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UNCLASSIFIED
Mo99_COMM_PROC_CTP_1174: ANM Mo99 Project - Commissioning Plan - Mo-99 Production Process
Page 1 of 51
Revision: B Effective Date: March 2017 Approved by: ANM Mo99 Program Manager Custodian: ANM Project Quality
UNCLASSIFIED
ANM MO99 PROJECT
Commissioning Plan Mo-99 Production Process
Mo99_COMM_PROC_CTP_1174
March 2017
Mo99_COMMProduction PRevision: B Approved by
1. Purpo2. Scope
2.1. In2.2. O
3. Defini4. Backg5. Comm
5.1. Le5.2. Te5.3. P5.4. P5.5. V
6. Comm6.1. W6.2. A6.3. A
7. Comm7.1. C7.2. Te7.3. D7.4. C7.5. In7.6. C7.7. N7.8. C
7.8.1. 7.8.2. 7.8.3. 7.8.4.
7.9. In7.10. 7.11. 7.12.
8. Docum8.1. W8.2. A
9. RefereAppendix A
PA.1 TrA.2
Appendix B ‘FB.1 WB.2 PB.3 SyB.4B.4.1 B.4.2 B.4.3 B.4.4 B.4.5 B.4.6 PB.5 CB.6B.6.1 B.6.2
Appendix C
M_PROC_CTProcess
y: ANM Mo99
ose ...............e ..................n-Scope ........Out-of-Scope itions, Abbrground ........missioning Read Project Eechnical Manroject Enginerocess Operalidation Co-
missioning SWatpac Const
NM Mo99 PrNM Mo99 Pr
missioning ..Commissionin
est Equipmeesign Docum
Commissioninnstallation ChContinuity and
oise Level ACommissionin
MolybdeHydrogeDissolutioCommiss
n-Process SaLiquid WasKey PerformCommissio
mentation –Watpac Const
NM Mo99 Prence DocumA: Commersons Perforaining SummB: ConstFor InstallatioWatpac Pract
rocess Safetystem Comp
DissolutioHydrogePurificatiEvaporatDispensiIn-Proces
ost-ConstrucContinuity and
ContinuitMechanic
C: Equip
P_1174: ANM
9 Program Man
....................
....................
.......................................
reviations an....................ResponsibilEngineer .....nager ..........eer ..............rator(s) ........-ordinator ....Strategy ......tructions Ptyroject – Instrroject – Proc....................ng Personneent Calibratiomentation forng Records -hecks (Equipd Point Chec
Assessment .ng of Processnum-99 Procn Converter on Cell – Prosioning Runsampling and te Sampling mance Paramning Schedu
– Watpac antruction Pty Lroject Workg
ments ..........missioning Porming Commmary ...........truction andon’ Documenical Completty Systems Vponent - Instaon Hot Cell (n Conversionon Hot Cell (tion Hot Cell ng / Packagiss Samplingction Cleanind Point Checty Checks of cal Lines - Pment Calibr
UNC
M Mo99 Proje
nager
UNC
Tab
....................
....................
....................
....................nd Acronym....................ities ....................................................................................................................................
y Ltd .............rumentation acess Workgro....................l Details and
on .................r Installation Prerequisite
pment and Utcks....................................s Operationscess Overvie– Testing.....
ocess Comms - Process OTesting ........and Testing
meters .........ule ................d ANM Mo9Ltd ...............group ................................
Personnel anmissioning R....................
d Installationntation ..........tion HandoveVerification ...allation Chec(DCEL1) ......n Hot Cell (H(PCEL1) ......(ECEL1) .....
ing Hot Cell (Cell (IPSC).
ng Verificatiocks................
Electrical Eqoint Checks.
ration Check
CLASSIF
ct - Commiss
CLASSIF
ble of Con
....................
....................
....................
....................ms ....................................................................................................................................................................................................and Control Woup ..................................
d Training .........................Checks .......
es ................tility Services........................................s ..................ew ....................................
missioning ....Operations ....................... ...........................................................
99 Project ................................................................nd Training
Roles ................................n Document....................er – Process....................cks ...................................
HCELL) ................................................(DSPC1 / PK....................
on .....................................quipment .........................ks ................
FIED
sioning Plan
FIED
tents
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...................Workgroup ....................................................................................................................s) ............................................................................................................................................................................................................................................................................................................... ..........................................................tation .............................. Related Doc..................................................................................................................
KGC1)............................................................................................................................
- Mo-99
ECusto
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....................cumentation ....................................................................................................................................................................................................................................................................
Effective Dateodian: ANM P
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..................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................... Checks ..............................................................................................................................................................................................................................................................
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10 11 11 11 12 12 12 12 12 12 13 13 13 13 14 14 14 15 15 15 15 15 15 17 17 18 19 19 20 23 24 24 24 24 25 25 25 27 28 28 29 30
Mo99_COMMProduction PRevision: B Approved by
Appendix D CD.1 HD.2 WD.3 CD.4 HD.5
Appendix E
M_PROC_CTProcess
y: ANM Mo99
D: CommCommissionin
ydrogen ConWater Run SigCold Run Sign
ot Run Sign-E: Comm
P_1174: ANM
9 Program Man
missioning Dng Prerequisnverter Test gn-Off Sheetn-Off Sheet .-Off Sheet ...
missioning (
UNC
M Mo99 Proje
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UNC
Documentatites Sign-OffSign-Off Shet ...........................................................including E
CLASSIF
ct - Commiss
CLASSIF
tion ..............f ...................eet ...........................................................................quipment) N
FIED
sioning Plan
FIED
....................
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...................
...................
...................Non-Conform
- Mo-99
ECusto
....................
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....................mances ......
Effective Dateodian: ANM P
.......................................................................................................................................
Page 3 of 51
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31 31 32 46 47 49 51
UNCLASSIFIED
Mo99_COMM_PROC_CTP_1174: ANM Mo99 Project - Commissioning Plan - Mo-99 Production Process
Page 4 of 51
Revision: B Effective Date: March 2017 Approved by: ANM Mo99 Program Manager Custodian: ANM Project Quality
UNCLASSIFIED
Revision Details Print name, date and initial each box
Rev. Letter
Description of Revision Prepared Reviewed Approved Agreed
A Initial Issue
B Updated Commissioning Schedule; Noise Level Assessment; and updates from SAC Review
Notes: 1. Revision shall be verified in accordance with the Quality Plan for the project.
2. Revision to be agreed by the relevant Client.
UNCLASSIFIED
Mo99_COMM_PROC_CTP_1174: ANM Mo99 Project - Commissioning Plan - Mo-99 Production Process
Page 5 of 51
Revision: B Effective Date: March 2017 Approved by: ANM Mo99 Program Manager Custodian: ANM Project Quality
UNCLASSIFIED
Distribution List
Controlled Copy Number Location Details
Electronic Archive Copy Projects on ANSTO NetAPP (Fianna) P:\eris
1 Archive File Hardcopy
ERIS Database, Building 25
2 ANM Mo99 Project
UNCLASSIFIED
Mo99_COMM_PROC_CTP_1174: ANM Mo99 Project - Commissioning Plan - Mo-99 Production Process
Page 6 of 51
Revision: B Effective Date: March 2017 Approved by: ANM Mo99 Program Manager Custodian: ANM Project Quality
UNCLASSIFIED
1. Purpose This commissioning plan describes the strategy, resources, methodology, and acceptance criteria for commissioning the production process in the new ANM Mo-99 facility (Building 88).
