PURE & CURE PROTOCOL No.

:
HEALTHCARE ALARM VERIFICATION PROTOCOL H/GNP/0119
FOR INCUBATORS REVISION No.:00
PVT. LTD., EFFECTIVE DATE:
(MICROBIOLOGY, Q-BLOCK)
HARIDWAR
PAGE No.: 1 of 10

ALARM VERIFICATION

PROTOCOL

FOR

INCUBATORS

(MICROBIOLOGY, Q-BLOCK)

SUPERSEDES PROTOCOL No. NIL

DATE OF VERIFICATION

FORMAT No.: QAH-093/F06-02

PURE & CURE PROTOCOL No.:
HEALTHCARE ALARM VERIFICATION PROTOCOL H/GNP/0119
FOR INCUBATORS REVISION No.:00
PVT. LTD., EFFECTIVE DATE:
(MICROBIOLOGY, Q-BLOCK)
HARIDWAR
PAGE No.: 2 of 10

PROTOCOL CONTENTS

S. NO. TITLE PAGE NO.

1.0

PROTOCOL APPROVAL 3

2.0 OBJECTIVE 4

3.0 SCOPE 4

4.0 RESPONSIBILITY 4

5.0 REASON FOR VERIFICATION 4

6.0 SITE OF STUDY 5

7.0 EQUIPMENT DETAILS 5

8.0 SYSTEM DESCRIPTION 5

9.0 REASON OF QUALIFICATION 6

10.0 SITE OF STUDY 6

11.0 FREQUENCY OF QUALIFICATION 6

12.0 PRE QUALIFICATION REQUIREMENTS 7

13.0 QUALIFICATION METHODOLOGY & TESTS PERFORMED 8

14.0 CHECKLIST OF ALL TEST AND CHECKS 9

15.0 REFERENCES 9

16.0 DOCUMENTS TO BE ATTACHED 9

17.0 NON COMPLIANCE 10

18.0 DEVIATION 10

19.0 CHANGE CONTROL 10

20.0 ABBREVIATIONS 10

FORMAT No.: QAH-093/F06-02

PURE & CURE PROTOCOL No.:
HEALTHCARE ALARM VERIFICATION PROTOCOL H/GNP/0119
FOR INCUBATORS REVISION No.:00
PVT. LTD., EFFECTIVE DATE:
(MICROBIOLOGY, Q-BLOCK)
HARIDWAR
PAGE No.: 3 of 10
1.0 PROTOCOL APPROVAL:

PREPARED BY:

DESIGNATION NAME SIGNATURE DATE

OFFICER/EXECUTIVE
(QUALITY ASSURANCE)

REVIEWED BY:

DESIGNATION NAME SIGNATURE DATE

OPERATING MANAGER
(QUALITY ASSURANCE)
HEAD
(QUALITY CONTROL
/MICROBIOLOGY)
HEAD
(ENGINEERING)

APPROVED BY:

DESIGNATION NAME SIGNATURE DATE

HEAD
(QUALITY ASSURANCE)

FORMAT No.: QAH-093/F06-02

PURE & CURE PROTOCOL No.:
HEALTHCARE ALARM VERIFICATION PROTOCOL H/GNP/0119
FOR INCUBATORS REVISION No.:00
PVT. LTD., EFFECTIVE DATE:
(MICROBIOLOGY, Q-BLOCK)
HARIDWAR
PAGE No.: 4 of 10
2.0 OBJECTIVE:

 To provide documented evidence that the installed Audio Visual Alarm System is working
consistently, repeatedly and reproducibly to provide the alarm when temperature inside the
Incubation chamber/area goes beyond the specified limit and the results meet the pre-
defined acceptance criteria.
 To confirm the suitability of the Standard Operating Procedures for all routine activities
associated with the system.

