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Operating Limits and Conditions

P-50099

CONTENTS

1. Purpose ......................................................................................................................... 2
2. Scope ............................................................................................................................. 2
3. Definitions and Abbreviations ..................................................................................... 2
3.1 Abbreviations ....................................................................................................... 2
3.2 Definitions ............................................................................................................ 3
4. Responsibilities ............................................................................................................ 4
4.1 General Manager ................................................................................................. 4
4.2 Operations Manager ............................................................................................ 4
4.3 Senior Operators/ Process Operators ................................................................. 4
4.4 High Reliability Officer ......................................................................................... 4
5. Precautions ................................................................................................................... 4
6. Introduction ................................................................................................................... 4
7. Methodology of Identification ...................................................................................... 4
8. Identified Safety Limits of the ANM Mo-99 Facility .................................................... 5
9. Identified Operating Limits of the ANM Mo-99 Facility ............................................. 6
10. Modes of Operation ...................................................................................................... 7
11. Operational Limits and Conditions ............................................................................. 8
12. Records ....................................................................................................................... 15
13. References .................................................................................................................. 15

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1. Purpose
The purpose of this document is to define the operating modes and to specify the operational
limits and conditions for the various modes of operation arising from the ANM Mo-99 Facility
(Building 88), located within ANSTO LHSTC.
This plan should be read in conjunction with the ANM plans and arrangements:
 Q-50081 Effective Control Plan (1)
 Q-50082 Safety Management Plan (2)
 Q-50083 ANM Radiation Protection Plan (3)
 Q-50084 Waste Management Plan (4)
 Q-50085 Security Plan (5)
 Q-50086 Emergency Plan (6)
for the management of safety within the facility.
Potential accident scenarios and actions are also outlined in the ANM Mo-99 Facility Safe and
Secure Operations (7).

2. Scope
This document applies to the ANM Mo-99 Facility (Building 88), and all associated operations
and processes undertaken. Included in the operation is the transport of irradiated target plates
from OPAL to the facility.

3. Definitions and Abbreviations

3.1 Abbreviations
The following abbreviations have been used in this document:
3.1.1 ALARA: As low as reasonably achievable
3.1.2 ANM: ANSTO Nuclear Medicine
3.1.3 ANSTO: Australian Nuclear Science and Technology Organisation
3.1.4 ARPANSA: Australian Radiation Protection and Nuclear Safety Agency
3.1.5 B(U): Type B (Unilateral) container.
0
3.1.6 C: Degrees Celsius
3.1.7 CEO: Chief Executive Officer
3.1.8 DAC: Derived Air Concentration
3.1.9 IAEA: International Atomic Energy Agency
3.1.10 ILLW: Intermediate Level Liquid Waste
3.1.11 kPa: Kilopascals
3.1.12 LHSTC: Lucas Heights Science and Technology Centre
3.1.13 Mo-99: Molybdenum-99
3.1.14 OLC: Operating Limit and Condition
3.1.15 OPAL: Open Pool Australian Light-water Reactor

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3.1.16 PSAR: Preliminary Safety Analysis Report
3.1.17 SAC: Safety Assurance Committee
3.1.18 SAR: Safety Analysis Report
3.1.19 WHS: Work Health and Safety