The plan is structured to enhance current ANSTO commissioning practices and is aligned with the ISPE guidelines for commissioning and validation of a GMP facility.
2. Scope 2.1. In-Scope
In scope work includes commissioning activities, understanding the design intent; functional testing of the equipment and start-up of the chemical process associated with molybdenum-99 production in the facility hot cells. Specifically:
a) Commissioning Personnel and Training Summary
b) Documentation Checks
c) Installation verification (Equipment and Utility Services)
d) Point-to-point and continuity testing (Mechanical and Control Instrumentation)
e) Functional performance testing of each system (Dissolution, Hydrogen Conversion, Purification, Evaporation, Dispensing and Packaging)
f) Execution of at least one Water Run to check start-up sequences
g) Execution of an End-to-End (Cold) Run to simulate operating objectives
h) Execution of two low activity (Hot) Runs and one high activity (Hot) Run, subject to ARPANSA regulatory approval.
2.2. Out-of-Scope The scope of work does not include the following:
a) Works conducted by the Principal Contractor, as per Section 6.1 below.
b) Re-engineering and re-work of the Principal’s work.
3. Definitions, Abbreviations and Acronyms Term Definition
ANM ANSTO Nuclear Medicine
Commissioning “A well planned, documented, and managed engineering approach to the start-up and turnover of facilities, systems, and equipment to the End-User that results in a safe and functional environment that meets established design requirements and stakeholder expectations”, ISPE Guide Commissioning and Qualification, 2001
Cold Run The process of going completely through a radioactive operational procedure without using radioactive materials. This process helps the Operator prepare all necessary equipment and organize the procedure for when radioactive materials will be used.
ECP ANSTO Engineering and Capital Programs
GMP Good Manufacturing Practice
Hot Run A ‘Hot Run’ uses all chemical materials for a process run, including irradiated target plates.
I&C Instrumentation and Control
ITP Inspection and Test Plan
ISPE International Society of Pharmaceutical Engineering
UNCLASSIFIED
Mo99_COMM_PROC_CTP_1174: ANM Mo99 Project - Commissioning Plan - Mo-99 Production Process
Page 7 of 51
Revision: B Effective Date: March 2017 Approved by: ANM Mo99 Program Manager Custodian: ANM Project Quality
UNCLASSIFIED
Term Definition
Mo-99 Molybdenum-99
Water Run A ‘Water Run’ is a process run which uses only water through the process and no process chemicals. All systems, including the nitrogen supply and gaseous waste systems are required to be operational. No water is introduced into any of the gas management system pipework.
4. Background The design and construction of the ANM Mo-99 facility has been a major achievement for the ANSTO managers, project engineers, designers, technical staff and international collaboration partner, NTP Radioisotopes SOC Ltd. Their specialised knowledge and current experience with operations and maintenance of radiopharmaceutical facilities has achieved a world class designed facility which will have minimal radiological impact to the environmental and operations staff.
A major contributor to the construction work has been the Principal Contractor, Watpac Construction Pty Ltd and their sub-contractors.
Commissioning the building services, facility and molybdenum-99 process will be the result of the combined efforts of Watpac, ANSTO and NTP. This shared responsibility means essential planning and collaboration between the organisations are important elements to minimising any overlap or risks of gaps in commissioning.
Ultimately, the ANM Mo99 Project Team is responsible for delivering a fully functional facility to the ANM Client.
5. Commissioning Responsibilities This section describes the roles and responsibilities of persons involved in the design, installation, testing and commissioning of the systems being tested. It shall be acceptable for one person to act in more than one role e.g. the Technical Manager may also act as the Tester and it may be beneficial to do so.
5.1. Lead Project Engineer The Lead Project Engineer is responsible for designing the systems associated with the Mo-99 production process and for ensuring that the tests described in this document are a complete and thorough test of system functions, and correctness of installation. It shall be the responsibility of the Project Engineer to approve changes to the design arising from specification non-compliance.
5.2. Technical Manager The Technical Manager in association with the Lead Project Engineer will manage the overall commissioning activities, and supervision of other technical and engineering personnel and subcontractors required for inspection, testing and commissioning tasks; and ensuring the implementation of any design modifications. The overall responsibility of commissioning may be shared between the Lead Project Engineer and ANM Technical Manager.
5.3. Project Engineer The Project Engineer is responsible for performing all inspections and tests as listed in this plan and recording all observations and results as appropriate. The Project Engineer shall identify any protocol deviations or non-conformances based on the outcome of the tests and inspections.
5.4. Process Operator(s) There may be multiple Process Operators who will assist with operating the process equipment to carry out the various commissioning activities. Each person involved in commissioning testing shall be listed in Section 7.1 of this document.
5
6
6
Mo99_COMMProduction PRevision: B Approved by
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Page 8 of 51
e: March 2017Project Quality
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UNCLASSIFIED
Mo99_COMM_PROC_CTP_1174: ANM Mo99 Project - Commissioning Plan - Mo-99 Production Process
Page 9 of 51
Revision: B Effective Date: March 2017 Approved by: ANM Mo99 Program Manager Custodian: ANM Project Quality
UNCLASSIFIED
The scope of Watpac’s commissioning work will include: Relevant to Process
Commissioning
Building
Basement No
Ground Floor No
Mezzanine Level No
Base Building Services
HVAC – Central Chilled and Hot Water System Yes
Electrical Services Partially
Hydraulic Services Partially
Building Management System No
Cranes / Hoists (Base Building Only) No
Fire Services No
Passenger Lift No
Security Services No
Main Production Units and Production Support Services
Compressed Air Yes
Control, Protection and Monitoring System (CPMS) Yes
DCELL Pack Air Treatment Yes
Environmental Monitoring System Yes
Hot Cells Yes
Nitrogen Yes
Process Heating and Water Cooling System (Sub-System of AVS)
Yes
Purified Water System Yes
Mechanical Blue Secondary Supply Partially
Mechanical Red Secondary Supply Partially
Air Locks and Loading Bays No
cGMP Laboratory Area No
Conveyor Systems No
Helium and P10 Gas No
Mechanical HVAC (White 1) No
Mechanical HVAC (White 2) No
PADIRAC System No
Pass Throughs No
Rear of Cell Crane, Container Handling Crane and Jib Crane (Production Support)
No
UNCLASSIFIED
Mo99_COMM_PROC_CTP_1174: ANM Mo99 Project - Commissioning Plan - Mo-99 Production Process
Page 10 of 51
Revision: B Effective Date: March 2017 Approved by: ANM Mo99 Program Manager Custodian: ANM Project Quality
UNCLASSIFIED
The scope of Watpac’s commissioning work will include: Relevant to Process
Commissioning
Radioactive Waste Handling and Nuclear Safety Systems
Active Ventilation System (AVS) Partially
Liquid Waste System (LWS) Partially
Radiation Monitoring System (RMS) No
Stack Monitoring System No
Cranes, Monorails & Hoists (Radioactive Waste Handling Only) No
The above listing also indicates whether or not the systems being commissioned by Watpac are relevant to the process commissioning activities. That is, the outputs from Watpac’s commissioning activities are likely to provide inputs to the process commissioning testing.
