacket heating   active  active Yes Coane, John 13-Feb-2020 (UTC)
Fan   active  active Yes Coane, John 13-Feb-2020 (UTC)
Evacuation target value   1013 mbar  1013 mbar Yes Coane, John 13-Feb-2020 (UTC)
Evacuation ramp   400 mbar/min  400 mbar/min Yes Coane, John 13-Feb-2020 (UTC)
Additional value evacuation   1013 mbar  1013 mbar Yes Coane, John 13-Feb-2020 (UTC)
Additional time evacuation   0 sec  0 sec Yes Coane, John 13-Feb-2020 (UTC)
Steam target value  2113 mbar  2113 mbar Yes Coane, John 13-Feb-2020 (UTC)
Steam ramp  70 mbar/min  70 mbar/min Yes Coane, John 13-Feb-2020 (UTC)
Steam monitoring temperature  0.0 °C  0.0 °C Yes Coane, John 13-Feb-2020 (UTC)
Additional value steam  2113 mbar  2113 mbar Yes Coane, John 13-Feb-2020 (UTC)
Additional time steam  0 sec  0 sec Yes Coane, John 13-Feb-2020 (UTC)
Report filter value  6  6 Yes Coane, John 13-Feb-2020 (UTC)
SteriPres  Program Parameters   Program Parameters Yes Coane, John 13-Feb-2020 (UTC)
Support pressure   not active  not active Yes Coane, John 13-Feb-2020 (UTC)
Jacket heating   active  active Yes Coane, John 13-Feb-2020 (UTC)
Fan   not active  not active Yes Coane, John 13-Feb-2020 (UTC)
Steam target value   2113 mbar  2113 mbar Yes Coane, John 13-Feb-2020 (UTC)
Steam ramp  300 mbar/min  300 mbar/min Yes Coane, John 13-Feb-2020 (UTC)
Sterilization monitoring 121.0 °C  121.0 °C Yes Coane, John 13-Feb-2020 (UTC)
temperature 
Sterilization time   480 sec  480 sec Yes Coane, John 13-Feb-2020 (UTC)
Report filter value  6  6 Yes Coane, John 13-Feb-2020 (UTC)
AirFract Program Parameters  Program Parameters Yes Coane, John 13-Feb-2020 (UTC)
Number of fractions   1  1 Yes Coane, John 13-Feb-2020 (UTC)
Jacket heating   active  active Yes Coane, John 13-Feb-2020 (UTC)

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Table 6: As-Left Bowie Dick Test Parameters Verification

Parameter Expected Parameter Value As-Found Parameter Value Parameter Values Performed By Date
Acceptable? (Yes / No)
Fan   not active  not active Yes Coane, John 13-Feb-2020 (UTC)
Evacuation target value  100 mbar  100 mbar Yes Coane, John 13-Feb-2020 (UTC)
Evacuation ramp  2000 mbar/min  2000 mbar/min Yes Coane, John 13-Feb-2020 (UTC)
Additional value evacuation  10 mbar  10 mbar Yes Coane, John 13-Feb-2020 (UTC)
Additional time evacuation  300 sec  300 sec Yes Coane, John 13-Feb-2020 (UTC)
Ventilation target value  800 mbar  800 mbar Yes Coane, John 13-Feb-2020 (UTC)
Ventilation ramp  1000 mbar/min  1000 mbar/min Yes Coane, John 13-Feb-2020 (UTC)
Additional value ventilation  800 mbar  800 mbar Yes Coane, John 13-Feb-2020 (UTC)
Additional time ventilation  0 sec  0 sec Yes Coane, John 13-Feb-2020 (UTC)
Report filter value  6  6 Yes Coane, John 13-Feb-2020 (UTC)
AirFract Program Parameters  Program Parameters Yes Coane, John 13-Feb-2020 (UTC)
Number of fractions   1  1 Yes Coane, John 13-Feb-2020 (UTC)
Jacket heating   active  active Yes Coane, John 13-Feb-2020 (UTC)
Fan   not active  not active Yes Coane, John 13-Feb-2020 (UTC)
Evacuation target value  100 mbar  100 mbar Yes Coane, John 13-Feb-2020 (UTC)
Evacuation ramp  2000 mbar/min  2000 mbar/min Yes Coane, John 13-Feb-2020 (UTC)
Additional value evacuation  10 mbar  10 mbar Yes Coane, John 13-Feb-2020 (UTC)
Additional time evacuation  30 sec  30 sec Yes Coane, John 13-Feb-2020 (UTC)
Ventilation target value  800 mbar  800 mbar Yes Coane, John 13-Feb-2020 (UTC)
Ventilation ramp  1000 mbar/min  1000 mbar/min Yes Coane, John 13-Feb-2020 (UTC)
Additional value ventilation  800 mbar  800 mbar Yes Coane, John 13-Feb-2020 (UTC)
Additional time ventilation  0 sec  0 sec Yes Coane, John 13-Feb-2020 (UTC)
Report filter value  6  6 Yes Coane, John 13-Feb-2020 (UTC)
LastAirFract Program Parameters  Program Parameters Yes Coane, John 13-Feb-2020 (UTC)
Jacket heating   active  active Yes Coane, John 13-Feb-2020 (UTC)

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 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Table 6: As-Left Bowie Dick Test Parameters Verification

Parameter Expected Parameter Value As-Found Parameter Value Parameter Values Performed By Date
Acceptable? (Yes / No)
Fan   not active  not active Yes Coane, John 13-Feb-2020 (UTC)
Evacuation target value  100 mbar  100 mbar Yes Coane, John 13-Feb-2020 (UTC)
Evacuation ramp  2000 mbar/min  2000 mbar/min Yes Coane, John 13-Feb-2020 (UTC)
Additional value evacuation  10 mbar  10 mbar Yes Coane, John 13-Feb-2020 (UTC)
Additional time evacuation  0 sec  0 sec Yes Coane, John 13-Feb-2020 (UTC)
Ventilation target value  0 mbar  0 mbar Yes Coane, John 13-Feb-2020 (UTC)
Ventilation ramp  1000 mbar/min  1000 mbar/min Yes Coane, John 13-Feb-2020 (UTC)
Report filter value  6  6 Yes Coane, John 13-Feb-2020 (UTC)

Table 7: As-Left Leak Test  Parameters Verification

Parameter Expected Parameter Value As-Found Parameter Value Parameter Values Acceptable? Performed By Date
(Yes / No)
Jacket pressure  2050 mbar  2050 mbar Yes Coane, John 13-Feb-2020 (UTC)
Liquid sterilization program  not active  not active Yes Coane, John 13-Feb-2020 (UTC)
Temperature monitoring pre- None  None Yes Coane, John 13-Feb-2020 (UTC)
Treatment
Pos. temperature hysteresis   0.0 °C  0.0 °C Yes Coane, John 13-Feb-2020 (UTC)
Neg. temperature hysteresis   0.0 °C  0.0 °C Yes Coane, John 13-Feb-2020 (UTC)
Air detector   not active  not active Yes Coane, John 13-Feb-2020 (UTC)
Temperature monitoring  None  None Yes Coane, John 13-Feb-2020 (UTC)
sterilization 
Correlation monitoring  not active  not active Yes Coane, John 13-Feb-2020 (UTC)
Differential monitoring of control  not active  not active Yes Coane, John 13-Feb-2020 (UTC)
sensors
F0 value calculation   not active  not active Yes Coane, John 13-Feb-2020 (UTC)

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 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Table 7: As-Left Leak Test  Parameters Verification

Parameter Expected Parameter Value As-Found Parameter Value Parameter Values Acceptable? Performed By Date
(Yes / No)
Temperature monitoring Post  None  None Yes Coane, John 13-Feb-2020 (UTC)
Treatment
Pos. temperature hysteresis   0.0°C  0.0°C Yes Coane, John 13-Feb-2020 (UTC)
Neg. temperature hysteresis   0.0°C  0.0°C Yes Coane, John 13-Feb-2020 (UTC)
Ventilation filter FIS active   active  active Yes Coane, John 13-Feb-2020 (UTC)
Ventilation filter FIF active   not active  Not active Yes Coane, John 13-Feb-2020 (UTC)
Basic time interval for recording   10 sec.  10 sec Yes Coane, John 13-Feb-2020 (UTC)
Temperature monitoring   Active Sensor 1  Active Sensor 1 Yes Coane, John 13-Feb-2020 (UTC)
 VacLeakTest  Program Values  Program Values Yes Coane, John 13-Feb-2020 (UTC)
Jacket heating   active  active Yes Coane, John 13-Feb-2020 (UTC)
Fan   not active  not active Yes Coane, John 13-Feb-2020 (UTC)
Evacuation target value  70 mbar  70 mbar Yes Coane, John 13-Feb-2020 (UTC)
Evacuation ramp  2000 mbar/min  2000 mbar/min Yes Coane, John 13-Feb-2020 (UTC)
Stabilization time  300 sec  300 sec Yes Coane, John 13-Feb-2020 (UTC)
Test time   600 sec  600 sec Yes Coane, John 13-Feb-2020 (UTC)
Ventilation ramp   1000 mbar/min  1000 mbar/min Yes Coane, John 13-Feb-2020 (UTC)
Report filter value   6  6 Yes Coane, John 02-Mar-2020 (UTC)

Table 8: As-Left  Filter Inline Sterilization  Parameters Verification

Parameter Expected Parameter Value As-Found Parameter Value Parameter Values Acceptable? Performed By Date
(Yes / No)
Jacket pressure  2150 mbar  2150 mbar Yes Coane, John 13-Feb-2020 (UTC)
Liquid sterilization program  not active  not active Yes Coane, John 13-Feb-2020 (UTC)
Temperature monitoring pre-  Active Sensor 1, Sensor 2  Active Sensor 1, Sensor 2 Yes Coane, John 06-Mar-2020 (UTC)
Treatment

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 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Table 8: As-Left  Filter Inline Sterilization  Parameters Verification

Parameter Expected Parameter Value As-Found Parameter Value Parameter Values Acceptable? Performed By Date
(Yes / No)
Pos. temperature hysteresis   5.0 °C  5.0 °C Yes Coane, John 13-Feb-2020 (UTC)
Neg. temperature hysteresis   1.0 °C  1.0 °C Yes Coane, John 13-Feb-2020 (UTC)
Air detector   not active  not active Yes Coane, John 13-Feb-2020 (UTC)
Temperature monitoring Active Sensor 1, Sensor 2  Active Sensor 1, Sensor 2 Yes Coane, John 13-Feb-2020 (UTC)
sterilization
Correlation monitoring  not active  not active Yes Coane, John 13-Feb-2020 (UTC)
Differential monitoring of control  active  active Yes Coane, John 13-Feb-2020 (UTC)
sensors
F0 value calculation   not active  not active Yes Coane, John 13-Feb-2020 (UTC)
Pos. temperature hysteresis   3.0°C  3.0°C Yes Coane, John 13-Feb-2020 (UTC)
Neg. temperature hysteresis   0.0°C  1.0°C Yes Coane, John 13-Feb-2020 (UTC)
Temperature monitoring Post  Active Sensor 1, Sensor 2  Active Sensor 1, Sensor 2 Yes Coane, John 13-Feb-2020 (UTC)
Treatment
Pos. temperature hysteresis   3.0°C  3.0°C Yes Coane, John 13-Feb-2020 (UTC)
Neg. temperature hysteresis   3.0°C  3.0°C Yes Coane, John 13-Feb-2020 (UTC)
Ventilation filter FIS active   active  active Yes Coane, John 13-Feb-2020 (UTC)
Ventilation filter FIF active   not active  not active  Yes Coane, John 13-Feb-2020 (UTC)
Basic time interval for recording   5 sec.  5 sec. Yes Coane, John 13-Feb-2020 (UTC)
Temperature monitoring Post  Temp: Active Sensor 1, Sensor 2, Sensor 3  Temp: Active Sensor 1, Sensor 2, Sensor 3 Yes Coane, John 13-Feb-2020 (UTC)
Treatment
StemFract Program Parameters   Program Parameters Yes Coane, John 13-Feb-2020 (UTC)
Number of fractions  4  4 Yes Coane, John 13-Feb-2020 (UTC)
Jacket heating  active  active Yes Coane, John 13-Feb-2020 (UTC)
Fan  not active  not active Yes Coane, John 13-Feb-2020 (UTC)
Evacuation target value  60 mbar  60 mbar Yes Coane, John 13-Feb-2020 (UTC)
Evacuation ramp  500 mbar/min  500 mbar/min Yes Coane, John 13-Feb-2020 (UTC)

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Table 8: As-Left  Filter Inline Sterilization  Parameters Verification

Parameter Expected Parameter Value As-Found Parameter Value Parameter Values Acceptable? Performed By Date
(Yes / No)
Additional value evacuation  60 mba  60 mbar Yes Coane, John 13-Feb-2020 (UTC)
Additional time evacuation  60 sec  60 sec Yes Coane, John 13-Feb-2020 (UTC)
Steam target value  2010 mbar  2010 mbar Yes Coane, John 13-Feb-2020 (UTC)
Steam ramp  400 mbar/min  400 mbar/min Yes Coane, John 13-Feb-2020 (UTC)
Steam monitoring temperature  0.0 °C  0.0 °C Yes Coane, John 13-Feb-2020 (UTC)
Additional value steam  2010 mbar  2010 mbar Yes Coane, John 13-Feb-2020 (UTC)
Additional time steam  60 sec  60 sec Yes Coane, John 13-Feb-2020 (UTC)
Report filter value  6  6 Yes Coane, John 13-Feb-2020 (UTC)
SteamFract Program Parameters   Program Parameters Yes Coane, John 13-Feb-2020 (UTC)
Number of fractions   1  1 Yes Coane, John 13-Feb-2020 (UTC)
Jacket heating   active  active Yes Coane, John 13-Feb-2020 (UTC)
Fan   active  active Yes Coane, John 13-Feb-2020 (UTC)
Evacuation target value  1013 mbar  1013 mbar Yes Coane, John 13-Feb-2020 (UTC)
Evacuation ramp  400 mbar/min  400 mbar/min Yes Coane, John 13-Feb-2020 (UTC)
Additional value evacuation  1013 mbar  1013 mbar Yes Coane, John 13-Feb-2020 (UTC)
Additional time evacuation  0 sec  0 sec Yes Coane, John 13-Feb-2020 (UTC)
Steam target value  2220 mbar  2220 mbar Yes Coane, John 13-Feb-2020 (UTC)
Steam ramp  70 mbar/min  70 mbar/min Yes Coane, John 13-Feb-2020 (UTC)
Steam monitoring temperature  0.0 °C  0.0 °C Yes Coane, John 13-Feb-2020 (UTC)
Additional value steam  2242 mbar  2242 mbar Yes Coane, John 13-Feb-2020 (UTC)
Additional time steam  0 sec  0 sec Yes Coane, John 13-Feb-2020 (UTC)
Report filter value  6  6 Yes Coane, John 13-Feb-2020 (UTC)
SteriPres  Program Parameters   Program Parameters Yes Coane, John 13-Feb-2020 (UTC)
Support pressure   not active  not active Yes Coane, John 13-Feb-2020 (UTC)
Jacket heating   active  active Yes Coane, John 13-Feb-2020 (UTC)