3.2 Definitions
The following definitions have been used in this document:
3.2.1 Actions: A task or set of tasks that must be undertaken, when a limiting
condition is not met, to restore the plant to a safe state.
3.2.2 Activity: Any operation, task or inspection performed by a person or people.
3.2.3 Evacuate: Transfer plant operations into a safe state then exit the building and
meet at the external muster point.
3.2.4 Halted: Terminate processes as expediently as practical. Actions may be taken
to place the process in a safe state (e.g. turn off heaters) but no consideration of
the impact on the quality of the batch will be taken. Irradiated target plates will
not be transferred from OPAL to the ANM Mo-99 Facility while operations are
halted.
3.2.5 Limiting Condition: The lowest functional capability or performance level of
equipment or parameters required to meet the assumptions of the safety
analyses.
3.2.6 Operable: Capable of operating if required, support equipment taken into
account.
3.2.7 Operational: Currently fulfilling its function, support equipment taken into
account.
3.2.8 Operational Limits and Conditions: A set of rules which set forth parameter
limits, the functional capability and the performance levels of equipment and
personnel approved by the regulatory body for safe operation of the facility.
3.2.9 Operational Task: A task included in the manufacturing batch record or Task
List which is undertaken by an operator. This excludes tasks that are
undertaken for inspection or maintenance.
3.2.10 Safety Limits: Limits on process variables within which the operation of the
facility has been shown to be safe.
3.2.11 Safety Systems: Systems important to safety, provided to ensure the safe
shutdown of the facility or to limit the consequences of anticipated operational
occurrences and accident conditions.
3.2.12 Surveillance Requirements: Actions undertaken to confirm whether or not the
various operational limits and conditions are being satisfied.
3.2.13 Suspend: Complete the current batch if there is no immediate risk to the
operator or other people. Do not commence any more production batches.
Irradiated target plates will not be transferred from OPAL to the ANM Mo-99
Facility while operations are suspended.

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4. Responsibilities
4.1 General Manager
The General Manager is responsible for:
(a) The overall responsibility for the safe operation of the facility;
(b) Communicating any breaches of OLCs to ARPANSA in accordance with the
Licence Conditions for the facility; and
(c) Ensuring that any breaches of OLCs are fully investigated to prevent
recurrences.
Note: The General Manager is also the License Nominee for the ANM Mo-99 Facility.
4.2 Operations Manager
The Operations Manager is responsible for:
(a) Production activities of Mo-99 within the ANM Mo-99 Facility;
(b) Ensuring that the OLCs are followed by the Process Operators and
Maintenance personnel in the ANM Mo-99 Facility; and
(c) Performing role of Facility Officer.
4.3 Senior Operators/ Process Operators
The Senior Operators/ Process Operators are responsible for:
(a) Performing surveillance tasks to ensure that Operating Limits and Conditions
are continuously being met.
4.4 High Reliability Officer
The High Reliability Officer is responsible for:
(a) Ensuring all production personnel are trained in the application of OLC’s within
the ANM Mo-99 Facility.
5. Precautions
5.1 The precautions to be applied in undertaking any tasks required to comply with the
OLCs are detailed in the individual work instructions and forms used for normal
operations.
6. Introduction
6.1 The OLCs are mandatory and must be complied with at all applicable times.
6.2 The OLC requirements cannot be amended without prior approval of the CEO,
ARPANSA and any breaches of the OLCs shall be reported to the CEO, ARPANSA
within 72 hours.

7. Methodology of Identification
The methodology for identifying the Safety Limits and Operating Limits comprise the following
three steps.
7.1 Examine the safety categorisation of the processing facility and identify any specific
limits inherent in the physical design of the facility (8) (9).
7.2 Examine the accident analyses undertaken for the facility (10) and referenced in the
SAR (11) to identify controls that manage the risk of accidents.
7.3 Review the facility process and operations using the guidance of the Operational Limits
and Conditions and Operating Procedures for Research Reactors (12).

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This was undertaken by personnel working for ANSTO and then reviewed by production
personnel from ANM, Engineering and Capital Programs Divisions. The outcome of the
identification process is given in Section 8 and Section 9 and is divided into Safety Limits and
Operating Limits.

8. Identified Safety Limits of the ANM Mo-99 Facility

The two identified Safety Limits for the ANM Mo-99 Facility are listed in Table 1 below.