6.2. ANM Mo99 Project – Instrumentation and Control Workgroup The integration of commissioning activities with ANM Project I&C Team includes:
Relevant to Process
Commissioning
Control, Protection and Monitoring System (CP&MS) Mo99_COMM_INTG_CTP_6820
Active Ventilation System Partially
Liquid Waste Management System No
Hot Cells Control System Yes
Process Water Chillers Yes
Gas Alarm Panel (Nitrogen / Compressed Air) Yes
Radiation Monitors and Stack Monitoring No
Facility Safety Instrumented System Partially
Crane Systems Interface No
ANSTO Site Operations Centre No
Mo99 Process Control System (PCS) Mo99_PROC_CTRL_ES_0430
Hydrogen Conversion Yes
Dissolution – Control of Process Equipment Yes
Purification – Control of Process Equipment Yes
Evaporation – Control of Process Equipment Yes
Dispensing – Control of Process Equipment Yes
Signal Interfaces with Plant Wide CP&MS Partially
UNCLASSIFIED
Mo99_COMM_PROC_CTP_1174: ANM Mo99 Project - Commissioning Plan - Mo-99 Production Process
Page 11 of 51
Revision: B Effective Date: March 2017 Approved by: ANM Mo99 Program Manager Custodian: ANM Project Quality
UNCLASSIFIED
Relevant to Process
Commissioning
ANM Process and Environmental Monitoring System (EMS) Mo99_VALD_EMON_URS_0643
Hot Cell Equipment – Process Parameter(s) Monitoring Yes
Sampling Hot Cell – Environment Monitoring No
Production Cell Face – Environment Monitoring No
Rear of Cell – Environment Monitoring No
GMP Manufacturing Rooms – Environment Monitoring No
Asset Management System (I&C) Mo99_FACL_CTRL_ES_6925
Operator Interface Logging (HMI / Alarms) Indirect
Operation of Plant Equipment – Logging set-point changes Indirect
PLC Logic Changes Yes
Software Change Management Yes
6.3. ANM Mo99 Project – Process Workgroup Commissioning activities undertaken by the Process Group will be focused on the process equipment and process chemistry; and where available, will adhere to the qualification and validation protocols outlined in the ANM Project Validation Master Plan (3).
Detailed Design Construction Operation
DQ FAT/SAT Commissioning IOQ PQ/PV
Process (In-Cell Equipment) ANM/ECP ANM ANM/ECP ANM/ECP ANM/ECP
Process (I&C GMP-Related Only) ECP W/ECP W/ECP ANM/ECP ANM/ECP
Production Hot Cells W/ECP W W/ECP W/ANM ANM/ECP
Key: W = Watpac; ANM = ANM Operations; ECP = ANSTO E&CP Project Team
DQ: Design Qualification; FAT: Factory Acceptance Testing (if required) GEP: Good Engineering Practice; SAT: Site Acceptance Testing (if required) IOQ: Installation / Operational Qualification PQ/PV: Performance Qualification / Process Validation
7. Commissioning For each of the following sub-sections 7.1 to 7.6, complete the respective activities before proceeding to Commissioning of Process Operations.
7.1. Commissioning Personnel Details and Training All personnel involved with the testing activities should be trained; authorised to conduct the tasks and their details recorded as tabulated in Appendix A.1 - Table 1.
The appropriate training records should be completed, as per ANM Training Procedure, P-50009. A training summary needs to be completed as tabulated in Appendix A.2 - Table 2: Training Record.
UNCLASSIFIED
Mo99_COMM_PROC_CTP_1174: ANM Mo99 Project - Commissioning Plan - Mo-99 Production Process
Page 12 of 51
Revision: B Effective Date: March 2017 Approved by: ANM Mo99 Program Manager Custodian: ANM Project Quality
UNCLASSIFIED
7.2. Test Equipment Calibration All test equipment required for the testing shall be identified and recorded in the table in Appendix C: . The test equipment calibration date shall also be recorded to ensure the equipment lies within its valid calibration.
7.3. Design Documentation for Installation Checks Approved design documentation will be used to verify that the process equipment and systems are installed correctly and perform to functional specifications.
The Tester shall record revision numbers of the documents listed in the table Appendix B.1 that are present at the time of testing.
The Project Engineer/Technical Manager confirms that all drawings and documents present are the latest revision.
7.4. Commissioning Records - Prerequisites This section describes the actions that must take place before beginning the testing:
1) Completion checks of Watpac commissioning activities which are relevant to process (Refer to Appendix B.2 );
2) Isolation of specific services (power, compressed air) that must take place;
3) Confirmation that interruptions to site operations has been minimised and communicated to those affected;
4) Confirmation that the testing has an accompanying SWMES; and
5) Verification that post-construction cleaning has been carried out for the pipework, ducts, tubes, vessels, tanks, etc. (Refer to Appendix B.5 Post-Construction Cleaning Verification).
Confirm that the pre-test procedure has been performed by completing the Appendix B.3 protocol.
7.5. Installation Checks (Equipment and Utility Services) Prior to performing any functional performance testing, it is essential to verify the construction and/or installation of equipment and materials used.
The results obtained from prior ITPs, FAT or SAT checks should be utilised to support this activity.
Refer to Appendix B.4 System Component - Installation Checks.
7.6. Continuity and Point Checks ANSTO has developed and installed the I&C equipment for the Process Control System. During the installation of I&C components, a visual inspection and continuity testing is performed to verify that the installation complies with the ‘As-Built’ documentation and the correct connections are made between the contact points of field devices and the PLC control unit.
Following successful continuity testing, point-to-points tests are performed to verify the input/output of the field devices. Complete the verification of this electrical work by using the form in Appendix B.6.1 Continuity Checks of Electrical Equipment.
Point checks of all in-cell mechanical lines are also performed as verification that equipment lines are connected correctly and pressure tested where necessary. Complete the verification of this mechanical work by using the form in Appendix B.6.2 Mechanical Lines - Point Checks.
7.7. Noise Level Assessment During commissioning, an assessment of noise levels in the facility should be carried out. Use the checklist provided in the WHS Management System for identifying Hazardous Noise, AF-5171.
UNCLASSIFIED
Mo99_COMM_PROC_CTP_1174: ANM Mo99 Project - Commissioning Plan - Mo-99 Production Process
Page 13 of 51
Revision: B Effective Date: March 2017 Approved by: ANM Mo99 Program Manager Custodian: ANM Project Quality
UNCLASSIFIED
7.8. Commissioning of Process Operations
7.8.1. Molybdenum-99 Process Overview The neutron irradiation of uranium-alloy targets occurs in a non-GMP environment in the OPAL reactor. Cold targets will be pre-heated in a furnace to simulate temperatures comparable to that in the OPAL reactor.
After dissolution of the targets, the molybdenum-99 is separated from the mixture of nuclides and purified using chromatographic processes to obtain molybdenum-99 with a high level of radionuclidic purity. These processes occur in hot cells DCEL1, PCEL1 and ECEL1 in a GMP environment complying with PIC/S Code of GMP, Part II for APIs.
The final dispensing process in DSPC1 is also compliant with PIC/S Code of GMP, Part II for APIs.
There is no aseptic or sterilisation processing stage, as the final product, sodium molybdate [99Mo] (fission) solution is despatched from the facility as a non-sterile product.