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 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Table 8: As-Left  Filter Inline Sterilization  Parameters Verification

Parameter Expected Parameter Value As-Found Parameter Value Parameter Values Acceptable? Performed By Date
(Yes / No)
Fan   not active  not active Yes Coane, John 13-Feb-2020 (UTC)
Steam target value   2242 mbar  2242 mbar Yes Coane, John 13-Feb-2020 (UTC)
Steam ramp  1000 mbar/min  1000 mbar/min Yes Coane, John 13-Feb-2020 (UTC)
Sterilization monitoring 123.2 °C  123.2 °C Yes Coane, John 13-Feb-2020 (UTC)
temperature 
Sterilization time   1800 sec  1800 sec Yes Coane, John 13-Feb-2020 (UTC)
Report filter value  6  6 Yes Coane, John 13-Feb-2020 (UTC)
AirFract Program Parameters  Program Parameters Yes Coane, John 13-Feb-2020 (UTC)
Number of fractions   2  2 Yes Coane, John 13-Feb-2020 (UTC)
Jacket heating   active  active Yes Coane, John 13-Feb-2020 (UTC)
Fan   active  active Yes Coane, John 13-Feb-2020 (UTC)
Evacuation target value  100 mbar  100 mbar Yes Coane, John 13-Feb-2020 (UTC)
Evacuation ramp  1000 mbar/min  1000 mbar/min Yes Coane, John 13-Feb-2020 (UTC)
Additional value evacuation  100 mbar  100 mbar Yes Coane, John 13-Feb-2020 (UTC)
Additional time evacuation  600 sec  60 sec No Coane, John 02-Mar-2020 (UTC)
Ventilation target value  800 mbar  800 mbar Yes Coane, John 13-Feb-2020 (UTC)
Ventilation ramp  1000 mbar/min  1000 mbar/min Yes Coane, John 13-Feb-2020 (UTC)
Additional value ventilation  800 mbar  800 mbar Yes Coane, John 13-Feb-2020 (UTC)
Additional time ventilation  90 sec  90 sec Yes Coane, John 13-Feb-2020 (UTC)
Report filter value  6  6 Yes Coane, John 13-Feb-2020 (UTC)
AirFract Program Parameters  Program Parameters Yes Coane, John 13-Feb-2020 (UTC)
Number of fractions   1  1 Yes Coane, John 13-Feb-2020 (UTC)
Jacket heating   active  active Yes Coane, John 13-Feb-2020 (UTC)
Fan   not active  not active Yes Coane, John 13-Feb-2020 (UTC)
Evacuation target value  100 mbar  100 mbar Yes Coane, John 13-Feb-2020 (UTC)

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Table 8: As-Left  Filter Inline Sterilization  Parameters Verification

Parameter Expected Parameter Value As-Found Parameter Value Parameter Values Acceptable? Performed By Date
(Yes / No)
Evacuation ramp  1000 mbar/min  1000 mbar/min Yes Coane, John 13-Feb-2020 (UTC)
Additional value evacuation  100 mbar  100 mbar Yes Coane, John 13-Feb-2020 (UTC)
Additional time evacuation  0 sec  0 sec Yes Coane, John 13-Feb-2020 (UTC)
Ventilation target value  800 mbar  800 mbar Yes Coane, John 13-Feb-2020 (UTC)
Ventilation ramp  1000 mbar/min  1000 mbar/min Yes Coane, John 13-Feb-2020 (UTC)
Additional value ventilation  800 mbar  800 mbar Yes Coane, John 13-Feb-2020 (UTC)
Additional time ventilation  90 sec  90 sec Yes Coane, John 13-Feb-2020 (UTC)
Report filter value  6  6 Yes Coane, John 13-Feb-2020 (UTC)
LastAirFract Program Parameters  Program Parameters Yes Coane, John 13-Feb-2020 (UTC)
Jacket heating   active  active Yes Coane, John 13-Feb-2020 (UTC)
Fan   not active  not active Yes Coane, John 13-Feb-2020 (UTC)
Evacuation target value  100 mbar  100 mbar Yes Coane, John 13-Feb-2020 (UTC)
Evacuation ramp  1000 mbar/min  1000 mbar/min Yes Coane, John 13-Feb-2020 (UTC)
Additional value evacuation  100 mbar  100 mbar Yes Coane, John 13-Feb-2020 (UTC)
Additional time evacuation  0 sec  0 sec Yes Coane, John 13-Feb-2020 (UTC)
Ventilation ramp  1000 mbar/min  1000 mbar/min Yes Coane, John 13-Feb-2020 (UTC)
Report filter value  6  6 Yes Coane, John 13-Feb-2020 (UTC)

Test Review (To be completed by Validation)

# Summary (Yes / No / N/A) Performed By Date
1 The as-found settings and/or set points on the system were recorded prior to qualification testing. Yes Coane, John 13-Feb-2020
(UTC)
2  The as-left settings and/or set points on the system were recorded at the conclusion of all testing. Yes Coane, John 13-Feb-2020
(UTC)

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 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Test Review (To be completed by Validation)

# Summary (Yes / No / N/A) Performed By Date
3 Deviation(s) required? Yes Coane, John 02-Mar-2020
(UTC)
4 Deviation(s) resolved and referenced, if applicable? Yes Coane, John 06-Mar-2020
(UTC)

Comments
# Comments: Performed By Date
1  Tables 5 and 8 have an expected parameter value of 600 seconds for "Additional time evacuation" during the post-treatment phase. This was due to Coane, John 02-Mar-2020
a protocol generation error. The correct value should be 60 seconds as documented during execution. Refer to Deviation #2 in Section 15. (UTC)
2 Table 6 "Report filter value 6 **" in the SteamFrac is recorded as "6" as field only accepts numerical values. This was a protocol generation error. Coane, John 12-Mar-2020
(UTC)
3  N/A Coane, John 06-Mar-2020
(UTC)
Note: If there are no comments in the "Comments" table above, type "No Comments" in the first line. The remaining empty rows will be considered "N/A". Otherwise, "N/A" all unused rows.

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12.5 Filter Integrity Test Certification Verification (IOQ - AUT-10202-CAM-03-14)

1. Test Objective.

Provide evidence that the filters used during the validation are integral and that the certification has been conducted according to Brammer specifications
and//or SOPs.

2. Scope

This test is applicable to all new or modified filters within the System # AUT-10202.

3. Acceptance Criteria

• All sterilizing grade filters have been verified to be integral prior to and after any validation activities requiring their use. 

12.5.1 Field Execution - Filter Integrity Test Certification Verification (IOQ - AUT-10202-CAM-03-14)

Procedure:

1. Record the manufacturer/model/serial number of all filters listed in Table 1.

2. Ensure that integrity tests have been performed on each filter in Table 1 before and after a Wrapped Goods sterilization cycle.
3. Attach a record of the certifications.
4. Determine if each filter has been found to be integral and record "Pass" or "Fail" in Table 1.
 

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Table 1: Filter Integrity Test Certification Verification

# Equipment Number / Filter ID Manufacturer / Model# Serial # (See Note 1) Attachment Acceptable? Performed By Date
(Pass / Fail / N/A)
1  V3101 / V3102 (Before Wrapped Goods Filter Housing:  Pall/ N/A Pre-Use FIT.JPG Pass Coane, John 03-Mar-2020
cycle) PGTD105G23UD1H4 (UTC)

Filter Cartridge:
Pall/  AB05PFR2PVH4
2  V3101 / V3102 (After Wrapped Goods Filter Housing: Pall/ N/A Post-Use FIT.JPG Pass Coane, John 03-Mar-2020
cycle) PGTD105G23UD1H4 (UTC)

Filter Cartridge: Pall/

AB05PFR2PVH4
Note 1: There are multiply housings in use and when the filter is changed the housing is also changed with the same house model but different serial
number.

Table 2: Additional Filter Integrity Test Certification Verification

# Equipment Number / Filter ID Manufacturer / Model# Serial # (if applicable) Attachment Acceptable? Performed By Date
(Pass / Fail / N/A)
1  N/A  N/A  N/A N/A N/A Coane, John 03-Mar-2020
(UTC)
2  N/A  N/A  N/A N/A N/A Coane, John 03-Mar-2020
(UTC)
3  N/A  N/A  N/A N/A N/A Coane, John 03-Mar-2020
(UTC)
4  N/A  N/A  N/A N/A N/A Coane, John 03-Mar-2020
(UTC)
5  N/A  N/A  N/A N/A N/A Coane, John 03-Mar-2020
(UTC)
Note: If there are pieces of equipment identified during the execution of this test that are necessary for verification but are not included in Table 1, record
those pieces of equipment and capture the results of the verification in Table 2. "N/A" all unused rows in Table 2.

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Test Review (To be completed by Validation)

# Summary (Yes / No / N/A) Performed By Date
1 All sterilizing grade filters have been verified to be integral prior to and after any validation activities requiring their Yes Coane, John 03-Mar-2020
use? (UTC)
2 Deviation(s) required? No Coane, John 03-Mar-2020
(UTC)
3 Deviation(s) resolved and referenced, if applicable? N/A Coane, John 03-Mar-2020
(UTC)
 

Comments
# Comments: Performed By Date
1 The Filter Integrity Tests were performed as the last test cases of the OQ. A wrapped goods cycle and a In-Line Filter Sterilization cycle was run Coane, John 06-Mar-2020
between the pre and post filter integrity verification tests. (UTC)
2 The Wrapped Goods and In-Line Filter Sterilization batch reports are presented in Section 16. Coane, John 12-Mar-2020
(UTC)
3 The date format in the Belimed autoclave Batch Reports is dd/mm/yyyy. Coane, John 12-Mar-2020
(UTC)
Note: If there are no comments in the "Additional Comments" table above, type "No Comments" in the first line. The remaining empty rows will be
considered "N/A". Otherwise, "N/A" all unused rows.

12.6 Sequence of Operations Verification (IOQ - AUT-10202-CAM-03-15)

1. Test Objective

Provide evidence that equipment with embedded software correctly sequences through process steps as required.

2. Scope
This test is required for for all components of System #  AUT-10202 that have an embedded control system.

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NOTE:  This testing is only required if the equipment has an embedded control system or is a standalone system with security functions.

3. Test Case Parameters

Table 1: Wrapped Goods Cycle Sequence 
# Sequence Name
1 Pre-treatment, step 001, Evacuation
2 Pre-treatment, step 002, Evacuation
3 Pre-treatment, step 003, Steam
4 Pre-treatment, step 004, Steam
5 Pre-treatment, step 005, Evacuation
6 Pre-treatment, step 006, Evacuation 
7 Pre-treatment, step 007, Steam
8 Pre-treatment, step 008, Steam
9 Pre-treatment, step 009, Evacuation
10 Pre-treatment, step 010, Evacuation
11 Pre-treatment, step 011, Steam
12 Pre-treatment, step 012, Steam 
13 Pre-treatment, step 013, Evacuation
14 Pre-treatment, step 014, Evacuation
15 Pre-treatment, step 015, Steam
16 Pre-treatment, step 016, Steam
17 Pre-treatment, step 017, Evacuation
18 Pre-treatment, step 019, Steam
19 Sterilization, step 021, Steam
20 Post-treatment, step 022, Evacuation
21 Post-treatment, step 023, Evacuation
22 Post-treatment, step 024, Venting
23 Post-treatment, step 025, Venting

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Table 1: Wrapped Goods Cycle Sequence 

# Sequence Name
24 Post-treatment, step 026, Evacuation
25 Post-treatment, step 027, Evacuation
26 Post-treatment, step 028, Venting
27 Post-treatment, step 029, Venting
28 Post-treatment, step 030, Evacuation
29 Post-treatment, step 032, Venting
30 Post-treatment, step 033, Venting
31 Post-treatment, step 034, Evacuation
32 Post-treatment, step 036, Venting
33 Initial position

Table 2: Leak Test Cycle Sequence

# Sequence Name
1 Pre-treatment, step 001, Evacuation
2 Pre-treatment, step 002, Stabilization
3 Pre-treatment, step 003, Leak-testing
4 Pre-treatment, step 004,Venting
5 Initial position

Table 3: Bowie Dick Test Cycle Sequence

# Sequence Name
1 Pre-treatment, step 001, Evacuation
2 Pre-treatment, step 002, Evacuation
3 Pre-treatment, step 003, Steam

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Table 3: Bowie Dick Test Cycle Sequence

# Sequence Name
4 Pre-treatment, step 004, Steam
5 Pre-treatment, step 005, Evacuation
6 Pre-treatment, step 006, Evacuation 
7 Pre-treatment, step 007, Steam
8 Pre-treatment, step 008, Steam
9 Pre-treatment, step 009, Evacuation
10 Pre-treatment, step 010, Evacuation
11 Pre-treatment, step 011, Steam
12 Pre-treatment, step 012, Steam 
13 Pre-treatment, step 013, Evacuation
14 Pre-treatment, step 014, Evacuation
15 Pre-treatment, step 015, Steam
16 Pre-treatment, step 016, Steam
17 Pre-treatment, step 017, Evacuation
18 Pre-treatment, step 019, Steam
19 Sterilization, step 021, Steam
20 Post-treatment, step 022, Evacuation
21 Post-treatment, step 023, Evacuation
22 Post-treatment, step 024, Venting
23 Post-treatment, step 025, Venting
24 Post-treatment, step 026, Evacuation
25 Post-treatment, step 027, Evacuation
26 Post-treatment, step 028, Venting
27 Post-treatment, step 030, Evacuation
28 Post-treatment, step 032, Venting

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Table 3: Bowie Dick Test Cycle Sequence

# Sequence Name
29 Initial position

Table 4: Filter Inline Sterilization Cycle Sequence

# Sequence Name
1 Pre-treatment, step 001, Evacuation
2 Pre-treatment, step 002, Evacuation
3 Pre-treatment, step 003, Steam
4 Pre-treatment, step 004, Steam
5 Pre-treatment, step 005, Evacuation
6 Pre-treatment, step 006, Evacuation 
7 Pre-treatment, step 007, Steam
8 Pre-treatment, step 008, Steam
9 Pre-treatment, step 009, Evacuation
10 Pre-treatment, step 010, Evacuation
11 Pre-treatment, step 011, Steam
12 Pre-treatment, step 012, Steam 
13 Pre-treatment, step 013, Evacuation
14 Pre-treatment, step 014, Evacuation
15 Pre-treatment, step 015, Steam
16 Pre-treatment, step 016, Steam
17 Pre-treatment, step 017, Evacuation
18 Pre-treatment, step 019, Steam
19 Sterilization, step 021, Steam
20 Post-treatment, step 022, Evacuation

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Table 4: Filter Inline Sterilization Cycle Sequence

# Sequence Name
21 Post-treatment, step 023, Evacuation
22 Post-treatment, step 024, Venting
23 Post-treatment, step 025, Venting
24 Post-treatment, step 026, Evacuation
25 Post-treatment, step 027, Evacuation
26 Post-treatment, step 028, Venting
27 Post-treatment, step 029, Venting
28 Post-treatment, step 030, Evacuation
29 Post-treatment, step 032, Venting
30 Post-treatment, step 033, Venting
31 Post-treatment, step 034, Evacuation
32 Post-treatment, step 036, Venting
33 Initial position

4.  Acceptance Criteria

• Each recipe and/or critical control module on the system operates and transitions as specified. 