3.0 SCOPE:
 This Protocol is prepared to Challenge the Audio Visual Alarm system in Incubation
chamber/areas of Microbiology Laboratory of Q block at Pure & Cure Healthcare Pvt. Ltd.,
Haridwar.
 This activity is trigger against the Change Control No.-CC/H-I/QC/20/0294

4.0 RESPONSIBILITY:
The Verification Group, comprising of a representative from each of the following Departments,
shall be responsible for overall compliance of this Protocol:

DEPARTMENTS RESPONSIBILITIES
 Preparation, review and approval of cleaning Verification
protocol.
Quality Assurance  Protocol training.
 To monitor all alarm Verification activities and ensuring the
Alarm Verification & Challenge as per the protocol.
 Review of Verification Protocol.
Quality Control  Execution of alarm verification activity in coordination with
Engineering and Quality Assurance.
 Review of Verification Protocol.
Engineering  To co-ordinate and support Verification Activity.
 Responsible for Trouble shooting during execution (If Occurs).

5.0 REASON FOR VERIFICATION:

 Against the Change Control No.-CC/H - I/QC/20/0294

FORMAT No.: QAH-093/F06-02

PURE & CURE PROTOCOL No.:
HEALTHCARE ALARM VERIFICATION PROTOCOL H/GNP/0119
FOR INCUBATORS REVISION No.:00
PVT. LTD., EFFECTIVE DATE:
(MICROBIOLOGY, Q-BLOCK)
HARIDWAR
PAGE No.: 5 of 10
6.0 SITE OF STUDY:
 Microbiology Laboratory, Q-Block, Pure and Cure Healthcare Pvt. Ltd. Haridwar.

7.0 EQUIPMENT DETAILS:

Following are the key detail of incubator and temperature limit.
TABLE NO. 1.0

S. NO. INCUBATOR ID. TEMP. LIMIT

1. PC/INS/S-39/01 55-60°C

2. PC/INS/S-39/02 35-39°C

3. PC/INS/S-39/03 42-44°C

4. PC/INS/S-39/04 55-60°C

5. PC/INS/S-39/05 20-25°C

6. PC/INS/S-39/06 30-35°C

7. PC/INS/S-39/07 20-25°C

8. PC/INS/S-39/08 30-35°C

9. PC/INS/S-39/09 35-39°C

8.0 SYSTEM DESCRIPTION:

The Temperature monitoring system contains Control Panel box, Temperature Sensors and Audio
Visual Alarm Unit in Incubation chamber/area. The Audio visual alarm system is provided to
indicate the user when temperature of the incubator chamber goes beyond specific temperature.
The System consists of following Parts:-

 Temperature Sensors

 Control Panel Box

 Audio Visual Alarm Unit in Incubation chamber/area. (Audio alarm with red light indicator)

FORMAT No.: QAH-093/F06-02

PURE & CURE PROTOCOL No.:
HEALTHCARE ALARM VERIFICATION PROTOCOL H/GNP/0119
FOR INCUBATORS REVISION No.:00
PVT. LTD., EFFECTIVE DATE:
(MICROBIOLOGY, Q-BLOCK)
HARIDWAR
PAGE No.: 6 of 10
8.1 ALARM MECHANISM:
The System is designed to provide the Alarm in audio visual form when fluctuation in temperatures
occurs beyond the set point or min./max. set value of temperature. There is a provision for setting up
of a upper and lower limit inside the control panel box beyond which the system provide audio visual
alarm (audio alarm with red light indicator) at the respective incubation Chamber panel.

8.2 SENSOR LOCATION:

There are two Temperature sensors which are located in each incubation Room at the Hot Point.
Details of sensor as per below table:

INCUBATOR ID. TEMPERATURE SENSOR

PC/INS/S-39/01 PC/INS/S-39/01/TS-01

PC/INS/S-39/02 PC/INS/S-39/02/TS-01

PC/INS/S-39/03 PC/INS/S-39/03/TS-01

PC/INS/S-39/04 PC/INS/S-39/04/TS-01

PC/INS/S-39/05 PC/INS/S-83/01/TS-01

PC/INS/S-39/06 PC/INS/S-83/01/TS-02

PC/INS/S-39/07 PC/INS/S-39/07/TS-01

PC/INS/S-39/08 PC/INS/S-39/08/TS-01

PC/INS/S-39/09 PC/INS/S-39/09/TS-01

9.0 REASON FOR QUALIFICATION:

 New Alarm system installed in Microbiology Section, Q-Block at Pure & Cure Healthcare Pvt.
Ltd., Haridwar.

