Generation and Distribution System Developing Professional Practice Alternative submission method Task Self-Reflection

FIND A SOLUTION AT Academic Writers Bay

Title Page
Installation and Functional Verification Protocol
For
Hot Detergent and Hot PUW
Generation and Distribution System
Author
Author’s Title / Position

Document Number
Revision Number
Revision Date

Approvals Page
Prepared By: ________________________ Date: ____________
Validation Engineer
Approved By: ________________________ Date: ____________
Validation Manager
Your signature attests that you have reviewed this document and it complies with relevant validation policies & procedures
Approved By: ________________________ Date: ____________
Engineering
Your signature attests that……(align with ‘Responsibilities’ Protocol Section-10)
Approved By: ________________________ Date: ____________
QA
Your signature attests that……(align with ‘Responsibilities’ Protocol Section-10)
Approved By: ________________________ Date: ____________
etc.
Your signature attests that……(align with ‘Responsibilities’ Protocol Section-10)
Document Revision History
Revision
Date of Issue
Reason for revision update
A
12 Jan 2012
Issued for review

14 Mar 2012
Issued for approval and use

Table of Contents
Title Page 1
Approvals Page 3
Document Revision History 4
Table of Contents 5
Protocol Objective 7
System Description 7
Scope 9
System Impact Assessment 9
Component Impact Assessment 9
Summary Table – Operational Critical Components 10
P&ID Scope 13
Reference Documentation 15
Definitions/ Glossary 16
Responsibilities / Subject Matter Experts 17
Installation Verification Testing Procedures 18
P&ID Walkdown Testing Procedure 18
Equipment Installation Verification Procedure 20
Instrument Installation Verification Procedure 22
Piping Installation Verification Procedure 24
Calibration Program Verification 25
Preventative Maintenance Program Verification 25
Draft SOP Verification 25
Test-Instrument Calibration Verification 25
Progression Approval to Proceed to Functional Verification 26
Operational-Critical-Instrument Calibration Verification Form 27
Functional Verification Testing Procedures 29
Hot Detergent System – Level Control 30
Hot Detergent System – Flow Control 31
Hot Detergent System – Temperature Control 33
Hot Detergent System – Detergent Dosing Control 35
Hot PUW System – Level Control 37
Hot PUW System – Flow Control 37
Hot PUW System – Temperature Control 37
Approved SOP Verification 38
Protocol Quality Procedures 38
Signature Log 38
Deviation Procedure 39
Change Control Procedure 39
IOQ Protocol Summary Report 39
List of Appendices 40
Appendix A – Protocol Signature Log 41

Appendix B – Installation Verification GMP checksheets 43
P&ID Walkdown Installation Verification 43
Equipment Installation Verification 44
Instrument Installation Verification 55
Piping Installation Verification 66
Calibration Program Verification 71
Preventative Maintenance Program Verification 73
Draft SOP Verification 74
Test-Instrument Calibration Verification 75
Appendix C: OQ GMP check-sheets 76
Hot Detergent System – Level Control 76
Hot Detergent System – Flow Control 79
Hot Detergent System – Temperature Control 83
Hot Detergent System – Detergent Dosing Control 86
Hot PUW System – Level Control 89
Hot PUW System – Flow Control 91
Hot PUW System – Temperature Control 95
Approved SOP Verification 98
Appendix D: Deviation log 99
Appendix E: Deviation Form 100
Appendix F: Change Control Log 106
Appendix G: Change Control Form 107
Appendix H: Component Impact Assessment 111
Appendix I: Traceability Matrix 116
Protocol Objective
The objective of this protocol is to provide testing evidence that will prove that the ‘Hot Detergent and Hot PUW Generation and Distribution’ system is fit for its intended use. Testing will incorporate both installation verification and functional verification test.
System Description Prepare a summary ‘System Description’. Suggestions include drawing a process flow / block diagram; listing critical operational features; and, describing the major equipment components in the context of their installation and functional features.
Scope
System Impact Assessment The ‘Hot Detergent and Hot PUW Generation and Distribution’ is considered a ‘direct impact’ system because:
Component Impact Assessment
The Component Impact Assessment will drive the scope of the installation and functional verifications. Product contact plus operational critical components must be included in the installation verifications. The operationally critical components will drive the functionality testing.
Summary Table – Operational Critical Components # *Operational Critical Component **Additional components in the loop (if applicable) Rationale 123456789101112131415161718192021222324252627282930
P&ID Scope
In Protocol Section-7.4 include a copy/scan of the P&ID and either draw a ‘scope bubble’ or yellow-highlight the ‘in-scope’ components.
Reference Documentation
Document #
Document Description
Document Location
##.####.##.#
P&ID
Engineering Library
##.####.##.#
Instrument List
Engineering Library
##.####.##.#
Equipment List
Engineering Library
##.####.##.#
E&I Drawings
Engineering Library
##.####.##.#
Line List
Engineering Library
##.####.##.#
Commissioning Protocol
Engineering Library
##.####.##.#
Site VMP
QA Library
##.####.##.#
URS
QA Library
##.####.##.#
System Impact Assessment
QA Library
##.####.##.#
Validation Plan
QA Library
##.####.##.#
FRS
Engineering Library
##.####.##.#
Validation SOP
QA Library
##.####.##.#
Change Control SOP
QA Library
##.####.##.#
Deviation Procedure
QA Library
##.####.##.#
Training SOP
QA Library
##.####.##.#
Site documentation policy
QA Library
##.####.##.#
Site Glossary
QA Library
Definitions/ Glossary
Acronym
Definition
E&I
Electrical & Instrumentation
FRS
Functional Requirement Specification
IQ
Installation Qualification
OQ
Operational Qualification
P&ID
Piping & Instrumentation Diagram
SME
Subject Matter Expert.
SOP
Standard Operating Procedure
URS
User Requirement Specification
VMP
Validation Master Plan

Responsibilities / Subject Matter Experts
Validation
Prepare Protocol
Departmental Review & Approval of Protocol
Execute Protocol, including dotting i’s & crossing t’s
Co-Ordinate input from other responsible departments
Document Deviations
Prepare Report
Quality Assurance
Quality control
Manufacturing
Engineering
Maintenance/ Calibrations
HR / Training
EHS
Installation Verification Testing Procedures
P&ID Walkdown Testing Procedure
1. Description of Test
The objective of the test is to verify all direct impact components are installed and orientated correctly as per the functional illustration on the P&ID.
2. Linkage to Requirements Challenged
Confirm correct installation and orientation of direct impact components as per the P&ID schematic illustration.
3. Acceptance Criteria
All direct impact components are functionally installed and orientated correctly as per the P&ID specification.
4. Prerequisites and/or Assumptions
All commissioning activities are complete and commissioning punch-list items are closed out.
All testers shall be trained and educated in the test method listed in section-5 below: it is crucial to the success of the testing effort that the testing process be well understood by all participants.
5. Test Method
On a blank copy of the P&ID draw in the direct-impact system boundary in black-ink
Walk down the P&ID and using a yellow-highlighter confirm each component is correctly installed and orientated as represented on the P&ID
Confirm all component tag numbers are correct
Confirm all lines are correctly labelled
Confirm all lines where applicable are correctly insulated
Ensure all flow direction components are orientated correctly
Ensure all instruments indicators are orientated correctly so as operators can readily view them in the field
Ensure all commissioning filters are installed in filter-housings
On the P&ID any additions shall be drawn in using blue-ink, any deletions shall be crossed-out using red ink, comments shall be inserted using green-ink, and sign and date any entries on the P&ID using black-ink
6. Expected Results and Actual results
In the IQ GMP test-sheet(s) overleaf, reach a conclusion as to whether each test step has been successfully completed by transcribing bold text from the ‘Expected Results’ column into the corresponding ‘Actual Results’ field.
Assess each step listed and determine whether the step has passed or failed.
The person performing the test should be identified and the date the testing was performed should be recorded.
At the bottom of the test script a validation peer (other than the person performing the test) shall review the script post execution.
Quality Assurance (QA) shall approve the completed test.

Validation Peer Review

Print Name

Signature

Date

Equipment Installation Verification Procedure
1. Description of Test
The objective of the test is twofold:
To verify that all direct impact equipment components are of the correct specification as per the detailed mechanical data sheets
To verify that all direct impact equipment components are installed and configured correctly as per the functional illustration on the P&ID.
2. Linkage to Requirements Challenged
Confirm correct installation and primary specifications of direct impact equipment components as detailed in the P&ID and URS.
3. Acceptance Criteria
All direct impact components are of the correct specification, are functionally installed and configured as per the P&ID, the vendor handover documentation is complete, and appropriate material certification is available.
4. Prerequisites and/or Assumptions
All commissioning activities are complete and commissioning punch-list items are closed out.
All testers shall be trained and educated in the test method listed in section-5 below: it is crucial to the success of the testing effort that the testing process be well understood by all participants.
5. Test Method
On the equipment IQ GMP test sheets confirm the equipment description and critical design features. Inspect the installed equipment item in the field and while referencing the vendor’s documentation package verify specification conformance.
Confirm that the vendor handover package is in place and contains correct material certificates.
In the field visually confirm the following:
Equipment item is installed as per P&ID, is securely fitted and is free from damage
Nameplate is securely fitted, clearly legible and its details conform to the design specification
All process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID
6. Expected Results and Actual results
In the equipment IQ verification forms, reach a conclusion as to whether each test step has been successfully completed by transcribing bold text from the ‘Expected Results’ column into the corresponding ‘Actual Results’ field where appropriate.
Assess each step listed and determine whether the step has passed or failed.
The person performing the test should be identified and the date the testing was performed should be recorded.
At the bottom of the test script a validation peer (other than the person performing the test) shall review the script post execution.
Quality Assurance (QA) shall approve the completed test.
Validation Peer Review

Print Name

Signature

Date
Instrument Installation Verification Procedure
1. Description of Test
The objective of the test is twofold:
To verify that all direct impact instruments are of the correct specification as per the detailed instrument data sheets
To verify that all direct impact instruments components are installed and configured correctly as per the functional illustration on the P&ID.
2. Linkage to Requirements Challenged
URS refers to major P&ID components. The system P&ID details all necessary process instrumentation: confirm correct installation and specification of direct impact instrument components.
3. Acceptance Criteria
All direct impact instruments are of the correct specification, are functionally installed and configured as per the P&ID, the vendor handover documentation is complete, and appropriate material, calibration and loop-check certification is available.
4. Prerequisites and/or Assumptions
All commissioning activities are complete and commissioning punch-list items are closed out.
All testers shall be trained and educated in the test method listed in section-5 below: it is crucial to the success of the testing effort that the testing process be well understood by all participants.
5. Test Method
On Part-1 of the instrument GMP test sheets confirm the instrument description and critical design features. Inspect the installed instrument item in the field and while referencing the vendor’s documentation package verify conformance:
Manufacturer
Calibrated Range
MOC
Loop Checked
On Part-2 of the instrument GMP test sheets confirm that the appropriate vendor documentation is available in accordance with the following:
Vendor handover package is in place
Material Certification is available for wetted parts
Calibration Certification is available
Loop Checksheet is available (Yes/No)
In the field visually confirm, on Part-3 of the instrument GMP test sheets confirm, the following:
Instrument item is installed as per P&ID, is securely fitted and is free from damage
Instrument and cabling is correctly tagged and details conform to the design specification
Instrument orientated correctly and is accessible for calibration and maintenance
6. Expected Results and Actual results
In the instrument verification forms, reach a conclusion as to whether each test step has been successfully completed by transcribing bold text from the ‘Expected Results’ column into the corresponding ‘Actual Results’ field where appropriate.
Assess each step listed and determine whether the step has passed or failed.
The person performing the test should be identified and the date the testing was performed should be recorded.
At the bottom of the test script a validation peer (other than the person performing the test) shall review the script post execution.
Quality Assurance (QA) shall approve the completed test.
Validation Peer Review