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12.6.1 Field Execution - Sequence of Operations Verification (IOQ - AUT-10202-CAM-03-15)

Procedure:

1. Obtain access to the system software.

2. Execute the system program and record the operations executed in Table 5.
3. Compare the operations executed to the sequence required by engineering specifications. The correct sequence of operations for each recipe is provided in Tables 1-4 of this section (Section
12.6).
4. Ensure that all operations are executed in the correct sequence as required by engineering specifications.
5. Testing can be completely concurrently with other operational tests.

Table 5: Sequence of Operations Verification

# Recipe / Critical Control Module Cycle Version# Operations Executed Attachment (If Applicable) Pass / Fail / N/A Performed By Date
1 Wrapped Goods 5  Wrapped Goods program cycle performed to completion with Batch_0000220_2020-02- Pass Coane, John 06-Mar-2020 (UTC)
no alarms/events. See attached batch report from the system. 11_15-51-48.pdf
This run was completed concurrently with testing in Section
12.8.
2 Leak Test 1 Leak Test program cycle performed to completion with no Batch_0000218_2020-02- Pass Coane, John 06-Mar-2020 (UTC)
alarms/events. See attached batch report from the 11_15-50-59.pdf
system. This run was completed concurrently with testing in
Section 12.11.
3 Bowie Dick  (Air Removal) Test 10 Bowie-Dick program cycle performed to completion with no Batch_0000219_2020-02- Pass Coane, John 06-Mar-2020 (UTC)
alarms/events. See attached batch report from the 11_15-51-23.pdf
system. This run was completed concurrently with the empty
chamber sterilization testing in Sections 12.8 and 12.12.
4 Filter Sterilization 1 Batch_0000230_2020-02- Pass Coane, John 06-Mar-2020 (UTC)
Filter Inline Sterilization program cycle performed to 28_15-21-51.pdf
completion with no alarms/events. See attached batch report
from the system.

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Test Review (To be completed by Validation)

# Summary (Yes / No / N/A) Performed By Date
1 Each recipe and/or critical control module on the system operates and transitions as specified. Yes Coane, John 06-Mar-2020
(UTC)
2 Deviation(s) required? No Coane, John 06-Mar-2020
(UTC)
3 Deviation(s) resolved and referenced, if applicable? N/A Coane, John 06-Mar-2020
(UTC)

Comments
# Comments Performed By Date
1 The date format in the Belimed autoclave Batch Reports is dd/mm/yyyy. Coane, John 12-Mar-2020
(UTC)
2 N/A Coane, John 12-Mar-2020
(UTC)
3 N/A Coane, John 12-Mar-2020
(UTC)
Note: If there are no comments in the "Comments" table above, type "No Comments" in the first line. The remaining empty rows will be considered "N/A". Otherwise, "N/A" all unused rows.

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12.7 Automated Valve Actuation Testing (IOQ - AUT-10202-CAM-03-16)

1. Test Objective

Provide evidence that the valves communicate correctly and the user interface reflects the appropriate status of the valve.

Note:  The valve numbers provided in this test case are Belimed-specific numbers which are hard coded into the GUI (Graphics User Interface).

2. Scope
All automated valves in System # AUT-10202 will be verified in this test case.

3. Acceptance Criteria

• All automated valves on the system respond and communicate properly with the control system. 

12.7.1 Field Execution - Automated Valve Actuation Testing (IOQ - AUT-10202-CAM-03-16)

Procedure:

1. Record the current state of each of the valves listed in Table 1.

2. Change the state of the valve on the control system and verify that the state of the valve does change in Table 1.
3. Change the state of the valve back to its original state and verify the change in Table 1.
4. If valves have feedback and alarms exist, verify that an alarm activates when the valve state and corresponding indicator disagree. Record the result   
in Table 1.

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Table 1: Valve Position / Indicator Alarm Testing Table

# Valve # Current State State Changed? Return to Original State? Alarm Triggered? Performed By Date
(Open / Closed / N/A) (Yes / No / N/A) (Yes / No / N/A) (Yes / No / N/A)
1 Sampling Closed Yes Yes No Coane, John 02-Mar-2020
(UTC)
2 K307 Seal Door  (see Note) Closed Yes Yes No Coane, John 02-Mar-2020
(UTC)
3 K307 Release Door (see Closed Yes Yes No Coane, John 02-Mar-2020
Note) (UTC)
4 G904 (see Note) Closed Yes Yes No Coane, John 02-Mar-2020
(UTC)
5 Q4003 Closed Yes Yes No Coane, John 02-Mar-2020
(UTC)
6 Q4004 Closed Yes Yes Yes Coane, John 02-Mar-2020
(UTC)
7 Q3001 Closed Yes Yes No Coane, John 02-Mar-2020
(UTC)
8 Q3202 Open Yes Yes Yes Coane, John 02-Mar-2020
(UTC)
9 Q3203 Open Yes Yes No Coane, John 02-Mar-2020
(UTC)
10 Q1101 Closed Yes Yes No Coane, John 02-Mar-2020
(UTC)
11 Q1001 Closed Yes Yes No Coane, John 02-Mar-2020
(UTC)
12 Q1601 Closed Yes Yes No Coane, John 02-Mar-2020
(UTC)
13 Q1602 Closed Yes Yes No Coane, John 02-Mar-2020
(UTC)
14 Q4001 Closed Yes Yes No Coane, John 02-Mar-2020
(UTC)
15 Q4002 Closed Yes Yes No Coane, John 02-Mar-2020
(UTC)

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Table 1: Valve Position / Indicator Alarm Testing Table

# Valve # Current State State Changed? Return to Original State? Alarm Triggered? Performed By Date
(Open / Closed / N/A) (Yes / No / N/A) (Yes / No / N/A) (Yes / No / N/A)
16 Q2001 Closed Yes Yes No Coane, John 02-Mar-2020
(UTC)
17 Q2002 Closed Yes Yes No Coane, John 02-Mar-2020
(UTC)
18 Q2003 Closed Yes Yes No Coane, John 02-Mar-2020
(UTC)
Note: The door valves/releases will be implicitly tested by the opening and closing the system door. The door release and door close sequence can
damage the door seal if performed incorrectly. Therefore, only the programmed automated open/close buttons will be used to challenge the valves and
not manual forcing functions.

Table 2: Additional Valve Position / Indicator Alarm Testing Table

# Valve # Current State State Changed? Return to Original State? Alarm Triggered? Performed By Date
(Open / Closed / N/A) (Yes / No / N/A) (Yes / No / N/A) (Yes / No / N/A)
1 N/A N/A N/A N/A N/A Coane, John 03-Mar-2020
(UTC)
2 N/A N/A N/A N/A N/A Coane, John 03-Mar-2020
(UTC)
3 N/A N/A N/A N/A N/A Coane, John 03-Mar-2020
(UTC)
4 N/A N/A N/A N/A N/A Coane, John 03-Mar-2020
(UTC)
5 N/A N/A N/A N/A N/A Coane, John 03-Mar-2020
(UTC)
Note: If there are pieces of equipment identified during the execution of this test that are necessary for verification but are not included in Table 1, record
those pieces of equipment and capture the results of the verification in Table 2. "N/A" all unused rows in Table 2.

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Test Review (To be completed by Validation)

# Summary (Yes / No / N/A) Performed By Date
1 All automated valves on the system respond and communicate properly with the control system. Yes Coane, John 03-Mar-2020
(UTC)
2 Deviation(s) required? No Coane, John 03-Mar-2020
(UTC)
3 Deviation(s) resolved and referenced, if applicable? N/A Coane, John 03-Mar-2020
(UTC)

Comments
# Comments Performed By Date
1  The autoclave door can be returned to the 'closed door' state after the door is fully opened. Coane, John 03-Mar-2020
(UTC)
2 N/A Coane, John 03-Mar-2020
(UTC)
3 N/A Coane, John 03-Mar-2020
(UTC)
Note: If there are no comments in the "Comments" table above, type "No Comments" in the first line. The remaining empty rows will be considered
"N/A". Otherwise, "N/A" all unused rows.

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12.8 Autoclave Sterilization (Empty Chamber Mapping) (IOQ - AUT-10202-CAM-03-17)

1. Test Objective

Demonstrate the ability of the autoclave to control temperature in all locations within specified acceptable range.

2. Scope

Sterilization cycle verification of Autoclave AUT-10202 using Autoclave Cycle Wrapped Goods Cycle will be

covered by this test case.  

Validation will be conducted following the requirements specified in SOP-000601. One (1) run will be
performed for this equipment in order to provide evidence of temperature distribution.

3. Testing Prerequisites

• All personnel involved in the execution of this test procedure must be trained (i.e. applicable SOPs, validation
protocol, etc). 

4. Required Test Equipment/Materials

• Calibrated Kaye Validator or  Temperature Monitoring Devices (TMDs)

5. Test Case Parameters

Program cycle parameters for this test are listed on Table 1 below:

Table 1: Wrapped Goods Parameters

Parameter Parameter Value
Jacket pressure  2150 mbar
Liquid sterilization program  not active
Temperature monitoring pre-  Active Sensor 1, Sensor 2
Treatment
Pos. temperature hysteresis   5.0 °C
Neg. temperature hysteresis   1.0 °C
Air detector   not active
Temperature monitoring Active Sensor 1, Sensor 2
sterilization
Correlation monitoring  not active
Differential monitoring of control  active
sensors
F0 value calculation   not active
Pos. temperature hysteresis   3.0°C
Neg. temperature hysteresis   0.0°C

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Table 1: Wrapped Goods Parameters

Parameter Parameter Value
Temperature monitoring Post  Active Sensor 1, Sensor 2
Treatment
Pos. temperature hysteresis   3.0°C
Neg. temperature hysteresis   3.0°C
Ventilation filter FIS active   not active
Ventilation filter FIF active   not active
Basic time interval for recording   5 sec.
Batch Report  Temp: Active Sensor 1, Sensor 2, Sensor 3
StemFract Program Parameters 
Number of fractions  4
Jacket heating  active
Fan  not active
Evacuation target value  60 mbar
Evacuation ramp  500 mbar/min
Additional value evacuation  60 mba
Additional time evacuation  60 sec
Steam target value  2010 mbar
Steam ramp  400 mbar/min
Steam monitoring temperature  0.0 °C
Additional value steam  2010 mbar
Additional time steam  60 sec
Report filter value  6
SteamFract Program Parameters 
Number of fractions   1
Jacket heating   active
Fan   active
Evacuation target value  1013 mbar
Evacuation ramp  400 mbar/min
Additional value evacuation  1013 mbar
Additional time evacuation  0 sec
Steam target value  2220 mbar
Steam ramp  70 mbar/min
Steam monitoring temperature  0.0 °C
Additional value steam  2242 mbar
Additional time steam  0 sec
Report filter value  6
SteriPres  Program Parameters 
Support pressure   not active

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Table 1: Wrapped Goods Parameters

Parameter Parameter Value
Jacket heating   active
Fan   not active
Steam target value   2242 mbar
Steam ramp  1000 mbar/min
Sterilization monitoring 123.2 °C
temperature 
Sterilization time   1800 sec
Report filter value  6
AirFract Program Parameters
Number of fractions   2
Jacket heating   active
Fan   active
Evacuation target value  100 mbar
Evacuation ramp  1000 mbar/min
Additional value evacuation  100 mbar
Additional time evacuation  600 sec
Ventilation target value  800 mbar
Ventilation ramp  1000 mbar/min
Additional value ventilation  800 mbar
Additional time ventilation  90 sec
Report filter value  6
AirFract Program Parameters
Number of fractions   1
Jacket heating   active
Fan   not active
Evacuation target value  100 mbar
Evacuation ramp  1000 mbar/min
Additional value evacuation  100 mbar
Additional time evacuation  0 sec
Ventilation target value  800 mbar
Ventilation ramp  1000 mbar/min
Additional value ventilation  800 mbar
Additional time ventilation  90 sec
Report filter value  6
LastAirFract Program Parameters
Jacket heating   active
Fan   not active
Evacuation target value  100 mbar

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Table 1: Wrapped Goods Parameters

Parameter Parameter Value
Evacuation ramp  1000 mbar/min
Additional value evacuation  100 mbar
Additional time evacuation  0 sec
Ventilation ramp  1000 mbar/min
Report filter value  6

6. Acceptance Criteria

• All TMDs were placed according to a pre-approved TMD placement diagram.

• At least one TMD was placed adjacent to the control and/or drain probe.

• All TMDs remained within the Sterilization Band during the exposure phase.

• All TMDs meet an accumulated F0 of > 12 min during the exposure phase.

• All TMDs remained within 2°C of each other during the exposure phase.

• The theoretical temperature, based on the pressure of the system, at each time point must be within ± 2°C of
the measured temperature at each location in the autoclave.

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12.8.1 Field Execution - Autoclave Sterilization (Empty Chamber) - TMDs Setup (IOQ - AUT-10202-CAM-03-17)

Table 2: Setup and TC Placement

# Procedure Expected Results Actual Results Attachment  Pass/Fail Performed By Date
1 Verify the TMD placement A pre-approved placement  A pre-approved placement Pre-Approved TMD Pass Coane, John 03-Mar-2020 (UTC)
diagram has been pre- diagram (which includes TMD diagram (which includes TMD Diagram.pdf
approved by engineering and Location, and TMD List) is Location, and TMD List) is attached
CQV at a minimum. Attach the attached and has been pre- and has been pre-approved by
preapproved TMDs placement approved by engineering and engineering and CQV at a
map CQV at a minimum. minimum.
2 Verify a Bowie Dick Test was Bowie Dick Test was  Bowie Dick Test was successfully Bowie Dick Results and Pass Coane, John 03-Mar-2020 (UTC)
successfully completed per successfully completed prior to completed prior to test execution. Batch Report.pdf
procedure prior to test test execution. Copy of results Copy of test pack and batch report
execution. are attached. are attached.
Copy of results are attached.
3 Confirm that a leak test has A leak test was performed and  A leak test was performed Leak test after TC Pass Coane, John 03-Mar-2020 (UTC)
been successfully performed found acceptable. following thermocouple feed-thru Feedthru.pdf
prior to initiating any of the into the chamber.
Autoclave Sterilization (empty SOP-001252 for test frequency.
Chamber) test. A test is required whenever
Copy of results are attached. TMD's are fed into the chamber.
Copy of results are attached.
4 Verify TCs have been placed TCs were placed according  TCs were placed according to pre- Completed Empty Pass Coane, John 06-Mar-2020 (UTC)
according to pre-approved to pre-approved placement approved placement diagram. Chamber TMD
placement diagram. diagram. Copy of the completed Copy of the completed Pre- Diagram.pdf
Pre-Approved Placement Approved Placement Diagram is
Diagram is attached. attached.
5 Verify that the TMD and the TMD and the chamber control  TMD and the chamber control N/A Pass Coane, John 03-Mar-2020 (UTC)
chamber control system system date/time  verified.  system date/time verified. No
date/time are the same (±1 Adjustment (if any) was adjustment necessary.
minute) .  Adjust the TMD as performed and documented (if
required and/or document the applicable).
difference between the

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Table 2: Setup and TC Placement

# Procedure Expected Results Actual Results Attachment  Pass/Fail Performed By Date
systems.

Comments
# Comments: Performed By Date
1 The date format in the Belimed autoclave Batch Reports is dd/mm/yyyy. Coane, John 12-Mar-2020 (UTC)
2  N/A Coane, John 12-Mar-2020 (UTC)
3  N/A Coane, John 12-Mar-2020 (UTC)
Note: If there are no comments in the "Comments" table above, type "No Comments" in the first line. The remaining empty rows will be considered
"N/A". Otherwise, "N/A" all unused rows.

