1.

Title Page

Installation and Functional Verification Protocol

For

Hot Detergent and Hot PUW

Generation and Distribution System

Author Author’s Title / Position

Maria Kaluzna Validation Engineer Pfizer

Document Number Revision Number Revision Date

01 1 24JUN24

Maria Kaluzna Page 1

 2. Approvals Page
Subject Matter Experts -SMEs should take the lead role in verification of manufacturing elements. SME activities
typically include planning and defining verification strategies, defining acceptance criteria, execution of verification
tests, and reviewing results. SMEs are encouraged to understand, identify and leverage best practices and processes
related to automated equipment systems.

Prepared By: __Maria Kaluzna________________ Date: _24 JUN 2024_____

Validation Engineer

Approved By: __Daniel Crandol_____________ Date: _24 JUN 2024__

Validation Manager
Your signature attests that you have reviewed this document and it complies with
relevant validation policies & procedures.

Approved By: _Frank Roche_______________ Date: _24 JUN 2024___

Engineering
Your signature attests that that you have reviewed this document and confirm its
accuracy against the associated specifications and design.
(align with ‘Responsibilities’ Protocol Section-10)

Approved By: __Calvin Moore_____________ Date: _24 JUN 2024_____

QA
Your signature attests that you have reviewed this document and confirm it complies
with cGMPs regulatory requirements, local and corporate policies.
(align with ‘Responsibilities’ Protocol Section-10)

Approved By: __Nick Walsh__________ Date: __24 JUN 2024_______

Maintenance/ Calibrations Engineer
Your signature attests that you have reviewed this document and it complies with
relevant calibrations policies & procedures.
(align with ‘Responsibilities’ Protocol Section-10)

Approved By: __James Egan_____________ Date: _24 JUN 2024_____

Manufacturing
Your signature attests that you have reviewed this document and confirm it complies
with relevant manufacturing policies & procedures
(align with ‘Responsibilities’ Protocol Section-10)

Approved By: __Cian Brennan _____________ Date: _24 JUN 2024_____

HR/Training
Your signature attests that you have reviewed this document and confirm it complies
with relevant manufacturing policies & procedures
(align with ‘Responsibilities’ Protocol Section-10)

Approved By: __ Kathy McDonald _____________ Date: _24 JUN 2024_____

EHS
Your signature attests that you have reviewed this document and confirm it complies
with relevant manufacturing policies & procedures

Maria Kaluzna Page 2

 (align with ‘Responsibilities’ Protocol Section-10)

Approved By: __Matthew Doyle __________ Date: __24 JUN 2024____

QC
Your signature attests that you have reviewed this document and it complies with
relevant calibrations policies & procedures.
(align with ‘Responsibilities’ Protocol Section-10)

3. Document Revision History

Revision Date of Issue Reason for revision update

A 12 Jan 2012 Issued for review

0 14 Mar 2012 Issued for approval and use

1 24 Jun 2024 Approved

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 4. Table of Contents

1 Title Page...................................................................................................................1
2 Approvals Page..........................................................................................................2
3 Document Revision History......................................................................................3
4 Table of Contents......................................................................................................4
5 Protocol Objective.....................................................................................................6
6 System Description....................................................................................................6
7 Scope.........................................................................................................................7
7.1 System Impact Assessment...............................................................................7
7.2 Component Impact Assessment........................................................................7
7.3 Summary Table - Operational Critical Components.........................................8
7.4 P&ID Scope.....................................................................................................10
8 Reference Documentation.......................................................................................11
9 Definitions/ Glossary...............................................................................................12
10 Responsibilities / Subject Matter Experts............................................................13
11 Installation Verification Testing Procedures.......................................................14
11.1 P&ID Walkdown Testing Procedure...............................................................14
11.2 Equipment Installation Verification Procedure...............................................16
11.3 Instrument Installation Verification Procedure...............................................18
11.4 Piping Installation Verification Procedure......................................................20
11.5 Calibration Program Verification....................................................................21
11.6 Preventative Maintenance Program Verification............................................21
11.7 Draft SOP Verification....................................................................................21
11.8 Test-Instrument Calibration Verification........................................................21
12 Progression Approval to Proceed to Functional Verification..............................22
12.1 Operational-Critical-Instrument Calibration Verification Form.....................23
13 Functional Verification Testing Procedures........................................................25
13.1 Hot Detergent System – Level Control...........................................................26
13.2 Hot Detergent System – Flow Control............................................................28
13.3 Hot Detergent System – Temperature Control................................................30
13.4 Hot Detergent System – Detergent Dosing Control........................................32
13.5 Hot PUW System – Level Control..................................................................34
13.6 Hot PUW System – Flow Control...................................................................34
13.7 Hot PUW System – Temperature Control.......................................................34
13.8 Approved SOP Verification............................................................................34
14 Protocol Quality Procedures................................................................................35
14.1 Signature Log..................................................................................................35
14.2 Deviation Procedure........................................................................................35
14.3 Change Control Procedure..............................................................................35
15 IOQ Protocol Summary Report...........................................................................36
16 List of Appendices...............................................................................................37
16.1 Appendix A - Protocol Signature Log.............................................................38
16.2 Appendix B - Installation Verification GMP checksheets..............................39
16.2.1 P&ID Walkdown Installation Verification..............................................39
16.2.2 Equipment Installation Verification........................................................40
16.2.3 Instrument Installation Verification........................................................50
16.2.4 Piping Installation Verification...............................................................65
16.2.5 Calibration Program Verification............................................................71

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 16.2.6 Preventative Maintenance Program Verification....................................73
16.2.7 Draft SOP Verification............................................................................75
16.2.8 Test-Instrument Calibration Verification................................................77
16.3 Appendix C: OQ GMP check-sheets...............................................................79
16.3.1 Hot Detergent System – Level Control...................................................79
16.3.2 Hot Detergent System – Flow Control....................................................82
16.3.3 Hot Detergent System – Temperature Control........................................85
16.3.4 Hot Detergent System – Detergent Dosing Control................................88
16.3.5 Hot PUW System – Level Control..........................................................91
16.3.6 Hot PUW System – Flow Control...........................................................94
16.3.7 Hot PUW System – Temperature Control...............................................97
16.3.8 Approved SOP Verification..................................................................100
16.4 Appendix D: Deviation log...........................................................................101
16.5 Appendix E: Deviation Form........................................................................102
16.6 Appendix F: Change Control Log.................................................................110
16.7 Appendix G: Change Control Form..............................................................111
16.8 Appendix H: Component Impact Assessment...............................................116
16.9 Appendix I: Traceability Matrix..........................................................................121

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 5. 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.
Installation Verification IQ-are documented inspections and tests that are performed to verify the installation of
critical aspects of a manufacturing system.
 Complies with approved design and specification documents.
 Fulfils product and process quality related requirements (i.e. material, construction and calibrated
ranges).
Functional Verification OQ-Functional testing is documented inspections and tests that are performed to verify
the functionality of a manufacturing system process before routine operations.
 Tests should include conditions encompassing upper and lower operating limits, to demonstrate that
the system is ready for the intended use and
 Fulfils process and product quality-related requirements.

6. 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.
The ‘Hot Detergent and Hot PUW Generation and Distribution Skid’ will be used to generate and
re-circulate two different cleaning fluids:
• Hot Detergent Solution: A dilute detergent solution heated to 80ºC.
• Hot PUW2 Process Water: Water heated to 80ºC.
The skid will consist of the equipment items outlined below together with all necessary
instrumentation for control and monitoring of the process:
• Hot PUW2 Process Water Tank 1
• Hot Detergent Solution Tank 1
• Centrifugal Recirculation Pumps 4
• Detergent Dosing Pump 1
• Heat Exchangers 2
1. The Detergent Tank is fed directly from the 25°C PUW1 water loop.
2. The PUW1 process water is mixed with concentrated detergent and heated in a Plate and
Frame heat exchanger to 80ºC.
3. A duty/standby pump arrangement is used to re-circulate the hot detergent solution.
4. The hot detergent solution supply temperature is maintained by a closed loop control system,
which modulates steam flow to the heat exchanger HX-211.
5. The PUW2 hot process water tank is fed directly from the 25°C PUW1 water loop.
6. The PUW1 Process water is heated to 80oC in a plate and frame heat exchanger.
7. A duty/standby pump arrangement is used to re-circulate the PUW2 fluid.
8. The PUW2 hot process water supply temperature is maintained by a closed loop control
system, which modulates steam flow to the heat exchanger HX-411.

The system is comprised of a number of tanks and piping, in addition to heat exchangers, which
are utilised for the purpose of generating and transporting hot water (steam) for the purpose of
sterilising medical production systems. This is done to guarantee that the medicines that are
created are free of impurities and are suitable for consumption without any contaminants. In order
to bring water to a temperature that is safe for consumption, the system is comprised of a boiler
that provides heat. Following this, the pure steam is channelled through a network of pipes and
pipings, which are then utilised for the purpose of tank sterilisation. In addition, the pure hot steam
is utilised in the process of sterilising piping systems, filters, and items that are contained within

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sterilisers. Sterilisers for pharmaceutical products are utilised in certain tanks that are included
within the system. In clean room systems, the system also dehumidifies the air, and the
detergents are employed for additional cleaning once the cleaning process has been completed.
The 50-PUW1-S6-148-IH pipeline, which is responsible for transporting hot vapour, is considered
to be one of the most important pipelines in the system. In the event that this pipeline is not
properly managed, for instance if the valve opening breaks in this pipeline, it will ultimately result
in a buildup of high pressure, with the potential for an explosive situation. The system supplies
and distributes cleaning and rinsing solutions for permanent vessels, process lines, in-line
equipment, and associated piping.
The equipment of the Hot Detergent and Hot PUW Generation and Distribution system will
undergo cleaning cycles with precisely regulated flowrates, durations, temperatures, and chemical
concentrations. This process aims to sterilise the medical production systems and guarantee that
the pharmaceuticals produced are devoid of impurities and contaminants. The device produces
thermal energy to raise the temperature of water to a level that is considered safe.

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Maria Kaluzna Page 8
 7. Scope
7.1. System Impact Assessment

The ‘Hot Detergent and Hot PUW Generation and Distribution’ is considered a ‘direct impact’
system because:
 Its is involved in the cleaning of product contact equipment.
 Its function may have an impact of product quality and patient safety.
This system operates by cleaning equipment that comes into touch with the product and
simultaneously produces and circulates two cleaning fluids. This process directly affects the
quality of the product. The manufacturing and distribution of hot detergent and hot PUW are
explained using a "direct impact" approach.

The ‘Hot Detergent and Hot PUW Generation and Distribution’ is considered a ‘direct impact’
system because: This system has a direct impact on product quality as it cleans product contact
equipment in a process and this system is used to generate and re-circulate two different cleaning
fluids. This is why hot Detergent and Hot PUW Generation and Distribution' is considered a 'direct
impact' system. Explanation: The system has a direct impact on the quality of the products
because it has a cleaning system in which the product is equipped in the process. The direct
impact system also facilitates to recirculate and manufacture the two separate cleaning fluids. It
has a direct impact on the manufacturing of a medicinal product for the safety of a patient. The
breakdown of this system would influence patient's security and product quality. Detergents are a
class of molecules known as surfactants whose unique property is to break apart the forces
formed by the interaction of hydrophobic-hydrophilic molecules among the sample. The molecular
head is attracted to water known as hydrophilic while the tail is attracted to dirt and grease called
hydrophobic.
"Commissioning and Qualification" is covered in ISPE Baseline Guide, Volume 5. The terminology
"qualification" and "commissioning" are defined and made clearer in Baseline Guide 5,
"Commissioning and Qualification," along with the degree of regulation pertaining to the former.
After boundaries have been logically established, the following criteria can be used to evaluate
systems: Direct Impact, where the system "is expected to have a direct impact on product
quality"; No Impact, where the system "will not have any impact, either directly or indirectly, on
product quality". • Indirect Impact: In this scenario, the system will usually support a Direct Impact
system even though it is not anticipated to have a direct influence on product quality.
System Direct Impact
Indirect Impact
No Impact
WFI System X
Chilled Water System X
Utilities Monitoring System X
Electronic Batch Record System X
Non-Process HVAC X
Laminar Flow Area X
Sprinkler System X
Typical System Impact Matrix
Verification / Qualification Protocol
The Impact Spectrum
Your factory is made up of numerous different systems such as:

 Parking facilities
 Elevators
 Office air conditioner
 Chilled water production
 Air conditioner

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  Building management system
 Autoclave
 Purified water system
 Clean-In-Place (CIP) system

GEP

Each of these systems is made up of many different items, components, subsystems and
instruments.
There is a tendency among novice CQV, C&Q, validation technicians and engineers to qualify
100% of the components in every system. The safest approach is surely that.
Nevertheless, as the economist Thomas Sowell observed,
Trade-offs are the only solutions.
A 100%-of-items-in-every-system approach certainly has its drawbacks.
Qualify -the design and use of these systems can affect their impact Verification / Qualification
Protocol.