Print Name

Signature

Date
Piping Installation Verification Procedure
1. Description of Test
The objective of the test is to verify all direct impact pipes are installed and orientated correctly as per the functional illustration on the P&ID and piping Isometrics.
2. Linkage to Requirements Challenged
Confirm correct installation and orientation of direct impact piping as per the P&ID schematic illustration and piping isometrics.
3. Acceptance Criteria
All direct impact components are functionally installed and orientated correctly as per the P&ID’s and isometrics’ specifications.
4. Prerequisites and/or Assumptions
All commissioning activities are complete and commissioning punch-list items are closed out.
All testers shall be trained and educated in the test method listed in section-5 below: it is crucial to the success of the testing effort that the testing process be well understood by all participants.
5. Test Method
Pre-populate the piping verification with the Tag # and material-of-construction (MOC) details.
In the field enter the details of the weld log for every each pipe Tag #.
Confirm the Weld Log is complete, as the Weld Log collates material-of-construction certificates and weld inspection certificates.
In the field record the details of the Pressure Test Pack for every each pipe Tag #.
Confirm the Pressure Test is complete verifying the absence of leaks
In the field enter the details of the Construction Dossier for every each pipe Tag #.
Confirm all slopes have been checked and verified as correct from the Construction Dossier.
6. Expected Results and Actual results
In the IQ GMP test-sheet(s) overleaf, reach a conclusion as to whether each test step has been successfully completed by transcribing bold text from the ‘Expected Results’ column into the corresponding ‘Actual Results’ field.
Assess each step listed and determine whether the step has passed or failed.
The person performing the test should be identified and the date the testing was performed should be recorded.
At the bottom of the test script a validation peer (other than the person performing the test) shall review the script post execution.
Quality Assurance (QA) shall approve the completed test.Validation Peer ReviewPrint NameSignatureDate
Calibration Program Verification
During installation verification we need to verify that instruments are in the calibration system. Here summarize a ‘Calibration Program Verification’ procedure that complements the form in Protocol Section-16.2.5.
Preventative Maintenance Program Verification
During IQ, we need to verify that instruments are in the Preventative Maintenance system. Here summarize a ‘Preventative Maintenance Program Verification’ procedure that complements the form in Protocol Section-16.2.6.
Draft SOP Verification
Prior to proceeding to functional verification, we need to ensure the required SOPs are in-draft. Propose a list of necessary standard operating procedures for the ‘Hot Detergent and Hot PUW Generation and Distribution’ system and enter the equivalent details into the form in Protocol Section-16.2.7. Ensure the details in the list of draft SOPs aligns with Protocol Section-13.8 ‘Approved SOP Verification’ and its associated form in Protocol Section-16.3.8.
Test-Instrument Calibration Verification
Suggest a list of test instruments that may be required for the testing phase. Enter the equivalent details into the form in Protocol Section-16.2.8
Progression Approval to Proceed to Functional Verification
The signatories below verify the following:
That the installation verification testing phase is sufficiently complete and permission is given to progress to the functional verification testing phase.
All critical deviations from the installation verification testing phase have been closed out, or a change control initiated in its place.
All critical items are installed.
All operational critical instruments will remain in a calibrated state during the functional verification testing phase.
Prepared By: ________________________ Date: ____________
Validation Engineer
Approved By: ________________________ Date: ____________
Validation Manager
Your signature attests that you have reviewed this document and it complies with relevant validation policies & procedures
Approved By: ________________________ Date: ____________
Engineering
Your signature attests that……(align with ‘Responsibilities’ Protocol Section-2)
Approved By: ________________________ Date: ____________
QA
Your signature attests that……(align with ‘Responsibilities’ Protocol Section-2)
Approved By: ________________________ Date: ____________
etc.
Your signature attests that……(align with ‘Responsibilities’ Protocol Section-2)
Operational-Critical-Instrument Calibration Verification Form
Page _ __ of _ __
Operational-Critical-Instrument Calibration Verification Form

Critical instruments associated with the system will remain in a calibrated state during the anticipated OQ execution timeframe? (Yes/No)
Verified By / Date

Comments:

Reviewed By: Validation

Date:

Approved By: (QA)

Date:

Page _ __ of _ __
Operational-Critical-Instrument Calibration Verification Form

Critical instruments associated with the system will remain in a calibrated state during the anticipated OQ execution timeframe? (Yes/No)
Verified By / Date

Comments:

Reviewed By: Validation

Date:

Approved By: (QA)

Date:

Functional Verification Testing Procedures
13.3.1 Hot Detergent System – Level Control
13.3.2 Hot Detergent System – Flow Control
13.3.3 Hot Detergent System – Temperature Control
13.3.4 Hot Detergent System – Detergent Dosing Control
13.3.5 Hot PUW System – Level Control
13.3.6 Hot PUW System – Flow Control
13.3.7 Hot PUW System – Temperature Control
13.3.8 Approved SOP Verification
Hot Detergent System – Level Control
1. Short description of the test
The objective of this test is to confirm that the Hot Detergent Tank is filled and maintained to a level of 5775 litres +/-5% from the 25°C PUW1 water loop.
2. Linkage to the requirements challenged
URS Section 3.3:
The system shall have the facility to maintain the level in the Hot Detergent Tank at 5775 litres +/-5%.
Operationally Critical Component(s):
Hydrostatic Pressure Type level transmitter LT-002
Low level Switch (tuning fork type) LS-004
High Level Switch (tuning fork type) LS-006
3. Acceptance criteria for the test
The level measurement LT-002 shall read 5775 litres +/-5% before, during and after the maximum instantaneous detergent drawdown.
4. Prerequisites and or assumptions
All commissioning activities are complete and commissioning punch-list items are closed out.
All testers shall be trained and educated in the test method listed in section-5 below: it is crucial to the success of the testing effort that the testing process be well understood by all participants.
Level transmitter LT-002 is currently within calibration
5. Specific Test Steps
The Hot Detergent Tank is fed directly from the 25°C PUW1 water loop.
At time = 0 (t0-min) confirm the level in the Detergent Tank.
Note the level in the tank every 5-minutes until it reaches 5775 litres +/-5%. The filling of the tank should stop automatically at this level.
Open the drain valve at the bottom of the tank and flow the water to drain. The tank should automatically start filling again from the 25°C PUW1 water loop and maintain a level of 5775 litres +/-5%.
Note the level in the tank every 5-minutes for 30-minutes.
Close the drain valve and the level in the tank should maintain 5775 litres +/-5% for a further 30-minutes with no further drawdown.
In the table provided confirm the level in the Hot Detergent Tank by recording the value at successive 5-minute intervals, noting the time for each measurement
Print out the readings of level in the tank (LT-002) from the computer control system during the test period and append to this test section.
6. Expected results and Actual results
In the check-sheets in Appendix-C1, reach a conclusion as to whether each test step has been successfully completed by transcribing bold text from the ‘Expected Results’ column into the corresponding ‘Actual Results’ field.
Assess each step listed and determine whether the step has passed or failed.
The person performing the test should be identified and the date the testing was performed should be recorded.
At the bottom of the test script a validation peer (other than the person performing the test) shall review the script post execution.
Quality Assurance (QA) shall approve the completed test.
Validation Peer Review

Print Name

Signature

Date
Hot Detergent System – Flow Control
1. Short description of the test
The objective of this test is to confirm that the flow rate of the Hot Detergent transfer loop is maintained between 3,000 litres/hr +/-5% and 25,000 litres/hr +/-5%, before, during and after the transfer of water from the Hot Detergent Tank into reactors RE-119 and RE-140 (which are both to be filled at the same time at a rate of 11,000 litres/hr each).
2. Linkage to the requirements challenged
The system shall be capable of achieving and maintaining a maximum outward flowrate of the loop to reactors RE-119 and RE-140 of 25,000 litres/hr +/-5%
The system shall be capable of achieving and maintaining a minimum return flowrate of the loop to the Hot Detergent tank of 3,000 litres/hr +/-5% when filling the two reactors RE-119 and RE-140 at a rate of 11,000 litres/hr.
The maximum number of simultaneous users being washed by the CIP system shall be two.
Operationally Critical Component(s):
Magnetic Flow Transmitter FT-002
Magnetic Flow Transmitter FT-004
Hydrostatic Pressure Type level transmitter LT-002
Hydrostatic Pressure Type level transmitter LT-119
Hydrostatic Pressure Type level transmitter LT-140
3. Acceptance criteria for the test
The online flow measurement FT-002 (on the outward flow loop) shall read 25,000 litres/hr +/-5% before, during and after the maximum transfer flowrate into RE-119 and RE-140.
The online flow measurement FT-004 (on the return loop) shall read 3,000 litres/hr +/-5% to before, during and after the maximum transfer flowrate into RE-119 and RE-140.
4. Prerequites and or assumptions
All commissioning activities are complete and commissioning punch-list items are closed out.
All testers shall be trained and educated in the test method listed in section-5 below: it is crucial to the success of the testing effort that the testing process be well understood by all participants.
Flow transmitters FT-002 and FT-004 and level transmitters LT-002, LT-119 and LT-140 are currently within calibration
5. Specific Test Steps
Check the Hot Detergent Tank is filled to a level of 5775 litres +/-5% from the 25°C PUW1 water loop, noting the level reading on LT-002
Start the Hot Detergent Pump circulating.
Confirm the initial flow reading of FT-002 and FT-004 at time = 0 (t0-min) and note the flow every 5-minutes for 30-minutes.
Open the transfer valves to RE-119 and RE-140 and transfer 5,500 litres into each vessel (this will take approximately 30-minutes), noting the level on LT-119 and LT-140
Note the flow reading on FT-002 and FT-004 every 5-minutes during the transfer.
Note the level in the Hot Detergent Tank maintains 5775 litres +/-5% (LT-002) during the transfer
After transferring 5,500 litres into both RE-119 and Re-140 stop the transfer and maintain the CIP skid in normal recirculation operation mode for a further 30-minutes with no further drawdown.
In the table provided confirm the level in the Hot Detergent Tank (LT-002) and the flowrate readings of FT-002 and FT-004 by recording the value at successive 5-minute intervals, noting the time for each measurement.
In the same table also record the values for level in reactor RE-119 and reactor RE-140 from level-transmitters LT-119 and LT-140.
Print out the readings of FT-002, FT-004, LT-119 and LT-140 from the computer control system during the test period and append to this test section.
6. Expected results and Actual results
In the check-sheets in Appendix-C1, reach a conclusion as to whether each test step has been successfully completed by transcribing bold text from the ‘Expected Results’ column into the corresponding ‘Actual Results’ field.
Assess each step listed and determine whether the step has passed or failed.
The person performing the test should be identified and the date the testing was performed should be recorded.
At the bottom of the test script a validation peer (other than the person performing the test) shall review the script post execution.
Quality Assurance (QA) shall approve the completed test.
Validation Peer Review

READ ALSO...   Challenges in Global Supply Chain Management - No Plagiarism

Print Name

Signature

Date
Hot Detergent System – Temperature Control
1. Short description of the test
The objective of this test is to confirm that the supply temperature of Hot Detergent is maintained at 80°C±5°C, before, during and after maximum instantaneous detergent drawdown when the two biggest users (reactors RE-119 and RE-140) are being be charged simultaneously.
2. Linkage to the requirements challenged
The Hot Detergent supply temperature shall be maintained by a closed loop control system, which modulates steam flow to the heat exchanger.
The control system shall be capable of controlling the supply temperature to within +/-5°C of the setpoint (80°C±5°C).
Operationally Critical Component(s):
Bimetalic Temperature Indicator TI-008
3 wire RTD Temperature transmitter TT-002
3 wire RTD Temperature transmitter TT-004
Magnetic Flow Transmitter FT-002
Magnetic Flow Transmitter FT-004
Hydrostatic Pressure Type level transmitter LT-002
Hydrostatic Pressure Type level transmitter LT-119
Hydrostatic Pressure Type level transmitter LT-140
3. Acceptance criteria for the test
The online temperature measurements TT-002 (on the outward loop) & TT004 (on the return loop) reads 80°C±5°C before, during and after the maximum instantaneous detergent drawdown to fill RE-119 and RE-140.
4. Prerequites and or assumptions
All commissioning activities are complete and commissioning punch-list items are closed out.
All testers shall be trained and educated in the test method listed in section-5 below: it is crucial to the success of the testing effort that the testing process be well understood by all participants.
Temperature transmitters TT-002 & TT-004, flow transmitters FT-002 and FT-004, level transmitters LT-002, LT-119 and LT-140 are currently within calibration
5. Specific Test Steps
Check the Hot Detergent Tank is filled to a level of 5775 litres +/-5% from the 25°C PUW1 water loop, noting the level reading on LT-002
Start the Hot Detergent Pump circulating and confirm the initial flow reading of FT-002 and FT-004 are 25,000 litres/hr
Note the initial temperature of TT-002 and TT-004 at time = 0 (t0-min) and commence heating the recirculating water to up 80°C±5°C noting the temperature readings every 5-minutes.
Maintain the temperature at 80°C±5°C for 30-minutes on the recirculation loop.
Open the transfer valves to RE-119 and RE-140 and transfer 5,500 litres into each vessel (this will take approximately 30-minutes), noting the level on LT-119 and LT-140
Note the flow reading on FT-002 and FT-004 and the level reading in the Hot Detergent Tank (LT-002) every 5-minutes during the transfer.
Note the temperature of TT-002 and TT-004 during the transfer. It should maintain 80°C±5°C
After transferring 5,500 litres into both RE-119 and RE-140 stop the transfer and maintain the CIP skid in normal recirculation operation mode for a further 30-minutes with no further drawdown.
In the table provided confirm the temperature of TT-002 and TT-004, and in the reactors (LT-119 and LT-140) and the flowrate readings of FT-002 and FT-004 by recording the value at successive 5-minute intervals, noting the time for each measurement.
Print out the readings of TT-002, TT-004, FT-002, FT-004, LT-119 and LT-140 from the computer control system during the test period and append to this test section.
6. Expected results and Actual results
In the check-sheets in Appendix-C1, reach a conclusion as to whether each test step has been successfully completed by transcribing bold text from the ‘Expected Results’ column into the corresponding ‘Actual Results’ field.
Assess each step listed and determine whether the step has passed or failed.
The person performing the test should be identified and the date the testing was performed should be recorded.
At the bottom of the test script a validation peer (other than the person performing the test) shall review the script post execution.
Quality Assurance (QA) shall approve the completed test.
Validation Peer Review