Table 1
Safety Limits for the ANM Mo-99 Facility

Safety Limit How Identified How failure could compromise safety

Maximum Design limitation Over-pressure of processing plant could rupture

pressure in the identified in SAR piping, connections or vessels.
processing plant (11). This could potentially release hydrogen gas and form
a flammable gas cloud in the cell, which in
conjunction with other multiple failures could ignite
and damage the contents of the cell by overpressure
and cause active material to be expelled from the hot
cells into the operating area of the ANM Mo-99
Facility.
The rupture could also release active material into
the cell and the pressure burst could cause active
material to be expelled from the hot cells into the
operating area of the ANM Mo-99 Facility.
However, in normal operations, the pressure in the
process vessels does not exceed atmospheric
pressure. The vessels are capable of withstanding
pressures far in excess of the nominal design
pressure. The dissolver, tested to a pressure of
1200kPa, is protected from over pressurisation by a
bursting disk set in the range of 1027 to 1155kPa at
25°C.
It is not credible that the physical limit of the vessels
could be exceeded. Therefore, no OLC is required to
enforce the limit.
Maximum Design limitation Over-pressure of any gaseous waste storage tank
pressure in identified in SAR could cause a rupture of the affected tank(s).
gaseous waste (11). This could release active material into the cell and
storage tanks. the pressure burst could cause active material to be
expelled from the hot cells in to the operating area of
the ANM Mo-99 Facility.
However, in normal operations, the pressure in the
gas storage tanks does not exceed atmospheric
pressure. Furthermore, the vessels are capable of
withstanding pressures far in excess of the nominal
design pressure.
It is not credible that the physical limit of the vessels
could be exceeded. Therefore, no OLC is required to
enforce the limit.

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9. Identified Operating Limits of the ANM Mo-99 Facility
The eight identified Operating Limits for the ANM Mo-99 Facility are listed in Table 2 below.
Table 2:
Operating Limits for the ANM Mo-99 Facility
Operating Limit How Identified How failure could compromise safety
Availability of The SAR (11) Commencing the production run without the standby
Extract ventilation identifies this as an and emergency fans available may compromise
important defence in depth.
operational limit.
Quantities and The SAR (11) There is the potential for a criticality accident if too
locations of identifies this as an much nuclear material is within the hot cells. This
nuclear material important incident could cause injuries to operations personnel
operational limit. as well as eject active particles and gases from the
facility.
Availability of The SAR (11) and Higher than permitted dose rates can cause radiation
radiation the IAEA guide injury to personnel. Detection of high radiation levels
monitoring units (12) identify this as allows mitigating actions.
an important
operational limit.
Airborne The SAR (11) Airborne contamination can lead to significant
contamination identifies this as an internal dose to operators.
sampling alarms important
operational limit.
Presence of This is identified in If adequate numbers of trained personnel are not
personnel the SAR (11) and present, the operators could have an increased
the IAEA guide chance of fatigue. This may cause a loss of control of
(12). the process which could lead to an increased risk of
a safety incident occurring that could cause injury or
dose to personnel.
Functionality of The SAR (11) The rear cell maintenance door on the Packaging
Packaging Cell identifies this as an Cell does not have any interlocks. If the radiation
radiation monitor. important alarm was not functioning and maintenance staff
operational limit. open the maintenance door there is potential for the
maintenance staff to receive significant dose.
Containment The SAR (11) Failure of the containment system could lead to
system maintains identifies this as an airborne contamination and significant internal dose
integrity important to operators and other staff.
operational limit.
Packaging Cell The SAR (11) Failure of this interlock could lead to potential
B(U) container identifies this as an radiation exposure due to product being accidently
interlock is important dropped through an open B(U) port.
operational operational limit.

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10. Modes of Operation

The modes of operation for the Facility are shown in Table 3. These modes of operation are
used to define when specific requirements in the OLCs are to be met. Any activities and
requirements not associated with routine operation and maintenance of the safety related
systems shall be the subject of specific submissions to SAC.