The approach of qualifying 100% of items in every system is not the solution due to its trade-offs,
such as being expensive and wasteful, making medicines less affordable, increasing regulatory
burden, and not being a one-time cost. Additionally, every item must be documented and
managed according to the change control procedure. The biggest trade-off is the risk of
something being missed, as not every system or item has a critical impact on product quality and
patient safety. To address these issues, impact assessments can be conducted at system-level
and component-level levels. System-level impact assessment determines which systems within
the plant are crucial, while component-level impact assessment identifies which components are
crucial to product quality. Good Engineering Practices (GEPs) are used to manage the design,
installation, and commissioning of systems and their components within a facility, and these
systems must also be qualified by regulatory authorities like FDA and EMA when approving
medicines being manufactured in that facility.

Use conventions:
• Upstream/ Downstream side of valves;
• Last valve on distribution system;
• Instrumentation controlled by a skid part of skid system.

7.2. 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.

 Evaluating the impact of the equipment will increase the ability to install and operate. Contact
elements and critical work elements should be included in the installation analysis. The
functionality of the product will lead to experimental studies.
 The second step evaluates the importance of physical properties that affect product quality,
evaluates the system's components' criticality in terms of product quality. This guide specifies
the process of determining the relationship between the type of interference on the product or
one of its components and criticality of the machine or equipment. The approach for
determining the relationship between the criticality of a system or one of its components and
the type of influence it has on the product is outlined in the Guide.
 Direct effects may have non-essential properties as well as essential properties. However,
indirect effects may not have significant characteristics.

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  If the latter is found to occur during the impact evaluation, System Impact Assessment
process, the components must be assessed, and the system's impact or the component's
criticality must be reconsidered again.
Please see section 16.8, Appendix H for details.

7.3. Summary Table - Operational Critical Components

# *Operational **Additional Rationale
Critical components in the
Component loop (if
applicable)
1 P-207 (Detergent Linked to FL-399, It is on the hot detergent supply line and it must
Centrifugal HX-211. work to control flow. Detergent Centrifugal
Transfer Pump) Transfer Pump. Essential for transfers of
detergent, which affects the effectiveness of the
system’s cleaning.

2 P-209 (Detergent Linked to FL-399, It is on the hot detergent supply line and it must
Centrifugal HX-211. work to control flow, Helps maintain proper flow of
Transfer Pump) detergent solution, critical for effective cleaning
and product safety.

3 P-415(PUW2 Linked to FL-401, It is on the hot PUW2 supply line and it must work
Centrifugal HX-411. to control flow. Ensures proper flow of purified
Transfer Pump) water, essential for rinsing after cleaning to
remove residual detergent.

4 P-417(PUW2 Linked to FL-401, It is on the hot PUW2 supply line and it must work
Centrifugal HX-411. to control flow. Same rationale as P-415, ensuring
Transfer Pump) proper flow of purified water for rinsing.

5 P-223 (Detergent Linked to V034 It is on the process line and it must work to control
Metering Pump) Sanitary the flow of concentrated detergent. Detergent
Diaphragm Valve Metering Pump. Controls precise concentration of
and V036 Sanitary detergent solution, operationally critical for
Diaphragm Valve, effective cleaning.
FS 005L (Low
Flow switch) and
FA005L.

6 LS-003 (Low Linked to It is located on the hot PUW2 tank, T-411. It must
Level Switch LAL003LL. work to alert low levels in the tank.
Tuning fork type)

7 LS-004 (Low Linked to LA004LL It is located on the hot detergent tank, T-211. It
Level Switch must work to alert low levels in the tank. It is part
Hot detergent
Tuning fork type) of the hot detergent tank and used to track the
Tank.
level when it gets too low.

8 LS-005 (High LA005H. It is located on the hot PUW2 tank, T-411. It must
Level Switch work to alert high levels in the tank.
Tuning fork type)

9 LS-006 (High LA006, SG002 It is located on the hot detergent tank, T-211. It

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 Level Switch Vessel sight glass must work to alert high levels in the tank. It is part
(Tuning fork (sanitary design). of the hot detergent tank and used to track the
type) level when it gets too high.

10 LT-001 LIT001, Hot PUW It is located on the hot PUW2 tank, T-411. It must
(Hydrostatic Tank. work to regulate the amount of PUW entering the
Pressure type tank. Part of the Hot PUW2 Tank. Used to
level measure the tank level.
Transmitter)

11 LT-002 LIT002, Hot It is located on the hot detergent tank, T-211. It

(Hydrostatic Detergent Tank T- must work to regulate the amount of PUW
Pressure type 211. entering the tank. Part of the Hot Detergent Tank
level and is used to measure the tank level.
Transmitter)

12 TI-007 (Bimetalic Hot PUW2 Tank T- It is located within the thermowell on hot
Temperature 411. detergent tank, T-411. It must work to provide a
indicator) temperate reading of inside the vessel. Part of the
Hot PUW2 tank and is used to record the tanks
temperature. Bimetalic Temperature indicator
provides temperature monitoring for detergent
solution, operationally critical for effective
cleaning.

13 TI-008 (Bimetalic Hot Detergent It is located within the thermowell on hot

Temperature Tank T-211. detergent tank, T-211. It must work to provide a
indicator) temperate reading of inside the vessel. Part of the
Hot detergent tank and is used to record the tanks
temperature.

14 TI-009 (Bimetalic 65-PUW2-S6-160- It is located on the hot PUW2 supply line. It must
Temperature IH, close to HX- work to provide a temperature reading of fluid in
indicator) 411 Hot PUW2 the line. Indicate the temperature on the supply
Heat Exchanger. line.

15 TI-010 (Bimetalic 65-DETERGENT- It is located on the hot detergent supply line. It

Temperature SS1-154-IH next must work to provide a temperature reading of
indicator) to HX-211 Hot fluid in the line, indicate the temperature on the
Detergent supply line.
Exchanger.

16 CT-001 CIT001, PT002, It is on the hot detergent supply line and must
(Conductivity FT002, 65- work to regulate the dosage of detergent
transmitter) DETERGENT- supplied. Is on the hot detergent supply line and
SS1-154-IH. is used to record the conductivity on the supply
line. Conductivity transmitter measures
conductivity of purified water, critical for ensuring
proper rinsing and removal of detergent residues.
It is on the hot detergent supply line and must
work to regulate the dosage of detergent
supplied.

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17 FS-005 (Low FA005L, 25- It is located on the process line. It must work to
Flow switch) PROCESS-S6- alert low flow coming from the detergent metering
162-NI, close to pump, P-223. Low Flow switch. Detects low flow
FL-401. conditions, which could indicate issues with
cleaning or rinsing processes.
It is on the hot PUW2 supply line and must work
18 FT-001 Monitors flow in
to measure the flow of fluid in the supply line.
(Magnetic flow piping systems,
Magnetic flow Transmitter. Handles detergent,
Transmitter) FIT001. V041,
which again critical for operational control and
PT001, V007, 65-
frequently relevant for product operation.
PUW2-SS1-160- Measures and provides feedback on detergent
IH. solution flow, operationally critical for ensuring
proper cleaning.
19 FT-002 FIT002, 65- It is on the hot detergent supply line and must
(Magnetic flow DETERGENT- work to measure the flow of fluid in the supply
Transmitter) SS1-154-IH, line. Measures and provides feedback on purified
CT001, V014. water flow for rinsing.

20 FT-003 FIT003, 65- It is on the hot PUW2 return line and must work to
(Magnetic flow PUW2-S6-164-IH, measure the flow of fluid in the line.
Transmitter) PI005, XV005.

21 FT-004 FIT004, TT004, It is on the hot detergent return line and must
(Magnetic flow PI006, 65- work to measure the flow of fluid in the line.
Transmitter) DETERGENT-S6-
163-IH.

22 TT-001(3 wire TIT001, TI009, 65- It is on the hot PUW2 supply line and must work
RTD PUW2-S6-160-IH, to record temperature of the supply. 3 wire RTD
Temperature 25-VENT-S6-173- Temperature transmitters. Monitors and transmits
transmitters) NI. temperature data, vital for operational control.
Provides temperature measurement and
feedback, essential for controlling detergent
solution temperature.

23 TT-002 (3 wire TIT002, TI010, It is on the hot detergent return line and must
RTD V042, PSV002, work to record temperature of the supply.
Temperature 25-VENT-S6-172-
transmitters) NI.

24 TT-003 (3 wire TIT003, PI005, 65- It is on the hot PUW2 return line and must work to
RTD PUW2-S6-164-IH. record temperature.
Temperature
transmitters)

25 TT-004(3 wire Linked to TCV-006 It is on the hot detergent return line and must
RTD work to record temperature (of the return
TIT004,
Temperature detergent). 3 wire RTD Temperature transmitters.
transmitters) 65-DETERGENT- Monitors and transmits temperature data, vital for
S6-163-IH, FT004. operational control.

26 TCV-005 (Steam V020, 65-PLANT It is on the plant steam line and must work to

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 Temperature STEAM-CS5-183- control steam temperature coming from the Heat
control valve) IH, 5-PLANT exchanger, HX-411.
CONDENSATE-
CS5-184-IH,
V021, 100-PLANT
STEAM-CS5-241-
IH.

27 TCV-006(Steam V019, 65-PLANT It is on the plant steam line and must work to
Temperature STEAM-CS5-183- control steam temperature coming from the Heat
control valve) IH, close to HX- exchanger, HX-211. Steam Temperature control
211, 100-PLANT valve. Monitors and transmits data about the
STEAM-CS5-241- temperature of steam, which also plays a role in
operational control.
IH.

28 PT-001 (Sanitary PIT001, TI009, It is located on the hot PUW2 supply line. It must
Diaphragm type FT001, 65-PUW2- work to measure the pressure on the supply line.
Pressure S6-160-IH, on the
Indicating way to X-411.
transmitters)
It is located on the hot detergent supply line. It
29 PT-002 (Sanitary Linked to system
must work to measure the pressure on the supply
Diaphragm type pressure controls,
line. Sanitary Diaphragm type Pressure Indicating
Pressure PIT002, TI010,
transmitters. Monitors pressure in the system,
Indicating CT001, 65- which is essential for safety. Measures and
transmitters) DETERGENT- provides feedback on purified water flow for
SS1-154-IH, close rinsing.
to HX-211.

30 PI-003 V003, P-209, Located on the hot PUW2 supply line. It must
(Diaphragm type SCS209, 65- work to give a pressure reading.
pressure PUW2-S6-159-IH.
indicator)

31 PI-004 V010, V012, 65- Located on the hot detergent supply line. It must
(Diaphragm type DETERGENT - work to give a pressure reading.
pressure S6-153-IH, close
indicator) to P-207.

32 PI-005 Ft003, TT003, 65- Located on the hot PUW2 return line. It must work
(Diaphragm type PUW2-S6-164-IH, to give a pressure reading. Diaphragm type
pressure HOT PUW2 pressure indicator, Provides pressure monitoring
indicator) RETURN. for detergent solution line, operationally critical for
proper flow and preventing over-pressurization.

33 PI-006 XV006, FT004, Located on the plant steam line. It must work to
(Diaphragm type 65-DETERGENT- give a pressure reading. Diaphragm type
pressure S6-163-IH, HOT pressure indicator. Provides pressure monitoring
indicator) DETERGENT for purified water line.
RETURN.