Print Name

Signature

Date
Hot Detergent System – Detergent Dosing Control
1. Short description of the test
At 80°C±5°C, 2% ± 0.05% detergent concentration is equivalent to 500 μScm-1 ± 0.25 μScm-1. The objective of this test is to confirm that the supply detergent concentration, at a temperature of 80°C±5°C, is maintained at 500 μScm-1 ± 0.25 μScm-1, before, during and after maximum instantaneous detergent drawdown when the two biggest users (reactors RE-119 and RE-140) are being be charged simultaneously.
2. Linkage to the requirements challenged
URS Section 3.5:
The system shall have the facility to automatically dose STERIS 100 detergent to the required concentration (2% ± 0.05%)
Online conductivity measurement shall be provided to verify the detergent concentration
Operationally Critical Component(s):
Conductivity transmitter CT-001
3 wire RTD Temperature transmitter TT-002
3 wire RTD Temperature transmitter TT-004
Magnetic Flow Transmitter FT-002
Magnetic Flow Transmitter FT-004
Hydrostatic Pressure Type level transmitter LT-002
Hydrostatic Pressure Type level transmitter LT-119
Hydrostatic Pressure Type level transmitter LT-140
3. Acceptance criteria for the test
At 80°C±5°C, the online conductivity measurement CT-001 read 500 μScm-1 ± 0.25 μScm-1 before, during and after the maximum instantaneous detergent drawdown.
4. Prerequisites and or assumptions
All commissioning activities are complete and commissioning punch-list items are closed out.
All testers shall be trained and educated in the test method listed in section-5 below: it is crucial to the success of the testing effort that the testing process be well understood by all participants.
Conductivity transmitter CT-001, temperature transmitters TT-002 & TT-004, flow transmitters FT-002 and FT-004, level transmitters LT-002, LT-119 and LT-140 are currently within calibration
5. Specific Test Steps
Check the Hot Detergent Tank is filled to a level of 5775 litres +/-5% with PUW water loop (noting the level reading on LT-002)
Start up the hot detergent recirculation system. Give the system time to warm up until it is recirculating this water at 80°C±5°C (noting the temperature readings on TT-002 and TT-004) at a flow of 25,000 litres/hr (noting the flow readings on FT-002 and FT-004)
Start introducing detergent into the recirculation system at time = 0 (t0-min) and note the conductivity measurement of the recirculating water every 5-minutes for the next 30 minutes. The concentration of detergent in the water is measured by its conductivity using CT-001 until it reaches a level of 500 μScm-1 ± 0.25 μScm-1 (equivalent to a detergent concentration of 2% ± 0.05%).
Maintain the conductivity of the recirculation loop at 500 μScm-1 ± 0.25 μScm-1 at a temperature of 80°C±5°C and a flow of 25,000 litres/hr. Open the transfer valves to RE-119 and RE-140 and transfer 5,500 litres into each vessel (this will take approximately 30-minutes), noting the level on LT-119 and LT-140
Note the conductivity readings (CT-001) for the recirculation loop every 5-minutes during the transfer, in addition to the temperature (80°C±5°C) and the flow (25,000 litres/hr) and the level of Hot Detergent Tank.
After transferring 5,500 litres into both RE-119 and RE-140 stop the transfer and maintain the CIP skid in normal recirculation operation mode for a further 30-minutes with no further drawdown.
In the table provided confirm the conductivity of CT-001, the temperature of TT-002 and TT-004, and in the reactors (LT-119 and LT-140) and the flowrate readings of FT-002 and FT-004 by recording the value at successive 5-minute intervals, noting the time for each measurement.
Print out the readings of CT-001, TT-002, TT-004, FT-002, FT-004, LT-119 and LT-140 from the computer control system during the test period and append to this test section.
6. Expected results and Actual results
In the check-sheets in Appendix-C1, reach a conclusion as to whether each test step has been successfully completed by transcribing bold text from the ‘Expected Results’ column into the corresponding ‘Actual Results’ field.
Assess each step listed and determine whether the step has passed or failed.
The person performing the test should be identified and the date the testing was performed should be recorded.
At the bottom of the test script a validation peer (other than the person performing the test) shall review the script post execution.
Quality Assurance (QA) shall approve the completed test.
Validation Peer Review

Print Name

Signature

Date
Hot PUW System – Level Control
1. Short Description of the Test
2. Linkage to Requirements Challenged
3. Acceptance Criteria for the Test
4. Prerequisites and/or assumptions
5. Specific Test Steps
6. Expected Results and Actual Results
Hot PUW System – Flow Control
1. Short Description of the Test
2. Linkage to Requirements Challenged
3. Acceptance Criteria for the Test
4. Prerequisites and/or assumptions
5. Specific Test Steps
6. Expected Results and Actual Results
Hot PUW System – Temperature Control
1. Short Description of the Test
2. Linkage to Requirements Challenged
3. Acceptance Criteria for the Test
4. Prerequisites and/or assumptions
5. Specific Test Steps
6. Expected Results and Actual Results
Approved SOP Verification
In Protocol Section-13.8 ‘Approved SOP Verification’ ensure this list of approved SOPs aligns with Protocol Section-11.7 and its associated form in Protocol Section-16.2.7. Enter the equivalent details in the form collated in Protocol Section-16.3.8.
Protocol Quality Procedures
Signature Log Summarize ‘Signature-Log’ procedure that complements the log in Protocol Section-16.1.
Deviation Procedure
Summarize a protocol deviation procedure that complements the Deviation log in Protocol Section-16.4 and the Deviation Form in Protocol Section-16.5.
Change Control Procedure
Summarize a Change Control deviation procedure that complements the Change Control log in Protocol Section-16.6 and the Change Control Form in Protocol Section-16.7.
IOQ Protocol Summary Report
Following field execution of this validation protocol a validation report that cross-references the validation protocol will be prepared, summarising the results obtained, commenting on any deviations observed, and drawing the appropriate conclusions, including recommending changes to correct deficiencies.
List of Appendices
Appendix A: Signature Log
Appendix B: Installation Verification GMP checksheets
P&ID Walkdown Installation Verification
Equipment Installation Verification
Instrument Installation Verification
Piping Installation Verification
Calibration Program Verification
Preventative Maintenance Program Verification
Draft SOP Verification
Test-Instrument Calibration Verification
Appendix C: Functional Verification check-sheets
Hot Detergent System – Level Control
Hot Detergent System – Flow Control
Hot Detergent System – Temperature Control
Hot Detergent System – Detergent Dosing Control
Hot PUW System – Level Control
Hot PUW System – Flow Control
Hot PUW System – Temperature Control
Appendix D: Deviation log
Appendix E: Deviation form
Appendix F: Change control log
Appendix G: Change control form
Appendix H: Component Impact Assessment
Appendix I: Traceability Matrix
Appendix A – Protocol Signature Log
Page __ of __
Signature Log

Printed Name
Signature
Initials
Date
Company/Title/Department
GMP Trained (Yes / No)

Comments:

Reviewed By: Validation

Date:

Approved By: (QA)

Date:

Appendix B – Installation Verification GMP checksheets
P&ID Walkdown Installation Verification
P&ID #

P&ID Description

Test Step
Expected Results
Actual Results
Pass / Fail
Initials and Date (dd/mmm/yyyy)
1
Walk down the P&ID and using a yellow-highlighter confirm each component is correctly installed and orientated as represented on the P&ID
Components correctly installed

2
Confirm all component tag numbers are correct
Tag numbers correct

3
Confirm all lines are correctly labelled
Lines correctly labelled

4
Confirm all lines where applicable are correctly insulated
Lines correctly insulated

5
Ensure all flow direction components are orientated correctly
Flow directions correct

6
Ensure all instruments indicators are orientated correctly so as operators can readily view them
Indicators orientated correctly

7
Ensure all commissioning filters are installed in filter-housings
Filters installed

Validation Peer Review

Print Name

Signature

Date

QA Approval

Print Name

Signature

Date

Equipment Installation Verification
Sheet __ of __
____ Installation Verification
Tag #: ______
Equipment Description and Critical Design Features
Inspect the installed equipment item and the vendor’s documentation and verify correct specification conformance
Specified
Actual
Verification (Pass/Fail)
Initials / Date
1
Manufacturer

2
Capacity

3
M.O.C.

4
Design Pressure Range

5
Design Temp Range

Documentation Verification
Confirm that the vendor handover package is in place and contains correct material certificates
Verification (Pass/Fail)
Initials
Date
1
Vendor handover package is in place

2
Material Certification is available for wetted parts

Installation Verification
Visually inspect, and subsequently verify, the correct installation of the equipment item in the field
Verification (Pass/Fail)
Initials
Date
1
Equipment item is installed as per P&ID, is securely fitted and is free from damage

2
Nameplate is securely fitted, clearly legible and its details conform to the design specification

3
All process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID

Validation Peer Review

Print Name

Signature

Date

QA Approval

Print Name

Signature

Date

Sheet __ of __
____ Installation Verification
Tag #: ______
Equipment Description and Critical Design Features
Inspect the installed equipment item and the vendor’s documentation and verify correct specification conformance
Specified
Actual
Verification (Pass/Fail)
Initials / Date
1
Manufacturer

2
Capacity

3
M.O.C.

4
Design Pressure Range

5
Design Temp Range

Documentation Verification
Confirm that the vendor handover package is in place and contains correct material certificates
Verification (Pass/Fail)
Initials
Date
1
Vendor handover package is in place

2
Material Certification is available for wetted parts

Installation Verification
Visually inspect, and subsequently verify, the correct installation of the equipment item in the field
Verification (Pass/Fail)
Initials
Date
1
Equipment item is installed as per P&ID, is securely fitted and is free from damage

2
Nameplate is securely fitted, clearly legible and its details conform to the design specification

3
All process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID

Validation Peer Review

Print Name

Signature

Date

QA Approval

Print Name

Signature

Date

Sheet __ of __
____ Installation Verification
Tag #: ______
Equipment Description and Critical Design Features
Inspect the installed equipment item and the vendor’s documentation and verify correct specification conformance
Specified
Actual
Verification (Pass/Fail)
Initials / Date
1
Manufacturer

2
Capacity

3
M.O.C.

4
Design Pressure Range

5
Design Temp Range

Documentation Verification
Confirm that the vendor handover package is in place and contains correct material certificates
Verification (Pass/Fail)
Initials
Date
1
Vendor handover package is in place

2
Material Certification is available for wetted parts

Installation Verification
Visually inspect, and subsequently verify, the correct installation of the equipment item in the field
Verification (Pass/Fail)
Initials
Date
1
Equipment item is installed as per P&ID, is securely fitted and is free from damage

2
Nameplate is securely fitted, clearly legible and its details conform to the design specification

3
All process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID

Validation Peer Review

Print Name

Signature

Date

QA Approval

Print Name

Signature

Date

Sheet __ of __
____ Installation Verification
Tag #: ______
Equipment Description and Critical Design Features
Inspect the installed equipment item and the vendor’s documentation and verify correct specification conformance
Specified
Actual
Verification (Pass/Fail)
Initials / Date
1
Manufacturer

2
Capacity

3
M.O.C.

4
Design Pressure Range

5
Design Temp Range

Documentation Verification
Confirm that the vendor handover package is in place and contains correct material certificates
Verification (Pass/Fail)
Initials
Date
1
Vendor handover package is in place

2
Material Certification is available for wetted parts

Installation Verification
Visually inspect, and subsequently verify, the correct installation of the equipment item in the field
Verification (Pass/Fail)
Initials
Date
1
Equipment item is installed as per P&ID, is securely fitted and is free from damage

2
Nameplate is securely fitted, clearly legible and its details conform to the design specification

3
All process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID

Validation Peer Review

Print Name

Signature

Date

QA Approval

Print Name

Signature

Date

Sheet __ of __
____ Installation Verification
Tag #: ______
Equipment Description and Critical Design Features
Inspect the installed equipment item and the vendor’s documentation and verify correct specification conformance
Specified
Actual
Verification (Pass/Fail)
Initials / Date
1
Manufacturer

2
Capacity

3
M.O.C.

4
Design Pressure Range

5
Design Temp Range

Documentation Verification
Confirm that the vendor handover package is in place and contains correct material certificates
Verification (Pass/Fail)
Initials
Date
1
Vendor handover package is in place

2
Material Certification is available for wetted parts

Installation Verification
Visually inspect, and subsequently verify, the correct installation of the equipment item in the field
Verification (Pass/Fail)
Initials
Date
1
Equipment item is installed as per P&ID, is securely fitted and is free from damage