12.8.2 Field Execution - Autoclave Sterilization (Empty Chamber) - Test Run (IOQ - AUT-10202-CAM-03-17)

Table 2:  Cycle Test 
# Procedure Expected Result Actual Result Attachment Pass / Fail Performed By Date
1 Load the autoclave sterilization Cycle program Wrapped Goods  Cycle program Wrapped Goods N/A Pass Coane, John 03-Mar-2020
program for Wrapped Goods version #5 is loaded. version #5 is loaded. (UTC)
version #5.
2 Record the exposure Wrapped Goods cycle sterilization   124°C (2242 mbar) See steam N/A Pass Coane, John 13-Mar-2020
temperature to be used for this temperature is recorded. table in Section 16 (UTC)
cycle.
3 Record the exposure time to be Wrapped Goods cycle sterilization  1800 seconds (30 minutes) N/A Pass Coane, John 03-Mar-2020
used for this cycle. time is recorded. (UTC)
4 Start the equipment  cycle and Cycle started and the date/time are Cycle started on 05Feb2020 at N/A Pass Coane, John 03-Mar-2020
simultaneously start the Kaye recorded. 1609. (UTC)
validator. Record the date / time
the cycle was started.

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Table 2:  Cycle Test 
# Procedure Expected Result Actual Result Attachment Pass / Fail Performed By Date
5 Record the start  date/time of Exposure cycle started and its date /  05 Feb 20 17:13:30 N/A Pass Coane, John 03-Mar-2020
the exposure cycle. time are recorded. (UTC)
6 Record the end date/time of the Exposure cycle completed and its  05 Feb 20 17:43:30 N/A Pass Coane, John 03-Mar-2020
exposure cycle. date / time are recorded. (UTC)
7 Record the equipment cycle end Equipment cycle end date / time are Cycle ended on 05Feb2020 at N/A Pass Coane, John 03-Mar-2020
date / time recorded. 1758. (UTC)
8 Ensure that the equipment cycle Cycle completed  without faults or Cycle completed with no faults nor N/A Pass Coane, John 03-Mar-2020
completed as required (no faults alarms. alarms occurred. (UTC)
or alarms)
 

Comments
# Comments: Performed By Date
1 No comments Coane, John 03-Mar-2020
(UTC)
2      
3      
Note: If there are no comments in the "Comments" table above, type "No Comments" in the first line. The remaining empty rows will be considered
"N/A". Otherwise, "N/A" all unused rows.

12.8.3 Field Execution - Autoclave Sterilization (Empty Chamber) - Test Results (IOQ - AUT-10202-CAM-03-17)

Table 4: Qualification Report Attachments

# Procedure Attachment Performed By Date
1 Attach a copy of the system batch report for the Wrapped Goods cycle run to support this Batch_0000220_2020-02-11_15-51-48.pdf Coane, John 06-Mar-2020 (UTC)
qualification.

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Table 4: Qualification Report Attachments

# Procedure Attachment Performed By Date
2 Generate and attach the Kaye Summary report documenting data collected from the TMDs Kaye Graph and Summary Report.pdf Coane, John 06-Mar-2020 (UTC)
during testing execution.
3 Generate and attach the Kaye Detail report documenting data collected from the TMDs Kaye Detail Report.pdf Coane, John 06-Mar-2020 (UTC)
during test execution.
4 Generate and attach report documentation data collected from the ambient TMD for the Kaye Ambient TC Reports.pdf Coane, John 06-Mar-2020 (UTC)
duration of the study.
5 Attach a graph from the PI data historian for the study period. PI Report.PNG Coane, John 06-Mar-2020 (UTC)
6 Attach any additional files used to verify results. OQ Run 1 Batch 220.xlsx Coane, John 06-Mar-2020 (UTC)
7 Attach any additional files used to verify results. N/A Coane, John 06-Mar-2020 (UTC)
 

Test Review (To be completed by Validation)

# Procedure Expected Result Actual Result Pass / Fail / N/A Performed By Date
1 Record the TMD and reading of the lowest TMD # / lowest temperature during  TC #4 / 123.37°C Pass Coane, John 06-Mar-2020 (UTC)
temperature observed during the exposure exposure period is recorded.
period.
2 Record the TMD and reading of the highest TMD # / highest temperature during  TC #6, TC #3 / 124.24°C Pass Coane, John 06-Mar-2020 (UTC)
temperature observed during the exposure exposure period is recorded.
period.
3 Average temperature observed during the Average temperature during exposure  124.04 °C Pass Coane, John 06-Mar-2020 (UTC)
exposure period. period is recorded.
4 Verify all TMDs were placed according to a  All TMDs were placed according to a  All TMDs were placed Pass Coane, John 06-Mar-2020 (UTC)
pre-approved TMD placement diagram. pre-approved TMD placement diagram. according to a pre-approved
TMD placement diagram.

5 At least one TMD was placed adjacent to  Record the TMD placed next to the  TC #04 was placed next to Pass Coane, John 06-Mar-2020 (UTC)
the control probe. control probe. the control probe.
6 At least one TMD was placed in the drain.  Record the TMD placed in the drain.  TC #05 placed in the drain. Pass Coane, John 06-Mar-2020 (UTC)
7 Review the attached data from the TMDs. All TMDs > 121.1°C  All TMDs in autoclave> Pass Coane, John 06-Mar-2020 (UTC)

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 Document Version:  1.0 
 Equipment ID:  AUT-10202 
 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Test Review (To be completed by Validation)

# Procedure Expected Result Actual Result Pass / Fail / N/A Performed By Date
Verify that all TMDs achieved a temperature 121.1°C
> 121.1°C during the entire sterilization
hold.
8 Record the TMD and reading of the lowest TMD # / lowest temperature must be >  TC #4 / 123.37°C Pass Coane, John 06-Mar-2020 (UTC)
temperature observed during the exposure 121.1°C
time.
9 Record the TMD and reading of the highest TMD # / highest temperature must not  TC #6, TC #3 / highest Pass Coane, John 06-Mar-2020 (UTC)
temperature observed during the exposure exceed 3°C above the set point temperature did not exceed
time. temperature. 3°C above (127°C) the set
point temperature.
10 Verify that all TMDs achieved a lethality (F0) All TMDs F0 ≥ 12 minutes  All TMDs F0 ≥ 12 minutes Pass Coane, John 06-Mar-2020 (UTC)
value ≥ 12 minutes during the exposure
time
11 Record the TMD and Lethality (F0) value TMD # / lowest F0 meets or exceeds 12  TC #4 / Fo=56.46 Pass Coane, John 06-Mar-2020 (UTC)
corresponding to the lowest cumulative minutes.
lethality during the exposure time.
12  Verify all TMDs remained within 2°C of the  All TMDs remained within 2°C of the  All TMDs remained within Pass Coane, John 06-Mar-2020 (UTC)
each other during the exposure phase. each other during the exposure phase. 2°C of the each other during
the exposure phase. Actual
Range was 0.87°C.
13 The theoretical temperature, based on the The Saturated Steam Pressure and the Saturated Steam Pressure = Pass Coane, John 06-Mar-2020 (UTC)
pressure of the system, at each time point measured exposure temperature is 2242 mbar which is 124°C.
must be within ±2°C of the measured within ± 2°C of each other at each Minimum temperature was
temperature at each location in the location. 123.37 and maximum
autoclave.  temperature was 124.24.
The measure temperature
range met the acceptance
range of 122 to 126 °C.
14 Verify that the TMD adjacent to the control Post calibration is acceptable.  Post calibration was Pass Coane, John 06-Mar-2020 (UTC)
probe passes post-calibration and that no acceptable
more than one TMD (or 10% for more than
20) fails post-calibration.
15 Deviation(s) required? Yes / No / N/A  No Pass Coane, John 06-Mar-2020 (UTC)
16 Deviation(s) resolved and referenced, if Yes / No / N/A  N/A N/A Coane, John 06-Mar-2020 (UTC)
applicable?
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Test Review (To be completed by Validation)

# Procedure Expected Result Actual Result Pass / Fail / N/A Performed By Date
17 All acceptance criteria have been Yes / No / N/A Yes Pass Coane, John 06-Mar-2020 (UTC)
performed as required or proper justification
has been recorded

Comments
# Comments: Performed By Date
1  Note the first line of post-treatment phase in the Belimed batch report in line 1, table 4 is a part of the sterilization phase. Coane, John 06-Mar-2020
(UTC)
2 The date format in the Belimed autoclave Batch Reports is dd/mm/yyyy. Coane, John 12-Mar-2020
(UTC)
3 N/A Coane, John 06-Mar-2020
(UTC)
Note: If there are no comments in the "Comments" table above, type "No Comments" in the first line. The remaining empty rows will be considered
"N/A". Otherwise, "N/A" all unused rows.

12.9 Access Rights Testing (IOQ - AUT-10202-CAM-03-18)

1. Test Objective

Provide evidence that the system accessibility is limited and controlled and that the functionality is accessible with the proper authorization level.

2. Scope

All user security levels listed in Table 1 below. One representative user account from each security level has been chosen to be tested in this protocol.
Each user account password will be verified to be correct. Each user account will be verified to have the correct permissions and restrictions listed in
Table 2. These user accounts shall be created prior to test execution per system operating instructions and removed following test completion.
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Table 1: AUT-10202 User Accounts

# Security Level User Account Name
1 Maintenance mcqv
2 Operator ocqv
3 Supervisor scqv
4 Validator vcqv
5 Administrator acqv
 

Table 2: Autoclave Access Levels/Rights

# Navigation  Operator Supervisor Validator Access  Maintenance  Administrator Access
Access Rights Description Access Access  Access 
1  Menu:  Allowed   Allowed  Allowed  Allowed  Allowed
 Displaying the menu
2  Menu  Allowed  Allowed   Allowed   Allowed   Allowed 
Program parameters: Reading program parameters 
3  Menu - Program parameters:   Not Allowed  Not Allowed   Allowed   Allowed   Allowed 
 Creating/modifying program parameters, incl. process 
direction, monitoring sensors, program export/import 
4  Menu - Calibrate temperature / pressure sensors  Not Allowed  Allowed   Allowed   Allowed   Allowed 
 Reading temperature and pressure sensor’s calibration
5  Menu - Calibrate temperature / pressure sensors  Not Allowed  Not Allowed  Not Allowed Allowed   Allowed 
Calibrating temperature and pressure sensors
6  Menu - Align temperature / pressure sensors Not Allowed  Allowed   Allowed   Allowed   Allowed 
Reading temperature and pressure sensor’s
alignment 
7  Menu - Calibrate temperature / pressure sensors Not Allowed  Not Allowed   Allowed   Allowed   Allowed 
 Aligning temperature and pressure sensors
8  Menu - Settings - Machine configuration  Not Allowed  Allowed  Not Allowed  Allowed  Allowed

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 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Table 2: Autoclave Access Levels/Rights

# Navigation  Operator Supervisor Validator Access  Maintenance  Administrator Access
Access Rights Description Access Access  Access 
Reading machine configuration 
9  Menu - Settings - General settings Not Allowed  Allowed   Allowed   Allowed   Allowed 
 Reading machine parameters 
10 Menu - Settings - General settings  Not Allowed  Not Allowed   Allowed   Allowed   Allowed
Setting machine parameters
11  Menu - Settings - Process settings Not Allowed  Allowed   Allowed   Allowed   Allowed
 Reading the machine settings 
12  Menu - Settings - Process settings Not Allowed  Not Allowed   Allowed   Allowed   Allowed
 Setting the machine settings
13  Menu - Automatic mode / Time I Date Not Allowed  Allowed   Allowed   Allowed   Allowed
 Reading system settings
14  Menu - Automatic mode Not Allowed  Allowed  Not Allowed  Allowed  Allowed
Setting the system settings
15  Menu - Time I Date Not Allowed  Allowed  Not Allowed  Allowed  Allowed
Setting date, time and displaying format
16  Menu - Automatic mode Not Allowed  Allowed  Not Allowed  Allowed  Allowed
 Setting automatic mode and operation start/stop
17  Menu - Automatic mode Not Allowed  Allowed  Not Allowed  Allowed  Allowed
Setting automatic start program
18  Menu – User management Not Allowed  Allowed  Not Allowed  Not Allowed  Allowed
Administrating users
19  Menu – Group management Not Allowed  Allowed  Not Allowed  Not Allowed  Allowed
Administrating user group (and authorizations)
20  Menu - Maintenance / Door seal / Force actuators  Not Allowed  Not Allowed  Not Allowed Allowed  Allowed
Performing maintenance work and acknowledging
maintenance messages. Controlling door seal, actuators
and sensors
21  Process  Allowed   Allowed  Allowed  Allowed  Allowed
Change unloading side (before process start /
only if sterilizer has two doors)
22  Process - Control Allowed   Allowed  Allowed  Allowed  Allowed
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 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Table 2: Autoclave Access Levels/Rights

# Navigation  Operator Supervisor Validator Access  Maintenance  Administrator Access
Access Rights Description Access Access  Access 
Selecting a program, entering batch data, starting the batch
(also after an error)
23  Process - Control Not Allowed   Allowed  Allowed  Allowed  Allowed
Perform a manual step change
24  Lock a batch (at the end of a batch with alarms)  Allowed   Allowed  Allowed  Allowed  Allowed
25  Release a batch (at the end of a batch with Not Allowed   Allowed  Allowed  Allowed  Allowed
alarms)
26  Alarm history Allowed   Allowed  Allowed  Allowed  Allowed
Acknowledging all alarms
27  Shutdown GUI program (Show Windows Desktop) Not Allowed   Allowed  Not Allowed  Allowed  Allowed

3. Acceptance Criteria

• Each user could only access system functions that were specific to their user access level.

• The system prevented access to a user account when incorrect login credentials were entered.

• The system reverted to its predefined default access after a predetermined lockout period.