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34 PI-007 (Local V018, V019, 100- Located on the hot detergent return line. It must
pressure PLANT STEAM- work to give a pressure reading
indicators c/w CS5-241-IH.
bourdon type
gauges)

35 PI-008 V035, 25- Located on the process line. It must work to give
(Diaphragm type PROCESS-S6- a pressure reading. Monitors pressure of steam
pressure 162-NI, near supply, operationally critical for proper heating of
indicator) FL401. P-223. detergent solution.

36 HX-211 65-PLANT PUW2 Plate Heat Exchanger. Maintains required

(Detergent Plate STEAM-CS5-183- temperature of detergent solution, operationally
Heat Exchanger) IH, 65- critical for effective cleaning.
DETERGENT-
SS1-154-IH HOT
DETERGENT
SUPPLY, 65-
DETERGENT -
S6-153-IH, V013.

37 HX-411 (PUW2 65-PUW2-S6-160- PUW2 Plate Heat Exchanger. Critical component

Plate Heat IH, HOT PUW2 product,
Exchanger) SUPPLY, 65-
PUW2-S6-159-IH,
V005, ST003,
V025, 65-PLANT
STEAM-CS5-183-
IH.

38 PSV-001 25-VENT-S6-173- PUW2 Sanitary Pressure Relief Valve. Helps

NI, 65-PUW2-S6- maintain safe pressure levels in purified water
160-IH, close to lines, preventing over pressurization and potential
HX-411. equipment damage.

39 PSV-002 25-VENT-S6-172- Detergent Sanitary Pressure Relief Valve.

NI, TT02, next to Maintains safe pressure levels in detergent lines.
XH-211, next to
65-DETERGENT-
SS1-154-IH HOT
DETERGENT
SUPPLY.
Hot PUW2 Tank. Handles PUW2 used in
40 T-411 (Hot Lines: 100-VENT-
processes that directly affect product safety.
PUW2 Tank) S6-168-NI, 0-
PUW1-S6-148-IH,
65-PUW2-S6-164-
IH, 80-PUW1-S6-
486-IH, 80-PUW1-
S6-486-IH, 80-
PUW2-S6-155-IH

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 & LIT001, LT001,
LS003, LAL003,
TI007, SG001,
ZS030, LS005,
LA005, XV008,
PRV001.

41 T-211 (Hot Surrounded by: Hot Detergent Tank Product contact critical
Detergent Tank) 50-DRAIN-S6-170- component,
NI, 80-
DETERGENT-S6-
149-IH, 100-
VENT-S6-166-NI,
50-PUW1-S6-147-
IH, 80-PUW1-S6-
486-IH, XV009,
LA006, LS006,
SG002, ZS031,
TI008, LS004,
LA004, XV004,
XV002, LT002,
LIT002, SG006.

42 XV-008 On 50-PUW1-S6- Is on line 148 and controls the supply of 25ºC

(Actuated 148-IH, next to Hot PUW1 entering the Hot PUW2 tank.
Sanitary Ball PUW2 Tank.
Valve)

43 XV-009 On 50-PUW1-S6- Is on line 147 and controls the supply of 25ºC

(Actuated 147-IH, next to Hot PUW1 entering the Hot detergent tank.
Sanitary Ball Detergent Tank.
Valve)

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7.4. 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.

A piping and instrumentation diagram, or P&ID, shows the piping and related components of a
physical process flow. It’s most commonly used in the engineering field.
P&IDS are foundational to the maintenance and modification of the process that it graphically
represents. At the design stage, the diagram also provides the basis for the development of
system control schemes. For processing facilities, it’s a graphic representation of:
Key piping and instrument details
Control and shutdown schemes
Safety and regulatory requirements
Basic start up and operational information
Piping and Instrumentation Diagrams (P&IDs) are visual representations that depict the functional
connections between piping, instrumentation, and system equipment components in the field of
instrumentation and control. They are commonly developed by engineers who are creating a
manufacturing process for a physical plant.
Typically, these facilities necessitate intricate chemical or mechanical procedures, which are
carefully planned using P&IDs to build a plant and ensure plant safety. P&IDs also serve as a
point of reference for Process Safety Information (PSI) in Process Safety Management (PSM).
When encountering an issue, it is advisable to begin by examining the P&ID (Process and
Instrumentation Diagram).
Piping and Instrumentation Diagrams (P&IDs) are highly useful records that are essential to have
readily available. They serve multiple purposes, such as optimising an existing process, replacing
equipment, or providing guidance for the design and execution of a new facility.

The use of Management of Change (MOC) allows for safe and efficient planning of modifications
based on the provided record.
Field techs, engineers, and operators use P&IDs to better understand P&IDs. P&IDs are used by
field techs, engineers, and operators to better understand P&IDs.
Understand the process and how the instrumentation is used to understand the process.
The two are interconnected. They're also great for educating people.
Contractors are involved.
P&IDs, in the realm of instrumentation and control, are schematic diagrams that depict the
functional connections between pipe, instrumentation, and system equipment components.
Engineers involved in constructing a physical plant typically develop these.

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Maria Kaluzna Page 18
Maria Kaluzna Page 19
8. 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

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9. Definitions/ Glossary

Acronym Definition

BDS Bulk Drug Substance

EHS Environment, Health & Safety

E&I Electrical & Instrumentation

FDA The United States Food and Drug Administration is a federal agency of
the Department of Health and Human Services.

FRS Functional Requirement Specification

GMP Good Manufacturing Practices

IQ Installation Qualification
International Society for Pharmaceutical Engineering
ISPE

OQ Operational Qualification

P&ID Piping & Instrumentation Diagram

QA Quality Assurance

QC Quality Control

SME Subject Matter Expert.

SOP Standard Operating Procedure

URS User Requirement Specification

VMP Validation Master Plan

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10. Responsibilities / Subject Matter Experts

1. 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

2. Quality Assurance

Headers are not typically displayed on Process Unit/Utility P&IDs. Lines to or from a header must
end with a number enclosed in arrow boxes. If a header serves only two or three users within a unit
and can be shown with the correct sequence of branches, it should be fully displayed on the
Process Unit/Utility P&ID. The Verification Body's quality manual should include procedures for
ensuring the required level of quality and reliability in verification activities. This includes quality
assurance measures such as review and auditing. This includes the reviews and audits outlined in
Table 2, 'Quality assurance steps for verification bodies'.
Location Target Task Verification Body External Technical Expert
Internal Auditor
Verification body Specific verification Review Review
protocol
Test body Test plan Review -
Test body Tests system Test system audit -
performance and
test body quality
management
system
Test body Test performance Test performance -
audit
Test body Test report Review -
Verification body Verification report Review Review
Verification body Statement of Review Review
verification
Table - Quality assurance steps for verification body.
 Review and approval of the validation protocol and report.
 Confirm CV adheres to regulatory requirements and validation SOP’s.
 Review and approve any deviations/investigations related to cleaning studies.

3. Quality control

The national accreditation bodies are responsible for ensuring that ETV Verification Bodies comply
with the standards set by ISO/IEC 17020 for inspection bodies type A, as well as this General
Verification Protocol. This includes the requirement for a quality management system that adheres
to the principles of EN ISO 9001. Additionally, the analytical laboratories must adhere to the
requirements of ISO/IEC 17025 for the specific methods of testing and calibration. The Verification
Body holds the ultimate responsibility for ensuring that the verification process is carried out in
accordance with this General Verification Protocol. It is the duty of the Verification Body to oversee

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and monitor the test body's adherence to the procedures outlined in this GVP and the relevant
specific verification protocol.

Verification Body Assessment, quality assurance and control

Quality assurance and control

Test Body
Assessments Results

Results
Accreditation Body Analytical Laboratory
Assessment

Figure-Principles of quality assurance in ETV (indicative only).

 Complete testing of samples taken under this protocol.
 Adhere to all SOP’s / WI’s/ Protocols associated with testing of cleaning validation samples.
 Review and approve samples.

4. Manufacturing

The primary goal of Environmental Technology Verification (ETV) is to facilitate the adoption of
environmental technologies by offering technology innovators, manufacturers, and investors the
opportunity to obtain third-party validation of the effectiveness of novel environmental solutions. This
enables makers to substantiate the dependability of their assertions, while aiding technology buyers
in identifying advancements that align with their requirements.
The anticipated effect on technology markets is to expedite the adoption and dissemination of
cutting-edge environmental technologies.
 Protocol and report evaluation and authorization (review and approval).
 Follow/adhere any, all Standard Operating Procedures (SOPs) related to the functioning of the
system/equipment.
 Implement suitable measures to regulate the utilisation of the equipment. Implement
appropriate controls on the use of the equipment.
 Follow the established steps for setting up. Set-up according to procedures.
 Ensure that all duties/tasks linked to the procedure have been done with the required training.
 Implementation/execution of cleaning protocols, procedures.

5. Engineering

ETV prioritises quantitative and measurable factors that can be assessed through testing and are
directly linked to a technology's performance and its environmental benefits. The environmental
value contributed is assessed from a life-cycle standpoint, taking into account the primary
advantages and impacts during the technology's lifespan, utilising a simplified and restricted life-
cycle methodology. ETV differs in its purpose and does not offer the same data as other specialised
environmental tools that rely on life-cycle information, such as Life-Cycle Analysis (LCA),
Environmental Product Declaration (EPD), or Product Environmental Footprint (PEF).
 Engineering is accountable for ensuring the secure functioning and upkeep of equipment.
Responsible for the safe operation and maintenance.
 Ensure that the system is prepared and capable of being executed. Verify system readiness
for execution.
 Adhere to the procedures for managing changes. Follow Change Control Procedures.

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  Apply suitable measures to regulate the use of equipment. Implement appropriate controls
on the use of equipment.

6. Maintenance/ Calibrations

The looking into handle might be archived to guarantee an satisfactory level of quality and
unwavering quality. Portrayal of the strategy for recording surveys might be included within the
quality manual. Non-analytical estimation strategies need to be clearly depicted in
the test arrange, counting required calibration and quality control. The records of test information
(crude information) should be put away, exchanged, maintained and controlled in arrange to
guarantee information judgment for a period characterized within the test arrange, but not shorter
than 5 a long time from completion of the test.
 Responsible for maintaining equipment and system.
 Ensuring equipment is within calibration date.
 Calibrating new equipment.

7. HR / Training

A strategy on instruction, preparing and information of modern staff within the test body should be
included in a quality manual and should portray how the test body guarantees that tests are done by
staff with satisfactory competences and information of their obligations.
The faculty capable for carrying out the test exercises might have the taking after:
1. sound specialized and professional preparing covering all the test exercises done by the test
body;
2. palatable information of the prerequisites of the test methods they carry out and satisfactory
specialist to carry out those strategies;
3. the capacity to draw up reports and records illustrating that test strategies have been carried
out and prerequisites of this GVP and the particular confirmation convention have been
fulfilled.

8. EHS

Conduct verification activities with utmost professional integrity and technical competence in the
relevant field. Ensure complete independence from any external pressures or inducements, such as
financial incentives, that could potentially affect judgement or the outcome of verification activities.
This is particularly important when dealing with individuals or groups with a vested interest in the
results.
 Review and approve risk assessments for new equipment. Installation Verification Testing
Procedures.

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11. Installation Verification Testing Procedures

11.1. 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.
Test bodies must meet the applicable requirements outlined in part C Quality management with
regards to their involvement in the verification process (C.I), quality management (C.III), and quality
assurance and control for tests and analyses (C.IV). Additionally, the verification protocol specific to
the technology being tested, as outlined in Chapter B.IV, may impose additional requirements on
test bodies, especially in terms of quality assurance and control, to ensure the accuracy and
reliability of test results and data for the technology under consideration.

2. Linkage to Requirements Challenged

Confirm correct installation and orientation of direct impact components as per the P&ID schematic
illustration.
In the event of a need, the proposer shall decide on test bodies. The Verification Body is usually
involved in discussions with the proposer to ensure that designated test bodies meet its qualification
standards. The proposers determine who become test bodies although Verification Body itself may
have this capacity for testing. In such cases, it is necessary for the proponent to designate analytical
laboratories where the samples are to be tested.