2
Nameplate is securely fitted, clearly legible and its details conform to the design specification

3
All process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID

Validation Peer Review

Print Name

Signature

Date

QA Approval

Print Name

Signature

Date

Sheet __ of __
____ Installation Verification
Tag #: ______

Equipment Description and Critical Design Features

Inspect the installed equipment item and the vendor’s documentation and verify correct specification conformance
Specified
Actual
Verification (Pass/Fail)
Initials / Date

1
Manufacturer

2
Capacity

3
M.O.C.

4
Design Pressure Range

5
Design Temp Range

Documentation Verification

Confirm that the vendor handover package is in place and contains correct material certificates
Verification (Pass/Fail)
Initials
Date

1
Vendor handover package is in place

2
Material Certification is available for wetted parts

Installation Verification

Visually inspect, and subsequently verify, the correct installation of the equipment item in the field
Verification (Pass/Fail)
Initials
Date

1
Equipment item is installed as per P&ID, is securely fitted and is free from damage

2
Nameplate is securely fitted, clearly legible and its details conform to the design specification

3
All process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID

Validation Peer Review

Print Name

Signature

Date

QA Approval

Print Name

Signature

Date

Sheet __ of __
____ Installation Verification
Tag #: ______
Equipment Description and Critical Design Features
Inspect the installed equipment item and the vendor’s documentation and verify correct specification conformance
Specified
Actual
Verification (Pass/Fail)
Initials / Date
1
Manufacturer

2
Capacity

3
M.O.C.

4
Design Pressure Range

5
Design Temp Range

Documentation Verification
Confirm that the vendor handover package is in place and contains correct material certificates
Verification (Pass/Fail)
Initials
Date
1
Vendor handover package is in place

2
Material Certification is available for wetted parts

Installation Verification
Visually inspect, and subsequently verify, the correct installation of the equipment item in the field
Verification (Pass/Fail)
Initials
Date
1
Equipment item is installed as per P&ID, is securely fitted and is free from damage

2
Nameplate is securely fitted, clearly legible and its details conform to the design specification

3
All process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID

Validation Peer Review

Print Name

Signature

Date

QA Approval

Print Name

Signature

Date

Sheet __ of __
____ Installation Verification
Tag #: ______
Equipment Description and Critical Design Features
Inspect the installed equipment item and the vendor’s documentation and verify correct specification conformance
Specified
Actual
Verification (Pass/Fail)
Initials / Date
1
Manufacturer

2
Capacity

3
M.O.C.

4
Design Pressure Range

5
Design Temp Range

Documentation Verification
Confirm that the vendor handover package is in place and contains correct material certificates
Verification (Pass/Fail)
Initials
Date
1
Vendor handover package is in place

2
Material Certification is available for wetted parts

Installation Verification
Visually inspect, and subsequently verify, the correct installation of the equipment item in the field
Verification (Pass/Fail)
Initials
Date
1
Equipment item is installed as per P&ID, is securely fitted and is free from damage

2
Nameplate is securely fitted, clearly legible and its details conform to the design specification

3
All process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID

Validation Peer Review

Print Name

Signature

Date

QA Approval

Print Name

Signature

Date

Sheet __ of __
____ Installation Verification
Tag #: ______
Equipment Description and Critical Design Features
Inspect the installed equipment item and the vendor’s documentation and verify correct specification conformance
Specified
Actual
Verification (Pass/Fail)
Initials / Date
1
Manufacturer

2
Capacity

READ ALSO...   Bone

3
M.O.C.

4
Design Pressure Range

5
Design Temp Range

Documentation Verification
Confirm that the vendor handover package is in place and contains correct material certificates
Verification (Pass/Fail)
Initials
Date
1
Vendor handover package is in place

2
Material Certification is available for wetted parts

Installation Verification
Visually inspect, and subsequently verify, the correct installation of the equipment item in the field
Verification (Pass/Fail)
Initials
Date
1
Equipment item is installed as per P&ID, is securely fitted and is free from damage

2
Nameplate is securely fitted, clearly legible and its details conform to the design specification

3
All process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID

Validation Peer Review

Print Name

Signature

Date

QA Approval

Print Name

Signature

Date

Sheet __ of __
____ Installation Verification
Tag #: ______

Equipment Description and Critical Design Features

Inspect the installed equipment item and the vendor’s documentation and verify correct specification conformance
Specified
Actual
Verification (Pass/Fail)
Initials / Date

1
Manufacturer

2
Capacity

3
M.O.C.

4
Design Pressure Range

5
Design Temp Range

Documentation Verification

Confirm that the vendor handover package is in place and contains correct material certificates
Verification (Pass/Fail)
Initials
Date

1
Vendor handover package is in place

2
Material Certification is available for wetted parts

Installation Verification

Visually inspect, and subsequently verify, the correct installation of the equipment item in the field
Verification (Pass/Fail)
Initials
Date

1
Equipment item is installed as per P&ID, is securely fitted and is free from damage

2
Nameplate is securely fitted, clearly legible and its details conform to the design specification

3
All process and utility connections, and instrumentation are connected up to the correct nozzles/flanges, as per P&ID

Validation Peer Review

Print Name

Signature

Date

QA Approval

Print Name

Signature

Date

Instrument Installation Verification
Sheet __ of __
___ Installation Verification

Part-1: ___ Transmitter Description and Critical Design Features
Inspect the installed instrument item and the vendor’s documentation and verify correct specification conformance
Tag #
Specified Manufacturer
Actual
Specified Range
Actual
Specified MOC
Actual
Loop Checked (Yes/No)
Verification (Pass/Fail)
Initials / Date
__-__

__-__

__-__

__-__

__-__

Validation Peer Review

Print Name

Signature

Date

QA Approval

Print Name

Signature

Date

Sheet __ of __
____ Installation Verification

Part-2: ___ Documentation Verification
Confirm that the vendor handover package is in place and contains correct material certificates
Tag #
*Vendor handover package is in place (Yes/No)
Material Certification is available for wetted parts (Yes/No)
Cert #
Calibration Certification is available (Yes/No)
Cert #
Loop Checksheet is available (Yes/No)
Checksheet #
Verification (Pass/Fail)
Initials / Date
__-__

__-__

__-__

__-__

__-__

Validation Peer Review

Print Name

Signature

Date

QA Approval

Print Name

Signature

Date

Sheet __ of __
___ Installation Verification

Part-3: ___ Installation Verification
Visually inspect, and subsequently verify, the correct installation of the instrument item in the field
Tag #
Instrument item is installed as per P&ID, is securely fitted and is free from damage (Yes/No)
Instrument and cabling is correctly tagged and details conform to the design specification (Yes/No)
Instrument orientated correctly and is accessible for calibration and maintenance (Yes/No)
Verification (Pass/Fail)
Initials
Date
__-__

__-__

__-__

__-__

__-__

Validation Peer Review

Print Name

Signature

Date

QA Approval

Print Name

Signature

Date

Sheet __ of __
___ Installation Verification

Part-1: ___ Transmitter Description and Critical Design Features
Inspect the installed instrument item and the vendor’s documentation and verify correct specification conformance
Tag #
Specified Manufacturer
Actual
Specified Range
Actual
Specified MOC
Actual
Loop Checked (Yes/No)
Verification (Pass/Fail)
Initials / Date
__-__

__-__

__-__

__-__

__-__

Validation Peer Review

Print Name

Signature

Date

QA Approval

Print Name

Signature

Date

Sheet __ of __
____ Installation Verification

Part-2: ___ Documentation Verification
Confirm that the vendor handover package is in place and contains correct material certificates
Tag #
*Vendor handover package is in place (Yes/No)
Material Certification is available for wetted parts (Yes/No)
Cert #
Calibration Certification is available (Yes/No)
Cert #
Loop Checksheet is available (Yes/No)
Checksheet #
Verification (Pass/Fail)
Initials / Date
__-__

__-__

__-__

__-__

__-__

Validation Peer Review

Print Name

Signature

Date

QA Approval

Print Name

Signature

Date

Sheet __ of __
___ Installation Verification

Part-3: ___ Installation Verification
Visually inspect, and subsequently verify, the correct installation of the instrument item in the field
Tag #
Instrument item is installed as per P&ID, is securely fitted and is free from damage (Yes/No)
Instrument and cabling is correctly tagged and details conform to the design specification (Yes/No)
Instrument orientated correctly and is accessible for calibration and maintenance (Yes/No)
Verification (Pass/Fail)
Initials
Date
__-__

__-__

__-__

__-__

__-__

Validation Peer Review

Print Name

Signature

Date

QA Approval

Print Name

Signature

Date

Sheet __ of __
___ Installation Verification

Part-1: ___ Transmitter Description and Critical Design Features
Inspect the installed instrument item and the vendor’s documentation and verify correct specification conformance
Tag #
Specified Manufacturer
Actual
Specified Range
Actual
Specified MOC
Actual
Loop Checked (Yes/No)
Verification (Pass/Fail)
Initials / Date
__-__

__-__

__-__

__-__

__-__

Validation Peer Review

Print Name

Signature

Date

QA Approval

Print Name

Signature

Date

Sheet __ of __
____ Installation Verification

Part-2: ___ Documentation Verification
Confirm that the vendor handover package is in place and contains correct material certificates
Tag #
*Vendor handover package is in place (Yes/No)
Material Certification is available for wetted parts (Yes/No)
Cert #
Calibration Certification is available (Yes/No)
Cert #
Loop Checksheet is available (Yes/No)
Checksheet #
Verification (Pass/Fail)
Initials / Date
__-__

__-__

__-__

__-__

__-__

Validation Peer Review

Print Name

Signature

Date

QA Approval

Print Name

Signature

Date

Sheet __ of __
___ Installation Verification

Part-3: ___ Installation Verification
Visually inspect, and subsequently verify, the correct installation of the instrument item in the field
Tag #
Instrument item is installed as per P&ID, is securely fitted and is free from damage (Yes/No)
Instrument and cabling is correctly tagged and details conform to the design specification (Yes/No)
Instrument orientated correctly and is accessible for calibration and maintenance (Yes/No)
Verification (Pass/Fail)
Initials
Date
__-__

__-__

__-__

__-__

__-__

Validation Peer Review

Print Name

Signature

Date

QA Approval

Print Name

Signature

Date

Sheet __ of __
___ Installation Verification

Part-1: ___ Transmitter Description and Critical Design Features
Inspect the installed instrument item and the vendor’s documentation and verify correct specification conformance
Tag #
Specified Manufacturer
Actual
Specified Range
Actual
Specified MOC
Actual
Loop Checked (Yes/No)
Verification (Pass/Fail)
Initials / Date
__-__

__-__

__-__

__-__

__-__

Validation Peer Review

Print Name

Signature

Date

QA Approval

Print Name

Signature

Date

Sheet __ of __
____ Installation Verification

Part-2: ___ Documentation Verification
Confirm that the vendor handover package is in place and contains correct material certificates
Tag #
*Vendor handover package is in place (Yes/No)
Material Certification is available for wetted parts (Yes/No)
Cert #
Calibration Certification is available (Yes/No)
Cert #
Loop Checksheet is available (Yes/No)
Checksheet #
Verification (Pass/Fail)
Initials / Date
__-__

__-__

__-__

__-__

__-__

Validation Peer Review

Print Name

Signature

Date

QA Approval

Print Name

Signature

Date

Sheet __ of __
___ Installation Verification

Part-3: ___ Installation Verification
Visually inspect, and subsequently verify, the correct installation of the instrument item in the field
Tag #
Instrument item is installed as per P&ID, is securely fitted and is free from damage (Yes/No)
Instrument and cabling is correctly tagged and details conform to the design specification (Yes/No)
Instrument orientated correctly and is accessible for calibration and maintenance (Yes/No)
Verification (Pass/Fail)
Initials
Date
__-__

__-__

__-__

__-__

__-__

Validation Peer Review

Print Name

Signature

Date

QA Approval

Print Name

Signature

Date

Sheet __ of __
___ Installation Verification

Part-1: ___ Transmitter Description and Critical Design Features
Inspect the installed instrument item and the vendor’s documentation and verify correct specification conformance
Tag #
Specified Manufacturer
Actual
Specified Range
Actual
Specified MOC
Actual
Loop Checked (Yes/No)
Verification (Pass/Fail)
Initials / Date
__-__

__-__

__-__

__-__

__-__

Validation Peer Review

Print Name

Signature

Date

QA Approval

Print Name

Signature

Date

Sheet __ of __
____ Installation Verification

Part-2: ___ Documentation Verification
Confirm that the vendor handover package is in place and contains correct material certificates
Tag #
*Vendor handover package is in place (Yes/No)
Material Certification is available for wetted parts (Yes/No)
Cert #
Calibration Certification is available (Yes/No)
Cert #
Loop Checksheet is available (Yes/No)
Checksheet #
Verification (Pass/Fail)
Initials / Date
__-__