The processing line is in a dedicated facility.
7.8.2. Hydrogen Converter – Testing Each Hydrogen Converter (HYC01, HYC02, HYC03 and HYC04) is to undergo a series of tests prior to being used in any target dissolution process.
Tests are to be carried out and records established to certify the following:
a) Each hydrogen converter is wired in compliance with AS/NZS 3000
b) Measure Element Resistance data for each Converter heater
c) Determine the Megger Insulation Resistance for each Converter
d) Check the PCS set points for Conversion and Regeneration
e) Record temperature data against time for each operation mode of the Converter
f) Determine the % efficiency of conversion of hydrogen to water for each Cold and Hot Run
All test results are to be recorded on the form in Appendix D.2
7.8.3. Dissolution Cell – Process Commissioning ANSTO will conduct commissioning tests of the Hot Cell operations according to the instructions which are written in the ANM manufacturing records.
Major auxiliary systems, equipment, and functions (include I&C) that are important to all Hot Cell operations are all included as part of the Dissolution Cell tests.
UNCLASSIFIED
Mo99_COMM_PROC_CTP_1174: ANM Mo99 Project - Commissioning Plan - Mo-99 Production Process
Page 14 of 51
Revision: B Effective Date: March 2017 Approved by: ANM Mo99 Program Manager Custodian: ANM Project Quality
UNCLASSIFIED
7.8.4. Commissioning Runs - Process Operations The current arrangement of commissioning runs as represented in the ANM Project Validation Master Plan (3) consist of:
Run Run Type Production
Line Dissolver
Test Water 1
1 Cold
1 DIS01
2 Cold DIS02
ARPANSA Approval Required to Hot Commission
3 Hot (Low Act) 1 DIS01 4 Hot (Low Act) 1 DIS02
5 Hot (High Act) 1 DIS01
or DIS02
Note: The number of ‘Water Runs’ may vary, but at least one ‘Water Run’ will be necessary.
The results from each run will be recorded on the ANM Manufacturing Run sheets and should be reviewed when complete by filling in the Appendix D: Commissioning Documentation Sheets.
The final molybdenum-99 product produced from the Hot (High Act) Run will be retained for QC and stability testing; any other molybdenum-99 produced will be decayed and then disposed in LLLW. Active solid and liquid wastes will be treated in the same manner as during production.
7.9. In-Process Sampling and Testing During all Cold and Hot commissioning runs, in-process sampling and chemical testing will be performed.
Description of In-Process Testing Commissioning Methodology (Use ANM Mo-99 Instructions)
1) Sampling and testing of the process stream solutions at different stages of the run
I-50122
Section 8: Sampling and dilution
For the Low Activity ‘Hot’ runs, sampling and dilutions need to be appropriate for the activity of the run. Record the samples submitted and obtain sign-off using the Commissioning Documentation Sign-Off Sheets, Appendix D:
Testing of samples from the process stream will be performed by the ANM Radiochemist and results determined as required.
7.10. Liquid Waste Sampling and Testing During all Cold and Hot commissioning runs, sampling of the ILLW stream will be performed.
Description of In-Process Testing Commissioning Methodology (Use ANM Mo-99 Instructions)
1) Sampling and testing of the ILLW waste stream I-50182: ILLW Sample Analysis
Record the samples submitted and obtain sign-off using the Commissioning Documentation Sign-Off Sheets, Appendix D: .
Results obtained from the testing of the ILLW waste streams will not be available until the samples have decayed for several weeks.
UNCLASSIFIED
Mo99_COMM_PROC_CTP_1174: ANM Mo99 Project - Commissioning Plan - Mo-99 Production Process
Page 15 of 51
Revision: B Effective Date: March 2017 Approved by: ANM Mo99 Program Manager Custodian: ANM Project Quality
UNCLASSIFIED
7.11. Key Performance Parameters The key process parameters need to evaluated and confirmed during execution of the commissioning runs.
Notes: # Confirm ‘Expected Result’ during Commissioning
^ Filtration time acceptance criteria is only applicable to the Hot Run process
* Part 1 of Batch Record, refers to ANM Mo-99 Document No. M-1001728 [Ref: (4)]
* Part 2 of Batch Record, refers to ANM Mo-99 Document No. M-50161 [Ref: (5)]
7.12. Commissioning Schedule The results obtained from the Hot Runs may form part of the Performance Qualification (PQ) for the process equipment qualification.
8. Documentation – Watpac and ANM Mo99 Project 8.1. Watpac Construction Pty Ltd
Watpac and its subcontractors have structured their commissioning documentation in a hierarchical manner, which includes:
Commissioning Acceptance Test Plan (CTP)
Commissioning Acceptance Test Plan Sign Off Sheets (CTPS)
Commissioning Method Statement (CMS)
Commissioning Results Sheet (CRS) Reference: Mo99_FACL_OTH_ER_2218
This document structure is detailed in the Watpac Project Commissioning Plan (2) as well as in the Commissioning Documentation Guidelines issued to their sub-contractors.
8.2. ANM Mo99 Project Workgroup In addition to the Appendices of this Commissioning Plan, the ANSTO project workgroups will adopt and use documentation for commissioning which has been prepared by the ANM Operations and Validation teams. This documentation set is described in the ANM Project Validation Master Plan (3) and consists of:
ANM Mo-99 Procedures and Manufacturing Forms
Methodology and forms capturing the data from each Water Run, Cold Runs and Hot Runs.
Installation/Operational Qualification (IOQ) protocols
For checking equipment installation against design specifications and ITPs, as well as verifying the initial operational parameters.
Performance Qualification / Process Validation (PQ/PV) protocols
PQ/PV protocols are used for checking the routine and limiting operating parameters of the equipment and process equipment.
9. Reference Documents 1. Q-50027 ANM Mo-99 User Requirements Specification. 2. Watpac - ANM Mo99 Commissioning Plan. 2015. Mo99_FACL_OTH_ER_2216. 3. Q-50019 ANM Project Validation Master Plan. 4. M-1001728 Manufacturing Record Sodium Molybdate (Mo-99) Solution - Part 1. 5. M-50161 Manufacturing Record: Sodium Molybdate [Mo-99] (Fission) Solution - Part 2. 6. M-50204 Blending and Dispensing of Sodium Molybdate [Mo-99] (Fission) Solution. 7. Watpac - ANM Mo99 CPMS Integrated Testing Commissioning Test Plan. Mo99_COMM_INTG_CTP_6820.
UNCLASSIFIED
Mo99_COMM_PROC_CTP_1174: ANM Mo99 Project - Commissioning Plan - Mo-99 Production Process
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UNCLASSIFIED
8. ANM Mo99 Project - Process Control System - Functional Specification. Mo99_PROC_CTRL_ES_0430. 9. ANM Mo99 Project - Environmental Monitoring System URS. Mo99_VALD_EMON_URS_0643. 10. ANM Mo99 Project - Process Data Sheet. Mo99_PROC_GEN_ER_0118. 11. I-50122 Reconciliation of Mo-99 Sampled at different Stages of the Sodium Molybdate [Mo-99] (Fission) Manufacturing Process. 12. I-50182 ILLW Sample Ananlysis and Reporting of Uranium to Criticality Officer. 13. AF-5171 ANSTO Identifying Hazardous Noise Checklist.