For each PFD, multiple P&IDs will be required to provide all the needed data.

Among other information, P&ID contains details about piping and therefore it is an integral part of
this drawing. An alternative approach could involve numbering each pipe and providing separate
details about every line in a table attached along with this drawing.

If possible, larger units should be shown as bigger symbols in this diagram so that they are
identified by their physical sizes.

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https://miro.medium.com/v2/resize:fit:640/format:webp/
1*jk6TGE4QI8avf_n4m74ybQ.jpeg
P&ID for Benzene Distillation (adapted from Kauffman, D., Flow Sheets and
Diagrams, AIChE Modular Instruction, Series G: Design of Equipment, series editor J.
Beckman, AIChE, New York, 1986, vol. 1, Chapter G.1.5, AIChE copyright © 1986
AIChE, all rights reserved)
Utility connections are identified by a numbered box in the P&ID. The number within the box
identifies the specific utility. The key identifying the utility connections is shown in a table on the
P&ID.

3. Acceptance Criteria

All direct impact components are functionally installed and orientated correctly as per the P&ID
specification.
Perform HAZOP design/review. It is utilized as a reference archive for the management of handle
security data (PSI) in Prepare Security Administration (PSM).It permits getting the fundamental data
to be able to analyze the dangers of the prepare, the potential disappointments and the existing
shields in arrange to minimize the most noteworthy number of blunders in operation, plan or
humans. conditional acknowledgment of existing information, in which case the conditions for
acknowledgment shall be point by point in the particular confirmation convention; these conditions
may incorporate the re-testing of particular prerequisites or basic estimations.

4. Prerequisites and/or Assumptions

1. All commissioning activities are complete and commissioning punch-list items are closed
out.
2. 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.

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5. Test Method

1. On a blank copy of the P&ID draw in the direct-impact system boundary in black-ink.
2. Walk down the P&ID and using a yellow-highlighter confirm each component is correctly
installed and orientated as represented on the P&ID.
3. Confirm all component tag numbers are correct.
4. Confirm all lines are correctly labelled.
5. Confirm all lines where applicable are correctly insulated.
6. Ensure all flow direction components are orientated correctly.
7. Ensure all instruments indicators are orientated correctly so as operators can readily view
them in the field.
8. Ensure all commissioning filters are installed in filter-housings.
9. 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

1. 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.
2. Assess each step listed and determine whether the step has passed or failed.
3. The person performing the test should be identified and the date the testing was performed
should be recorded.
4. At the bottom of the test script a validation peer (other than the person performing the test)
shall review the script post execution.
5. Quality Assurance (QA) shall approve the completed test.

Validation Peer Review

AISLING FIELD Aisling Filed 18 MAR 24

Print Name Signature Date

11.2. 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

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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

1. All commissioning activities are complete and commissioning punch-list items are closed
out.
2. 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

1. 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.
2. Confirm that the vendor handover package is in place and contains correct material
certificates.
3. In the field visually confirm the following:
 Equipment/instrument 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. Instrument and cabling are correctly tagged and 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

1. 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.
2. Assess each step listed and determine whether the step has passed or failed.
3. The person performing the test should be identified and the date the testing was performed
should be recorded.
4. At the bottom of the test script a validation peer (other than the person performing the test)
shall review the script post execution.
5. Quality Assurance (QA) shall approve the completed test.

Validation Peer Review

BRIAN ROCHE Brian Roche 18 MAR 24

Print Name Signature Date

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11.3. 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

1. All commissioning activities are complete and commissioning punch-list items are closed
out.
2. 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

1. 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,
2. 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 Checks heet is available (Yes/No).
3. 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.

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  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

1. 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.
2. Assess each step listed and determine whether the step has passed or failed.
3. The person performing the test should be identified and the date the testing was performed
should be recorded.
4. At the bottom of the test script a validation peer (other than the person performing the test)
shall review the script post execution.
5. Quality Assurance (QA) shall approve the completed test.

Validation Peer Review

JONATHAN WALSH Jonathan Walsh 16MARCH24

Print Name Signature Date

11.4. 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

1. All commissioning activities are complete and commissioning punch-list items are closed
out.

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 2. 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

1. Pre-populate the piping verification with the Tag # and material-of-construction (MOC)
details.
2. In the field enter the details of the weld log for every each pipe Tag #.
3. Confirm the Weld Log is complete, as the Weld Log collates material-of-construction
certificates and weld inspection certificates.
4. In the field record the details of the Pressure Test Pack for every each pipe Tag #.
5. Confirm the Pressure Test is complete verifying the absence of leaks
6. In the field enter the details of the Construction Dossier for every each pipe Tag #.
7. Confirm all slopes have been checked and verified as correct from the Construction Dossier.

6. Expected Results and Actual results

1. 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.
2. Assess each step listed and determine whether the step has passed or failed.
3. The person performing the test should be identified and the date the testing was performed
should be recorded.
4. At the bottom of the test script a validation peer (other than the person performing the test)
shall review the script post execution.
5. Quality Assurance (QA) shall approve the completed test.

Validation Peer Review

ADAM CHANEY Adam Chaney 19MARCH24

Print Name Signature Date

11.5. 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.

To verify that we are validating in-house installation during installation verification, we shall have the
instruments in the calibration system. Calibration is a test procedure (only one) for verification
testing and takes measurements as if you were calibrating, and then with the same results but
obtain numerical values that does not depend on the concentration (mg/mL) or the quantity (%) by
the test obtained by the test procedure. Calibration verification refers to testing materials of known
concentration in the same manner as patient samples in order to ensure that the calibration of the
instrument or test system for patient test results is in alignment with the requirements for calibration

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across the reportable range. The manufacturer of the test system should provide instruction on how
to perform calibration and the frequency with which it should be done. Calibration must conform to
or exceed the performance of the manufacturer’s instructions and the laboratories.

This protocol ensures that the Hot Detergent and Hot PUW Generation and Distribution system's
critical instruments are within calibration at the time of execution, as listed and verified in Testing
Sections, 16.2.5, of this protocol.

11.6. 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.

1. All of the reagents utilized for a test strategy are changed to modern part numbers, unless
the research facility can illustrate that changing reagent parcel numbers does not influence
the range utilized to report understanding test comes about, and control values are too not
unfavourably affected by reagent part number changes.
2. There is major preventive upkeep or replacement of basic parts that may impact the test’s
execution. This incorporates when the research facility sends a test framework to the
producer for repairs. The laboratory must check the calibration of a repaired test framework
some time recently continuing patient testing and announcing comes about.
3. Control materials reflect an abnormal drift or move, or are exterior of the laboratory’s
satisfactory limits and other implies of surveying and correcting unsatisfactory control values
come up short to recognize and redress the issue.
4. The laboratory has decided that the test systems reportable extend for quiet test results
ought to be checked more regularly.
Pumps: Each pump in the system underwent preventative maintenance to guarantee
their mechanical integrity and proper functioning.
Heat exchangers: Preventative maintenance was conducted on both heat
exchangers in the system, and the heating elements were examined to verify their
proper functioning.
Filters: Preventative maintenance was performed on each of the filters in the system
to ensure their suitability for the intended function.
Pressure Safety Valves: Each of the PSV's in the system underwent preventative
maintenance to ensure their proper functioning at the designated pressure.
Temperature Indicator: Preventative maintenance was performed on both
temperature indicators of the tanks to maintain accurate temperature readings.
Level transmitter: Preventative maintenance was performed on both level indicators
of the tanks to ensure accurate level readings.

11.7. 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.
Standard operating procedures (SOPs) are a great way to ensure that a process or procedure is
consistently followed throughout an organisation, regardless of whether there are temporary or
permanent staff changes. This helps to minimise inconsistency and enhance quality. Standard
operating procedures (SOPs) should include precise work instructions and can be utilised as part of

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a people training programme. They can also indicate conformity with organisational and regulatory
regulations. It helps alleviate worries about safety and reduces the likelihood of misunderstandings.
Standard Operating Procedures (SOPs) are useful for re-creating project operations when no other
references are accessible, which is especially useful for evaluating historical data for present
application. Furthermore, when auditing procedures, inspectors often employ SOPs as checklists. In
the end, having a proper SOP will help you save time and effort while also making your work more
credible, easier to compare, and more legally defendable. Using published methods does not
eliminate the requirement for standard operating procedures. A standard operating procedure
(SOP) for a standard analytical technique, for instance, should go into more depth than what's
actually in the published method itself when outlining the steps to follow.
Standard Operating Procedures can be employed in a staff training programme as they offer exact
job instructions and showcase adherence to organisational and regulatory requirements. It
eradicates the potential for misinterpretation while simultaneously resolving safety apprehensions.
SOP-235 Operational and maintenance of CIP wash tanks 12
SOP-157 CIP procedures for bioreactors 4.3
SOP-1002 Operational and maintenance of steam supply line 6.7
SOP-645 Operational and maintenance of hot detergent line 15.6
SOP-880 Operational and maintenance of PUW1 supply line 3.9
SOP-184 Operational and maintenance of pumps in generation and distribution system 1.7
SOP #: Operation of the Hot detergent system Revision 1
11302
SOP #: Operation of the Hot PUW2 system Rev/0
11303
SOP #: Cleaning the Hot PUW2 and Hot Detergent system Rev.0
11304
SOP #: 11325 Examine the attachments and connections on the Hot detergent and hot PUW generation and distribution Rev.2
skid.
SOP #: 11330 Assembling and disassembling the Hot detergent and hot PUW generation and distribution skid Rev.3

11.8. 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

Twice a day, at least four hours apart, check and record the incubator's temperature. A

NIST certified thermometer must be used to verify thermometers at least once a year,

following the guidelines outlined in SOP JSELEB-111. The JSEL Quality Manual's

appendix G contains a list of equipment and their SOP numbers for calibration of

laboratory equipment.

List of test instruments that may be required for the testing phase.

 Steam Temperature control valve,

 Steam Temperature control valve,

 3 wire RTD Temperature transmitters,

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  3 wire RTD Temperature transmitters,

 3 wire RTD Temperature transmitters,

 3 wire RTD Temperature transmitters,

 Sanitary Diaphragm type Pressure Indicating transmitters,

 Sanitary Diaphragm type Pressure Indicating transmitters,

 Magnetic flow Transmitter,

 Magnetic flow Transmitter,

 Magnetic flow Transmitter,

 Magnetic flow Transmitter,

 Conductivity transmitter,

 Bimetalic Temperature indicator,

 Bimetalic Temperature indicator,

 Bimetalic Temperature indicator,

 Bimetalic Temperature indicator,

 Hydrostatic Pressure type level Transmitter,

 Hydrostatic Pressure type level Transmitter,

 Actuated Sanitary Ball Valve,

 Actuated Sanitary Ball Valve,

 High Level Switch (Tuning fork type),

High Level Switch (Tuning fork type).

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12. 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: ____Maria Kaluzna_______________ Date: 15MAR24___

Validation Engineer
Approved By: __Daniel Crandol_____________ Date: _18MAR24__
Validation Manager
Your signature attests that you have reviewed this document and it complies with
relevant validation policies & procedures.