__-__

__-__

__-__

__-__

Validation Peer Review

Print Name

Signature

Date

QA Approval

Print Name

Signature

Date

Sheet __ of __
___ Installation Verification

Part-3: ___ Installation Verification
Visually inspect, and subsequently verify, the correct installation of the instrument item in the field
Tag #
Instrument item is installed as per P&ID, is securely fitted and is free from damage (Yes/No)
Instrument and cabling is correctly tagged and details conform to the design specification (Yes/No)
Instrument orientated correctly and is accessible for calibration and maintenance (Yes/No)
Verification (Pass/Fail)
Initials
Date
__-__

__-__

__-__

__-__

__-__

Validation Peer Review

Print Name

Signature

Date

QA Approval

Print Name

Signature

Date

Piping Installation Verification
Sheet __ of __
Piping Installation Verification

Tag #
MOC
*Weld Log #
*Weld Log Complete (Yes/No)
Pressure Test Pack-#
Pressure Test Complete (Yes/No)
Construction Dossier #
**Slopes Checked (Yes/No)
Verification (Pass/Fail)
Initials / Date
__-__-__-__-__

__-__-__-__-__

__-__-__-__-__

__-__-__-__-__

__-__-__-__-__

__-__-__-__-__

__-__-__-__-__

*Weld Log collates material-of-construction certificates and weld inspection certificates
**Construction Dossier collates slope-check documentation

Validation Peer Review

Print Name

Signature

Date

QA Approval

Print Name

Signature

Date

Sheet __ of __
Piping Installation Verification

Tag #
MOC
*Weld Log #
*Weld Log Complete (Yes/No)
Pressure Test Pack-#
Pressure Test Complete (Yes/No)
Construction Dossier #
**Slopes Checked (Yes/No)
Verification (Pass/Fail)
Initials / Date
__-__-__-__-__

__-__-__-__-__

__-__-__-__-__

__-__-__-__-__

__-__-__-__-__

__-__-__-__-__

__-__-__-__-__

__-__-__-__-__

*Weld Log collates material-of-construction certificates and weld inspection certificates
**Construction Dossier collates slope-check documentation

Validation Peer Review

Print Name

Signature

Date

QA Approval

Print Name

Signature

Date

Sheet __ of __
Piping Installation Verification

Tag #
MOC
*Weld Log #
*Weld Log Complete (Yes/No)
Pressure Test Pack-#
Pressure Test Complete (Yes/No)
Construction Dossier #
**Slopes Checked (Yes/No)
Verification (Pass/Fail)
Initials / Date
__-__-__-__-__

__-__-__-__-__

__-__-__-__-__

__-__-__-__-__

__-__-__-__-__

__-__-__-__-__

__-__-__-__-__

__-__-__-__-__

*Weld Log collates material-of-construction certificates and weld inspection certificates
**Construction Dossier collates slope-check documentation

Validation Peer Review

Print Name

Signature

Date

QA Approval

Print Name

Signature

Date

Sheet __ of __
Piping Installation Verification

Tag #
MOC
*Weld Log #
*Weld Log Complete (Yes/No)
Pressure Test Pack-#
Pressure Test Complete (Yes/No)
Construction Dossier #
**Slopes Checked (Yes/No)
Verification (Pass/Fail)
Initials / Date
__-__-__-__-__

__-__-__-__-__

__-__-__-__-__

__-__-__-__-__

__-__-__-__-__

__-__-__-__-__

__-__-__-__-__

__-__-__-__-__

*Weld Log collates material-of-construction certificates and weld inspection certificates
**Construction Dossier collates slope-check documentation

Validation Peer Review

Print Name

Signature

Date

QA Approval

Print Name

Signature

Date

Sheet __ of __
Piping Installation Verification

Tag #
MOC
*Weld Log #
*Weld Log Complete (Yes/No)
Pressure Test Pack-#
Pressure Test Complete (Yes/No)
Construction Dossier #
**Slopes Checked (Yes/No)
Verification (Pass/Fail)
Initials / Date
__-__-__-__-__

__-__-__-__-__

__-__-__-__-__

__-__-__-__-__

__-__-__-__-__

__-__-__-__-__

__-__-__-__-__

__-__-__-__-__

*Weld Log collates material-of-construction certificates and weld inspection certificates
**Construction Dossier collates slope-check documentation

Validation Peer Review

Print Name

Signature

Date

QA Approval

Print Name

Signature

Date

Sheet __ of __
Piping Installation Verification

Tag #
MOC
*Weld Log #
*Weld Log Complete (Yes/No)
Pressure Test Pack-#
Pressure Test Complete (Yes/No)
Construction Dossier #
**Slopes Checked (Yes/No)
Verification (Pass/Fail)
Initials / Date
__-__-__-__-__

__-__-__-__-__

__-__-__-__-__

__-__-__-__-__

__-__-__-__-__

__-__-__-__-__

__-__-__-__-__

__-__-__-__-__

*Weld Log collates material-of-construction certificates and weld inspection certificates
**Construction Dossier collates slope-check documentation

Validation Peer Review

Print Name

Signature

Date

QA Approval

Print Name

Signature

Date

Calibration Program Verification
Page ___ of ___
CALIBRATION PROGRAM VERIFICATION FORM

No.
Steps
Yes/No
Verified By
Date
1
Critical component list attached and cross referenced from commissioning documents

2
Calibration list attached and cross referenced from site calibration program

3
All critical components confirmed to be entered into the site calibration program

Deviation Report Required (Yes/No)
Acceptance Criteria Met: (Yes/No):
Comments:

Reviewed By: Validation

Date:

Approved By: (QA)

Date:

Preventative Maintenance Program Verification
Page ___ of ___
Preventative Maintenance Program Verification Form

No.
Description
Verified By / Date
1
Component:

PM#:
Location:
Effective Date:
2
Component:

PM#:
Location:
Effective Date:
3
Component:

PM#:
Location:
Effective Date:
4
Component:

PM#:
Location:
Effective Date:
5
Component:

PM#:
Location:
Effective Date:
6
Component:

PM#:
Location:
Effective Date:
Comments:

Reviewed By: Validation

Date:

Approved By: (QA)

Date:

Draft SOP Verification
Page _ __ of _ __
Standard Operating Procedure Verification Form

No.
Description
Verified By / Date
1
Title:

SOP #:
Revision #:
Date:
2
Title:

SOP #:
Revision #:
Date:
3
Title

SOP #:
Revision #:
Date:
4
Title:

SOP #:
Revision #:
Date:
5
Title:

SOP #:
Revision #:
Date:
6
Title:

SOP #:
Revision #:
Date:
Comments:

Reviewed By: Validation

Date:

Approved By: (QA)

Date:

Test-Instrument Calibration Verification
Page _ _ of _ __
Test Instrument Calibration Verification Form
Objective: To document all test instruments used in the execution of this protocol.
Test Instrument Description
Identification Number
Calibration Date
Calibration Due Date
Verified By / Date

Comments:

Reviewed By: Validation

Date:

Approved By: (QA)

Date:

Appendix C: OQ GMP check-sheets
Hot Detergent System – Level Control Test Step # Operational Test Step Description Expected Result Actual Result Pass / Fail Initials Date (dd/mmm/yyyy) 1 Confirm the initial level in the hot detergent tank LT-002 = 0 0 PASS GPC 11/Feb/2020 2 Fill the hot detergent tank from the PUW1 water loop until it stops filling automatically. LT-002 = 5775 litres ± 5% 5775 PASS GPC 11/Feb/2020 3 Open the drain valve and the tank should automatically start filling again from the PUW1 water loop to remain full. LT-002 = 5775 litres ± 5% 5775 PASS GPC 11/Feb/2020 4 Close the drain valve and check that the level in the tank remains full in normal operation mode for a further 30-minutes LT-002 = 5775 litres ± 5% 5775 PASS GPC 11/Feb/2020 5 Print out the associated trends for level LT-002 the test period and append to this test section. Trends attached Trends attached PASS GPC 11/Feb/2020

Reviewed By (Validation Peer Review)

Date

Approved By (Quality Assurance)

Date
In the following table, at successive 5-minute intervals record the level in the hot detergent tank of the level transmitter LT-002. Ensure that during the time period the values are recorded correspond to the following:
The 30-minutes for filling the hot detergent tank (starting at t0-min)
Automatic filling during the draining of the hot detergent tank
The 30-minutes following the closing of the drain valve
Time minutes
Time HH/MM
Expected LT-002 (Litres)
Actual LT-002 (Litres)
Pass / Fail
Initials
Date (dd/mmm/yyyy)
t0-min
13:00


PASS
GPC
11/Feb/2020
t5-min
13:05
<5,775
916
PASS
GPC
11/Feb/2020
t10-min
13:10
<5,775
1832
PASS
GPC
11/Feb/2020
t15-min
13:15
<5,775
2750
PASS
GPC
11/Feb/2020
t20-min
13:20
<5,775
3664
PASS
GPC
11/Feb/2020
t25-min
13:25
<5,775
4580
PASS
GPC
11/Feb/2020
t30-min
13:30
5,775 ± 5%
5775
PASS
GPC
11/Feb/2020
t35-min
13:35
5,775 ± 5%
5775
PASS
GPC
11/Feb/2020
t40-min
13:40
5,775 ± 5%
5775
PASS
GPC
11/Feb/2020

Reviewed By (Validation Peer Review)

Date

Approved By (Quality Assurance)

Date

Time minutes
Time HH/MM
Expected LT-002 (Litres)
Actual LT-002 (Litres)
Pass / Fail
Initials
Date (dd/mmm/yyyy)
t45-min
13:45
5,775 ± 5%
5775
PASS
GPC
11/Feb/2020
t50-min
13:50
5,775 ± 5%
5775
PASS
GPC
11/Feb/2020
t55-min
13:55
5,775 ± 5%
5775
PASS
GPC
11/Feb/2020
t60-min
14:00
5,775 ± 5%
5775
PASS
GPC
11/Feb/2020
t65-min
14:05
5,775 ± 5%
5775
PASS
GPC
11/Feb/2020
t70-min
14:10
5,775 ± 5%
5775
PASS
GPC
11/Feb/2020
t75-min
14:15
5,775 ± 5%
5775
PASS
GPC
11/Feb/2020
t80-min
14:20
5,775 ± 5%
5775
PASS
GPC
11/Feb/2020
t85-min
14:25
5,775 ± 5%
5775
PASS
GPC
11/Feb/2020

Reviewed By (Validation Peer Review)

Date

Approved By (Quality Assurance)

Date
Hot Detergent System – Flow Control
Test Step #
Operational Test Step Description
Expected Result
Actual Result
Pass / Fail
Initials
Date
1
Start the hot detergent pump circulating
FT-002 = 25,000 litres/hr ±5% FT-004 = 25,000 litres/hr ±5°C
FT-002 = 25,000 litres/hr FT-004 = 25,000 litres/hr
PASS
GPC
11/Feb/2020
2
Confirm the initial flow reading of FT-002 and FT-004
FT-002 = 25,000 litres/hr ±5% FT-004 = 25,000 litres/hr ±5%
FT-002 = 25,000 litres/hr FT-004 = 25,000 litres/hr
PASS
GPC
11/Feb/2020
3
Open the transfer valves to RE-119 and RE-140 and transfer 5,500 litres into each vessel, confirming the level reading on LT-119 and LT-140 (this will take approximately 30-minutes). Confirm the flow readings FT-002 and FT-004
LT-119 = 5,500 Litres LT-140 = 5,500 LitresFT-002 = 25,000 litres/hr ±5% FT-004 = 3,000 litres/hr ±5%
LT-119 = 5,500 litres LT-140 = 5,500 litresFT-002 = 25,000 litres/hr FT-004 = 3,000 litres/hr
PASS
GPC
11/Feb/2020
4
After the transfer stops, maintain the hot detergent system in normal recirculation mode for a further 30-minutes with no further drawdown.
FT-002 = 25,000 litres/hr ±5% FT-004 = 25,000 litres/hr ±5%
FT-002 = 25,000 litres/hr ±5% FT-004 = 25,000 litres/hr ±5%
PASS
GPC
11/Feb/2020
5
Print out the associated trends for level LT-119 and LT-140, flow FT-002 and FT-004 during the test period and append to this test section.
Trends attached
Trends attached
PASS
GPC
11/Feb/2020
Reviewed By (Validation Peer Review)

Date

Approved By (Quality Assurance)

Date
In the following table, at successive 5-minute intervals record the online indicator values of flow transmitters FT-002 and FT-004 and level-transmitters LT-119 and LT-140. Ensure that during the time period the values are recorded correspond to the following:
The 30-minutes before the transfer from the hot detergent tank to the reactors RE-119 and RE-140 (starting at t0-min)
During the transfer to RE-119 and RE-140 to the full 5,500L charge to each reactor
The 30-minutes following the stopping of the transfer to RE-119 and RE-140
Time Mins
Time HH/MM
Expected Flow FT-002 / FT-004 Litres/hr
Actual FT-002 Litres/hr
Actual FT-004 Litres/hr
Expected LT-119 Litres
Expected LT-140 Litres
Actual LT-119 (Litres)
Actual LT-140 (Litres)
Pass / Fail
Initials
Date (dd/mmm/yyyy)
t0-min
13:00
FT-002 25,000 ± 5% FT-004 25,000 ± 5%
25,490
25,490