12.9.1 Field Execution - Access Rights Testing (IOQ - AUT-10202-CAM-03-18)

Procedure:

1. Create user accounts listed in Table 1 per operating instructions in section 9.7.
2. For each user account listed in Table 1, enter the default password and verify that access to the account is granted.
3. For each user account, enter at least three incorrect passwords and verify that access to the account is denied.
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4. For each user account, verify that the correct permissions and restrictions, listed in Table 2, are applied based on the security level specified
in Table 1.
5. For each user account, verify that the system automatically logs out and reverts to the Default user after a predetermined amount of time.
6. Following completion of Access Rights Testing, remove all test IDs below. Refer to operating instructions in section 9.7

Table 3: User Account Access Testing

# User Account Default Password Wrong Passwords Reverts to Default Access User Account Result? Performed By Date
Correct? Fail? at Timeout? (Pass / Fail / N/A)
(Yes / No / N/A) (Yes / No / N/A) (Yes / No / N/A)
1 Maintenance Yes Yes Yes Pass Coane, John 31-Jan-2020 (UTC)
2 Operator Yes Yes Yes Pass Coane, John 31-Jan-2020 (UTC)
3 Supervisor Yes Yes Yes Pass Coane, John 31-Jan-2020 (UTC)
4 Validator Yes Yes Yes Pass Coane, John 31-Jan-2020 (UTC)
5 admin Yes Yes Yes Pass Coane, John 31-Jan-2020 (UTC)

Table 4:  Operator Access Rights Verification

# Navigation  Expected Access Rights Access Level Verified? Performed By Date
Access Rights Description (Yes / No / N/A)
1  Menu:  Allowed  Yes Coane, John 06-Feb-2020 (UTC)
 Displaying the menu
2  Menu  Allowed Yes Coane, John 06-Feb-2020 (UTC)
Program parameters: Reading program parameters 
3  Menu - Program parameters:   Not Allowed Yes Coane, John 06-Feb-2020 (UTC)
 Creating/modifying program parameters, incl. process 
direction, monitoring sensors, program export/import 
4  Menu - Calibrate temperature / pressure sensors  Not Allowed Yes Coane, John 06-Feb-2020 (UTC)
 Reading temperature and pressure sensor’s calibration
5  Menu - Calibrate temperature / pressure sensors  Not Allowed Yes Coane, John 06-Feb-2020 (UTC)
Calibrating temperature and pressure sensors
6  Menu - Align temperature / pressure sensors Not Allowed Yes Coane, John 06-Feb-2020 (UTC)
Reading temperature and pressure sensor’s

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 Equipment ID:  AUT-10202 
 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Table 4:  Operator Access Rights Verification

# Navigation  Expected Access Rights Access Level Verified? Performed By Date
Access Rights Description (Yes / No / N/A)
alignment 
7  Menu - Calibrate temperature / pressure sensors Not Allowed Yes Coane, John 06-Feb-2020 (UTC)
 Aligning temperature and pressure sensors
8  Menu - Settings - Machine configuration  Not Allowed Yes Coane, John 06-Feb-2020 (UTC)
Reading machine configuration 
9  Menu - Settings - General settings Not Allowed Yes Coane, John 06-Feb-2020 (UTC)
 Reading machine parameters 
10 Menu - Settings - General settings  Not Allowed Yes Coane, John 06-Feb-2020 (UTC)
Setting machine parameters
11  Menu - Settings - Process settings Not Allowed Yes Coane, John 06-Feb-2020 (UTC)
 Reading the machine settings 
12  Menu - Settings - Process settings Not Allowed Yes Coane, John 06-Feb-2020 (UTC)
 Setting the machine settings
13  Menu - Automatic mode / Time I Date Not Allowed Yes Coane, John 06-Feb-2020 (UTC)
 Reading system settings
14  Menu - Automatic mode Not Allowed Yes Coane, John 06-Feb-2020 (UTC)
Setting the system settings
15  Menu - Time I Date Not Allowed Yes Coane, John 06-Feb-2020 (UTC)
Setting date, time and displaying format
16  Menu - Automatic mode Not Allowed Yes Coane, John 06-Feb-2020 (UTC)
 Setting automatic mode and operation start/stop
17  Menu - Automatic mode Not Allowed Yes Coane, John 06-Feb-2020 (UTC)
Setting automatic start program
18  Menu – User management Not Allowed Yes Coane, John 06-Feb-2020 (UTC)
Administrating users
19  Menu – Group management Not Allowed Yes Coane, John 06-Feb-2020 (UTC)
Administrating user group (and authorizations)
20  Menu - Maintenance / Door seal / Force actuators  Not Allowed Yes Coane, John 06-Feb-2020 (UTC)
Performing maintenance work and acknowledging
maintenance messages. Controlling door seal, actuators
and sensors
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 Equipment ID:  AUT-10202 
 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Table 4:  Operator Access Rights Verification

# Navigation  Expected Access Rights Access Level Verified? Performed By Date
Access Rights Description (Yes / No / N/A)
21  Process  Allowed  Yes Coane, John 06-Feb-2020 (UTC)
Change unloading side (before process start /
only if sterilizer has two doors)
22  Process - Control Allowed  Yes Coane, John 06-Feb-2020 (UTC)
Selecting a program, entering batch data, starting the batch
(also after an error)
23  Process - Control Not Allowed  Yes Coane, John 06-Feb-2020 (UTC)
Perform a manual step change
24  Lock a batch (at the end of a batch with alarms)  Allowed  Yes Coane, John 06-Feb-2020 (UTC)
25  Release a batch (at the end of a batch with Not Allowed  Yes Coane, John 06-Feb-2020 (UTC)
alarms)
26  Alarm history Allowed  Yes Coane, John 06-Feb-2020 (UTC)
Acknowledging all alarms
27  Shutdown GUI program (Show Windows Desktop) Not Allowed  Yes Coane, John 06-Feb-2020 (UTC)

Table 5: Supervisor Access Rights Verification

# Navigation  Expected Access Rights Access Level Verified? (Yes / Performed By Date
Access Rights Description No / N/A)
1  Menu:   Allowed Yes Coane, John 06-Feb-2020 (UTC)
 Displaying the menu
2  Menu  Allowed Yes Coane, John 06-Feb-2020 (UTC)
Program parameters: Reading program parameters 
3  Menu - Program parameters:   Not Allowed  Yes Coane, John 06-Feb-2020 (UTC)
 Creating/modifying program parameters, incl. process 
direction, monitoring sensors, program export/import 
4  Menu - Calibrate temperature / pressure sensors  Allowed  Yes Coane, John 06-Feb-2020 (UTC)
 Reading temperature and pressure sensor’s calibration

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 Equipment ID:  AUT-10202 
 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Table 5: Supervisor Access Rights Verification

# Navigation  Expected Access Rights Access Level Verified? (Yes / Performed By Date
Access Rights Description No / N/A)
5  Menu - Calibrate temperature / pressure sensors  Not Allowed Yes Coane, John 06-Feb-2020 (UTC)
Calibrating temperature and pressure sensors
6  Menu - Align temperature / pressure sensors  Allowed  Yes Coane, John 06-Feb-2020 (UTC)
Reading temperature and pressure sensor’s
alignment 
7  Menu - Calibrate temperature / pressure sensors  Not Allowed  Yes Coane, John 06-Feb-2020 (UTC)
 Aligning temperature and pressure sensors
8  Menu - Settings - Machine configuration  Allowed Yes Coane, John 06-Feb-2020 (UTC)
Reading machine configuration 
9  Menu - Settings - General settings  Allowed  Yes Coane, John 06-Feb-2020 (UTC)
 Reading machine parameters 
10 Menu - Settings - General settings   Not Allowed  Yes Coane, John 06-Feb-2020 (UTC)
Setting machine parameters
11  Menu - Settings - Process settings  Allowed  Yes Coane, John 06-Feb-2020 (UTC)
 Reading the machine settings 
12  Menu - Settings - Process settings  Not Allowed  Yes Coane, John 06-Feb-2020 (UTC)
 Setting the machine settings
13  Menu - Automatic mode / Time I Date  Allowed  Yes Coane, John 06-Feb-2020 (UTC)
 Reading system settings
14  Menu - Automatic mode  Allowed Yes Coane, John 06-Feb-2020 (UTC)
Setting the system settings
15  Menu - Time I Date  Allowed Yes Coane, John 06-Feb-2020 (UTC)
Setting date, time and displaying format
16  Menu - Automatic mode  Allowed Yes Coane, John 06-Feb-2020 (UTC)
 Setting automatic mode and operation start/stop
17  Menu - Automatic mode  Allowed Yes Coane, John 06-Feb-2020 (UTC)
Setting automatic start program
18  Menu – User management  Allowed Yes Coane, John 06-Feb-2020 (UTC)
Administrating users
19  Menu – Group management  Allowed Yes Coane, John 06-Feb-2020 (UTC)
Administrating user group (and authorizations)
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 Equipment ID:  AUT-10202 
 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Table 5: Supervisor Access Rights Verification

# Navigation  Expected Access Rights Access Level Verified? (Yes / Performed By Date
Access Rights Description No / N/A)
20  Menu - Maintenance / Door seal / Force actuators  Not Allowed Yes Coane, John 06-Feb-2020 (UTC)
Performing maintenance work and acknowledging
maintenance messages. Controlling door seal, actuators
and sensors
21  Process   Allowed Yes Coane, John 06-Feb-2020 (UTC)
Change unloading side (before process start /
only if sterilizer has two doors)
22  Process - Control  Allowed Yes Coane, John 06-Feb-2020 (UTC)
Selecting a program, entering batch data, starting the batch
(also after an error)
23  Process - Control  Allowed Yes Coane, John 06-Feb-2020 (UTC)
Perform a manual step change
24  Lock a batch (at the end of a batch with alarms)   Allowed Yes Coane, John 06-Feb-2020 (UTC)
25  Release a batch (at the end of a batch with  Allowed Yes Coane, John 06-Feb-2020 (UTC)
alarms)
26  Alarm history  Allowed Yes Coane, John 06-Feb-2020 (UTC)
Acknowledging all alarms
27  Shutdown GUI program (Show Windows Desktop)  Allowed Yes Coane, John 06-Feb-2020 (UTC)

Table 6:  Validator Access Rights Verification

# Navigation  Expected Access Rights Access Level Verified? Performed By Date
Access Rights Description (Yes / No / N/A)
1  Menu:   Allowed Yes Coane, John 06-Feb-2020 (UTC)
 Displaying the menu
2  Menu   Allowed  Yes Coane, John 06-Feb-2020 (UTC)
Program parameters: Reading program parameters 
3  Menu - Program parameters:   Allowed  Yes Coane, John 06-Feb-2020 (UTC)
 Creating/modifying program parameters, incl. process 
direction, monitoring sensors, program export/import 

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 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Table 6:  Validator Access Rights Verification

# Navigation  Expected Access Rights Access Level Verified? Performed By Date
Access Rights Description (Yes / No / N/A)
4  Menu - Calibrate temperature / pressure sensors  Allowed  Yes Coane, John 06-Feb-2020 (UTC)
 Reading temperature and pressure sensor’s calibration
5  Menu - Calibrate temperature / pressure sensors  Not Allowed Yes Coane, John 06-Feb-2020 (UTC)
Calibrating temperature and pressure sensors
6  Menu - Align temperature / pressure sensors  Allowed  Yes Coane, John 06-Feb-2020 (UTC)
Reading temperature and pressure sensor’s
alignment 
7  Menu - Calibrate temperature / pressure sensors  Allowed  Yes Coane, John 06-Feb-2020 (UTC)
 Aligning temperature and pressure sensors
8  Menu - Settings - Machine configuration  Not Allowed Yes Coane, John 06-Feb-2020 (UTC)
Reading machine configuration 
9  Menu - Settings - General settings  Allowed  Yes Coane, John 06-Feb-2020 (UTC)
 Reading machine parameters 
10 Menu - Settings - General settings   Allowed  Yes Coane, John 06-Feb-2020 (UTC)
Setting machine parameters
11  Menu - Settings - Process settings  Allowed  Yes Coane, John 06-Feb-2020 (UTC)
 Reading the machine settings 
12  Menu - Settings - Process settings  Allowed  Yes Coane, John 06-Feb-2020 (UTC)
 Setting the machine settings
13  Menu - Automatic mode / Time I Date  Allowed  Yes Coane, John 06-Feb-2020 (UTC)
 Reading system settings
14  Menu - Automatic mode  Not Allowed Yes Coane, John 06-Feb-2020 (UTC)
Setting the system settings
15  Menu - Time I Date  Not Allowed Yes Coane, John 06-Feb-2020 (UTC)
Setting date, time and displaying format
16  Menu - Automatic mode  Not Allowed Yes Coane, John 06-Feb-2020 (UTC)
 Setting automatic mode and operation start/stop
17  Menu - Automatic mode  Not Allowed Yes Coane, John 06-Feb-2020 (UTC)
Setting automatic start program
18  Menu – User management  Not Allowed Yes Coane, John 06-Feb-2020 (UTC)
Administrating users
Page 165 of 196 01-Mar-2023 (UTC)
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 Equipment ID:  AUT-10202 
 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Table 6:  Validator Access Rights Verification

# Navigation  Expected Access Rights Access Level Verified? Performed By Date
Access Rights Description (Yes / No / N/A)
19  Menu – Group management  Not Allowed Yes Coane, John 06-Feb-2020 (UTC)
Administrating user group (and authorizations)
20  Menu - Maintenance / Door seal / Force actuators  Not Allowed Yes Coane, John 06-Feb-2020 (UTC)
Performing maintenance work and acknowledging
maintenance messages. Controlling door seal, actuators
and sensors
21  Process   Allowed Yes Coane, John 06-Feb-2020 (UTC)
Change unloading side (before process start /
only if sterilizer has two doors)
22  Process - Control  Allowed Yes Coane, John 06-Feb-2020 (UTC)
Selecting a program, entering batch data, starting the batch
(also after an error)
23  Process - Control  Allowed Yes Coane, John 06-Feb-2020 (UTC)
Perform a manual step change
24  Lock a batch (at the end of a batch with alarms)   Allowed Yes Coane, John 06-Feb-2020 (UTC)
25  Release a batch (at the end of a batch with  Allowed Yes Coane, John 06-Feb-2020 (UTC)
alarms)
26  Alarm history  Allowed Yes Coane, John 06-Feb-2020 (UTC)
Acknowledging all alarms
27  Shutdown GUI program (Show Windows Desktop)  Not Allowed Yes Coane, John 06-Feb-2020 (UTC)

Table 7: Maintenance Access Rights Verification

# Navigation  Expected Access Rights Access Rights Performed By Date
Access Rights Description Verified? (Yes / No /
N/A)
1  Menu:   Allowed Yes Coane, John 06-Feb-2020 (UTC)
 Displaying the menu
2  Menu  Allowed Yes Coane, John 06-Feb-2020 (UTC)
Program parameters: Reading program parameters 

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Table 7: Maintenance Access Rights Verification