10.0 SITE OF STUDY:

 Microbiology Section, Q-Block, at Pure & Cure Healthcare Pvt. Ltd., Haridwar.

11.0 FREQUENCY OF QUALIFICATION:

 Initially
 After major modification.

FORMAT No.: QAH-093/F06-02

PURE & CURE PROTOCOL No.:
HEALTHCARE ALARM VERIFICATION PROTOCOL H/GNP/0119
FOR INCUBATORS REVISION No.:00
PVT. LTD., EFFECTIVE DATE:
(MICROBIOLOGY, Q-BLOCK)
HARIDWAR
PAGE No.: 7 of 10
12.0 PRE – QUALIFICATION REQUIREMENTS:
The below mentioned activities should be completed prior to commencing the performance
qualification activity for temperature Controller.

12.1Training:
 Training shall be imparted to the all concerned person and record shall be maintained with the
qualification report.

12.2Verification of Documents:
 Verify the relevant documents such as relevant SOP for their existence and Record the
observations for documents in the below mentioned table.

12.3Calibration Status
 Before Start the activity, ensure the calibration status of the temperature sensors.

FORMAT No.: QAH-093/F06-02

PURE & CURE PROTOCOL No.:
HEALTHCARE ALARM VERIFICATION PROTOCOL H/GNP/0119
FOR INCUBATORS REVISION No.:00
PVT. LTD., EFFECTIVE DATE:
(MICROBIOLOGY, Q-BLOCK)
HARIDWAR
PAGE No.: 8 of 10

13.0 QUALIFICATION METHODOLOGY & TESTS PEROFRMED:

13.1ALARM VERIFICATION:
13.1.1 Method:
 Alarm system should be verified, Challenge the system by increasing the temperature beyond the
limit and checked the system for alarm, similarly Challenge the system by dropping the
temperature below set point and checked the system for alarm.
Challenge of lower Limit of temperature:
 Deliberately, Set the lower limit value more than the display temperature value in control panel
box, alarm will blow. This is the alarm for lower limit challenge.
Challenge of Upper Limit of temperature:
 Deliberately, Set the Upper limit value less than the display temperature value in control panel
box, alarm will blow. This is the alarm for Upper limit challenge.
S. INCUBATOR TEMP.
CASE METHOD
No. ID. LIMIT
Set the lower limit value more than the display
When Challenge Lower
value. Alarm will blow for lower limit
Limit value of temperature.
1. challenge.
PC/INS/S-39/01 55-60°C
Set the Upper limit value less than the display
When Challenge Upper Limit
value. Alarm will blow for Upper limit
value of temperature.
challenge.
Set the lower limit value more than the display
When Challenge Lower
value. Alarm will blow for lower limit
Limit value of temperature.
challenge.
2. PC/INS/S-39/02 35-39°C Set the Upper limit value less than the display
When Challenge Upper Limit value. Alarm will blow for Upper limit
value of temperature. challenge.
Set the lower limit value more than the display
When Challenge Lower
value. Alarm will blow for lower limit
Limit value of temperature.
challenge.
3. PC/INS/S-39/03 42-44°C
Set the Upper limit value less than the display
When Challenge Upper Limit
value. Alarm will blow for Upper limit
value of temperature.
challenge.
Set the lower limit value more than the display
When Challenge Lower
value. Alarm will blow for lower limit
Limit value of temperature.
challenge.
4. PC/INS/S-39/04 55-60°C
Set the Upper limit value less than the display
When Challenge Upper Limit
value. Alarm will blow for Upper limit
value of temperature.
challenge.
5. PC/INS/S-39/05 20-25°C When Challenge Lower Set the lower limit value more than the display
Limit value of temperature. value. Alarm will blow for lower limit
challenge.