PASS
GPC
11/Feb/2020
t5-min
13:05
FT-002 25,000 ± 5% FT-004 25,000 ± 5%
24,966
24,966




PASS
GPC
11/Feb/2020
t10-min
13:10
FT-002 25,000 ± 5% FT-004 25,000 ± 5%
25,019
25,019




PASS
GPC
11/Feb/2020
t15-min
13:15
FT-002 25,000 ± 5% FT-004 25,000 ± 5%
24,699
24,699




PASS
GPC
11/Feb/2020
t20-min
13:20
FT-002 25,000 ± 5% FT-004 25,000 ± 5%
25,243
25,243




PASS
GPC
11/Feb/2020
t25-min
13:25
FT-002 25,000 ± 5% FT-004 25,000 ± 5%
24,699
24,699




PASS
GPC
11/Feb/2020
t30-min
13:30
FT-002 25,000 ± 5% FT-004 25,000 ± 5%
25,243
25,243




PASS
GPC
11/Feb/2020
t35-min
13:35
FT-002 25,000 ± 5% FT-004 3,000 ± 5%
24,446
2,917
<5,500
<5,500
1,000
1,000
PASS
GPC
11/Feb/2020
t40-min
13:40
FT-002 25,000 ± 5% FT-004 3,000 ± 5%
25,009
3,109
<5,500
<5,500
2,000
2,000
PASS
GPC
11/Feb/2020
Reviewed By (Validation Peer Review)

Date

Approved By (Quality Assurance)

Date
Time mins
Time HH/MM
Expected Flow FT-002/ FT-004 Litres/hr
Actual FT-002 Litres/hr
Actual FT-004 Litres/hr
Expected LT-119 Litres
Expected LT-140 Litres
Actual LT-119 (Litres)
Actual LT-140 (Litres)
Pass / Fail
Initials
Date (dd/mmm/yyyy)
t45-min
13:45
FT-002 25,000 ± 5% FT-004 3,000 ± 5%
25,224
2,954
<5,500
<5,500
3,500
3,500
PASS
GPC
11/Feb/2020
t50-min
13:50
FT-002 25,000 ± 5% FT-004 3,000 ± 5%
24,765
3,149
<5,500
<5,500
4,500
4,500
PASS
GPC
11/Feb/2020
t55-min
13:55
FT-002 25,000 ± 5% FT-004 3,000 ± 5%
24,459
3,005
<5,500
<5,500
5,500
5,500
PASS
GPC
11/Feb/2020
t60-min
14:00
FT-002 25,000 ± 5% FT-004 3,000 ± 5%
25,809
2,959
5,500± 5%
5,500± 5%
5,500
5,500
PASS
GPC
11/Feb/2020
t65-min
14:05
FT-002 25,000 ± 5% FT-004 25,000 ± 5%
24,924
24,924
5,500± 5%
5,500± 5%
5,500
5,500
PASS
GPC
11/Feb/2020
t70-min
14:10
FT-002 25,000 ± 5% FT-004 25,000 ± 5%
24,255
24,255
5,500± 5%
5,500± 5%
5,500
5,500
PASS
GPC
11/Feb/2020
t75-min
14:15
FT-002 25,000 ± 5% FT-004 25,000 ± 5%
25,245
25,245
5,500± 5%
5,500± 5%
5,500
5,500
PASS
GPC
11/Feb/2020
t80-min
14:20
FT-002 25,000 ± 5% FT-004 25,000 ± 5%
25,457
25,457
5,500± 5%
5,500± 5%
5,500
5,500
PASS
GPC
11/Feb/2020
t85-min
14:25
FT-002 25,000 ± 5% FT-004 25,000 ± 5%
25,189
25,189
5,500± 5%
5,500± 5%
5,500
5,500
PASS
GPC
11/Feb/2020

Reviewed By (Validation Peer Review)

Date

Approved By (Quality Assurance)

Date
Hot Detergent System – Temperature Control
Test Step #
Operational Test Step Description
Expected Result
Actual Result
Pass / Fail
Initials
Date (dd/mmm/yyyy)
1
Start heating up the recirculating water loop in the hot detergent system to a steady 80°C ±5°C and confirm the temperature on TT-002 and TT-004.
TT-002 = 80°C±5°CTT-004 = 80°C±5°C
TT-002 = 82°C TT-004 = 79°C
PASS
GPC
11/Feb/2020
2
Open the transfer valves to reactors RE-119 and reactor RE-140, and transfer 5,500 litres into both reactors, noting the level on LT-119 and LT-140. Confirm that the temperature of the hot detergent system maintains 80°C ±5°C during the transfer on TT-002 and TT-004
LT-119 > 5,500 Litres LT-140 > 5,500 Litres TT-002 = 80°C±5°C TT-004 = 80°C±5°C
LT-119 = 5,500L LT-140 = 5,500L TT-002 = 82°C TT-004 = 79°C
PASS
GPC
11/Feb/2020
3
Following the transfer, maintain the hot detergent system in normal circulation mode for a further 30-minutes with no further drawdown.
No drawdown
No drawdown
PASS
GPC
11/Feb/2020
4
Print out the associated trends for temperature transmitters TT-002 and TT-004, and level-transmitters LT-119 and LT-140 during the test period and append to this test section.
Trends attached
Trends attached
PASS
GPC
11/Feb/2020

Reviewed By (Validation Peer Review)

Date

Approved By (Quality Assurance)

Date
In the following table, at successive 5-minute intervals record the online indicator values of, temperature transmitters TT-002 and TT-004, and level-transmitters LT-119 and LT-140. Ensure that during the time period the values are recorded correspond to the following:
The 30-minutes before the transfer from the hot detergent tank to the reactors RE-119 and RE-140 (starting at t0-min)
During the transfer to RE-119 and RE-140 to the full 5,500L charge to each reactor
The 30-minutes following the stopping of the transfer to RE-119 and RE-140
Time minutes
Time HH/MM
Expected TT-002 and TT-004 (°C)
Actual TT-002 (°C)
Actual TT-004 (°C)
Expected LT-119 LT-140 (Litres)
Actual LT-119 (Litres)
Actual LT-140 (Litres)
Pass / Fail
Initials
Date (dd/mmm/yyyy)
t0-min
13:00
<80°C
25°C
25°C



PASS
GPC
11/Feb/2020
t5-min
13:05
<80°C
40°C
40°C



PASS
GPC
11/Feb/2020
t10-min
13:10
<80°C
60°C
60°C



PASS
GPC
11/Feb/2020
t15-min
13:15
<80°C
75°C
75°C



PASS
GPC
11/Feb/2020
t20-min
13:20
80°C ±5°C
80°C
80°C



PASS
GPC
11/Feb/2020
t25-min
13:25
80°C ±5°C
81°C
80°C



PASS
GPC
11/Feb/2020
t30-min
13:30
80°C ±5°C
78°C
83°C



PASS
GPC
11/Feb/2020
t35-min
13:35
80°C ±5°C
80°C
78°C
<5,500
1,000
1,000
PASS
GPC
11/Feb/2020
t40-min
13:40
80°C ±5°C
80°C
78°C
<5,500
2,000
2,000
PASS
GPC
11/Feb/2020

READ ALSO...   Social Networks

Reviewed By (Validation Peer Review)

Date

Approved By (Quality Assurance)

Date
Time minutes
Time HH/MM
Expected TT-002 TT-004 (°C)
Actual TT-002 (°C)
Actual TT-004 (°C)
Expected LT-119 LT-140 (Litres)
LT-119 (Litres)
LT-140 (Litres)
Pass / Fail
Initials
Date (dd/mmm/yyyy)
t45-min
13:45
80°C ±5°C
81°C
82°C
<5,500
3,000
3,500
PASS
GPC
11/Feb/2020
t50-min
13:50
80°C ±5°C
79°C
82°C
<5,500
4,000
4,000
PASS
GPC
11/Feb/2020
t55-min
13:55
80°C ±5°C
82°C
80°C
<5,500
5,000
5,000
PASS
GPC
11/Feb/2020
t60-min
14:00
80°C ±5°C
81°C
83°C
5,500± 5%
5,500
5,500
PASS
GPC
11/Feb/2020
t65-min
14:05
80°C ±5°C
80°C
78°C
5,500± 5%
5,500
5,500
PASS
GPC
11/Feb/2020
t70-min
14:10
80°C ±5°C
80°C
81°C
5,500± 5%
5,500
5,500
PASS
GPC
11/Feb/2020
t75-min
14:15
80°C ±5°C
79°C
85°C
5,500± 5%
5,500
5,500
PASS
GPC
11/Feb/2020
t80-min
14:20
80°C ±5°C
80°C
78°C
5,500± 5%
5,500
5,500
PASS
GPC
11/Feb/2020
t85-min
14:25
80°C ±5°C
81°C
80°C
5,500± 5%
5,500
5,500
PASS
GPC
11/Feb/2020

Reviewed By (Validation Peer Review)

Date

Approved By (Quality Assurance)

Date
Hot Detergent System – Detergent Dosing Control
Test Step #
Operational Test Step Description
Expected Result
Actual Result
Pass / Fail
Initials
Date (dd/mmm/yyyy)
1
Start up the hot detergent recirculation system. Give the system time to warm up until it is recirculating water at 80°C.
TT-002 = 80°C±5°CTT-004 = 80°C±5°C
TT-002 = 81°C TT-004 = 80°C
PASS
GPC
11/Feb/2020
2
Commence introducing detergent into the recirculation loop at time = (t0-min) After 30 minutes, confirm the conductivity measurement CT-001 is reading 500 μScm-1 ± 5%.
CT-001 = 500 μScm-1 ± 5%
CT-001=505 μScm-1
PASS
GPC
11/Feb/2020
3
At time = (t30-min) open the transfer valves to reactors RE-119 and reactor RE-140, and transfer 5,500 litres into each reactor, noting the level on LT-119 and LT-140. Confirm that the temperature reading of the hot detergent system maintains 80°C ±5°C during the transfer on TT-002 and TT-004 and the conductivity reading remains at 500 μScm-1 ± 5%.
LT-119 > 5,500 Litres LT-140 > 5,500 Litres TT-002 = 80°C ±5°C TT-004 = 80°C ±5°C CT-001 = 500 μScm-1 ± 5%
LT-119 = 5,500L LT-140 = 5,500L TT-002 = 81°C TT-004 = 80°C CT-001=505 μScm-1
PASS
GPC
11/Feb/2020
4
Following the transfer, maintain the hot detergent system in normal circulation mode for a further 30-minutes with no further drawdown.
No drawdown
No drawdown
PASS
GPC
11/Feb/2020
5
Print out the associated trends for conductivity transmitter CT-001, temperature transmitters TT-002 and TT-004, and level-transmitters LT-119 and LT-140 during the test period and append to this test section.
Trends attached
Trends attached
PASS
GPC
11/Feb/2020

Reviewed By (Validation Peer Review)

Date

Approved By (Quality Assurance)

Date
In the following table, at successive 5-minute intervals record the online indicator values of conductivity measurement CT-001, temperature transmitters TT-002 and TT-004, and level-transmitters LT-119 and LT-140. Ensure that during the time period the values are recorded correspond to the following:
The 30-minutes before the transfer from the hot detergent tank to the reactors RE-119 and RE-140 (starting at t0-min)
During the transfer to RE-119 and RE-140 to the full 5,500L charge to each
The 30-minutes following the stopping of the transfer to RE-119 and RE-140
Time minutes
Time HH/MM
Expected CT-001 μScm-1
Actual CT-001 μScm-1
Expected TT-002 TT-004 (°C)
Actual TT-002 (°C)
Actual TT-004 (°C)
Expected LT-119 LT-140 (Litres)
LT-119 (Litres)
LT-140 (Litres)
Pass / Fail
Initials
Date (dd/mmm/yyyy)
t0-min
13:00
<500
100 μScm-1
80°C ±5°C
80°C
80°C



PASS
GPC
11/Feb/2020
t5-min
13:05
<500
200 μScm-1
80°C ±5°C
81°C
80°C



PASS
GPC
11/Feb/2020
t10-min
13:10
<500
300 μScm-1
80°C ±5°C
80°C
80°C



PASS
GPC
11/Feb/2020
t15-min
13:15
<500
400 μScm-1
80°C ±5°C
84°C
82°C



PASS
GPC
11/Feb/2020
t20-min
13:20
500 μScm-1 ± 5%
499 μScm-1
80°C ±5°C
80°C
79°C