AAP
T
Mo99_COMMProduction PRevision: B Approved by
Append PerA.1
Persons perfo
Role
Lead ProjecEngineer
Technical Manager
Project Eng
Process Operator Process Operator
Validation Co-ordinato
Table 1: Com
M_PROC_CTProcess
y: ANM Mo99
dix A: rsons Peorming addit
ct
gineer
or
mmissioning
P_1174: ANM
9 Program Man
Commrformingtional roles c
Name
g Personnel
UNC
M Mo99 Proje
nager
UNC
missiong Commian be added
Compa
ANM P
ANM T
ECP P
ANM P
ANM P
ANM Q
l Details
CLASSIF
ct - Commiss
CLASSIF
ing Peissioningd in the space
any / Title
Project Engin
Technical Ma
Project Engin
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Process Ope
Quality Repre
FIED
sioning Plan
FIED
ersonneg Rolese provided.
neer - Proces
anager
eer
rator
rator
esentative
- Mo-99
ECusto
el and
Initials
ss
P
Effective Dateodian: ANM P
Trainin
Signature
Page 17 of 51
e: March 2017Project Quality
ng
e Date
7 y
A
Mo99_COMMProduction PRevision: B Approved by
TraA.2 Training recTraining Off
There are s
a) F-50032b) F-50034c) F-50033d) F-50035
It is expecte
Table 2: Tr
Persons B
Completed
Verified By
M_PROC_CTProcess
y: ANM Mo99
ining Sucords are to ficer for trans
several pro-fo
2 Single ses4 Self-paced3 Training R5 Recognitio
ed that trainin
raining Reco
Being Traine
d By:
y:
P_1174: ANM
9 Program Man
mmary be completescription into
orma records
sion training d training rececord: Multip
on of Prior Le
ng is comple
ord Summar
ed
Name
UNC
M Mo99 Proje
nager
UNC
d according o the ANSTO
s available fo
record ord ple Sessionsearning and R
eted before e
ry
Type o
CLASSIF
ct - Commiss
CLASSIF
to the ANM O Learning M
or this purpos
s Recognition
execution of c
of Training
R
FIED
sioning Plan
FIED
Training Proanagement S
se, namely:
of Current C
commissionin
Procedure
Role
- Mo-99
ECusto
ocedure, P-50System (LMS
ompetency (
ng activities.
es / Instruct
Sig
P
Effective Dateodian: ANM P
0009 and suS).
(RPL/RCC)
tions Covere
gnature
Page 18 of 51
e: March 2017Project Quality
ubmitted to th
ed
Date
7 y
he
A
Mo99_COMM_PRProduction ProceRevision: B Approved by: AN
Appendix ‘For InB.1
Record the revisdated.
Document Num
ROC_CTP_1174: Aess
NM Mo99 Program M
B: Consstallation’ Dsion number and
mber / Title
ANM Mo99 Project -
Manager
UNCL
struction aDocumentati
sign-off on the ins
UN
- Commissioning P
LASSIFIED
and Instaion stallation docume
NCLASSIF
Plan - Mo-99
EfCusto
allation Do
entation relevant to
FIED
Page 1
ffective Date: Marcodian: ANM Project
ocumenta
o Commissioning
19 of 51
ch 2017 Quality
ation
. Additional entrie
RecordRevision N
es can be hand w
No. Initials
written, initialled an
Date
nd
Mo99_COMM_PRProduction ProceRevision: B Approved by: AN
Document Num
Verified By:
WatpacB.2 Watpac will be tabulated below,in detail the com
System Categ
System
Base Building
Building ManagSystem
Ventilation Serv
Hydraulic Servi
Electrical Servi
Main Producti
ROC_CTP_1174: Aess
NM Mo99 Program M
mber / Title
N
c Practical Cproviding System, which is relevan
mmissioning proce
ory
g Services
gement
vices
ices
ces
on Units and Su
ANM Mo99 Project -
Manager
UNCL
ame
Completion m Commissioning nt to the commissiess deliverables an
Document Num
pport Services
UN
- Commissioning P
LASSIFIED
R
Handover –Reports for each
ioning of the procnd documentation
ber and Revision
NCLASSIF
Plan - Mo-99
EfCusto
Role
– Process Reh of the systems cess, should be chn.
n
FIED
Page 2
ffective Date: Marcodian: ANM Project
S
elated Docuthat are commis
hecked for comple
Description
20 of 51
ch 2017 Quality
RecordRevision N
Signature
umentation Csioned by their Tetion. The Watpa
ComC
(Yes
No. Initials
Checks Trade Contractorsc Commissioning
mpletion heck s / No)
Date
Date
s. Each system, a Plan (2) describe
Comments
as es
UNCLASSIFIED
Mo99_COMM_PROC_CTP_1174: ANM Mo99 Project - Commissioning Plan - Mo-99 Production Process
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Revision: B Effective Date: March 2017 Approved by: ANM Mo99 Program Manager Custodian: ANM Project Quality
UNCLASSIFIED
System Category
System Document Number and Revision Description Completion
Check (Yes / No)
Comments
Hot Cell – DCEL1
Hot Cell – HCELL
Hot Cell – PCEL1
Hot Cell – ECEL1
Hot Cell – DSPC1
Hot Cell – PKGC1
Hot Cell – IPSC
Process Heating and Water Cooling System
HVAC and all subsystems
Control, Protection and Monitoring System
UNCLASSIFIED
Mo99_COMM_PROC_CTP_1174: ANM Mo99 Project - Commissioning Plan - Mo-99 Production Process
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UNCLASSIFIED
System Category
System Document Number and Revision Description Completion
Check (Yes / No)
Comments
Purified Water System
Compressed Air System
Nitrogen System
Padirac System (Hot Cells) Testing is included in each
Hot Cell Commissioning Acceptance Test Plan
Hot Cell - LLSW
Hot Cell - ILSW
Liquid Waste System
Radiation Monitoring System
Name Role Signature Date
Completed By:
Mo99_COMM_PRProduction ProceRevision: B Approved by: AN
Verified By:
ProcesB.3
System
Stack Monitorin
Active Ventilatio
ANM Dose AssReport
Safe Work Met
Outstanding SW
Verified By: / D
Completed By
Verified By:
ROC_CTP_1174: Aess
NM Mo99 Program M
ss Safety Sy
ng System
on System
sessment
thod Statements
WMSs, SWPs and
Date:
Nam
:
ANM Mo99 Project -
Manager
UNCL
ystems Verif
Document Num
s, Safe Work Perm
d Isolations have
me
UN
- Commissioning P
LASSIFIED
fication
ber and Revision
mits and Isolatio
been examined to
Role
Pro
Tec
NCLASSIF
Plan - Mo-99
EfCusto
n
ons
o determine if ther
e
oject Engineer
chnical Manager
FIED
Page 2
ffective Date: Marcodian: ANM Project
Description
re is any impact o
Sig
23 of 51
ch 2017 Quality
ComC
(Yes
on the Commissio
gnature
mpletion heck s / No)
ning work.
Comments
Date
Mo99_COMM_PRProduction ProceRevision: B Approved by: AN
SystemB.4 For each of theschematic drawi
B.4.1
Drawing
B.4.2
Drawing
B.4.3
Drawing
ROC_CTP_1174: Aess
NM Mo99 Program M
m Componee systems listed bngs.