FORMAT No.: QAH-093/F06-02

PURE & CURE PROTOCOL No.:
HEALTHCARE ALARM VERIFICATION PROTOCOL H/GNP/0119
FOR INCUBATORS REVISION No.:00
PVT. LTD., EFFECTIVE DATE:
(MICROBIOLOGY, Q-BLOCK)
HARIDWAR
PAGE No.: 9 of 10
When Challenge Upper Limit Set the Upper limit value less than the display
value of temperature. value. Alarm blow for Upper limit challenge.
Set the lower limit value more than the display
When Challenge Lower
value. Alarm will blow for lower limit
Limit value of temperature.
challenge.
6. PC/INS/S-39/06 30-35°C
Set the Upper limit value less than the display
When Challenge Upper Limit
value. Alarm will blow for Upper limit
value of temperature.
challenge.
Set the lower limit value more than the display
When Challenge Lower
value. Alarm will blow for lower limit
Limit value of temperature.
challenge.
7. PC/INS/S-39/07 20-25°C
Set the Upper limit value less than the display
When Challenge Upper Limit
value. Alarm will blow for Upper limit
value of temperature.
challenge.
Set the lower limit value more than the display
When Challenge Lower
value. Alarm will blow for lower limit
Limit value of temperature.
challenge.
8. PC/INS/S-39/08 30-35°C
Set the Upper limit value less than the display
When Challenge Upper Limit
value. Alarm will blow for Upper limit
value of temperature.
challenge.
Set the lower limit value more than the display
When Challenge Lower
value. Alarm will blow for lower limit
Limit value of temperature.
challenge.
9. PC/INS/S-39/09 35-39°C
Set the Upper limit value less than the display
When Challenge Upper Limit
value. Alarm will blow for Upper limit
value of temperature.
challenge.
*Photographs of execution of challenge method shall be taken and attached along with report.
13.1.2 Acceptance Criteria:
 When temperature drops below the limit and alarm should be generated.
 When temperatures reach above the limit and alarm should be generated.

14.0 CHECKLIST OF ALL TESTS AND CHECKS:

SR. NO. TEST AND CHECKS

1.0 Alarm Verification

15.0 REFERENCES:
 Validation Master Plan
 SOP title “Daily Temperature monitoring of Walk in Type Incubator” and SOP no.
“HML/035.

16.0 DOCUMENTS TO BE ATTACHED:

FORMAT No.: QAH-093/F06-02

PURE & CURE PROTOCOL No.:
HEALTHCARE ALARM VERIFICATION PROTOCOL H/GNP/0119
FOR INCUBATORS REVISION No.:00
PVT. LTD., EFFECTIVE DATE:
(MICROBIOLOGY, Q-BLOCK)
HARIDWAR
PAGE No.: 10 of 10
 Calibration certificate.
 Any other relevant data

17.0 NON COMPLIANCE:

In case of any Non-compliance observed during performance requalification, same shall be handled
through SOP for Handling of Non-Compliance (SOP NO. QAH/045-Current Version).

18.0 DEVIATION:
In case of any deviation observed during performance requalification, same shall be handled through
SOP for Handling of Deviation (SOP NO. QAH/123-Current Version).

19.0 CHANGE CONTROL, IF ANY:

If any change is required during performance requalification, same shall be handled through SOP for
Change Management (SOP NO. QAH/122-Current Version).

20.0 ABBREVIATIONS:
SOP : Standard Operating Procedure
QC : Quality Control
GNP : General protocol number
H : Plant code for Pure & Cure
CC : Change Control
INS : Instrument
PC : Pure & cure
0
C : degree centigrade
QAH : Quality Assurance department of Pure & Cure
HML : Microbiology department of Pure & Cure

FORMAT No.: QAH-093/F06-02