Approved By: _Frank Roche_______________ Date: _19MAR24___

Engineering
Your signature attests that that you have reviewed this document and confirm its
accuracy against the associated specifications and design.
……(align with ‘Responsibilities’ Protocol Section-2)

Approved By: __Calvin Moore_____________ Date: _22MAR24_____

QA
Your signature attests that you have reviewed this document and confirm it complies
with cGMPs regulatory requirements, local and corporate policies, that it complies
with relevant Quality Assurance policies & procedures……(align with
‘Responsibilities’ Protocol Section-2)

Approved By: __Nick Walsh__________ Date: __25MAR24_______

Maintenance/ Calibrations Engineer
Your signature attests that you have reviewed this document and it complies with
relevant calibrations policies & procedures.
……(align with ‘Responsibilities’ Protocol Section-2)

Approved By: __James Egan_____________ Date: _25MAR24_____

Manufacturing
Your signature attests that you have reviewed this document and confirm it complies
with relevant manufacturing policies & procedures
……(align with ‘Responsibilities’ Protocol Section-2)

Approved By: __Cian Brennan _____________ Date: _26MAR24_____

HR/Training
Your signature attests that you have reviewed this document and confirm it complies
with relevant manufacturing policies & procedures
……(align with ‘Responsibilities’ Protocol Section-2)

Approved By: __ Kathy McDonald _____________ Date: _26MAR24_____

EHS
Your signature attests that you have reviewed this document and confirm it complies
with relevant manufacturing policies & procedure
……(align with ‘Responsibilities’ Protocol Section-2)

Maria Kaluzna Page 35

Approved By: __Matthew Doyle __________ Date: __25MAR24____
QC
Your signature attests that you have reviewed this document and it complies with
relevant calibrations policies & procedures.
……(align with ‘Responsibilities’ Protocol Section-2)

Maria Kaluzna Page 36

 12.1.Operational-Critical-Instrument Calibration Verification Form
Page _ 1__ of _ _3_

Operational-Critical-Instrument Calibration Verification Form

Critical instruments associated with the system will remain in a

calibrated state during the anticipated OQ execution timeframe? Verified By / Date
(Yes/No)

Tests that are considered non-quantitative (e.g., Prothrombin Time (PT) and Activated Clotting Time
(ACT), which are measured in units of time) do not require calibration verification.
In order to meet the calibration verification requirements for automated cell counters, the laboratory
must adhere to the manufacturer's instructions for operating the instrument. Additionally, the laboratory
must test two levels of control materials each day of testing. The control results must meet the
laboratory's criteria for acceptability.
The laboratory must follow the manufacturer's instructions for operating the instrument and test three
levels of control materials (the lowest, mid-level, and highest level available) more than once per testing
day. The results of the tests must meet the laboratory's acceptability criteria, and the control materials
must be traceable to National Institute of Standards and Technology (NIST) reference materials in order
for the calibration verification requirements for automated chemistry analyzers to be considered met.
Providing that the calibration procedure for the test system incorporates three or more levels of
calibration material, as well as a low, a medium, and a high value, and that it is carried out at least once
every six months, then the requirement for calibration verification is also satisfied.
New lot numbers are assigned to all reagents used in a test procedure, unless the laboratory can prove
that changing lot numbers does not impact the reporting range of patient test results or affect control
values.

There is major preventive maintenance or replacement of critical parts that may influence the test’s
performance.This includes when the laboratory sends a test system to the manufacturer for repairs. The
laboratory must check the calibration of a repaired test system before resuming patient testing and
reporting results

Maria Kaluzna Page 37

 Page _ 2__ of _ 3__

LS-003 MK 15MAR24
LS-004 MK 15MAR24
LS-005 MK 15MAR24

LS-006 MK 15MAR24

LT-001 MK 15MAR24

LT-002 MK 15MAR24

TI-007 MK 15MAR24

TI-008 MK 15MAR24

TI-009 MK 15MAR24

TI-010 MK 15MAR24

CT-001 MK 15MAR24

FS-005 MK 15MAR24

FT-001 MK 15MAR24

FT-002 MK 15MAR24

FT-003 MK 15MAR24

FT-004 MK 15MAR24

TT-001 MK 15MAR24

TT-002 MK 15MAR24

TT-003 MK 15MAR24

TT-004 MK 15MAR24

XV-008 MK 15MAR24

XV-009 MK 15MAR24
Comments:
MK 15MAR24

Reviewed By:
Daniel Crandol Date: 18MAR24
Validation
Approved By:
Calvin Moore Date: 22MAR24
(QA)

Maria Kaluzna Page 38

 Page _3 __ of _ 3__
Operational-Critical-Instrument Calibration Verification Form

Critical instruments associated with the system will remain in a Verified By / Date
calibrated state during the anticipated OQ execution timeframe?
(Yes/No)
Auxiliary P&ID's refer to the P&ID's that depict the equipment pipes and instrumentation associated with
a certain item of equipment. An illustrative instance would be the supplementary apparatus, piping, and
instrumentation required for a substantial compressor. The objective is to maintain the Process Unit
P&ID's with minimal visual distractions.
The size, service, line number, Piping Material Specification, type of tracing and whether insulated shall
be indicated for each line on the P&ID's. Where lines leave/enter a P&ID the destination/origin
equipment tag shall be indicated.
When it comes to piping layout and design, any specific requirements should be clearly documented on
the P&ID's. These drawings must include the relevant keywords and symbols referenced in each
illustration.
Additional remarks/notes to elucidate the P&IDs will be included as necessary.
For instance, the P&ID must specify that a valve must be situated adjacent to a vessel orifice.
Headers aren't typically proven at the Process Unit/ Utility P&ID`s. A line to or from a header will be
terminated with a wide variety enclosed in an arrow boxes. When a header serves simplest or 3
customers inside a unit and may be proven with the best collection of branches, it will be completely
proven at the Process Unit/Utility P&ID.
Distribution P&ID's should accurately depict the sequence of take-offs from the headers based on the
physical layout of the equipment. This is essential for assisting in piping layout and line sizing, ultimately
enabling the achievement of an efficient piping layout.

TCV-005 MK 15MAR24
TCV-006 MK 15MAR24

PT-001 MK 15MAR24

PT-002 MK 15MAR24

PI-003 MK 15MAR24

PI-004 MK 15MAR24

PI-005 MK 15MAR24

PI-006 MK 15MAR24
PI-007 MK 15MAR24
PI-008 MK 15MAR24
Comments: MK 15MAR24

Reviewed By: Daniel Crandol Date: 18MAR24

Validation
Approved By: Calvin Moore Date: 22MAR24
(QA)

Maria Kaluzna Page 39

 13. 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

13.1. 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

1. All commissioning activities are complete and commissioning punch-list items are closed
out.
2. 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.
3. Level transmitter LT-002 is currently within calibration

Maria Kaluzna Page 40

5. Specific Test Steps

1. The Hot Detergent Tank is fed directly from the 25°C PUW1 water loop.
2. At time = 0 (t0-min) confirm the level in the Detergent Tank.
3. 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.
4. 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%.
5. Note the level in the tank every 5-minutes for 30-minutes.
6. Close the drain valve and the level in the tank should maintain 5775 litres +/-5% for further
30-minutes with no further drawdown.
7. 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
8. 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

1. 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.
2. Assess each step listed and determine whether the step has passed or failed.
3. The person performing the test should be identified and the date the testing was performed
should be recorded.
4. At the bottom of the test script a validation peer (other than the person performing the test)
shall review the script post execution.
5. Quality Assurance (QA) shall approve the completed test.

Validation Peer Review

AISLING FIELD Aisling Field 18MAY24

Print Name Signature Date

13.2. 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

Maria Kaluzna Page 41

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

1. 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%
2. 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.
3. 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

1. All commissioning activities are complete and commissioning punch-list items are closed
out.
2. 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.
3. 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

1. 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
2. Start the Hot Detergent Pump circulating.
3. Confirm the initial flow reading of FT-002 and FT-004 at time = 0 (t 0-min) and note the flow
every 5-minutes for 30-minutes.
4. 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
5. Note the flow reading on FT-002 and FT-004 every 5-minutes during the transfer.
6. Note the level in the Hot Detergent Tank maintains 5775 litres +/-5% (LT-002) during the
transfer

Maria Kaluzna Page 42

 7. 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.
8. 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.
9. 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.
10. 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

1. 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.
2. Assess each step listed and determine whether the step has passed or failed.
3. The person performing the test should be identified and the date the testing was performed
should be recorded.
4. At the bottom of the test script a validation peer (other than the person performing the test)
shall review the script post execution.
5. Quality Assurance (QA) shall approve the completed test.

Validation Peer Review

AISLING FIELD Aisling Field 18 MAY 24

Print Name Signature Date

Quality Control Review

MATTHEW DOYLE Matthew Doyle 18 MAY 24

Print Name Signature Date

13.3. 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).

Maria Kaluzna Page 43

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

1. All commissioning activities are complete and commissioning punch-list items are closed
out.
2. 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.
3. 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

1. 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
2. Start the Hot Detergent Pump circulating and confirm the initial flow reading of FT-002 and
FT-004 are 25,000 litres/hr
3. Note the initial temperature of TT-002 and TT-004 at time = 0 (t 0-min) and commence heating
the recirculating water to up 80°C±5°C noting the temperature readings every 5-minutes.
4. Maintain the temperature at 80°C±5°C for 30-minutes on the recirculation loop.
5. 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
6. 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.
7. Note the temperature of TT-002 and TT-004 during the transfer. It should maintain
80°C±5°C
8. 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.
9. 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.
10. 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.

Maria Kaluzna Page 44

6. Expected results and Actual results

1. 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.
2. Assess each step listed and determine whether the step has passed or failed.
3. The person performing the test should be identified and the date the testing was performed
should be recorded.
4. At the bottom of the test script a validation peer (other than the person performing the test)
shall review the script post execution.
5. Quality Assurance (QA) shall approve the completed test.

Validation Peer Review

JONATHAN WALSH
Jonathan Walsh 25 MAY 24
Print Name Signature Date

13.4. 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:

1. The system shall have the facility to automatically dose STERIS 100 detergent to the
required concentration (2% ± 0.05%)
2. 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,

Maria Kaluzna Page 45

  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

1. All commissioning activities are complete and commissioning punch-list items are closed
out.
2. 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.
3. 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

1. 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).
2. 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).
3. 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%).
4. 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.
5. 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.
6. 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.
7. 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.
8. 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

Maria Kaluzna Page 46

 1. 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.
2. Assess each step listed and determine whether the step has passed or failed.
3. The person performing the test should be identified and the date the testing was performed
should be recorded.
4. At the bottom of the test script a validation peer (other than the person performing the test)
shall review the script post execution.
5. Quality Assurance (QA) shall approve the completed test.
6.

Validation Peer Review

JONATHAN WALSH Jonathan Walsh 25 MAY 24

Print Name Signature Date

13.5. Hot PUW System – Level Control

1. Short Description of the Test
The objective of this test is to confirm that the Hot PUW2 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 4.4:

The system shall have the facility to maintain the level in the Hot PUW2 Tank at 5775 litres +/-5%.

Operationally Critical Component(s):

 Hydrostatic Pressure Type level transmitter LT-001,

 Low level Switch (tuning fork type) LS-003,
 High Level Switch (tuning fork type) LS-005.

3. Acceptance criteria for the test

The level measurement LT-001 shall read 5775 litres +/-5% before, during and after the maximum
instantaneous detergent drawdown.

4. Prerequisites and or assumptions

1. All of the commissioning operations have been finished, and all of the items on the
commissioning punch list have been closed out.

2. Each and every tester is required to receive training and education in the testing
process/method that is outlined in section 5 below: To ensure that the successful completion
of the testing endeavour, it is essential that all participants have a solid understanding of the
testing procedure.

3. At this moment, the level transmitter LT-001 is inside the calibration period- is currently
within calibration.

Maria Kaluzna Page 47

5. Specific Test Steps

1. The Hot PUW2 Tank is fed/ supplied directly from the 25°C PUW1 water loop.

2. At time = 0 (t0-min), verify the level in the heated PUW2 Tank.

3. Monitor the tank's level at 5-minute intervals until it reaches 5775 litres with a tolerance of +/-
5%. The tank should automatically cease filling at this particular level.

4. Activate the drain valve located at the base of the tank to release and remove the water. The
tank should initiate automatic refilling from the 25°C PUW1 water loop and sustain a volume
of 5775 litres with a tolerance of +/-5%.

5. Monitor the tank level at 5-minute intervals for a duration of 30 minutes.

6. After closing the drain valve, the level in the tank should remain at 5775 litres +/- 5% for an
additional 30 minutes without any further decrease.
7. Record the level in the Hot PUW2 Tank at repeated 5-minute intervals in the given table,
noting the time for each measurement.
8. Retrieve and record the level readings of tank LT-001 from the computer control system
throughout the testing period/ time, and add them to this specific test section.