Table 3:
Modes of Operation of the ANM Mo-99 Facility
Mode Description
Production The operation of plant and equipment associated with separation,
purification and reconstitution of Mo-99.
Regeneration When the task of hydrogen converter regeneration is performed.
Any of the four installed converters may not be started in regeneration
mode while any of the others are in production mode during a conversion.
Packaging The stage of operation once Production and dispensing of Mo-99 have
been completed. It is solely performed in the Packaging Cell.
Suspended When Production has been stopped and the plant has been placed in a
(safe mode) safe mode.
All other modes Any activity or plant status, other than “Production” or “Regeneration”
including:
 Maintenance, or
 Plant preparation prior to the commencement of a production
run, or
 Waste Transfer.

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11. Operational Limits and Conditions

Operational limits and conditions (OLCs) are a set of rules which set forth parameter limits, the
functional capability and the performance levels of equipment and personnel agreed by
ARPANSA for safe operation of the controlled facility/apparatus.
These OLCs are mandatory and must be complied with at all applicable times.
OLCs are considered breached if the required action is not taken in the allowed time once a
limiting condition has been exceeded. The CEO of ARPANSA must be notified in accordance
with the ARPANSA licence conditions in the event of a breach as per section 6.2.
If a limiting condition is exceeded and before the completion time is past, the limiting condition
is no longer exceeded, the specified action does not need to be taken.
OLCs must be approved by the regulator before implementation, and cannot be altered (other
than editorial changes) without regulatory approval.
Each of the eight OLC’s are described in Table 4 below. Surveillance requirements are listed
for each of the OLC’s. The general requirements on surveillance tasks are as follows:
(a) The specified surveillance requirements for inspection, calibration and maintenance are
met if the period between inspection, calibration and maintenance activities does not
exceed 1.25 times the interval specified in the SAP schedule.
(b) If it is discovered that a surveillance task was not performed within its specified
frequency, noting the allowance above, then for the item whose surveillance was
missed, the issue must be rectified as soon as possible ensuring that safety is not
compromised.
11.1 Content and Format of the OLCs
The OLCs are formatted in a manner consistent with international best practice and
consist of the following component parts:

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Table 4: Operating Limits and Conditions

Id Objective Limiting Applicability Actions Surveillance Bases

Condition Requirements
OLC1 To protect personnel from The active Condition 1. Do not Verify that the This condition is
accidental exposure to airborne ventilation system required during commence active ventilation required to ensure
radiation. (AVS) must be Production operations. system is operating that the required
operating such that 2. If operations are prior to reliability of the
it is capable of underway, commencement of ventilation
maintaining system suspend Production. Verify extraction is
pressures and flow operations. that flow rates are maintained.
rates. within operating
range (13).

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Id Objective Limiting Applicability Actions Surveillance Bases
Condition Requirements
OLC2 To protect personnel from The storage Condition Restore fissile Verify that filter The criticality
accidental exposure to radiation conditions of fissile required during material to its cup storage certificates are an
caused by a criticality event. material stated in all modes. designated storage conditions have essential
the criticality location as stated in not been exceeded administrative
certificate (14) are the criticality prior to each control to ensure
met. certificate (14) prior to production run that a criticality
commencing further (13). accident cannot
processing. Verify the occur.
concentration of
uranium in the
liquid waste
according to
Criticality
Certificate
conditions (15).
Verify compliance
with conditions in
criticality certificate
quarterly (16).