# Navigation  Expected Access Rights Access Rights Performed By Date
Access Rights Description Verified? (Yes / No /
N/A)
3  Menu - Program parameters:   Allowed  Yes Coane, John 06-Feb-2020 (UTC)
 Creating/modifying program parameters, incl. process 
direction, monitoring sensors, program export/import 
4  Menu - Calibrate temperature / pressure sensors  Allowed  Yes Coane, John 06-Feb-2020 (UTC)
 Reading temperature and pressure sensor’s calibration
5  Menu - Calibrate temperature / pressure sensors Allowed  Yes Coane, John 06-Feb-2020 (UTC)
Calibrating temperature and pressure sensors
6  Menu - Align temperature / pressure sensors  Allowed  Yes Coane, John 06-Feb-2020 (UTC)
Reading temperature and pressure sensor’s
alignment 
7  Menu - Calibrate temperature / pressure sensors  Allowed  Yes Coane, John 06-Feb-2020 (UTC)
 Aligning temperature and pressure sensors
8  Menu - Settings - Machine configuration  Allowed Yes Coane, John 06-Feb-2020 (UTC)
Reading machine configuration 
9  Menu - Settings - General settings  Allowed  Yes Coane, John 06-Feb-2020 (UTC)
 Reading machine parameters 
10 Menu - Settings - General settings   Allowed  Yes Coane, John 06-Feb-2020 (UTC)
Setting machine parameters
11  Menu - Settings - Process settings  Allowed  Yes Coane, John 06-Feb-2020 (UTC)
 Reading the machine settings 
12  Menu - Settings - Process settings  Allowed  Yes Coane, John 06-Feb-2020 (UTC)
 Setting the machine settings
13  Menu - Automatic mode / Time I Date  Allowed  Yes Coane, John 06-Feb-2020 (UTC)
 Reading system settings
14  Menu - Automatic mode  Allowed Yes Coane, John 06-Feb-2020 (UTC)
Setting the system settings
15  Menu - Time I Date  Allowed Yes Coane, John 06-Feb-2020 (UTC)
Setting date, time and displaying format
16  Menu - Automatic mode  Allowed Yes Coane, John 06-Feb-2020 (UTC)
 Setting automatic mode and operation start/stop

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 Document Version:  1.0 
 Equipment ID:  AUT-10202 
 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Table 7: Maintenance Access Rights Verification

# Navigation  Expected Access Rights Access Rights Performed By Date
Access Rights Description Verified? (Yes / No /
N/A)
17  Menu - Automatic mode  Allowed Yes Coane, John 06-Feb-2020 (UTC)
Setting automatic start program
18  Menu – User management  Not Allowed Yes Coane, John 06-Feb-2020 (UTC)
Administrating users
19  Menu – Group management  Not Allowed Yes Coane, John 06-Feb-2020 (UTC)
Administrating user group (and authorizations)
20  Menu - Maintenance / Door seal / Force actuators Allowed Yes Coane, John 06-Feb-2020 (UTC)
Performing maintenance work and acknowledging
maintenance messages. Controlling door seal, actuators
and sensors
21  Process   Allowed Yes Coane, John 06-Feb-2020 (UTC)
Change unloading side (before process start /
only if sterilizer has two doors)
22  Process - Control  Allowed Yes Coane, John 06-Feb-2020 (UTC)
Selecting a program, entering batch data, starting the batch
(also after an error)
23  Process - Control  Allowed Yes Coane, John 06-Feb-2020 (UTC)
Perform a manual step change
24  Lock a batch (at the end of a batch with alarms)   Allowed Yes Coane, John 06-Feb-2020 (UTC)
25  Release a batch (at the end of a batch with  Allowed Yes Coane, John 06-Feb-2020 (UTC)
alarms)
26  Alarm history  Allowed Yes Coane, John 06-Feb-2020 (UTC)
Acknowledging all alarms
27  Shutdown GUI program (Show Windows Desktop)  Allowed Yes Coane, John 06-Feb-2020 (UTC)

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Table 8:  Administrator Access Rights Verification

# Navigation  Administrator Access Expected Access Performed By Date
Access Rights Description Verified?
(Yes / No / N/A)
1  Menu:   Allowed Pass Coane, John 06-Feb-2020 (UTC)
 Displaying the menu

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Table 8:  Administrator Access Rights Verification

# Navigation  Administrator Access Expected Access Performed By Date
Access Rights Description Verified?
(Yes / No / N/A)
2  Menu   Allowed  Pass Coane, John 06-Feb-2020 (UTC)
Program parameters: Reading program parameters 
3  Menu - Program parameters:   Allowed  Pass Coane, John 06-Feb-2020 (UTC)
 Creating/modifying program parameters, incl. process 
direction, monitoring sensors, program export/import 
4  Menu - Calibrate temperature / pressure sensors  Allowed  Pass Coane, John 06-Feb-2020 (UTC)
 Reading temperature and pressure sensor’s calibration
5  Menu - Calibrate temperature / pressure sensors  Allowed  Pass Coane, John 06-Feb-2020 (UTC)
Calibrating temperature and pressure sensors
6  Menu - Align temperature / pressure sensors  Allowed  Pass Coane, John 06-Feb-2020 (UTC)
Reading temperature and pressure sensor’s
alignment 
7  Menu - Calibrate temperature / pressure sensors  Allowed  Pass Coane, John 06-Feb-2020 (UTC)
 Aligning temperature and pressure sensors
8  Menu - Settings - Machine configuration  Allowed Pass Coane, John 06-Feb-2020 (UTC)
Reading machine configuration 
9  Menu - Settings - General settings  Allowed  Pass Coane, John 06-Feb-2020 (UTC)
 Reading machine parameters 
10 Menu - Settings - General settings   Allowed Pass Coane, John 06-Feb-2020 (UTC)
Setting machine parameters
11  Menu - Settings - Process settings  Allowed Pass Coane, John 06-Feb-2020 (UTC)
 Reading the machine settings 
12  Menu - Settings - Process settings  Allowed Pass Coane, John 06-Feb-2020 (UTC)
 Setting the machine settings
13  Menu - Automatic mode / Time I Date  Allowed Pass Coane, John 06-Feb-2020 (UTC)
 Reading system settings
14  Menu - Automatic mode  Allowed Pass Coane, John 06-Feb-2020 (UTC)
Setting the system settings
15  Menu - Time I Date  Allowed Pass Coane, John 06-Feb-2020 (UTC)
Setting date, time and displaying format

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Table 8:  Administrator Access Rights Verification

# Navigation  Administrator Access Expected Access Performed By Date
Access Rights Description Verified?
(Yes / No / N/A)
16  Menu - Automatic mode  Allowed Pass Coane, John 06-Feb-2020 (UTC)
 Setting automatic mode and operation start/stop
17  Menu - Automatic mode  Allowed Pass Coane, John 06-Feb-2020 (UTC)
Setting automatic start program
18  Menu – User management  Allowed Pass Coane, John 06-Feb-2020 (UTC)
Administrating users
19  Menu – Group management  Allowed Pass Coane, John 06-Feb-2020 (UTC)
Administrating user group (and authorizations)
20  Menu - Maintenance / Door seal / Force actuators  Allowed Pass Coane, John 06-Feb-2020 (UTC)
Performing maintenance work and acknowledging
maintenance messages. Controlling door seal, actuators
and sensors
21  Process   Allowed Pass Coane, John 06-Feb-2020 (UTC)
Change unloading side (before process start /
only if sterilizer has two doors)
22  Process - Control  Allowed Pass Coane, John 06-Feb-2020 (UTC)
Selecting a program, entering batch data, starting the batch
(also after an error)
23  Process - Control  Allowed Pass Coane, John 06-Feb-2020 (UTC)
Perform a manual step change
24  Lock a batch (at the end of a batch with alarms)   Allowed Pass Coane, John 06-Feb-2020 (UTC)
25  Release a batch (at the end of a batch with  Allowed Pass Coane, John 06-Feb-2020 (UTC)
alarms)
26  Alarm history  Allowed Pass Coane, John 06-Feb-2020 (UTC)
Acknowledging all alarms
27  Shutdown GUI program (Show Windows Desktop)  Allowed Pass Coane, John 06-Feb-2020 (UTC)

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Test Review (To be completed by Validation)

# Summary (Yes / No / N/A) PerformedBy Date
1 Each user could only access system functions that were specific to their user access level. Yes Coane, John 06-Feb-2020
(UTC)
2  The system prevented access to a user account when incorrect login credentials are entered. Yes Coane, John 06-Feb-2020
(UTC)
3  The system reverted to its predefined default access after a predetermined lockout period. Yes Coane, John 06-Feb-2020
(UTC)
4 Deviation(s) required? No Coane, John 06-Feb-2020
(UTC)
5 Deviation(s) resolved and referenced, if applicable? N/A Coane, John 06-Feb-2020
(UTC)

Comments
# Comments: Performed By Date
1  No Comments Coane, John 06-Feb-2020
(UTC)
2      
3      
Note: If there are no comments in the "Comments" table above, type "No Comments" in the first line. The remaining empty rows will be considered
"N/A". Otherwise, "N/A" all unused rows.

12.10 Steam Quality Test (IOQ - AUT-10202-CAM-03-19)

1. Test Objective

Confirm the quality of the steam feeding the autoclave.

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Note:  Steam Quality Testing for this unit has previously been completed by an outside vendor with a Brammer Bio representative present. The vendor's
test report will be attached to this test case to support that all acceptance criteria were met.

2. Scope

Steam quality testing of all areas covered by System # AUT-10202 will be verified in this test case.

3. Acceptance Criteria

• The total non-condensable gases in the steam must not exceed 3.5%

• The dryness value of the steam must be ≥ 0.95.

• The superheat of the steam may not exceed 25K.

12.10.1 Field Execution - Steam Quality Test (IOQ - AUT-10202-CAM-03-19)

Procedure:

1. Obtain the Steam Quality Testing report(s) for the area/system.

2. Attach or record the location of the steam quality testing supporting documentation in Table 1.
3. Ensure documentation has been reviewed by an SME and that it was found to comply with specifications.
4. If the critical supporting documentation has been found to comply with specifications, record "Pass" in the Meets Specifications column,
otherwise record "Fail".

Table 1: Steam Quality Testing Verification Table

# Documentation Supporting Documentation Location Attachment (if applicable) Meets Specifications Performed by Date
(Pass / Fail / N/A)
1 Steam Quality Testing report SAP (WO# 4031381) Steam Quality Testing Pass Coane, John 02-Mar-2020 (UTC)
Report_AUT-10202.pdf
2 Other critical supporting documentation  N/A N/A N/A Coane, John 02-Mar-2020 (UTC)

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Test Review (To be completed by Validation)

# Summary (Yes / No / N/A) Performed By Date
1 The total non-condensable gases in the steam must not exceed 3.5%. Yes Coane, John 02-Mar-2020
(UTC)
2 The dryness value of the steam must be ≥ 0.95 Yes Coane, John 02-Mar-2020
(UTC)
3 The superheat of the steam may not exceed 25K. Yes Coane, John 02-Mar-2020
(UTC)
4 Deviation(s) required? No Coane, John 02-Mar-2020
(UTC)
5 Deviation(s) resolved and referenced, if applicable? N/A Coane, John 02-Mar-2020
(UTC)

Comments
# Comments: Performed by Date
1 See Section 12.1.2 for calibration certificate for the temperature sensor associated with the steam quality testing.  Coane, John 11-Mar-2020 (UTC)
2  N/A Coane, John 11-Mar-2020 (UTC)
3  N/A Coane, John 11-Mar-2020 (UTC)
Note: If there are no comments in the "Comments" table above, type "No Comments" in the first line. The remaining empty rows will be considered
"N/A". Otherwise, "N/A" all unused rows.

12.11 Leak Test (IOQ - AUT-10202-CAM-03-20)

1. Test Objective

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Demonstrate that the quantity of air leakage into the autoclave chamber during periods of vacuum does not exceed a level that will inhibit the penetration
of steam into the load and will not be a potential cause of contamination to the load during drying.

2. Scope

This test case will cover the leak test verification by Autoclave #  AUT-10202 using Autoclave Cycle Leak Test.

3. Test Case Parameters

Table 1: Leak Test Parameters

Parameter Parameter Value
Jacket pressure  2050 mbar
Liquid sterilization program  not active
Temperature monitoring pre- None
Treatment
Pos. temperature hysteresis   0.0 °C
Neg. temperature hysteresis   0.0 °C
Air detector   not active
Temperature monitoring  None
sterilization 
Correlation monitoring  not active
Differential monitoring of control  not active
sensors
F0 value calculation   not active
Temperature monitoring Post  None
Treatment
Pos. temperature hysteresis   0.0°C
Neg. temperature hysteresis   0.0°C
Ventilation filter FIS active   active

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Table 1: Leak Test Parameters

Parameter Parameter Value
Ventilation filter FIF active   not active
Basic time interval for recording   10 sec.
Temperature monitoring   Active Sensor 1
 VacLeakTest  Program Values
Jacket heating   active
Fan   not active
Evacuation target value  70 mbar
Evacuation ramp  2000 mbar/min
Stabilization time  300 sec
Test time   600 sec
Ventilation ramp   1000 mbar/min
Report filter value   6

4. Acceptance Criteria

• A leak test is executed successfully and the rate of pressure rise did not exceed 1.3 mbar/min.  

12.11.1 Field Execution - Leak Test (IOQ - AUT-10202-CAM-03-20)

Table 2: Leak Test Verification

 # Procedure Expected Result Actual Result Attachment Pass / Fail / N/A Performed By Date
1 Load the autoclave leak test Cycle Leak Test version #1 is  Cycle Leak Test version #1 N/A Pass Coane, John 03-Mar-2020 (UTC)
Cycle Leak Test version #1. loaded. is loaded.
2 Document recipe version# listed Recipe version# listed on the  Version 1 N/A Pass Coane, John 03-Mar-2020 (UTC)
on the HMI. HMI is documented.