Dissolution
g Number
Hydrogen C
g Number
Purification
g Number
ANM Mo99 Project -
Manager
UNCL
nt - Installatbelow, the Tester
Hot Cell (DC
RevisiNo.
Conversion H
RevisiNo.
Hot Cell (PC
RevisiNo.
UN
- Commissioning P
LASSIFIED
tion Checksr will verify that th
CEL1)
ion .
Drawing Type
Hot Cell (HCE
ion .
Drawing Type
CEL1)
ion .
Drawing Type
NCLASSIF
Plan - Mo-99
EfCusto
he piping, instrum
ELL)
FIED
Page 2
ffective Date: Marcodian: ANM Project
mentation and eq
Acceptance C
Acceptance C
Acceptance C
24 of 51
ch 2017 Quality
uipment are insta
riteria
riteria
riteria
alled as describe
Verified(Yes / No
Verified(Yes / No
Verified(Yes / No
ed in the P&ID an
o) Initials / Da
o) Initials / Da
o) Initials / Da
nd
ate
ate
ate
UNCLASSIFIED
Mo99_COMM_PROC_CTP_1174: ANM Mo99 Project - Commissioning Plan - Mo-99 Production Process
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UNCLASSIFIED
B.4.4 Evaporation Hot Cell (ECEL1)
Drawing Number Revision
No. Drawing
Type Acceptance Criteria Verified
(Yes / No) Initials / Date
B.4.5 Dispensing / Packaging Hot Cell (DSPC1 / PKGC1)
Drawing Number Revision
No. Drawing
Type Acceptance Criteria Verified
(Yes / No) Initials / Date
B.4.6 In-Process Sampling Cell (IPSC)
Drawing Number Revision
No. Drawing
Type Acceptance Criteria Verified
(Yes / No) Initials / Date
UNCLASSIFIED
Mo99_COMM_PROC_CTP_1174: ANM Mo99 Project - Commissioning Plan - Mo-99 Production Process
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UNCLASSIFIED
All System Component – Installation Checks Summary
Name Role Signature Date
Checked By:
Verified By:
Comments: (If necessary, complete any Drawing No.’s by hand, before verification)
Mo99_COMM_PRProduction ProceRevision: B Approved by: AN
Post-CB.5 Verify that post-c
Cleaning Proc
Verified By:
Comments:
ANM Mo-99 C
Procedure
ROC_CTP_1174: Aess
NM Mo99 Program M
Constructionconstruction clean
cedure
Nam
leaning Procedu
Description
ANM Mo99 Project -
Manager
UNCL
n Cleaning Vning has been car
e
ures
UN
- Commissioning P
LASSIFIED
Verificationrried out for the Ho
HCE
Veri
(Yes
Role
NCLASSIF
Plan - Mo-99
EfCusto
ot Cells, pipework
ELL DCE
ified
/ No)
Verif
(Yes
e
FIED
Page 2
ffective Date: Marcodian: ANM Project
k, tubes, vessels,
Hot
EL1 PCE
fied
/ No)
Verif
(Yes /
Sig
27 of 51
ch 2017 Quality
tanks, etc.
t Cell Identificatio
EL1 ECE
fied
/ No)
Verif
(Yes /
gnature
on
EL1 DSPC
ied
No)
Verifi
(Yes /
C1 PKGC
ed
No)
Verifie
(Yes / N
Date
C1
ed
No)
Mo99_COMM_PRProduction ProceRevision: B Approved by: AN
ContinB.6
B.6.1
Docume
ROC_CTP_1174: Aess
NM Mo99 Program M
nuity and Po
Continuity C
ent Number
ANM Mo99 Project -
Manager
UNCL
oint Checks
Checks of Ele
RevN
UN
- Commissioning P
LASSIFIED
ectrical Equi
vision No.
DocumTyp
NCLASSIF
Plan - Mo-99
EfCusto
pment
ment pe
FIED
Page 2
ffective Date: Marcodian: ANM Project
Acceptanc
28 of 51
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ce Criteria Verifie
(Yes / N
d No)
Initials / D
Date
UNCLASSIFIED
Mo99_COMM_PROC_CTP_1174: ANM Mo99 Project - Commissioning Plan - Mo-99 Production Process
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UNCLASSIFIED
B.6.2 Mechanical Lines - Point Checks
Document Number Revision
No. Document
Type Acceptance Criteria Verified
(Yes / No) Initials / Date
Name Role Signature Date
Checked By:
Verified By:
Comments:
UNCLASSIFIED
Mo99_COMM_PROC_CTP_1174: ANM Mo99 Project - Commissioning Plan - Mo-99 Production Process
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UNCLASSIFIED
Appendix C: Equipment Calibration Checks
Equipment Item Serial / ID No. Calibration Valid to
Date Signature Date
Table 1: Test Equipment Calibration Details
ATp
DIt
Mo99_COMM_PRProduction ProceRevision: B Approved by: AN
Appendix The Commissionipackage of delive
CommD.1 f tests are not bethis Sign-off sheet
Description of C
Reference
Appendix A.1
Appendix A.2
Appendix B.1
Appendix B.2
Appendix B.3
Appendix B.4
Appendix B.5
Appendix B.6
Appendix C:
Section Error! Reference source not found.
AF-5171
ROC_CTP_1174: Aess
NM Mo99 Program M
D: Comming Prerequisites rables.
issioning Peing performed dut.
Commissioning
Description
Persons Perform
Training Summa
‘For Installation
Watpac Practica
Process Safety
System Compo
Post-Constructi
Continuity and P
Equipment Cali
I-50206 Process
Noise Level Ass
ANM Mo99 Project -
Manager
UNCL
missioninSign-Off requires
rerequisitesuring the run, write
Prerequisite Doc
ming Commission
ary
’ Documentation
al Completion Ha
Systems Verifica
nent - Installation
on Cleaning Verif
Point Checks
bration Checks
s Plant Maintenan
sessment
UN
- Commissioning P
LASSIFIED
ng Docums all data collect
s Sign-Off e ‘Not Applicable’
cumentation
ning Roles
ndover – Process
tion
Checks
fication
nce – Activities
NCLASSIF
Plan - Mo-99
EfCusto
mentationted from Appendi
’ or ‘N/A’ in the ap
s Related Docume
FIED
Page 3
ffective Date: Marcodian: ANM Project
ix A to C activitie
ppropriate column
entation Checks
31 of 51
ch 2017 Quality
es being collated
ns. Ensure that an
CompleChec
(Yes /
and then review
ny records of resu
etion ck No)
Any NConfor
(Yes
wed as a comple
ults are attached
Non-rmance / No)
TechnManaIniti
ete
to
nical ager als
DT
1
Mo99_COMM_PRProduction ProceRevision: B Approved by: AN
HydrogD.2 This Appendix D.2
1) AS/NZS 3
Hydrogen Conv
Declaration:
By signing this f(known as the A
Certified By:
Hydrogen Conv
Declaration:
By signing this f(known as the A
Certified By:
ROC_CTP_1174: Aess
NM Mo99 Program M
gen Convert2 can be used as
3000 Complian
verter Identificati
form, I acknowledgAustralian/New Ze
Nam
verter Identificati
form, I acknowledgAustralian/New Ze
Nam
ANM Mo99 Project -
Manager
UNCL
ter Test Signthe sign-off sheet
nce
ion
ge and certify thaealand Wiring Rule
e (Print)
ion
ge and certify thaealand Wiring Rule
e (Print)
UN
- Commissioning P
LASSIFIED
n-Off Sheett for each Hydrog
t the identified Hyes).