PASS
GPC
11/Feb/2020
t25-min
13:25
500 μScm-1 ± 5%
502 μScm-1
80°C ±5°C
83°C
80°C



PASS
GPC
11/Feb/2020
t30-min
13:30
500 μScm-1 ± 5%
500 μScm-1
80°C ±5°C
78°C
83°C



PASS
GPC
11/Feb/2020
t35-min
13:35
500 μScm-1 ± 5%
503 μScm-1
80°C ±5°C
80°C
78°C
<5,500
1000
1000
PASS
GPC
11/Feb/2020
t40-min
13:40
500 μScm-1 ± 5%
497 μScm-1
80°C ±5°C
80°C
79°C
<5,500
2000
2000
PASS
GPC
11/Feb/2020

Reviewed By (Validation Peer Review)

Date

Approved By (Quality Assurance)

Date
Time minutes
Time HH/MM
Expected CT-001 μScm-1
Actual CT-001 μScm-1
Expected TT-002/4 (°C)
Actual TT-002 (°C)
Actual TT-004 (°C)
Expected LT-119 LT-140 (Litres)
Actual LT-119 (Litres)
Actual LT-140 (Litres)
Pass / Fail
Initials
Date (dd/mmm/yyyy)
t45-min
13:45
500 μScm-1± 5%
500 μScm-1
80°C ±5°C
81°C
80°C
<5,500
3,000
3,000
PASS
GPC
11/Feb/2020
t50-min
13:50
500 μScm-1± 5%
502 μScm-1
80°C ±5°C
79°C
82°C
<5,500
4,000
4,000
PASS
GPC
11/Feb/2020
t55-min
13:55
500 μScm-1± 5%
499 μScm-1
80°C ±5°C
82°C
80°C
<5,500
5,000
5,000
PASS
GPC
11/Feb/2020
t60-min
14:00
500 μScm-1± 5%
500 μScm-1
80°C ±5°C
80°C
81°C
5,500± 5%
5,500
5,500
PASS
GPC
11/Feb/2020
t65-min
14:05
500 μScm-1± 5%
503 μScm-1
80°C ±5°C
80°C
78°C
5,500± 5%
5,500
5,500
PASS
GPC
11/Feb/2020
t70-min
14:10
500 μScm-1± 5%
497 μScm-1
80°C ±5°C
80°C
81°C
5,500± 5%
5,500
5,500
PASS
GPC
11/Feb/2020
t75-min
14:15
500 μScm-1± 5%
498 μScm-1
80°C ±5°C
79°C
82°C
5,500± 5%
5,500
5,500
PASS
GPC
11/Feb/2020
t80-min
14:20
500 μScm-1± 5%
501 μScm-1
80°C ±5°C
80°C
80°C
5,500± 5%
5,500
5,500
PASS
GPC
11/Feb/2020
t85-min
14:25
500 μScm-1± 5%
500 μScm-1
80°C ±5°C
81°C
80°C
5,500± 5%
5,500
5,500
PASS
GPC
11/Feb/2020

Reviewed By (Validation Peer Review)

Date

Approved By (Quality Assurance)

Date
Hot PUW System – Level Control
Test Step #
Operational Test Step Description
Expected Result
Actual Result
Pass / Fail
Initials
Date (dd/mmm/yyyy)
1

2

3

4

5

Reviewed By (Validation Peer Review)

Date

Approved By (Quality Assurance)

Date
In the following table, at successive 5-minute intervals record the online indicator values of [INSERT INFORMATION].
Ensure that during the time period the values are recorded correspond to the following:
The 30-minutes for [INSERT INFORMATION]
Automatic filling during [INSERT INFORMATION]
The 30-minutes following [INSERT INFORMATION]
Time minutes
Time HH/MM
Expected LT-001 (Litres)_
Actual LT-001 (Litres)
Pass / Fail
Initials
Date (dd/mmm/yyyy)
t0-min

t5-min

t10-min

t15-min

t20-min

t25-min

t30-min

t35-min

t40-min

Reviewed By (Validation Peer Review)

Date

Approved By (Quality Assurance)

Date
Time minutes
Time HH/MM
Expected LT-001 (Litres)_
Actual LT-001 (Litres)
Pass / Fail
Initials
Date (dd/mmm/yyyy)
t45-min

t50-min

t55-min

t60-min

t65-min

t70-min

t75-min

t80-min

t85-min

Reviewed By (Validation Peer Review)

Date

Approved By (Quality Assurance)

Date
Hot PUW System – Flow Control
Test Step #
Operational Test Step Description
Expected Result
Actual Result
Pass / Fail
Initials
Date (dd/mmm/yyyy)
1

2

3

4

5

Reviewed By (Validation Peer Review)

Date

Approved By (Quality Assurance)

Date
In the following table, at successive 5-minute intervals record the online indicator values of [INSERT INFORMATION].
Ensure that during the time period the values are recorded correspond to the following:
The 30-minutes before [INSERT INFORMATION]
During [INSERT INFORMATION]
The 30-minutes following [INSERT INFORMATION]
Time minutes
Time HH/MM
Expected FT-001 / FT-003 Litres/hr
Actual FT-001 Litres/hr
Actual FT-003 Litres/hr
Expected LT-119 (Litres)
Expected LT-140 (Litres)
Actual LT-119 (Litres)
Actual LT-140 (Litres)
Pass / Fail
Initials
Date (dd/mmm/yyyy)
t0-min

t5-min

t10-min

t15-min

t20-min

t25-min

t30-min

t35-min

t40-min

Reviewed By (Validation Peer Review)

Date

Approved By (Quality Assurance)

Date
Time minutes
Time HH/MM
Expected FT-001 / FT-003 Litres/hr
Actual FT-001 Litres/hr
Actual FT-003 Litres/hr
Expected LT-119 (Litres)
Expected LT-140 (Litres)
Actual LT-119 (Litres)
Actual LT-140 (Litres)
Pass / Fail
Initials
Date (dd/mm/yyyy)
t45-min

t50-min

t55-min

t60-min

t65-min

t70-min

t75-min

t80-min

t85-min

Reviewed By (Validation Peer Review)

Date

Approved By (Quality Assurance)

Date
Hot PUW System – Temperature Control
Test Step #
Operational Test Step Description
Expected Result
Actual Result
Pass / Fail
Initials
Date (dd/mmm/yyyy)
1

2

3

4

5

Reviewed By (Validation Peer Review)

Date

Approved By (Quality Assurance)

Date
In the following table, at successive 5-minute intervals record the online indicator values of [INSERT INFORMATION].
Ensure that during the time period the values are recorded correspond to the following:
The 30-minutes before [INSERT INFORMATION]
During [INSERT INFORMATION]
The 30-minutes following [INSERT INFORMATION]
Time minutes
Time HH/MM
Expected TT-001 TT-003 (°C)
Actual TT-001 (°C)
Actual TT-003 (°C)
Expected LT-119 LT-140 (Litres)
Actual LT-119 (Litres)
Actual LT-140 (Litres)
Pass / Fail
Initials
Date (dd/mmm/yyyy)
t0-min

t5-min

t10-min

t15-min

t20-min

t25-min

t30-min

t35-min

t40-min

Reviewed By (Validation Peer Review)

Date

Approved By (Quality Assurance)

Date
Time minutes
Time HH/MM
Expected TT-001 TT-003 (°C)
Actual TT-001 (°C)
Actual TT-003 (°C)
Expected LT-119 LT-140 (Litres)
LT-119 (Litres)
LT-140 (Litres)
Pass / Fail
Initials
Date (dd/mmm/yyyy)
t45-min

t50-min

t55-min

t60-min

t65-min

t70-min

t75-min

t80-min

t85-min

Reviewed By (Validation Peer Review)

Date

Approved By (Quality Assurance)

Date
Approved SOP Verification
Page _ __ of _ __
Standard Operating Procedure Verification Form

No.
Description
Verified By / Date
1
Title:

SOP #:
Revision #:
Date:
2
Title:

SOP #:
Revision #:
Date:
3
Title

SOP #:
Revision #:
Date:
4
Title:

SOP #:
Revision #:
Date:
5
Title:

SOP #:
Revision #:
Date:
6
Title:

SOP #:
Revision #:
Date:
Comments:

Reviewed By Validation:

Date:

Approved By:(QA):

Date:

Appendix D: Deviation log
Deviation #
Deviation Summary Statement
Deviation Resolved (YES / No)
Date Verified
Date Approved
Related Change # (if applicable)

Reviewed By: (Validation)

Date:

*Reviewed By: (QA)

Date:

*Must be approved by QA if any deviations are deemed a ‘Direct Impact System’
Appendix E: Deviation Form
Deviation Details
Deviation#

Building / Area

Equipment / System

Protocol Section #

Protocol Test Descriptor

Deviation Category (Please Circle)
1
2
3
*4
*5
DEVIATION DESCRIPTION

2. Impact Assessment of Deviation
System GMP Category (Please Circle)
Component GMP Category (Please Circle)
*Direct
Indirect
No Impact
Critical
Non-Critical
Affected Items
Yes/No
Affected Items
Yes/No
User Requirement

Functional or Detailed Design Specifications

Testing Already Completed

System Documentation

Testing Protocols

Drawings

Validation Plan

Standard Operating Procedures

Training

Other

Details of Affected Items:
REFERENCES (AFFECTED ITEMS)
Document #
Title / Description
Revision

3. Resolution Description

4. Resolution Verification
Verified By: (Originator)

Date:

Approved By: (Validation)

Date:

*Approved By: (QA)

Date:

*Must be approved by QA only if a ‘Direct Impact System’
Deviation Details
Deviation#

Building / Area

Equipment / System

Protocol Section #

Protocol Test Descriptor

Deviation Category (Please Circle)
1
2
3
*4
*5
DEVIATION DESCRIPTION

2. Impact Assessment of Deviation
System GMP Category (Please Circle)
Component GMP Category (Please Circle)
*Direct
Indirect
No Impact
Critical
Non-Critical
Affected Items
Yes/No
Affected Items
Yes/No
User Requirement

Functional or Detailed Design Specifications

Testing Already Completed

System Documentation

Testing Protocols

Drawings

Validation Plan

Standard Operating Procedures

Training

Other

Details of Affected Items:
REFERENCES (AFFECTED ITEMS)
Document #
Title / Description
Revision

3. Resolution Description

4. Resolution Verification
Verified By: (Originator)

Date:

Approved By: (Validation)

Date:

*Approved By: (QA)

Date:

*Must be approved by QA only if a ‘Direct Impact System’
Deviation Details
Deviation#

Building / Area

Equipment / System

Protocol Section #

Protocol Test Descriptor

Deviation Category (Please Circle)
1
2
3
*4
*5
DEVIATION DESCRIPTION

2. Impact Assessment of Deviation
System GMP Category (Please Circle)
Component GMP Category (Please Circle)
*Direct
Indirect
No Impact
Critical
Non-Critical
Affected Items
Yes/No
Affected Items
Yes/No
User Requirement

Functional or Detailed Design Specifications

Testing Already Completed

System Documentation

Testing Protocols

Drawings

Validation Plan

Standard Operating Procedures

Training

Other

Details of Affected Items:
REFERENCES (AFFECTED ITEMS)
Document #
Title / Description
Revision

3. Resolution Description

4. Resolution Verification
Verified By: (Originator)

Date:

Approved By: (Validation)

Date:

*Approved By: (QA)

Date:

*Must be approved by QA only if a ‘Direct Impact System’
Deviation Details
Deviation#

Building / Area

Equipment / System

Protocol Section #

Protocol Test Descriptor

Deviation Category (Please Circle)
1
2
3
*4
*5
DEVIATION DESCRIPTION

2. Impact Assessment of Deviation
System GMP Category (Please Circle)
Component GMP Category (Please Circle)
*Direct
Indirect
No Impact
Critical
Non-Critical
Affected Items
Yes/No
Affected Items
Yes/No
User Requirement

Functional or Detailed Design Specifications

Testing Already Completed

System Documentation

Testing Protocols

Drawings

Validation Plan

Standard Operating Procedures

Training

Other

Details of Affected Items:
REFERENCES (AFFECTED ITEMS)
Document #
Title / Description
Revision

3. Resolution Description

4. Resolution Verification
Verified By: (Originator)

Date:

Approved By: (Validation)

Date:

*Approved By: (QA

Date:

Appendix F: Change Control Log
Change Control #
P&ID / System #
Summary Description of change
Direct / Indirect / No-Impact
Date Raised (dd/mmm/yyyy)
Pre-Approval Date (dd/mmm/yyyy)
Post-Approval Date (dd/mmm/yyyy)

Reviewed By: (Validation Engineering)

Date:

Appendix G: Change Control Form
Change Control Form
Project Title:

CHANGE #:

Project No:

P&ID / System:

Attachments (Yes/No):

Date:

SECTION 1: OBSERVATIONS AND PROPOSED CHANGE (to be completed by 1Project Engineer)
ORIGINAL DESIGN:
PROPOSED CHANGE:

2HAZOP TO BE UPDATED (Yes / No)