6. Expected results and Actual results

1. 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.
2. Assess each step listed and determine whether the step has passed or failed.
3. The person performing the test should be identified and the date the testing was performed
should be recorded.
4. At the bottom of the test script a validation peer (other than the person performing the test)
shall review the script post execution.
5. Quality Assurance (QA) shall approve the completed test.

Validation Peer Review

BRIAN ROCHE Brian Roche 18 JUN 24

Print Name Signature Date

13.6. Hot PUW System – Flow Control

1. Short Description of the Test

The purpose of this test is to verify that the flow rate of the Hot PUW2 transfer loop remains within
the range of 3,000 liters/hr +/-5% and 25,000 liters/hr +/- 5%. This verification is done before,
during, and after the transfer of water from the Hot PUW2 Tank to reactors RE-119 and RE-140.
Both reactors are to be filled simultaneously at a rate of 11,000 liters/hr each.

2. Linkage to Requirements Challenged

Maria Kaluzna Page 48

 1. 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%..
2. The system shall be capable of achieving and maintaining a minimum return flowrate of the
loop to the Hot PUW2 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.
3. The maximum number of simultaneous users being washed by the CIP system shall be two.

Operationally Critical Component(s):

 Magnetic Flow Transmitter FT-001,

 Magnetic Flow Transmitter FT-003,
 Hydrostatic Pressure Type level transmitter LT-001,
 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-001 (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-003, located on the return loop, should display a reading of
3,000 litres/hr with an acceptable deviation of +/-5% both before, during, and after the
maximum transfer flowrate into RE-119 and RE-140.

4. Prerequisites and/or assumptions

1. All operations related to commissioning have been finished and any remaining items on the
commissioning punch-list have been resolved.
2. All testers must undergo training and education in the test method specified in section-5
below. It is essential for the testing endeavor's success that all participants have a thorough
understanding of the testing process.
3. The flow transmitters FT-001 and FT-003, as well as the level transmitters LT-001, LT-119,
and LT-140, are presently calibrated.

5. Specific Test Steps

1. Verify that the Hot PUW2 Tank is filled to a volume of 5775 litres with a tolerance of +/-5% using
water from the 25°C PUW1 water loop. Record the level reading on LT-001.
2. Initiate the circulation of the Hot PUW2 Pump.
3. Verify the first flow measurement of FT-001 and FT-003 at time = 0 (t 0-min) and record the flow rate
every 5 minutes for a duration of 30 minutes.
4. Activate/ open the transfer valves for RE-119 and RE-140 and proceed to transfer 5,500 litres
into each vessel. This process will take approximately 30 minutes. Make sure to monitor the level on
LT-119 and LT-140.
5. Record the flow measurement on FT-001 and FT-003 every 5 minutes during the transfer.
6. The level in the Hot PUW2 Tank remains at 5775 litres +/-5% (LT001) during the transfer.
7. Cease the transfer after moving 5,500 litres into both RE-119 and RE-140. Keep the CIP skid in
regular recirculation operation mode for an additional 30 minutes without any further reduction in
volume.
8. Please verify the level in the Hot PUW2 Tank (LT-001) and the flowrate readings of FT-001 and
FT-003 in the accompanying table. Record the values at 5-minute intervals, noting the time for each

Maria Kaluzna Page 49

measurement.
9. Additionally, document the values for the level in reactor RE-119 and reactor RE-140 obtained
from the level-transmitters LT-119 and LT-140 in the same table.
10. Retrieve and record the data readings of FT-001, FT-003, LT-119, and LT-140 from the
computer control system throughout the duration of the test, and add them to this specific test
section.

6. Expected results and Actual results

1. In the check-sheets provided in Appendix-C1, determine if each test step has been properly
executed by copying the bold text from the 'Expected Results' column into the relevant
'Actual Results' field.
2. Evaluate each individual stage and ascertain whether it has been successful or not.

3. It is important to identify the individual conducting the exam and record the date on which
the testing took place.

4. After the test script is executed, a validation peer, who is not the person conducting the test,
shall evaluate the script.
5. The completed test must be approved by Quality Assurance (QA).

Validation Peer Review

BRIAN ROCHE Brian Roche 18 MAY 24

Print Name Signature Date

13.7. Hot PUW System – Temperature Control

1. Short Description of the Test

The objective of this test is to confirm that the supply temperature of Hot PUW 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 Requirements Challenged

 The Hot PUW supply temperature might be kept up by a closed circle control framework,
which balances steam stream to the warm 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-007,

 3 wire RTD Temperature transmitter TT-001,
 3 wire RTD Temperature transmitter TT-003,
 Magnetic Flow Transmitter FT-001,
 Magnetic Flow Transmitter FT-003,
 Hydrostatic Pressure Type level transmitter LT-001,

Maria Kaluzna Page 50

  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-001 (on the outward loop) and TT-003 (on the return
loop) indicate a temperature of 80°C±5°C before, during, and after the maximum instantaneous
detergent drawdown to fill RE-119 and RE-140.

4. Prerequisites and/or assumptions

1. All the activities related to commissioning have been finished and all the remaining tasks on
the commissioning punch-list have been resolved.
2. All testers must undergo training and education in the test method specified in section-5
below. It is essential for the success of the testing endeavour that all participants have a
thorough understanding of the testing process.
3. The temperature transmitters TT-001 and TT-003, flow transmitters FT-001 and FT-003, and
level transmitters LT-001, LT-119, and LT-140 are currently calibrated.

5. Specific Test Steps

1. Verify that the Hot PUW2 Tank is filled with a volume of 5775 litres, with a tolerance of +/-5%,
from the 25°C PUW1 water loop. Record the level reading on LT-001.
2. Commence the circulation of the Hot PUW2 Pump and verify that the initial flow readings of FT-
001 and FT-003 are 25,000 litres per hour.
3. Record the initial temperature of TT-001 and TT-003 at time = 0 (t0-min) and begin heating the
recirculating water until it reaches a temperature of 80°C±5°C. Take note of the temperature
measurements every 5 minutes.
4. Ensure that the temperature remains at 80°C±5°C for a duration of 30 minutes on the
recirculation loop.
5. Begin the transfer process by opening the transfer valves to RE-119 and RE-140. Transfer a total
of 5,500 litres into each vessel. This process will take approximately 30 minutes. Make sure to
observe and record the level on LT-119 and LT-140.
6. Monitor the flow readings on FT-001 and FT-003, as well as the level reading in the Hot
PUW2Tank (LT-001), every 5 minutes during the transfer.
7. Take note of the temperature of TT-001 and TT-003 during transferring. The temperature should
be maintained at 80°C±5°C.
8. Cease the transfer after moving 5,500 litres into both RE-119 and RE-140. Keep the CIP skid in
regular recirculation operation mode for an additional 30 minutes without any further reduction in
volume.
9. Please verify the temperature of TT-001 and TT-003, as well as the temperature in the reactors
(LT-119 and LT-140), and the flowrate readings of FT-001 and FT-003. Record these values at 5-
minute intervals, noting the time of each measurement.
10. During the test time, get and add the readings of TT-001, TT-003, FT-001, FT-003, LT-119, and
LT-140 from the computer control system to this test section.

6. Expected Results and Actual Results

1. In the check-sheets provided in Appendix-C1, determine if each test step has been properly
executed by copying the bold text from the 'Expected Results' column into the relevant
'Actual Results' field.
2. Evaluate each individual stage and assess whether it has been successful or not.

Maria Kaluzna Page 51

 3. The individual conducting the test should be recognised, and the date of testing should be
documented.
4. After the test script is completed, a validation peer, who is not the person conducting the
test, shall examine the script.
5. The completed test must be approved by Quality Assurance (QA).
Validation Peer Review

AISLING FIELD
Aisling Filed 18 MAY 24
Print Name Signature Date

13.8. 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.

The affirmed SOP confirmation frame in segment 16.3.8 contains a list of endorsed SOPs for the
utilize of the Hot cleanser and Hot PUW2 generation and Distribution/dissemination framework.
These SOPs adjust with the draft SOPs laid out in segment 16.2.7. Their most later modification
and successful date are included in case pertinent.
See Protocol Section-16.3.8.
SOP# Title Revision #
SOP-235 Operational and maintenance of CIP wash tanks 12
SOP-157 CIP procedures for bioreactors 4.3
SOP-1002 Operational and maintenance of steam supply line 6.7
SOP-645 Operational and maintenance of hot detergent line 15.6
SOP-880 Operational and maintenance of PUW1 supply line 3.9
SOP-184 Operational and maintenance of pumps in generation and distribution 1.7
system

14. Protocol Quality Procedures

14.1. Signature Log

Summarize ‘Signature-Log’ procedure that complements the log in Protocol Section-16.1.

The protocol signature log in section 16.1 contains a list of signatures of personnel who will approve
(see section 2, Approvals page) and SMEs that will contribute to this protocol (see section 10,
Responsibilities/Subject Matter Experts). Their printed names, initials and signatures are located in
section 16.1, as well as confirmation of their GMP training.
Every individual who has made an entry into the procedure is required to complete the Signature Log
Check form. This Signature Log Check sheet provides a concise summary of the individuals who
participated in the verification of this equipment for an auditor.

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 14.2. 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.
The deviation log in section 16.4 comprises a comprehensive record of the deviations that took place
during the validation process of the Hot Detergent & Hot PUW2 system. This log includes the
deviation number, a concise narrative of the deviation, the date when the deviation occurred,
information on whether the deviation has been resolved, and whether there is an accompanying
change number.
The deviation forms for each logged deviation are stored in section 16.5. The deviation form
provides confirmation of the system type (direct, indirect, or no impact), component type (critical or
non-critical), and the specific items that are affected.
The protocol/procedure for deviation check sheets entails promptly addressing any identified issues
by according to the prescribed procedure, promptly notifying the appropriate individuals, and
expeditiously resolving the problem. The approach should provide a comprehensive explanation of
the steps involved in identifying, recording, examining, and resolving any deviations.
Distinct deviations can be categorised into many groups:
 Rectification/ correction of protocol generation mistakes.
 Rectification of data entry errors during execution.
 Repeating a test due to a clearly recognised technical problem, an identifiable technical error
during execution.
Simplifying the criteria of a test. Reducing the complexity of a test's criteria.
 An exam has been eliminated. A test has been removed.

14.3. Change Control Procedure

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 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.

The change control log in section 16.6 contains a list of change settings
applied during system validation of hot detergent and hot PUW2. The log contains the change
control #, P&ID, change summary, change date, pre-commit date and post-commit date.
Section 16.7 stores the change management forms for each change management saved. The
change control form confirms the change #, impact on already committed items, proposed
change, system impact and component impact. Due to the proposed change, various tests and
documentation updates are required. The project engineer calculates the cost of the change
and its impact on the project schedule. Multiple signatures must be verified by the relevant staff. If
the change check is accepted, the list of documents to update is checked. Once the post-change
testing is completed and completed, multiple signatures will be required from the relevant
personnel.
Change management is a strategic process that ensures the smooth and systematic
implementation of modifications to a product or system. It reduces the likelihood of introducing
unwanted alterations to a system, which can lead to system defects or reversing modifications
made by other programme users.
The change control process is comprised of seven distinct steps:
 Explain the proposed modification. Describe the suggested change.
 Change must be documented/ recorded and supported with valid reasons, justified.
 Evaluate the potential hazards and repercussions of the modification. Assess the change's
risks and consequences.
 The change control committee will either accept or reject the request for change.
 Generate and evaluate the modification. Create and test the change.
 Authorise/approve the upgrade and implement it.
 Conclude the modification and thoroughly verify that all paperwork is in proper condition.
Close the change and double-check that all documentation is in order.

