ANM MO99 PROJECT - ARPANSA · Electronic Archive Copy Projects on ANSTO NetAPP (Fianna) P:\eris 1 Archive File Hardcopy ERIS Database, Building 25 2 ANM Mo99 Project . UNCLASSIFIED

$Page 1: ANM MO99 PROJECT - ARPANSA · Electronic Archive Copy Projects on ANSTO NetAPP (Fianna) P:\eris 1 Archive File Hardcopy ERIS Database, Building 25 2 ANM Mo99 Project . UNCLASSIFIED$
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

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e: March 2017Project Quality

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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


Appendix D CD.1 HD.2 WD.3 CD.4 HD.5

Appendix E

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31 31 32 46 47 49 51

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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.

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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

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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

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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.

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Page 8 of 51


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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

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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

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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.

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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.

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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.

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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.

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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.

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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


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

Process Ope

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


Trainin

Signature

Page 17 of 51


ng

e Date

7 y

A


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


0009 and suS).

(RPL/RCC)

tions Covere

gnature

Page 18 of 51


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


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


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

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Page 21 of 51


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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

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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:


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


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


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


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

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Page 25 of 51


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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)


No. Drawing



B.4.6 In-Process Sampling Cell (IPSC)


No. Drawing



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All System Component – Installation Checks Summary


Checked By:

Verified By:

Comments: (If necessary, complete any Drawing No.’s by hand, before verification)


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


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)


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


Acceptanc

28 of 51

ch 2017 Quality

ce Criteria Verifie

(Yes / N

d No)

Initials / D

Date

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Page 29 of 51


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B.6.2 Mechanical Lines - Point Checks

Document Number Revision

No. Document




Checked By:

Verified By:

Comments:

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Page 30 of 51


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Appendix C: Equipment Calibration Checks

Equipment Item Serial / ID No. Calibration Valid to

Date Signature Date

Table 1: Test Equipment Calibration Details

ATp

DIt


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


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


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


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

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Page 33 of 51


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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:


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:

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Page 34 of 51


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2) Element Resistance

Hydrogen Converter Identification

Element Resistance Value (in ohms) Verified By (Sign and Date)

Top Middle Bottom

3) Megger Insulation Resistance


Element Active to Earth - Resistance Value (in ohms) Verified By (Sign and Date)

Top Middle Bottom

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Page 35 of 51


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4) Process Control System (PCS) - Set Points


PCS Set Points

Checked By (Sign and Date)

Top Middle Bottom

T Indicator (TE001)

T Controller (TE004)

T Indicator (TE002)


T Indicator (TE003)

T Controller(TE006)

UNCLASSIFIED


Page 36 of 51


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5) Temperature Profile (Complete the table below and note when the 1st, 2nd and 3rd set points have been reached.)


Recorded Time (Hours)

Top Middle Bottom

T Indicator (TE001)


T Indicator (TE002)


T Indicator (TE003)


UNCLASSIFIED


Page 37 of 51


UNCLASSIFIED



Top Middle Bottom

T Indicator (TE001)


T Indicator (TE002)


T Indicator (TE003)


UNCLASSIFIED


Page 38 of 51


UNCLASSIFIED



Top Middle Bottom

T Indicator (TE001)


T Indicator (TE002)


T Indicator (TE003)


UNCLASSIFIED


Page 39 of 51


UNCLASSIFIED



Top Middle Bottom

T Indicator (TE001)


T Indicator (TE002)


T Indicator (TE003)


UNCLASSIFIED


Page 40 of 51


UNCLASSIFIED



Top Middle Bottom

T Indicator (TE001)


T Indicator (TE002)


T Indicator (TE003)




Top Middle Bottom

T Indicator (TE001)


T Indicator (TE002)


T Indicator (TE003)


UNCLASSIFIED


Page 41 of 51


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Top Middle Bottom

T Indicator (TE001)


T Indicator (TE002)


T Indicator (TE003)


UNCLASSIFIED


Page 42 of 51


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Top Middle Bottom

T Indicator (TE001)


T Indicator (TE002)


T Indicator (TE003)




Top Middle Bottom

T Indicator (TE001)


T Indicator (TE002)


T Indicator (TE003)


UNCLASSIFIED


Page 43 of 51


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Top Middle Bottom

T Indicator (TE001)


T Indicator (TE002)


T Indicator (TE003)


UNCLASSIFIED


Page 44 of 51


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Top Middle Bottom

T Indicator (TE001)


T Indicator (TE002)


T Indicator (TE003)


UNCLASSIFIED


Page 45 of 51


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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


Checked By:

Technical Manager

Comments:

DUc


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


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


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


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


Page 48 of 51


UNCLASSIFIED

DUc


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


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


Page 50 of 51


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Page 51 of 51


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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