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Table 2: Leak Test Verification

 # Procedure Expected Result Actual Result Attachment Pass / Fail / N/A Performed By Date
3 Start the leak test cycle.  Cycle started.   Cycle started N/A Pass Coane, John 03-Mar-2020 (UTC)
4 Assure that the pressure is Pressure at the beginning of  Pressure is reduced to 70 N/A Pass Coane, John 03-Mar-2020 (UTC)
reduced to no more than 70 mbar hold time is no more than 70 mbar during Stabilization
absolute (1.0 psia). mbar. phase. Pressure at beginning
of hold time is 72 mbar. 
5 Record the date, time, and initial Start date, time, and initial  Leak test started on N/A Pass Coane, John 03-Mar-2020 (UTC)
absolute pressure (P1) pressure recorded 05Feb2020 at 1110. Initial
pressure at beginning of hold
time is 72 mbar.
6 At the end of equilibrium time, Pressure at the end of  Pressure at end of N/A Pass Coane, John 03-Mar-2020 (UTC)
record the absolute pressure (P2) equilibrium time recorded. equilibrium is 75 mbar.
7 If P2-P1 exceeds 20 mbar, it may P2-P1 is less than 20 mbar  P2 - P1 = 75 - 72 = 3 mbar N/A Pass Coane, John 03-Mar-2020 (UTC)
indicate excessive condensation
and the test should be re-started at
step 4.
8 Record the vacuum hold end date / Vacuum hold time end date /  Leak test ended on N/A Pass Coane, John 03-Mar-2020 (UTC)
time time 05Feb2020 at 1128.
9 Record the final pressure PF Final absolute pressure at end  Final pressure at end of N/A Pass Coane, John 03-Mar-2020 (UTC)
hold cycle is 1006 mbar.
10 Calculate the pressure rise during Pressure increase (PF-P2) / (P2 - P1) /10 min = decay N/A Pass Coane, John 03-Mar-2020 (UTC)
the 600-sec period total vacuum hold time rate
(minutes) 75-72 mbar / 10 min = 0.3
mbar
11 Pressure increase may not exceed Pressure increase not to Pressure increase did not N/A Pass Coane, John 11-Mar-2020 (UTC)
1.3 mbar/min (0.02 psia/min) exceed 1.3 mbar/min (0.2 psia) exceed 1.2 mbar/min (0.2
for the 10-minute vacuum hold psia) for the 10-minute
period (13 mbar in total). vacuum hold period (13 mbar
in total)
12 Ensure that the vacuum hold cycle Cycle completed with no alarms  Cycle completed with no N/A Pass Coane, John 03-Mar-2020 (UTC)
completed as required (no faults or recorded. alarms recorded.
alarms).
13 Attach a copy of the system batch Copy of system batch report is  Copy of system batch report Batch_0000218_2 Pass Coane, John 03-Mar-2020 (UTC)
report. attached. is attached. 020-02-11_15-50-
59.pdf

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Test Review (To be completed by Validation)

# Summary (Yes / No / N/A) Performed By Date
1 Leak test executed successfully? Yes Coane, John 06-Mar-2020
(UTC)
2 Rate of pressure rise was ≤ 1.3 mbar/min? Yes Coane, John 06-Mar-2020
(UTC)
3 Deviation(s) required? No Coane, John 06-Mar-2020
(UTC)
4 Deviation(s) resolved and referenced, if applicable? N/A Coane, John 06-Mar-2020
(UTC)

Comments
# Comments: Recorded By Date
1 The date format in the Belimed autoclave Batch Reports is dd/mm/yyyy. Coane, John 12-Mar-2020
(UTC)
2  N/A Coane, John 12-Mar-2020
(UTC)
3  N/A Coane, John 12-Mar-2020
(UTC)
Note: If there are no comments in the "Comments" table above, type "No Comments" in the first line. The remaining empty rows will be considered
"N/A". Otherwise, "N/A" all unused rows.

12.12 Air Removal Test (IOQ - AUT-10202-CAM-03-21)

1. Test Objective

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To demonstrate the successful air removal from a high vacuum porous load autoclave cycle, which will provide the saturated steam conditions required
to adequately sterilize the load items.

2. Scope

Air Removal Test for Autoclave #  AUT-10202 using Autoclave Cycle 'Bowie Dick Test' will be covered by this test case.

3. Required Test Equipment

 Bowie Dick Air Removal Test Pack (Material #113409)

4. Test Case Parameters

 
Table 1: Bowie Dick Test Parameters
Parameter Parameter Value
Jacket pressure  2064 mbar
Liquid sterilization program  not active
Temperature monitoring Pre  Active Sensor 1, Sensor 2
Treatment
Pos. temperature hysteresis   5.0 °C
Neg. temperature hysteresis   1.0 °C
Air detector   not active
Correlation monitoring  active
Differential monitoring of control  active
sensors
F0 value calculation   not active
Temperature monitoring  Active Sensor 1, Sensor 2
sterilization 
Pos. temperature hysteresis   3.0°C

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Table 1: Bowie Dick Test Parameters

Parameter Parameter Value
Neg. temperature hysteresis   0.0°C
Temperature monitoring Post  None
Treatment
Pos. temperature hysteresis   0.0°C
Neg. temperature hysteresis   0.0°C
 Ventilation filter FIS active  not active
 Ventilation filter FIS active  not
Basic time interval for recording   10 sec.
Batch Report Sensors  Active Sensor 1, Sensor 2
StemFract Program Parameters 
Number of fractions   4
Jacket heating   active
Fan   not active
Evacuation target value   60 mbar
Evacuation ramp   500 mbar/min
Additional value evacuation   60 mbar
Additional time evacuation   60 sec
Steam target value  2010 mbar
Steam ramp  400 mbar/min
Steam monitoring temperature  0.0 °C
Additional value steam  2010 mbar
Additional time steam  60 sec
Report filter value  6 **
StemFract Program Parameters 
Number of fractions   1
Jacket heating   active

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Table 1: Bowie Dick Test Parameters

Parameter Parameter Value
Fan   active
Evacuation target value   1013 mbar
Evacuation ramp   400 mbar/min
Additional value evacuation   1013 mbar
Additional time evacuation   0 sec
Steam target value  2113 mbar
Steam ramp  70 mbar/min
Steam monitoring temperature  0.0 °C
Additional value steam  2113 mbar
Additional time steam  0 sec
Report filter value  6
SteriPres  Program Parameters 
Support pressure   not active
Jacket heating   active
Fan   not active
Steam target value   2113 mbar
Steam ramp  300 mbar/min
Sterilization monitoring 121.0 °C
temperature 
Sterilization time   480 sec
Report filter value  6
AirFract Program Parameters
Number of fractions   1
Jacket heating   active
Fan   not active
Evacuation target value  100 mbar

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Table 1: Bowie Dick Test Parameters

Parameter Parameter Value
Evacuation ramp  2000 mbar/min
Additional value evacuation  10 mbar
Additional time evacuation  300 sec
Ventilation target value  800 mbar
Ventilation ramp  1000 mbar/min
Additional value ventilation  800 mbar
Additional time ventilation  0 sec
Report filter value  6
AirFract Program Parameters
Number of fractions   1
Jacket heating   active
Fan   not active
Evacuation target value  100 mbar
Evacuation ramp  2000 mbar/min
Additional value evacuation  10 mbar
Additional time evacuation  30 sec
Ventilation target value  800 mbar
Ventilation ramp  1000 mbar/min
Additional value ventilation  800 mbar
Additional time ventilation  0 sec
Report filter value  6
LastAirFract Program Parameters
Jacket heating   active
Fan   not active
Evacuation target value  100 mbar

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Table 1: Bowie Dick Test Parameters

Parameter Parameter Value
Evacuation ramp  2000 mbar/min
Additional value evacuation  10 mbar
Additional time evacuation  0 sec
Ventilation target value  0 mbar
Ventilation ramp  1000 mbar/min
Report filter value  6

5. Acceptance Criteria

• An operating cycle has been successfully performed and the indicator exhibits a uniform color change.  

12.12.1 Field Execution - Air Removal Test (IOQ - AUT-10202-CAM-03-21)

Table 2: Air Removal Test

# Procedure Expected Result Actual Result Attachment Pass / Fail / N/A Performed By Date
1 Load the autoclave Air Removal Cycle Bowie Dick Test version  Bowie Dick Test version 10 is N/A Pass Coane, John 03-Mar-2020 (UTC)
Test Cycle Bowie Dick #10 is loaded loaded
Test version #10.
2 Document recipe version# listed Recipe version# listed on HMI  Program version number 10 N/A Pass Coane, John 03-Mar-2020 (UTC)
on the HMI. is documented. is used
3 Place the test pack on the bottom Test pack placed on bottom  Test pack is placed on N/A Pass Coane, John 03-Mar-2020 (UTC)
shelf of the Autoclave, over the shelf, over the drain. bottom shelf, over the drain.
drain.
4 Start the Air Removal Test Cycle. Date / Time Cycle started is Cycle started 05Feb2020 at N/A Pass Coane, John 03-Mar-2020 (UTC)
Record the date and time the cycle recorded. 1306

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Table 2: Air Removal Test

# Procedure Expected Result Actual Result Attachment Pass / Fail / N/A Performed By Date
began.
5 Allow the cycle to run to Date / Time Cycle ended is Cycle ended 05Feb2020 at N/A Pass Coane, John 03-Mar-2020 (UTC)
completion recorded. 1428.
6 Document cycle status. Attach a Cycle ran to completion without  Cycle ran to completion N/A Pass Coane, John 03-Mar-2020 (UTC)
copy of the cycle report from the alarms. without alarms.
system.
7 Following the cycle, evaluate the Color change of the indicator  Color change of the indicator Bowie Dick Test Pass Coane, John 13-Mar-2020 (UTC)
test card per SOP-001252. If the observed and recorded. observed and recorded. Results with
color change is uniform and dark, Batch Report
the air removal is successful. 219.pdf
Otherwise the test fails.
8 Attach a copy of the system batch Copy of system batch report is  Copy of batch report is Batch_0000219_2 Pass Coane, John 03-Mar-2020 (UTC)
report. attached. attached. 020-02-11_15-51-
23.pdf
 

Test Review (To be completed by Validation)

# Summary (Yes / No / N/A) Performed By Date
1 An operating cycle has been successfully performed and the indicator exhibits a uniform color change. Yes Coane, John 03-Mar-2020
(UTC)
2 Deviation(s) required? No Coane, John 03-Mar-2020
(UTC)
3 Deviation(s) resolved and referenced, if applicable? N/A Coane, John 03-Mar-2020
(UTC)

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Comments
# Comments: Performed By Date
1 The date format in the Belimed autoclave Batch Reports is dd/mm/yyyy. Coane, John 12-Mar-2020
(UTC)
2  N/A Coane, John 12-Mar-2020
(UTC)
3  N/A Coane, John 12-Mar-2020
(UTC)
Note: If there are no comments in the "Comments" table above, type "No Comments" in the first line. The remaining empty rows will be considered
"N/A". Otherwise, "N/A" all unused rows.

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13 System Instruments Calibration Verification

Record the Execution Start and Completion Dates in the Table 1 below. 

Record all system instruments for AUT-10202 in Table 2 below. Record the test case(s) that each instrument was utilized in. Record all calibration
information and attach a copy of the calibration certificate. Verify that each system instrument was in a calibrated state for the duration of execution.

Table 1: Protocol Execution Data

Execution Start Date Execution Completion Date Performed By Date
 21Jan2020 03Mar2020 Coane, John 03-Mar-2020 (UTC)
  
 
 

Table 2: System Instruments Calibration Verification 

# Instrument ID Instrument Description Test Cases(s) Calibration Due Attachment Instrument Calibration Performed By Date
Instrument Used In Date Valid for the duration
(DDMMMYY) of execution? 
(Yes / No / N/A)
1 PG-10202-001 Pressure Gauge 12.2, 12.6, 12.8, 31Oct20 PG-10202-001 Cal Yes Coane, John 03-Mar-2020 (UTC)
12.11, 12.12 Certificate.pdf
2 PG-10202-002  Pressure Gauge 12.2, 12.6, 12.8, 31Oct20 PG-10202-002 Cal Yes Coane, John 03-Mar-2020 (UTC)
12.11, 12.12 Certificate.pdf
3 PG-10202-003  Pressure Gauge  12.2, 12.6, 12.8, 31Oct20 PG-10202-003 Cal Yes Coane, John 03-Mar-2020 (UTC)
12.11, 12.12 Certificate.pdf
4 PG-10202-007  Pressure Gauge  12.2, 12.6, 12.8, 31Oct20 PG-10202-007 Cal Yes Coane, John 03-Mar-2020 (UTC)
12.11, 12.12 Certificate.pdf
5 PG-10202-008 Pressure Gauge  12.2, 12.6, 12.8, 31Oct20 PG-10202-008 Cal Yes Coane, John 03-Mar-2020 (UTC)
12.11, 12.12 Certificate.pdf
6  PI-10202-001 Pressure Indicator  12.2, 12.6, 12.8, 31Oct20 PI-10202-001 Cal Yes Coane, John 03-Mar-2020 (UTC)
12.11, 12.12 Certificate.pdf

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  Document Number:  IOQ - AUT-10202-CAM-03 
 Document Version:  1.0 
 Equipment ID:  AUT-10202 
 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Table 2: System Instruments Calibration Verification 

# Instrument ID Instrument Description Test Cases(s) Calibration Due Attachment Instrument Calibration Performed By Date
Instrument Used In Date Valid for the duration
(DDMMMYY) of execution? 
(Yes / No / N/A)
7  PI-10202-002  Pressure Indicator  12.2, 12.6, 12.8,  31Oct20 PI-10202-002 Cal Yes Coane, John 03-Mar-2020 (UTC)
12.11, 12.12 Certificate.pdf
8  PI-10202-003  Pressure Indicator  12.2, 12.6, 12.8, 31Oct20 PI-10202-003 Cal Yes Coane, John 03-Mar-2020 (UTC)
12.11, 12.12 Certificate.pdf
9 PI-10202-006 Pressure Indicator  12.2, 12.6, 12.8, 31Oct20 PI-10202-006 Cal Yes Coane, John 03-Mar-2020 (UTC)
12.11, 12.12 Certificate.pdf
10  PIT-10202-001  Pressure Transmitter  12.2, 12.6, 12.8, 31Oct20 PIT-10202-001 Cal Yes Coane, John 03-Mar-2020 (UTC)
12.11, 12.12 Certificate.pdf
11  PT-10202-001  Pressure Transmitter  12.2, 12.6, 12.8, 31Oct20 PT-10202-001 Cal Yes Coane, John 03-Mar-2020 (UTC)
12.11, 12.12 Certificate.pdf
12 PT-10202-002 Pressure Transmitter  12.2, 12.6, 12.8,  31Oct20 PT-10202-002 Cal Yes Coane, John 03-Mar-2020 (UTC)
12.11, 12.12 Certificate.pdf
13  PT-10202-003  Pressure Transmitter  12.2, 12.6, 12.8, 31Oct20 PT-10202-003 Cal Yes Coane, John 03-Mar-2020 (UTC)
12.11, 12.12 Certificate.pdf
14 PT-10202-004 Pressure Transmitter 12.2, 12.6, 12.8, 31Oct20 PT-10202-004 Cal Yes Coane, John 03-Mar-2020 (UTC)
12.11, 12.12 Certificate.pdf
15 TE-10202-002  Temperature Element  12.2, 12.6, 12.8, 31Oct20 TE-10202-002 Cal Yes Coane, John 03-Mar-2020 (UTC)
12.11, 12.12 Certificate.pdf
16  TE-10202-005  Temperature Element  12.2, 12.6, 12.8, 31Oct20 TE-10202-005 Cal Yes Coane, John 03-Mar-2020 (UTC)
12.11, 12.12 Certificate.pdf
17 TE-10202-010 Temperature Element  12.2, 12.6, 12.8,  31Oct20 TE-10202-010 Cal Yes Coane, John 03-Mar-2020 (UTC)
12.11, 12.12 Certificate.pdf
18  TE-10202-011  Temperature Element  12.2, 12.6, 12.8,  31Oct20 TE-10202-011 Cal Yes Coane, John 03-Mar-2020 (UTC)
12.11, 12.12 Certificate.pdf
19  TE-10202-012  Temperature Element  12.2, 12.6, 12.8,  31Oct20 TE-10202-012 Cal Yes Coane, John 03-Mar-2020 (UTC)
12.11, 12.12 Certificate.pdf
20  TI-10202-004  Temperature Indicator  12.2, 12.6, 12.8,  31Oct20 TI-10202-004 Cal Yes Coane, John 03-Mar-2020 (UTC)
12.11, 12.12 Certificate.pdf
21  TI-10202-007  Temperature Indicator  12.2, 12.6, 12.8,  31Oct20 TI-10202-007 Cal Yes Coane, John 03-Mar-2020 (UTC)
Page 187 of 196 01-Mar-2023 (UTC)
  Document Number:  IOQ - AUT-10202-CAM-03 
 Document Version:  1.0 
 Equipment ID:  AUT-10202 
 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Table 2: System Instruments Calibration Verification 