15. 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.
Regulations mandate that equipment, systems, and utilities utilised for GMP manufacturing or
services must exhibit suitability for their intended use and perform in accordance with their design
and functional requirements. To fulfil these requirements, it is necessary to create certification
protocols for the verification of installation, operation, and performance. These protocols must
ensure that the installation is done correctly, that there are sufficient support utilities, that the
operation is functioning properly across its whole range, and that the performance meets the stated
standard operating procedures (SOPs) and operational set points. Protocols must be established,
adhering to user and functional specifications, and receiving approval before implementation.
Oftentimes, firms fail to implement proper protocols, or the protocols are discovered to be lacking
essential information and frequently fail to provide the required testing for appropriateness and

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functional design criteria.
IQs provide evidence that the process or equipment complies with all specifications, has been
installed accurately, and has all necessary components and paperwork for ongoing operation.
The installation qualification verifies that the equipment/system and its components are correctly
installed in accordance with the original manufacturer's standards, as stated on page 43. During the
IQ, it is necessary to do calibrations for both major and ancillary equipment.
Additional factors to take into account include the design characteristics of the equipment, safety
measures, environmental circumstances, and the supplier's paperwork pertaining to preventive
maintenance.
The design of an IQ incorporates several aspects such as equipment, process pipework,
environment control systems, valves, lubricants, safety devices, alarms, instrumentation, and
utilities.

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 16. 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

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15.1. Appendix A - Protocol Signature Log
Page _1_ of _1_

Signature Log

Printed Name Signature Initials Date Company/Title/ GMP Trained

Department
(Yes / No)
MARIA KALUZNA Maria Kaluzna MK 25MAY24 Validation Yes
AISLING FIELD Aisling Field 26MAY24 Yes
AF Validation

BRIAN ROCHE Brian Roche BR 25MAY24 Validation Yes

JONATHAN Jonathan Walsh JW 24MAY24 Validation Yes

WALSH
FRANK ROCHE Frank Roche FR 25MAY24 Engineering Yes
JAMES EGAN James Egan JE 26MAY24 Manufacturing Yes
CALVIN MOORE Calvin Moore CM 27MAY24 QA Yes
NICK WALSH Nick Walsh NW 25MAY24 Calibrations Yes
MATTHEW Matthew Doyle MD 25MAY24 QC Yes
DOYLE
CIAN BRENNAN Cian Brennan CB 26MAY24 HR Yes
KATHY MC Kathy KMD 26MAY24 EHS Yes
DONALD McDonald

Comments: MK 25 MAY 24

Reviewed By: Maria Kaluzna Date: 27 MAY 24

Validation
Approved By: Calvin Moore Date: 27 MAY 24
(QA)

Maria Kaluzna Page 57

16.2. Appendix B - Installation Verification GMP checksheets

16.2.1. P&ID Walkdown Installation Verification

P&ID # P&ID 227

P&ID Description Hot detergent and hot PUW generation and distribution

Test Step Expected Actual Results Pass / Initials and Date

Results Fail (dd/mmm/yyyy)
1 Walk down the P&ID Components Components Pass MK 27/MAY/2024
and using a yellow- correctly correctly
highlighter confirm each installed
component is correctly
installed
installed and orientated
as represented on the
P&ID
2 Confirm all component Tag numbers Tag numbers Pass MK 27/MAY/2024
tag numbers are correct correct correct
3 Confirm all lines are Lines correctly Lines correctly Pass MK 27/MAY/2024
correctly labelled labelled labelled
4 Confirm all lines where Lines correctly Lines correctly Pass MK 27/MAY/2024
applicable are correctly insulated insulated
insulated
5 Ensure all flow direction Flow directions Flow directions Pass MK 27/MAY/2024
components are correct correct
orientated correctly
6 Ensure all instruments Indicators Indicators Pass MK 27/MAY/2024
indicators are orientated orientated orientated
correctly so as operators correctly correctly
can readily view them
7 Ensure all Filters installed Filters installed Pass MK 27/MAY/2024
commissioning filters are
installed in filter-
housings

Comments: N/A MK 27/MAY/2024

Validation Peer Review

JONATHAN WALSH Jonathan Walsh 27 MAY 24

Print Name Signature Date

QA Approval

CALVIN MOORE Calvin Moore 27 MAY 24

Print Name Signature Date

Maria Kaluzna Page 58

 16.2.2. Equipment Installation Verification
Sheet _1_ of 11 ____ Installation Verification Tag #: __ T-411 ___
Tank Installation Verification

Equipment Description and Critical Design Features

Inspect the installed equipment Specified Actual Verification Initials / Date
item and the vendor’s (Pass/Fail)
documentation and verify
correct specification
conformance
1 Manufacturer PASS MK 27.MAY 24
RAD ENG RAD ENG
2 Capacity PASS MK 27.MAY 24
6000L 6000L
3 M.O.C. PASS MK 27.MAY 24
316L SS 316L SS
4 Design Pressure Range PASS MK 27.MAY 24
FV to 1 Barg FV to 1 Barg
5 Design Temp Range PASS MK 27.MAY 24
0 to 177°C 0 to 177°C
Documentation Verification
Confirm that the vendor handover package Verification Initials Date
is in place and contains correct material (Pass/Fail)
certificates
1 Vendor handover package is in place PASS MK 27.MAY 24
2 Material Certification is available for PASS MK 27.MAY 24
wetted parts
Installation Verification
Visually inspect, and subsequently verify, the Verification Initials Date
correct installation of the equipment item in (Pass/Fail)
the field
1 Equipment item is installed as per PASS MK 27.MAY 24
P&ID, is securely fitted and is free from
damage
2 Nameplate is securely fitted, clearly PASS MK 27.MAY 24
legible and its details conform to the
design specification
3 All process and utility connections, and PASS MK 27.MAY 24
instrumentation are connected up to
the correct nozzles/flanges, as per
P&ID

Comments: N/A MK 27.MAY 24

Validation Peer Review

AISLING FIELD 27.MAY 24

Aisling Field
Print Name Signature Date

QA Approval

CALVIN MOORE Calvin Moore 27.MAY 24

Print Name Signature Date

Maria Kaluzna Page 59

 Sheet 2__ of 11 ____ Installation Verification Tag #: _ T-211 _____
Tank Installation Verification
Equipment Description and Critical Design Features
Inspect the installed equipment Specified Actual Verification Initials / Date
item and the vendor’s (Pass/Fail)
documentation and verify
correct specification
conformance
1 Manufacturer PASS MK 27 MAY 24
RAD ENG RAD ENG
2 Capacity PASS MK 27 MAY 24
6000L 6000L
3 M.O.C. PASS MK 27 MAY 24
316LSS 316LSS
4 Design Pressure Range PASS MK 27 MAY 24
FV to 1 Bar(g) FV to 1 Bar(g)
PASS MK 27 MAY 24
5 Design Temp Range 0 to 177oC 0 to 177oC
Documentation Verification
Confirm that the vendor handover package Verification Initials Date
is in place and contains correct material (Pass/Fail)
certificates
1 Vendor handover package is in place PASS MK 27.MAY 24
2 Material Certification is available for PASS MK 27.MAY 24
wetted parts
Installation Verification
Visually inspect, and subsequently verify, the Verification Initials Date
correct installation of the equipment item in (Pass/Fail)
the field
1 Equipment item is installed as per PASS MK 27.MAY 24
P&ID, is securely fitted and is free from
damage
2 Nameplate is securely fitted, clearly PASS MK 27.MAY 24
legible and its details conform to the
design specification
3 All process and utility connections, and PASS MK 27.MAY 24
instrumentation are connected up to
the correct nozzles/flanges, as per
P&ID

Comments: N/A MK 27.MAY 24

Validation Peer Review

Aisling Field 27.MAY 24
AISLING FIELD
Print Name Signature Date

QA Approval
Calvin Moore
CALVIN MOORE 27.MAY 24
Print Name Signature Date

Maria Kaluzna Page 60

 Sheet _3_ of _11_ ____ Installation Verification Tag #: HX-211_____
Heat Exchanger Installation Verification

Equipment Description and Critical Design Features

Inspect the installed Specified Actual Verification Initials / Date
equipment item and the (Pass/Fail)
vendor’s documentation and
verify correct specification
conformance
1 Manufacturer Exchanger Plus Exchanger Plus Pass JW 19 APR 24

2 Capacity 569.4 kW 569.4 kW Pass JW 19 APR 24

3 M.O.C. 316L SS 316L SS Pass JW 19 APR 24

4 Design Pressure Range FV to 10 Barg FV to 10 Barg Pass JW 19 APR 24

5 Design Temp Range 0 to 150°C 0 to 150°C Pass JW 19 APR 24

Documentation Verification
Confirm that the vendor handover package Verification Initials Date
is in place and contains correct material (Pass/Fail)
certificates
1 Vendor handover package is in place Pass JW 19 APR 24
2 Material Certification is available for Pass JW 19 APR 24
wetted parts
Installation Verification
Visually inspect, and subsequently verify, Verification Initials Date
the correct installation of the equipment (Pass/Fail)
item in the field
1 Equipment item is installed as per Pass JW 19 APR 24
P&ID, is securely fitted and is free
from damage
2 Nameplate is securely fitted, clearly Pass JW 19 APR 24
legible and its details conform to the
design specification
3 All process and utility connections, Pass JW 19 APR 24
and instrumentation are connected
up to the correct nozzles/flanges, as
per P&ID

Comments: N/A JW 19 APR 24

Validation Peer Review

MARIA KALUZNA Maria Kaluzna 19 APR 24

Print Name Signature Date

QA Approval

LAURA KEATING Laura Keating 19 APR 24

Print Name Signature Date

Maria Kaluzna Page 61

Sheet _4_ of _11_ ____ Installation Verification Tag #: _ HX-411_____
Heat Exchanger Installation Verification

Equipment Description and Critical Design Features

Inspect the installed Specified Actual Verification Initials / Date
equipment item and the (Pass/Fail)
vendor’s documentation and
verify correct specification
conformance
1 Manufacturer Exchanger Plus Exchanger Plus Pass JW 20 APR 24

2 Capacity 569.4 kW 569.4 kW Pass JW 20 APR 24

3 M.O.C. 316L SS 316L SS Pass JW 20 APR 24

4 Design Pressure Range FV to 10 Barg FV to 10 Barg Pass JW 20 APR 24

5 Design Temp Range 0 to 150°C 0 to 150°C Pass JW 20 APR 24

Documentation Verification
Confirm that the vendor handover package Verification Initials Date
is in place and contains correct material (Pass/Fail)
certificates
1 Vendor handover package is in place Pass JW 20 APR 24
2 Material Certification is available for Pass JW 20 APR 24
wetted parts
Installation Verification
Visually inspect, and subsequently verify, Verification Initials Date
the correct installation of the equipment (Pass/Fail)
item in the field
1 Equipment item is installed as per Pass JW 20 APR 24
P&ID, is securely fitted and is free
from damage
2 Nameplate is securely fitted, clearly Pass JW 20 APR 24
legible and its details conform to the
design specification
3 All process and utility connections, Pass JW 20 APR 24
and instrumentation are connected up
to the correct nozzles/flanges, as per
P&ID

Comments: N/A JW 20 APR 24

Validation Peer Review

MARIA KALUZNA Maria Kaluzna 20 APR 24

Print Name Signature Date

QA Approval
23 APR 24
LAURA KEATING Laura Keating
Print Name Signature Date

Maria Kaluzna Page 62

 _ Installation Verification Tag #: _ P-207_____
Sheet _5 of 11_ Pump Installation Verification
Equipment Description and Critical Design Features
Inspect the installed equipment Specified Actual Verification Initials / Date
item and the vendor’s (Pass/Fail)
documentation and verify
correct specification
conformance
1 Manufacturer PUMP MAN PUMP MAN PASS MK 28 MAY 24

2 Capacity 25M3/hr & 7 Bar(g) 25M3/hr & 7 Bar(g) PASS MK 28 MAY 24

3 M.O.C. 316L SS 316L SS PASS MK 28 MAY 24

4 Design Pressure Range FV to 10 Bar(g) FV to 10 Bar(g) PASS MK 28 MAY 24

5 Design Temp Range o

0 to 115 C o
0 to 115 C PASS MK 28 MAY 24

Documentation Verification
Confirm that the vendor handover package Verification Initials Date
is in place and contains correct material (Pass/Fail)
certificates
1 Vendor handover package is in place PASS MK 28 MAY 24
2 Material Certification is available for PASS MK 28 MAY 24
wetted parts
Installation Verification
Visually inspect, and subsequently verify, the Verification Initials Date
correct installation of the equipment item in the (Pass/Fail)
field
1 Equipment item is installed as per P&ID, is
securely fitted and is free from damage
PASS MK 28 MAY 24