Role
t the identified Hyes).
Role
NCLASSIF
Plan - Mo-99
EfCusto
en Converter.
ydrogen Converte
e
ydrogen Converte
e
FIED
Page 3
ffective Date: Marcodian: ANM Project
HYC0
r is wired for comp
Sig
HYC0
r is wired for comp
Sig
32 of 51
ch 2017 Quality
01
pliance with AS/N
gnature
02
pliance with AS/N
gnature
NZS 3000:2007 – E
NZS 3000:2007 – E
Electrical Installat
Date
Electrical Installat
Date
tions
tions
UNCLASSIFIED
Mo99_COMM_PROC_CTP_1174: ANM Mo99 Project - Commissioning Plan - Mo-99 Production Process
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UNCLASSIFIED
Hydrogen Converter Identification HYC03
Declaration:
By signing this form, I acknowledge and certify that the identified Hydrogen Converter is wired for compliance with AS/NZS 3000:2007 – Electrical Installations (known as the Australian/New Zealand Wiring Rules).
Name (Print) Role Signature Date
Certified By:
Hydrogen Converter Identification HYC04
Declaration:
By signing this form, I acknowledge and certify that the identified Hydrogen Converter is wired for compliance with AS/NZS 3000:2007 – Electrical Installations (known as the Australian/New Zealand Wiring Rules).
Name (Print) Role Signature Date
Certified By:
UNCLASSIFIED
Mo99_COMM_PROC_CTP_1174: ANM Mo99 Project - Commissioning Plan - Mo-99 Production Process
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UNCLASSIFIED
2) Element Resistance
Hydrogen Converter Identification
Element Resistance Value (in ohms) Verified By (Sign and Date)
Top Middle Bottom
3) Megger Insulation Resistance
Hydrogen Converter Identification
Element Active to Earth - Resistance Value (in ohms) Verified By (Sign and Date)
Top Middle Bottom
UNCLASSIFIED
Mo99_COMM_PROC_CTP_1174: ANM Mo99 Project - Commissioning Plan - Mo-99 Production Process
Page 35 of 51
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UNCLASSIFIED
4) Process Control System (PCS) - Set Points
Hydrogen Converter Identification
PCS Set Points
Checked By (Sign and Date)
Top Middle Bottom
T Indicator (TE001)
T Controller (TE004)
T Indicator (TE002)
T Controller (TE005)
T Indicator (TE003)
T Controller(TE006)
UNCLASSIFIED
Mo99_COMM_PROC_CTP_1174: ANM Mo99 Project - Commissioning Plan - Mo-99 Production Process
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UNCLASSIFIED
5) Temperature Profile (Complete the table below and note when the 1st, 2nd and 3rd set points have been reached.)
Hydrogen Converter Identification HYC01
Recorded Time (Hours)
Top Middle Bottom
T Indicator (TE001)
T Controller (TE004)
T Indicator (TE002)
T Controller (TE005)
T Indicator (TE003)
T Controller (TE006)
UNCLASSIFIED
Mo99_COMM_PROC_CTP_1174: ANM Mo99 Project - Commissioning Plan - Mo-99 Production Process
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UNCLASSIFIED
Hydrogen Converter Identification HYC01
Recorded Time (Hours)
Top Middle Bottom
T Indicator (TE001)
T Controller (TE004)
T Indicator (TE002)
T Controller (TE005)
T Indicator (TE003)
T Controller (TE006)
UNCLASSIFIED
Mo99_COMM_PROC_CTP_1174: ANM Mo99 Project - Commissioning Plan - Mo-99 Production Process
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Revision: B Effective Date: March 2017 Approved by: ANM Mo99 Program Manager Custodian: ANM Project Quality
UNCLASSIFIED
Hydrogen Converter Identification HYC02
Recorded Time (Hours)
Top Middle Bottom
T Indicator (TE001)
T Controller (TE004)
T Indicator (TE002)
T Controller (TE005)
T Indicator (TE003)
T Controller (TE006)
UNCLASSIFIED
Mo99_COMM_PROC_CTP_1174: ANM Mo99 Project - Commissioning Plan - Mo-99 Production Process
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UNCLASSIFIED
Hydrogen Converter Identification HYC02
Recorded Time (Hours)
Top Middle Bottom
T Indicator (TE001)
T Controller (TE004)
T Indicator (TE002)
T Controller (TE005)
T Indicator (TE003)
T Controller (TE006)
UNCLASSIFIED
Mo99_COMM_PROC_CTP_1174: ANM Mo99 Project - Commissioning Plan - Mo-99 Production Process
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UNCLASSIFIED
Hydrogen Converter Identification HYC02
Recorded Time (Hours)
Top Middle Bottom
T Indicator (TE001)
T Controller (TE004)
T Indicator (TE002)
T Controller (TE005)
T Indicator (TE003)
T Controller (TE006)
Hydrogen Converter Identification HYC03
Recorded Time (Hours)
Top Middle Bottom
T Indicator (TE001)
T Controller (TE004)
T Indicator (TE002)
T Controller (TE005)
T Indicator (TE003)
T Controller (TE006)
UNCLASSIFIED
Mo99_COMM_PROC_CTP_1174: ANM Mo99 Project - Commissioning Plan - Mo-99 Production Process
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UNCLASSIFIED
Hydrogen Converter Identification HYC03
Recorded Time (Hours)
Top Middle Bottom
T Indicator (TE001)
T Controller (TE004)
T Indicator (TE002)
T Controller (TE005)
T Indicator (TE003)
T Controller (TE006)
UNCLASSIFIED
Mo99_COMM_PROC_CTP_1174: ANM Mo99 Project - Commissioning Plan - Mo-99 Production Process
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UNCLASSIFIED
Hydrogen Converter Identification HYC03
Recorded Time (Hours)
Top Middle Bottom
T Indicator (TE001)
T Controller (TE004)
T Indicator (TE002)
T Controller (TE005)
T Indicator (TE003)
T Controller (TE006)
Hydrogen Converter Identification HYC04
Recorded Time (Hours)
Top Middle Bottom
T Indicator (TE001)
T Controller (TE004)
T Indicator (TE002)
T Controller (TE005)
T Indicator (TE003)
T Controller (TE006)
UNCLASSIFIED
Mo99_COMM_PROC_CTP_1174: ANM Mo99 Project - Commissioning Plan - Mo-99 Production Process
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Revision: B Effective Date: March 2017 Approved by: ANM Mo99 Program Manager Custodian: ANM Project Quality
UNCLASSIFIED
Hydrogen Converter Identification HYC04
Recorded Time (Hours)
Top Middle Bottom
T Indicator (TE001)
T Controller (TE004)
T Indicator (TE002)
T Controller (TE005)
T Indicator (TE003)
T Controller (TE006)
UNCLASSIFIED
Mo99_COMM_PROC_CTP_1174: ANM Mo99 Project - Commissioning Plan - Mo-99 Production Process
Page 44 of 51
Revision: B Effective Date: March 2017 Approved by: ANM Mo99 Program Manager Custodian: ANM Project Quality
UNCLASSIFIED
Hydrogen Converter Identification HYC04
Recorded Time (Hours)
Top Middle Bottom
T Indicator (TE001)
T Controller (TE004)
T Indicator (TE002)
T Controller (TE005)
T Indicator (TE003)
T Controller (TE006)
UNCLASSIFIED
Mo99_COMM_PROC_CTP_1174: ANM Mo99 Project - Commissioning Plan - Mo-99 Production Process
Page 45 of 51
Revision: B Effective Date: March 2017 Approved by: ANM Mo99 Program Manager Custodian: ANM Project Quality
UNCLASSIFIED
6) Conversion Efficiency Calculation
a) Perform the conversion operation using each Hydrogen Converter (HYC01, HYC02, HYC03 and HYC04) in accordance with the instructions provided in the ANM Mo-99 Batch document, M-1001728.