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Id Objective Limiting Applicability Actions Surveillance Bases
Condition Requirements
OLC3 To provide defence in depth to Local area Condition 1. Replace monitor Verify that Failure of these
protect personnel from radiation monitors required during with like-for-like Radiation units represents a
accidental radiation exposure. covering ground all modes with within 24 hours; Monitoring Units compromise of the
floor and the exception of OR are operating prior defence-in-depth
mezzanine must changeover and 2. Replace monitor to commencing against all
be operating testing of with temporary Production (13). radiation accident
monitors. local monitor and Radiation scenarios.
restrict access to Monitoring Units
area to essential are calibrated
personnel only. annually as per
Temporary Planned
monitors should be Maintenance
used no longer schedule.
than 2 weeks.
OLC4 To provide defence in depth to Local airborne Condition 1. Replace monitor Verify that local Failure of these
protect personnel from contamination required during with like-for-like; airborne units represents a
accidental airborne radiation sampling devices all modes with OR contamination compromise of the
exposure. covering ground the exception of 2. Replace monitor sampling devices defence-in-depth
floor and changeover and with temporary are operating prior against accidental
mezzanine must testing of local monitor and to commencing airborne radiation
be operating monitors. restrict access to Production (13). exposure
area to essential Radiation scenarios.
personnel only. Monitoring Units
Temporary are calibrated
monitors should annually as per
be used no longer Planned
than 2 weeks. Maintenance
schedule.

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Id Objective Limiting Applicability Actions Surveillance Bases
Condition Requirements
OLC5 To protect personnel from A minimum of 2 Condition is Production shall be Prior to The provision of at
fatigue related incidents which accredited required for suspended. In the commencing least two
could lead to accidental Operators shall be Production and event of an abnormal Production, verify accredited
radiation exposure, and to within the facility Regeneration. occurrence one staffing levels (13). Operators is
ensure safe operation of the boundary of accredited Operator required during
facility. Building 88 during is required to halt production so as to
each production production and bring ensure the safe
shift. the plant to a safe operation of the
state. plant. The
production process
is complex,
involving numerous
sequential
operations
conducted in
different parts of
the facility. The
presence of at
least two
accredited
personnel mitigates
errors which could
result in significant
radiological doses
to staff.

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Id Objective Limiting Applicability Actions Surveillance Bases
Condition Requirements
OLC6 Opening of the rear cell access Radiation alarm on Condition Repair alarm and if Verify that This requirement
door on the Packaging Cell Packaging Cell required during access is required radiation alarm on protects against
when there is a radioactive must be all modes with prior to repair, access Packaging Cell is both accidental
source present could lead to operational. the exception of can only be operational at least radiation exposure
potential radiation exposure. changeover and undertaken under once a week by opening the rear
testing of supervision of HPS during production cell access door as
monitors. and approval of periods (17). well as potential
Senior Operator. Radiation radiation exposure
Monitoring Units due to product
are calibrated being accidently
annually as per dropped through
Planned an open BU port.
Maintenance
schedule.

OLC7 Containment failure could lead Process Condition is Upon failure of the Prior to Failure of process
to potential for airborne radiation containment required for pressure and leak commencing containment
exposure. system is Production. test, production will dissolution, verify represents a
operational. not commence. integrity of process compromise of
containment by defence-in-depth
performing against accidental
pressure and airborne radiation
vacuum test to exposure
ensure that there scenarios.
is no loss of
vacuum or
pressure within 5
minutes (18).

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Id Objective Limiting Applicability Actions Surveillance Bases
Condition Requirements
OLC8 Packaging Cell B(U) container Packaging Cell Condition is Packaging cell is Verify integrity of This requirement
interlock failure could lead to B(U) container required for made inoperable until Packaging Cell protects against
potential radiation exposure. interlock is Packaging. interlock is repaired. B(U) container potential radiation
operational. The packaging cell interlock annually exposure due to
will be made as part of regular product being
inoperable if a failure planned accidently dropped
is identified during maintenance. through an open
operation. Radiation B(U) port.
Monitoring Unit is
calibrated annually
as per Planned
Maintenance
schedule.

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12. Records
The following records are to be maintained by ANM:
Responsibility
Records Type Storage Location Retention Disposition
(for storage)
ANM Mo-99 Facility
Request
Safe and Secure
assessment
Operation - Pre-Start ANM Quality Unit
Hard Quality Unit 15 Years from
Checks: Document Storage
ANSTO
Molybdenum-99
Records
Production
Blending and Request
Dispensing of assessment
ANM Quality Unit
Sodium Molybdate Hard Quality Unit 15 Years from
Document Storage
[Mo-99](fission) ANSTO
Solution Records
Manufacturing Request
Record: Sodium assessment
ANM Quality Unit
Molybdate [Mo-99] Hard Quality Unit 15 Years from
Document Storage
(Fission) Solution– ANSTO
Part 1 Records

Records are to be stored and archived according to instruction P-50010 Records Management
(19).