SECTION 2: IMPACT ASSESSMENT (to be completed by 1Engineering Validation)
AFFECTED APPROVED ITEMS
Yes/No
AFFECTED APPROVED ITEMS
Yes/No
3Validation Plan

3Project URS

3System Level URS

3System Impact Assessment

3Component Impact Assessment

3, 4Qualification Protocol(s)

4Commissioning Protocol(s)

4Other

3, 5DIRECT
5INDIRECT
5NO IMPACT
3SYSTEM IMPACT
Yes / No
Yes / No
Yes / No
SECTION 2 (Continued): IMPACT ASSESSMENT (to be completed by 1Engineering Validation)

3, 5OPER. CRITICAL
3, 5PRODUCT CONTACT
5NON CRITICAL
3COMPONENT IMPACT
Yes / No
Yes / No
Yes / No

5CONSTRUCTION
5COMMISSIONING
3, 5QUALIFICATION
PROJECT PHASE
Yes / No
Yes / No
Yes / No
SECTION 3: TESTING REQUIRED (to be completed by 1Engineering Validation)
4TESTING REQUIRED
4DOCUMENT UPDATES REQUIRED
Number of Test Pages Attached

SECTION 4: COST CALCULATIONS AND SCHEDULE (to be completed by 1Project Engineer)
6COST OF CHANGE

6IMPACT ON SCHEDULE (time)

SECTION 5: PRE-APPROVALS
PROJECT DISCIPLINE
PRINT NAME
SIGNATURE
DATE
PROJECT ENGINEER

PROJECT MANAGER

EHS

VALIDATION

QA

SECTION 6: REJECT CHANGE

PRINT NAME
SIGNATURE
DATE
CHANGE REJECTED BY

REASON FOR REJECTING CHANGE
SECTION 7: DOCUMENT UPDATES (to be completed by 1Engineering Validation)
DOCUMENT UPDATED
Yes/No/ N/A
DOCUMENT UPDATED
Yes/No/ N/A
3Commissioning and Qualification Plan

3Project URS

3System Level URS

3System Impact Assessment

3Component Impact Assessment

3, 4Qualification Protocol(s)

4Commissioning Protocol(s)

4Other

2HAZOP UPDATED (Yes / No)

SECTION 8: 4POST-CHANGE TESTING SUCCESSFUL EXECUTED AND COMPLETED

PRINT NAME
SIGNATURE
DATE
VERIFIED BY

SECTION 9: POST-CHANGE APPROVALS
PROJECT DISCIPLINE
PRINT NAME
SIGNATURE
DATE
PROJECT ENGINEER

PROJECT MANAGER

EHS

VALIDATION

QA

ADDITIONAL COMMENTS
1 Enter name and signatures details in approval section; 2 If ‘Yes’ EHS must approve change; 3 If ‘Yes’ QA must approve change; 4 Attach list accordingly; 5 Circle correct entry; 6 Attach additional cost breakdown, and if applicable details on updated schedule
Appendix H: Component Impact Assessment
Equipment Components

Critical
Non-Critical
Tag
Description
Operational Critical
Product Contact Critical

T-211
Hot Detergent Tank

T-411
Hot PUW2 Tank

P-207
Detergent Centrifugal Transfer Pump

P-209
Detergent Centrifugal Transfer Pump

P-415
PUW2 Centrifugal Transfer Pump

P-417
PUW2 Centrifugal Transfer Pump

P-223
Detergent Metering Pump

HX-211
Detergent Plate Heat Exchanger

HX-411
PUW2 Plate Heat Exchanger

FL-399
Detergent Cartridge Filter

FL-401
PUW2 Cartridge Filter

PSV-001
PUW2 Sanitary Pressure Relief Valve

PSV-002
Detergent Sanitary Pressure Relief Valve

Instrument Components

Critical
Non-Critical
Tag
Description
Operational Critical
Product Contact Critical

TCV-005
Steam Temperature control valve

TCV-006
Steam Temperature control valve

TT-001
3 wire RTD Temperature transmitters

TT-002
3 wire RTD Temperature transmitters

TT-003
3 wire RTD Temperature transmitters

TT-004
3 wire RTD Temperature transmitters

PT-001
Sanitary Diaphragm type Pressure Indicating transmitters

PT-002
Sanitary Diaphragm type Pressure Indicating transmitters

PI-007
Local pressure indicators c/w bourdon type gauges

FT-001
Magnetic flow Transmitter

FT-002
Magnetic flow Transmitter

FT-003
Magnetic flow Transmitter

FT-004
Magnetic flow Transmitter

FS-005
Low Flow switch

CT-001
Conductivity transmitter

PI-003
Diaphragm type pressure indicator

PI-004
Diaphragm type pressure indicator

PI-005
Diaphragm type pressure indicator

PI-006
Diaphragm type pressure indicator

PI-008
Diaphragm type pressure indicator

TI-007
Bimetalic Temperature indicator

TI-008
Bimetalic Temperature indicator

TI-009
Bimetalic Temperature indicator

TI-010
Bimetalic Temperature indicator

LS-003
Low Level Switch (Tuning fork type)

LS-004
Low Level Switch (Tuning fork type)

LS-005
High Level Switch (Tuning fork type)

LS-006
High Level Switch (Tuning fork type)

LT-001
Hydrostatic Pressure type level Transmitter

LT-002
Hydrostatic Pressure type level Transmitter

XV-003
Actuated Sanitary Butterfly Valve

XV-004
Actuated Sanitary Butterfly Valve

XV-008
Actuated Sanitary Ball Valve

XV-009
Actuated Sanitary Ball Valve

XV-001
Actuated Tuchenhagen Multiport divert Valves.

XV-002
Actuated Tuchenhagen Multiport divert Valves.

XV-005
Actuated Tuchenhagen Multiport divert Valves.

XV-006
Actuated Tuchenhagen Multiport divert Valves.

XV-007
Actuated Tuchenhagen Multiport divert Valves.

PRV-001
Back Pressure Regulating Valve

PRV-002
Back Pressure Regulating Valve

Piping Components

Critical
Non-Critical
Tag
Description
Operational Critical
Product Contact Critical

50-PUW1-S6-147-IH
From LN-486 To T-211

50-PUW1-S6-148-IH
From LN-486 To T-411

80-DETERGENT-S6-149-IH
From T-211 To FL-399

80-DETERGENT-S6-150-IH
From FL-399 To P-207

80-DETERGENT-S6-151-IH
From LN-150 To P-209

65-DETERGENT-S6-152-IH
From P-209 To LN-153

65-DETERGENT-S6-153-IH
From P-207 To HX-211

65-DETERGENT-SS1-154-IH
From HX-211 To XV-021 @ DETERGENT change-over valves

80-PUW2-S6-156-IH
From FL-401 To P-415

80-PUW2-S6-157-IH
From LN-156 To P-417

65-PUW2-S6-158-IH-
From P-417 To LN-159

65-PUW2-S6-159-IH-
From P-415 To HX-411

65-PUW2-SS1-160-IH-
From HX-411 To XV-016 @ PUW2 change-over valves

25-PROCESS-S6-161-NI
From Conc. Detergent Dosing System To P-223

25-PROCESS-S6-162-NI
From P-223 To LN-149

65-DETERGENT-SS1/S6-163-IH
From XV-018 @ DETERGENT change-over valves To T-211

65-PUW2-SS1/S6-164-IH
From XV-013 @ PUW2 change-over valves To T-411

100-VENT-S6-166-NI
From T-211 To Safe Area

25-DRAIN-S6-167-NI
From LN-166 To LN-176

100-VENT-S6-168-NI
From T-411 To Safe Area

25-DRAIN-S6-169-NI
From LN-168 To LN-176

50-DRAIN-S6-170-NI
From XV-002 @ T-211 outlet to LN-176

50-DRAIN-S6-171-NI
From XV-001 @ T-411 outlet to LN-176

25-VENT-S6-172-NI
From PSV-002 To LN-176

25-VENT-S6-173-NI
From PSV-001 To LN-176

50-DRAIN-S6-174-NI
From XV-006 @ T-211 inlet to LN-176

50-DRAIN-S6-175-NI
From XV-005 @ T-411 inlet to LN-176

80-DRAIN-SS1-176-NI
From Drain Lines to Drain Header

15-DRAIN-S6-177-NI
From P-207 To Drain

15-DRAIN-S6-178-NI
From P-209 To Drain

15-DRAIN-S6-179-NI
From P-415 To Drain

15-DRAIN-S6-180-NI
From P-417 To Drain

50-DRAIN-SS1-181-NI
From T-411 Pump Discharge To Drain

50-DRAIN-SS1-182-NI
From T-211 Pump Discharge To Drain

65-PLANT STEAM-CS5-183-IH
From LN-241 To HX-211 / HX-411

15-PLANT STEAM-CS5-184-IH
From LN-241 To LN-185

20-CONDENSATE-CS5-185-IH
From LN-184 To LN-242

40-CONDENSATE-CS5-186-IH
From HX-211 To LN-242

40-CONDENSATE-CS5-187-IH
From HX-411 To LN-242

100-PLANT STEAM-CS5-241-IH
From Existing Steam Header Level 2 To Cleaning generation Skid

80-CONDENSATE-CS5-242-IH
From Cleaning Generation Skid To Existing Condensate Header Level 4

40-COMPRESSED AIR-SS1-502-NI
From V-39 To Pneumatic Control

Appendix I: Traceability Matrix
Testing Traceability Matrix
Hot Detergent and Hot PUW Generation and Distribution
Plant Throughputs for Hot Detergent and Hot PUW Generation System
URS Item Number
User Requirement Description
Testing
Comment
1.1
The Hot Detergent system shall be capable of achieving and maintaining defined flowrates, at steady state conditions, e.g. maximum flow of 25,000 kg/hr ±5%, minimum flow of 3,000 kg/hr ±5% etc.
Operational / Functional Test – Hot Detergent System – Flow Control Procedure [Insert #] Check sheet [Insert #]
Conduct test during simultaneous maximum Hot Detergent drawdown into reactor RE-119 and reactor RE-140
1.2
The Hot PUW system shall be capable of achieving and maintaining defined flowrates, at steady state conditions, e.g. maximum flow of 25,000 kg/hr ±5%, minimum flow of 3,000 kg/hr ±5% etc.
Operational / Functional Test – Hot PUW System – Flow Control Procedure Section [Insert #] Check sheet [Insert #]
Conduct test during simultaneous maximum Hot PUW drawdown into reactor RE-119 and reactor RE-140
2 Skid Configuration
URS Item Number
User Requirement Description
Testing
Comment
2.1
The Skid shall consist of the following equipment items. The detailed design specifications for these equipment items are outlined in Appendix 1.Process water tank 1 Detergent solution tank 1 Centrifugal recirculation pumps 4 Detergent dosing pump 1 Heat exchangers 2
Equipment Installation Test Procedure [Insert #] Checksheet [Insert #]Piping Installation Test Procedure [Insert #] Checksheet [Insert #]
Conduct a P&ID walkdown and Equipment and Piping Installation Tests for the CIP Skid.
2.2
Instrumentation as illustrated on the P&ID-227 shall be supplied with the skid.
Instrument Installation Test Procedure [Insert #] Checksheet [Insert #]
Conduct a P&ID walkdown and Instrumentation Installation Test for the CIP SKID
3 Hot Detergent Solution Operation
URS Item Number
User Requirement Description
Testing
Comment
3.1
The Hot Detergent Tank shall be fed directly from the 25°C PUW1 water loop and shall maintain the level in the tank during maximum drawdown into the reactors being washed.
Operational / Functional Test – Hot Detergent System – Level Control Procedure [Insert #] Checksheet [Insert #]
Conduct test during simultaneous maximum Hot Detergent drawdown into reactor RE-119 and reactor RE-140
3.5
The system shall have the facility to automatically dose concentrated detergent to the required concentration (2% ±0.05%) during drawdown into the 2 reactors. Online conductivity measurement shall be provided to verify the detergent concentration.
Operational / Functional Test – “Detergent Dosing Control Procedure [Insert #] Checksheet [Insert #]
Conduct test during simultaneous maximum Hot Detergent drawdown into reactor RE-119 and reactor RE-140
4 Hot PUW Solution Operation
URS Item Number
User Requirement Description
Testing
Comment
4.4
The Hot PUW supply temperature shall be maintained by a closed loop control system, which modulates steam flow to the heat exchanger. The control system shall be capable of controlling the supply temperature to within ±5°C of the setpoint (80°C) during maximum drawdown of the Hot PUW for the 2 reactors.
Operational / Functional Test – Hot PUW System – Temperature Control Procedure [Insert #] Checksheet [Insert #]
Conduct test during simultaneous maximum Hot PUW drawdown into reactor RE-119 and reactor RE-140

Order from Academic Writers Bay
Best Custom Essay Writing Services

QUALITY: 100% ORIGINAL PAPERNO PLAGIARISM – CUSTOM PAPER