# Instrument ID Instrument Description Test Cases(s) Calibration Due Attachment Instrument Calibration Performed By Date
Instrument Used In Date Valid for the duration
(DDMMMYY) of execution? 
(Yes / No / N/A)
12.11, 12.12 Certificate.pdf
22  TIT-10202-001  Temperature  12.2, 12.6, 12.8,  31Oct20 TIT-10202-001 Cal Yes Coane, John 03-Mar-2020 (UTC)
Transmitter 12.11, 12.12 Certificate.pdf
23  TIT-10202-003  Temperature  12.2, 12.6, 12.8, 31Oct20 TIT-10202-003 Cal Yes Coane, John 03-Mar-2020 (UTC)
Transmitter 12.11, 12.12 Certificate.pdf
24  TIT-10202-004  Temperature  12.2, 12.6, 12.8, 31Oct20 TIT-10202-004 Cal Yes Coane, John 03-Mar-2020 (UTC)
Transmitter 12.11, 12.12 Certificate.pdf
25 N/A  N/A  N/A  N/A N/A N/A Coane, John 06-Mar-2020 (UTC)
26  N/A  N/A  N/A  N/A N/A N/A Coane, John 06-Mar-2020 (UTC)
27  N/A  N/A  N/A  N/A N/A N/A Coane, John 06-Mar-2020 (UTC)
28  N/A  N/A  N/A  N/A N/A N/A Coane, John 06-Mar-2020 (UTC)
29  N/A  N/A  N/A  N/A N/A N/A Coane, John 06-Mar-2020 (UTC)
30  N/A  N/A  N/A  N/A N/A N/A Coane, John 06-Mar-2020 (UTC)
31  N/A  N/A  N/A  N/A N/A N/A Coane, John 06-Mar-2020 (UTC)
32  N/A  N/A  N/A  N/A N/A N/A Coane, John 06-Mar-2020 (UTC)
33  N/A  N/A  N/A  N/A N/A N/A Coane, John 06-Mar-2020 (UTC)
34  N/A  N/A  N/A  N/A N/A N/A Coane, John 06-Mar-2020 (UTC)
35  N/A  N/A  N/A  N/A N/A N/A Coane, John 06-Mar-2020 (UTC)
36  N/A  N/A  N/A  N/A N/A N/A Coane, John 06-Mar-2020 (UTC)
37  N/A  N/A  N/A  N/A N/A N/A Coane, John 06-Mar-2020 (UTC)
38  N/A  N/A  N/A  N/A N/A N/A Coane, John 06-Mar-2020 (UTC)
39  N/A  N/A  N/A  N/A N/A N/A Coane, John 06-Mar-2020 (UTC)
40  N/A  N/A  N/A  N/A N/A N/A Coane, John 06-Mar-2020 (UTC)

Page 188 of 196 01-Mar-2023 (UTC)

  Document Number:  IOQ - AUT-10202-CAM-03 
 Document Version:  1.0 
 Equipment ID:  AUT-10202 
 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Note: "N/A" all unused rows in Table  2.

Comments
# Comments Performed By Date
1  No comments Coane, John 06-Mar-2020 (UTC)
2      
3      
Note: If there are no comments in the "Comments" table above, type "No Comments" in the first line. The remaining empty rows will be considered
"N/A". Otherwise, "N/A" all unused rows.

Page 189 of 196 01-Mar-2023 (UTC)

  Document Number:  IOQ - AUT-10202-CAM-03 
 Document Version:  1.0 
 Equipment ID:  AUT-10202 
 Document Name: Installation and Operational Qualification Protocol for AUT-10202

14 UR Traceability Matrix

Procedure

1. Record the details of the latest approved version of the User Requirement for the specified system in Table 1.
2. After execution is complete, indicate if each PPUR was properly verified and completed in the test specified. If "No", issue a protocol deviation.

Table 1:System User Requirements

# UR Document # Version # Attachment Performed By Date
1 DC-000452 3.0 DC-000452.PDF Coane, John 03-Mar-2020 (UTC)

Table 1: User Requirements Verification Table*

# PPUR # Requirement Description If tested in this protocol, specify test case/ protocol Requirement verified Performed By Date
section. as specified or testing
referenced?   
If not tested in this protocol, reference previous / (Yes / No / N/A) 
future protocols.
1 3.1.1 All process or product contact Verified in commissioning protocol CTP-AUT- Yes Coane, John 03-Mar-2020 (UTC)
components shall be designed to be non- 10202-CAM-01.
reactive, non-absorptive, cleanable, and
corrosion resistant to the process
materials.
2 3.1.2 All elastomers with process or product Verified in commissioning protocol CTP-AUT- Yes Coane, John 03-Mar-2020 (UTC)
contact shall be compatible with process 10202-CAM-01.
materials and suitable for high
temperature use. 
3 3.1.11 Autoclave shall include an integral air Verified in commissioning protocol CTP-AUT- Yes Coane, John 03-Mar-2020 (UTC)
filtration system. 10202-CAM-01.

4 3.1.17 Autoclave shall have, at a minimum, a Verified in commissioning protocol CTP-AUT- Yes Coane, John 03-Mar-2020 (UTC)
temperature sensor capable of measuring

Page 190 of 196 01-Mar-2023 (UTC)

  Document Number:  IOQ - AUT-10202-CAM-03 
 Document Version:  1.0 
 Equipment ID:  AUT-10202 
 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Table 1: User Requirements Verification Table*

# PPUR # Requirement Description If tested in this protocol, specify test case/ protocol Requirement verified Performed By Date
section. as specified or testing
referenced?   
If not tested in this protocol, reference previous / (Yes / No / N/A) 
future protocols.
the chamber temperature. 10202-CAM-01.

5 3.1.18 Autoclave shall have a temperature sensor Verified in commissioning protocol CTP-AUT- Yes Coane, John 03-Mar-2020 (UTC)
capable of measuring the jacket 10202-CAM-01.
temperature.

6 3.1.19 Autoclave shall have a pressure sensor(s) Verified in commissioning protocol CTP-AUT- Yes Coane, John 03-Mar-2020 (UTC)
capable of measuring the chamber 10202-CAM-01.
pressure.

7 3.1.25 The autoclaves shall include a vacuum Verified in commissioning protocol CTP-AUT- Yes Coane, John 03-Mar-2020 (UTC)
pump for air removal and drying. 10202-CAM-01.

8 3.2.3 Autoclave shall be capable of sterilizing Verified in commissioning protocol CTP-AUT- Yes Coane, John 03-Mar-2020 (UTC)
liquids, porous and non-porous materials. 10202-CAM-01.

9 3.2.5 Autoclave shall be capable of achieving Verified in commissioning protocol CTP-AUT- Yes Coane, John 03-Mar-2020 (UTC)
and maintaining the user-defined 10202-CAM-02.
temperature setpoint.

10 3.2.6 The air filtration system shall be steamed Verified in commissioning protocol CTP-AUT- Yes Coane, John 03-Mar-2020 (UTC)
in place and capable of integrity testing. 10202-CAM-02.

11 3.2.14 Jacket temperature must be ≤ to the Verified in commissioning protocol CTP-AUT- Yes Coane, John 03-Mar-2020 (UTC)
chamber. 10202-CAM-02.
12 3.4.3 The control system shall control and 12.6 Yes Coane, John 03-Mar-2020 (UTC)
monitor the pressure to the user-defined
setpoint.
13 3.4.4 The control system shall control and 12.6 Yes Coane, John 03-Mar-2020 (UTC)
monitor the user-defined temperature
setpoint.

Page 191 of 196 01-Mar-2023 (UTC)

  Document Number:  IOQ - AUT-10202-CAM-03 
 Document Version:  1.0 
 Equipment ID:  AUT-10202 
 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Table 1: User Requirements Verification Table*

# PPUR # Requirement Description If tested in this protocol, specify test case/ protocol Requirement verified Performed By Date
section. as specified or testing
referenced?   
If not tested in this protocol, reference previous / (Yes / No / N/A) 
future protocols.
14 3.10.1 The system control loops shall maintain 12.6 Yes Coane, John 03-Mar-2020 (UTC)
tuned control of the user-defined process
parameter set-points.

Note:  The following PPURs have been omitted because they are out of scope for this IOQ protocol and are PQ test verifications only:  3.2.4, 3.2.12,
3.2.13, 3.2.15, 3.3.1, 3.3.2, 3.3.3, 

Page 192 of 196 01-Mar-2023 (UTC)

  Document Number:  IOQ - AUT-10202-CAM-03 
 Document Version:  1.0 
 Equipment ID:  AUT-10202 
 Document Name: Installation and Operational Qualification Protocol for AUT-10202

15 Protocol Deviations

Use the table below to initiate a deviation. For each deviation, include a reference to the protocol location where the deviation occurred.  
 
Protocol Deviation Log
# Protocol Deviation Test Case Name / Section Number Run Number Table Number / Line Number Performed By Date
1 IOQ - AUT-10202-CAM-03-DEV-01 Section 10:  OQ Prerequisites  N/A  N/A Coane, John 06-Mar-2020 (UTC)
2 IOQ - AUT-10202-CAM-03-DEV-02 Set Point Verification / 12.4.1, 12.4.2 N/A Tables 1, 4, 5, and 8 Coane, John 06-Mar-2020 (UTC)
3 IOQ - AUT-10202-CAM-03-DEV-03 Section 6  N/A Table 2 Coane, John 11-Mar-2020 (UTC)
4 IOQ - AUT-10202-CAM-03-DEV-04 9.3.1  N/A Table 1 / Line 1 Coane, John 11-Mar-2020 (UTC)
5 N/A  N/A  N/A  N/A Coane, John 11-Mar-2020 (UTC)
6 N/A  N/A  N/A  N/A Coane, John 11-Mar-2020 (UTC)
7 N/A  N/A  N/A  N/A Coane, John 11-Mar-2020 (UTC)
8 N/A  N/A  N/A  N/A Coane, John 11-Mar-2020 (UTC)
9 N/A  N/A  N/A  N/A Coane, John 11-Mar-2020 (UTC)
10 N/A  N/A  N/A  N/A Coane, John 11-Mar-2020 (UTC)
11 N/A  N/A  N/A  N/A Coane, John 11-Mar-2020 (UTC)
12 N/A  N/A  N/A  N/A Coane, John 11-Mar-2020 (UTC)
13 N/A  N/A  N/A  N/A Coane, John 11-Mar-2020 (UTC)
14 N/A  N/A  N/A  N/A Coane, John 11-Mar-2020 (UTC)
15 N/A  N/A  N/A  N/A Coane, John 11-Mar-2020 (UTC)
Note: If there are no Deviations in the table above, type "N/A" in the first line. The remaining empty rows will be considered "N/A". Otherwise, "N/A" all
unused rows. 

Page 193 of 196 01-Mar-2023 (UTC)

  Document Number:  IOQ - AUT-10202-CAM-03 
 Document Version:  1.0 
 Equipment ID:  AUT-10202 
 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Comments
# Comments Performed By Date
1  No comments Coane, John 11-Mar-2020 (UTC)
2      
3      
Note: If there are no comments in the "Comments" table above, type "No Comments" in the first line. The remaining empty rows will be considered
"N/A". Otherwise, "N/A" all unused rows

Page 194 of 196 01-Mar-2023 (UTC)

  Document Number:  IOQ - AUT-10202-CAM-03 
 Document Version:  1.0 
 Equipment ID:  AUT-10202 
 Document Name: Installation and Operational Qualification Protocol for AUT-10202

16 Attachments

Use the table below to attach documentation to the protocol.

 
Attachments Log
# Attachment Attachment Description Test Case Number Run Number Step Number Performed By Date
1 AUT-10202 AUT-10202 system component information in SAP 9.4.1  N/A  N/A Coane, John 03-Mar-2020
Component SAP database. (UTC)
Information.pdf
2 Kaye Setup Kaye Setup Report 12.1.1  N/A  N/A Coane, John 06-Mar-2020
Report.pdf (UTC)
3 Batch_0000230_2020 In-Line Sterilization was performed to support filter integrity 12.5.1  N/A Table 1, after Coane, John 12-Mar-2020
-02-28_15-21-51.pdf testing, Section 12.5.1. step 1 and prior (UTC)
to step 2
4 WGC Wrapped Goods batch report 12.5.1  N/A Table 1. after Coane, John 18-Mar-2020
Batch_0000229_2020 step 1 and prior (UTC)
-03-18_15-48-17.pdf to step 2
5 Belimed Steam This is the steam table used by the Belimed software and 12.8.2   N/A Table 2 Step 2 Coane, John 18-Mar-2020
Table_for AUT-10202 was used to develop the sterilization cycles.  (UTC)
pressure
conversion.pdf
6 N/A  N/A  N/A  N/A  N/A Coane, John 06-Mar-2020
(UTC)
7 N/A  N/A  N/A  N/A  N/A Coane, John 06-Mar-2020
(UTC)
8 N/A  N/A  N/A  N/A  N/A Coane, John 06-Mar-2020
(UTC)
9 N/A  N/A  N/A  N/A  N/A Coane, John 06-Mar-2020
(UTC)
10 N/A  N/A  N/A  N/A  N/A Coane, John 06-Mar-2020
(UTC)
11 N/A  N/A  N/A  N/A  N/A Coane, John 06-Mar-2020

Page 195 of 196 01-Mar-2023 (UTC)

  Document Number:  IOQ - AUT-10202-CAM-03 
 Document Version:  1.0 
 Equipment ID:  AUT-10202 
 Document Name: Installation and Operational Qualification Protocol for AUT-10202

Attachments Log
# Attachment Attachment Description Test Case Number Run Number Step Number Performed By Date
(UTC)
Note: If there are no Attachments listed in the table above, type "N/A" in the first line. The remaining empty rows will be considered "N/A". Otherwise,
"N/A" all unused rows.  

Comments
# Comments Performed By Date
1 The date format in the Belimed autoclave Batch Reports is dd/mm/yyyy. Coane, John 12-Mar-2020 (UTC)
2  N/A Coane, John 12-Mar-2020 (UTC)
3  N/A Coane, John 12-Mar-2020 (UTC)
Note: If there are no comments in the "Comments" table above, type "No Comments" in the first line. The remaining empty rows will be considered
"N/A". Otherwise, "N/A" all unused rows.

Page 196 of 196 01-Mar-2023 (UTC)