b) Collect and measure the mass of water collected in the Condenser Water Collection Tank from the conversion process. c) Calculate the % Efficiency of the process. The expected water produced at 100% conversion for 19.34 moles Hydrogen (x 18) equals 348 mL.
Cold Run No. 1 Cold Run No. 2 Hot Run No. 1 (Low Activity)
Hot Run No. 2 (High Activity)
Hydrogen Converter Used
Production Run Date
No. of Target Plates Digested
Conversion Successful (Y / N)
Volume of Water Collected
% Efficiency
Name Role Signature Date
Checked By:
Technical Manager
Comments:
DUc
Mo99_COMM_PRProduction ProceRevision: B Approved by: AN
Water D.3 Use one sign-off scolumns. Ensure t
Description of C
Sequence
Water Run No.
______
Procedure to D
Step Proce
1
2
3
4
5
6
7
8
9
10
Checked By:
Comments:
ROC_CTP_1174: Aess
NM Mo99 Program M
Run Sign-Osheet for each Cothat any records o
Commissioning
Proces
____
OperatiPerform
Tests a
ispose of Inactiv
ss Operation
Nam
ANM Mo99 Project -
Manager
UNCL
Off Sheet ommissioning Waof results are attac
Procedure
ss Operation
ons with Water –mance Test
s indicated in Sec
ve DCEL1 Waste
e
UN
- Commissioning P
LASSIFIED
ater Run. If tests ached to this Sign-
Ac
ction 7.8.
Alpe
Noap
from Water Run
Role
Tec
NCLASSIF
Plan - Mo-99
EfCusto
are not being perfoff sheet.
cceptance Criter
ll tests performed erformance param
ote: Not all parampplicable for a ‘Wa
n
e
chnical Manager
FIED
Page 4
ffective Date: Marcodian: ANM Project
formed during the
ria
meet key meters.
meters will be ater Run’.
Sig
46 of 51
ch 2017 Quality
e run, write ‘Not A
Test Resu
gnature
Applicable’ or ‘N/A
ult Sig
OpeIn
A’ in the appropria
nature Da
erator itials
Da
Date
ate
ate
ate
DUc
Mo99_COMM_PRProduction ProceRevision: B Approved by: AN
Cold RD.4 Use one sign-off columns. Ensure t
Description of C
Sequence
Cold Run No.
__
Tests as indicateSection 7.8
Sample Identifi
Checked By:
Comments:
ROC_CTP_1174: Aess
NM Mo99 Program M
Run Sign-Offsheet for each C
that any records o
Commissioning
Proc
________
DissTarg
ed in HydrReco
cation Tank
Nam
ANM Mo99 Project -
Manager
UNCL
f Sheet Commissioning Rof results are attac
Procedure
cess Operation
solver Functional Tgets Dissolution)
rogen Converter Fovery Procedure
k(s) Sampled
e
UN
- Commissioning P
LASSIFIED
Run. If tests are nched to this Sign-
Test (Uranium
Failure – Test of
Role
Tec
NCLASSIF
Plan - Mo-99
EfCusto
not being performoff sheet.
Acceptan
All tests pperforman
Note: Notbe applica
All tests mparamete
Commen
e
chnical Manager
FIED
Page 4
ffective Date: Marcodian: ANM Project
med during the ru
nce Criteria
performed meet kence parameters.
t all parameters wable for a ‘Cold R
meet performanceers.
ts
Sig
47 of 51
ch 2017 Quality
un, write ‘Not Ap
Test Re
ey
will un’.
e
gnature
plicable’ or ‘N/A’
esult Sig
in the appropria
nature Da
Date
ate
ate
UNCLASSIFIED
Mo99_COMM_PROC_CTP_1174: ANM Mo99 Project - Commissioning Plan - Mo-99 Production Process
Page 48 of 51
Revision: B Effective Date: March 2017 Approved by: ANM Mo99 Program Manager Custodian: ANM Project Quality
UNCLASSIFIED
DUc
Mo99_COMM_PRProduction ProceRevision: B Approved by: AN
Hot RuD.5 Use one sign-off columns. Ensure t
Description of C
Sequence
Hot Run No.
__
Tests as indicateSection 7.8
Sample Identifi
Checked By:
Comments:
ROC_CTP_1174: Aess
NM Mo99 Program M
un Sign-Off Ssheet for each C
that any records o
Commissioning
Y/N
________
ed in
cation Tank
Nam
ANM Mo99 Project -
Manager
UNCL
Sheet Commissioning Rof results are attac
Procedure
Process Opera
Operations with– Low Activity T
Operations with– High Activity
k(s) Sampled
e
UN
- Commissioning P
LASSIFIED
Run. If tests are nched to this Sign-
ation
h Chemical ReageTargets
h Chemical ReageTargets
Role
Tec
NCLASSIF
Plan - Mo-99
EfCusto
not being performoff sheet.
Acceptan
ents All tests pkey perfoparamete
ents All tests pkey perfoparamete
e
chnical Manager
FIED
Page 4
ffective Date: Marcodian: ANM Project
med during the ru
nce Criteria
performed meet rmance
ers.
performed meet rmance
ers.
Sig
49 of 51
ch 2017 Quality
un, write ‘Not Ap
Test Re
gnature
plicable’ or ‘N/A’
sult Sig
in the appropria
gnature Da
Date
ate
ate
UNCLASSIFIED
Mo99_COMM_PROC_CTP_1174: ANM Mo99 Project - Commissioning Plan - Mo-99 Production Process
Page 50 of 51
Revision: B Effective Date: March 2017 Approved by: ANM Mo99 Program Manager Custodian: ANM Project Quality
UNCLASSIFIED
UNCLASSIFIED
Mo99_COMM_PROC_CTP_1174: ANM Mo99 Project - Commissioning Plan - Mo-99 Production Process
Page 51 of 51
Revision: B Effective Date: March 2017 Approved by: ANM Mo99 Program Manager Custodian: ANM Project Quality
UNCLASSIFIED
Appendix E: Commissioning (including Equipment) Non-Conformances Non-Conformances that occur during Commissioning need to be logged and summarised in Table 3 below. Equipment non-conformances originating from the Support Workshop should be documented according to ANSTO Instruction I-6863.
NC No. Description of Non-Conformance Recommended Solution Priority
(Low, Medium, High) CAPA Reference
(if required)
Table 3: Summary of Non-Conformances
End of Document