13. References
1. Q-50081 Effective Control Plan.
2. Q-50082 Safety Management Plan.
3. Q-50083 ANM Radiation Protection Plan.
4. Q-50084 Waste Management Plan.
5. Q-50085 Security Plan.
6. Q-50086 Emergency Plan.
7. P-50100 ANM Mo-99 Facility Safe and Secure Operations.
8. AG-2494 Guidance on the Radiological Safety Categorisation of Structures, Systems
and Components.
9. ANM-Mo99-C-LA-C4d ANSTO Nuclear Medicine Mo-99 Facility Construction Licence
Preliminary Safety Analysis Report.
10. Mo99_SAFE_XXXX_TN_0299_A ANM Mo99 Accident Scenarios and Recovery.
11. Q-50098 Safety Analysis Report: ANM Mo-99 Facility for Production of Molybdenum-99.
12. NS-G-4.4, 2008 IAEA Safety Standards, Operational Limits and Conditions and
Operating Procedures for Research Reactors, Safety Guide.
13. F-50137 ANM Mo-99 Facility Safe and Secure Operation - Pre-Start Checks:
Molybdenum-99 Production.

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14. CCT/187 ANSTO Nuclear Medicine Mo-99 Facility Operating Licence Submission
Criticality Certificate.
15. I-50123 Liquid Waste Transfer to Decay Tanks and Sampling.
16. AG-5445 Guide on ARPANSA Requirements.
17. M-10914 Blending and Dispensing of Sodium Molybdate [Mo-99](fission) Solution.
18. M-1001728 Manufacturing Record: Sodium Molybdate [Mo-99] (Fission) Solution– Part 1.
19. P-50010 Records Management.
20. Lu, Weijian. CCA/056 Criticality Assessment: The ANM Plant. April 2015.

History
Revision: Prepared by: Issue/Revision Summary: Date:

0 New Document for ANM 08 / 02 /2016

Correction of table of contents

error.
Correction to SAC abbreviation.
Amendment to section 6.2 to
1 reflect appropriate reporting 29 / 04 /2016
timeframes.
Addition of OLC8 regarding
Packaging Cell B(U) container
interlock.

Update after SAC comments.

Added suspended operations (safe
mode) to section 10.
OLC1: Re-worded to account for
redundancy in the AVS system.
OLC3 and OLC4: added two week
timeframe for use of temporary
monitors; added surveillance
frequency; changed limiting
condition to only include ground
floor and mezzanine; applicability
2 17 / 10 / 2016
modified to allow for change-over
and testing of monitors; added
annual calibration
OLC5: Wording changed from
“within the vicinity of B88” to “within
the facility boundary”; added
regeneration mode to applicability.
OLC6: applicability modified to
allow for change-over and testing
of monitors; changed actions to
better describe what happens if
limiting condition is not met;

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calibration of alarm on PM
schedule added.
OLC7: Added allowable leak rate
of no loss of vacuum/pressure
within 5 minutes.
OLC8: Added action that
packaging cell made inoperable if
failure is identified during
operation; added annual calibration
of monitor.

Table 4: Clarification that OLC5

3 mitigates risk of dose to staff.
29/03/2017

Approval
Position: Operations Date: 29 / 03 /2017
Name
Manager
Position: Client Office Date: 30/ 03 /2017
Name
Manager
Only the original master copy contains approval signatures.

Distribution
Internal: External:
ANM: ANSTO Content Server (Electronic, Not Applicable
users copy)
Hard Copy Master: ANM

END OF DOCUMENT

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