2 Nameplate is securely fitted, clearly legible PASS MK 28 MAY 24

and its details conform to the design
specification
3 All process and utility connections, and PASS MK 28 MAY 24
instrumentation are connected up to the
correct nozzles/flanges, as per P&ID

Comments: N/A MK 28 MAY 24

Validation Peer Review

BRIAN ROCHE Brian Roche 29 MAY 24

Print Name Signature Date

QA Approval
CALVIN MOORE Calvin Moore 29 MAY 24

Print Name Signature Date

Sheet _6 of 11_ ____ Installation Verification Tag #: __ P-209 ____

Maria Kaluzna Page 63

 Pump Installation Verification

Equipment Description and Critical Design Features

Inspect the installed equipment Specified Actual Verification Initials / Date
item and the vendor’s (Pass/Fail)
documentation and verify
correct specification
conformance
1 Manufacturer Pump Man Pump Man PASS MK 29 MAY 24

2 Capacity 25 m3/h & 7 barg 25 m3/h & 7 PASS MK 29 MAY 24

barg
3 M.O.C. 316L SS 316L SS PASS MK 29 MAY 24

4 Design Pressure Range FV to 10 barg FV to 10 barg PASS MK 29 MAY 24

5 Design Temp Range 0 to 115°C 0 to 115°C PASS MK 29 MAY 24

Documentation Verification
Confirm that the vendor handover package Verification Initials Date
is in place and contains correct material (Pass/Fail)
certificates
1 Vendor handover package is in place Pass MK MK 29 MAY 24
2 Material Certification is available for Pass MK MK 29 MAY 24
wetted parts
Installation Verification
Visually inspect, and subsequently verify, the Verification Initials Date
correct installation of the equipment item in (Pass/Fail)
the field
1 Equipment item is installed as per Pass MK MK 29 MAY 24
P&ID, is securely fitted and is free from
damage
2 Nameplate is securely fitted, clearly Pass MK MK 29 MAY 24
legible and its details conform to the
design specification
3 All process and utility connections, and Pass MK MK 29 MAY 24
instrumentation are connected up to
the correct nozzles/flanges, as per
P&ID

Comments: N/A MK 29 MAY 24

Validation Peer Review

AISLING FIELD Aisling Field 18 MAR 24

Print Name Signature Date

QA Approval
Laura Keating 19 MAR 24
LAURA KEATING
Print Name Signature Date

Maria Kaluzna Page 64

 Sheet _7 of 11_ ___ Installation Verification Tag #: P-415______
Pump Installation Verification

Equipment Description and Critical Design Features

Inspect the installed equipment Specified Actual Verification Initials / Date
item and the vendor’s (Pass/Fail)
documentation and verify
correct specification
conformance
1 Manufacturer Pump Man Pump Man Pass MK 26 MAY 24

2 Capacity 25 m3/h & 7 barg 25 m3/h & 7 Pass MK 26 MAY 24

barg
3 M.O.C. 316L SS 316L SS Pass MK 26 MAY 24

4 Design Pressure Range FV to 10 barg FV to 10 barg Pass MK 26 MAY 24

5 Design Temp Range 0 to 115°C 0 to 115°C Pass MK 26 MAY 24

Documentation Verification
Confirm that the vendor handover package is in Verification Initials Date
place and contains correct material certificates (Pass/Fail)
1 Vendor handover package is in place Pass MK 26 MAY 24
2 Material Certification is available for wetted Pass MK 26 MAY 24
parts
Installation Verification
Visually inspect, and subsequently verify, the Verification Initials Date
correct installation of the equipment item in the (Pass/Fail)
field
1 Equipment item is installed as per P&ID, is Pass MK 26 MAY 24
securely fitted and is free from damage
2 Nameplate is securely fitted, clearly legible Pass MK 26 MAY 24
and its details conform to the design
specification
3 All process and utility connections, and Pass MK 26 MAY 24
instrumentation are connected up to the
correct nozzles/flanges, as per P&ID

Comments: N/A MK 26 MAY 24

Validation Peer Review

AISLING FIELD Aisling Field 27 MAY 24

Print Name Signature Date

QA Approval

LAURA KEATING Laura Keating 27 MAY 24

Print Name Signature Date

Sheet _8_ of 11 ____ Installation Verification Tag #: _P-417_____

Maria Kaluzna Page 65

 Pump Installation Verification

Equipment Description and Critical Design Features

Inspect the installed Specified Actual Verification Initials / Date
equipment item and the (Pass/Fail)
vendor’s documentation and
verify correct specification
conformance
1 Manufacturer Pump Man Pump Man Pass MK 25 MAY 24

2 Capacity 25 m3/h & 7 barg 25 m3/h & 7 barg Pass MK 25 MAY 24

3 M.O.C. 316L SS 316L SS Pass MK 25 MAY 24

4 Design Pressure Range FV to 10 barg FV to 10 barg Pass MK 25 MAY 24

5 Design Temp Range 0 to 115°C 0 to 115°C Pass MK 25 MAY 24

Documentation Verification
Confirm that the vendor handover package Verification Initials Date
is in place and contains correct material (Pass/Fail)
certificates
1 Vendor handover package is in place Pass MK 25 MAY 24
2 Material Certification is available for Pass MK 25 MAY 24
wetted parts
Installation Verification
Visually inspect, and subsequently verify, Verification Initials Date
the correct installation of the equipment (Pass/Fail)
item in the field
1 Equipment item is installed as per Pass MK 25 MAY 24
P&ID, is securely fitted and is free
from damage
2 Nameplate is securely fitted, clearly Pass MK 25 MAY 24
legible and its details conform to the
design specification
3 All process and utility connections, Pass MK 25 MAY 24
and instrumentation are connected
up to the correct nozzles/flanges, as
per P&ID

Comments: N/A MK 25 MAY 24

Validation Peer Review

DANIEL CRANDOL Daniel Crandol 25 MAY 24

Print Name Signature Date

QA Approval

CALVIN MOORE Calvin Moore 25 MAY 24

Print Name Signature Date

Maria Kaluzna Page 66

 Sheet _9_ of _11_ ____ Installation Verification Tag #: P-223______
Pump Installation Verification

Equipment Description and Critical Design Features

Inspect the installed equipment Specified Actual Verification Initials / Date
item and the vendor’s (Pass/Fail)
documentation and verify
correct specification
conformance
1 Manufacturer Pump Safe Pump Safe Pass MK 27 MAY 24

2 Capacity 0.55kW 0.55kW Pass MK 27 MAY 24

3 M.O.C. 316L SS 316L SS Pass MK 27 MAY 24

4 Design Pressure Range 5 barg Max 5 barg Max Pass MK 27 MAY 24

5 Design Temp Range 10°C min - 40°C 10°C min - Pass MK 27 MAY 24
Max 40°C Max
Documentation Verification
Confirm that the vendor handover package Verification Initials Date
is in place and contains correct material (Pass/Fail)
certificates
1 Vendor handover package is in place Pass MK 27 MAY 24
2 Material Certification is available for Pass MK 27 MAY 24
wetted parts
Installation Verification
Visually inspect, and subsequently verify, the Verification Initials Date
correct installation of the equipment item in (Pass/Fail)
the field
1 Equipment item is installed as per Pass MK 27 MAY 24
P&ID, is securely fitted and is free from
damage
2 Nameplate is securely fitted, clearly Pass MK 27 MAY 24
legible and its details conform to the
design specification
3 All process and utility connections, and Pass MK 27 MAY 24
instrumentation are connected up to
the correct nozzles/flanges, as per
P&ID

Comments: N/A MK 27 MAY 24

Validation Peer Review

AISLING FIELD Aisling Filed 28 MAY 24

Print Name Signature Date

QA Approval

CALVIN MOORE Calvin Moore 28 MAY 24

Print Name Signature Date

Sheet _10_ of 11__ ____ Installation Verification Tag #: FL-399______

Maria Kaluzna Page 67

 Filter Installation Verification

Equipment Description and Critical Design Features

Inspect the installed equipment Specified Actual Verification Initials / Date
item and the vendor’s (Pass/Fail)
documentation and verify
correct specification
conformance
1 Manufacturer Thro Flow Thro Flow Pass MK 29 MAR 24

2 Capacity 1.5 ml Mesh 1.5 ml Mesh Pass MK 29 MAR 24

3 M.O.C. 316L SS/PTFE 316L Pass MK 29 MAR 24

SS/PTFE
4 Design Pressure Range FV to 10 Barg FV to 10 Barg Pass MK 29 MAR 24

5 Design Temp Range 0 to 150°C 0 to 150°C Pass MK 29 MAR 24

Documentation Verification
Confirm that the vendor handover package Verification Initials Date
is in place and contains correct material (Pass/Fail)
certificates
1 Vendor handover package is in place Pass MK MK 29 MAR 24
2 Material Certification is available for Pass MK MK 29 MAR 24
wetted parts
Installation Verification
Visually inspect, and subsequently verify, the Verification Initials Date
correct installation of the equipment item in (Pass/Fail)
the field
1 Equipment item is installed as per Pass MK MK 29 MAR 24
P&ID, is securely fitted and is free from
damage
2 Nameplate is securely fitted, clearly Pass MK MK 29 MAR 24
legible and its details conform to the
design specification
3 All process and utility connections, and Pass MK MK 29 MAR 24
instrumentation are connected up to
the correct nozzles/flanges, as per
P&ID

Comments: N/A MK 29 MAR 24

Validation Peer Review

BRIAN ROCHE Brian Roche 29 MAR 24

Print Name Signature Date

QA Approval

CALVIN MOORE Calvin Moore 29 MAR 24

Print Name Signature Date

Maria Kaluzna Page 68

 Sheet _11_ of 11__ ____ Installation Verification Tag #: _FL-401_____
Filter Installation Verification

Equipment Description and Critical Design Features

Inspect the installed equipment Specified Actual Verification Initials / Date
item and the vendor’s (Pass/Fail)
documentation and verify
correct specification
conformance
1 Manufacturer Thro Flow Thro Flow Pass MK 30 MAY 24

2 Capacity 1.5 ml Mesh 1.5 ml Mesh Pass MK 30 MAY 24

3 M.O.C. 316L SS/PTFE 316L SS/PTFE Pass MK 30 MAY 24

4 Design Pressure Range FV to 10 Barg FV to 10 Barg Pass MK 30 MAY 24

5 Design Temp Range 0 to 150°C 0 to 150°C Pass MK 30 MAY 24

Documentation Verification
Confirm that the vendor handover package Verification Initials Date
is in place and contains correct material (Pass/Fail)
certificates
1 Vendor handover package is in place Pass MK 30 MAY 24
2 Material Certification is available for Pass MK 30 MAY 24
wetted parts
Installation Verification
Visually inspect, and subsequently verify, the Verification Initials Date
correct installation of the equipment item in (Pass/Fail)
the field
1 Equipment item is installed as per Pass MK 30 MAY 24
P&ID, is securely fitted and is free from
damage
2 Nameplate is securely fitted, clearly Pass MK 30 MAY 24
legible and its details conform to the
design specification
3 All process and utility connections, and Pass MK 30 MAY 24
instrumentation are connected up to
the correct nozzles/flanges, as per
P&ID

Comments: N/A MK 30 MAY 24

Validation Peer Review

BRIAN ROCHE Brian Roche 30 MAY 24

Print Name Signature Date

QA Approval

CALVIN MOORE Calvin Moore 30 MAY 24

Print Name Signature Date

Maria Kaluzna Page 69

 16.2.3. Instrument Installation Verification
Sheet _1_ of _18_ ___ Installation Verification

Part-1: _Temperature __ Transmitter Description and Critical Design Features

Inspect the installed instrument item and the vendor’s documentation and verify correct specification conformance
Tag # Specified Actual Specified Range Actual Specified MOC Actual Loop Checked Verification Initials / Date
Manufacturer (Yes/No) (Pass/Fail)

_TCV-005__ SPIRAX SPIRAX 0 TO 177°C 0 TO CS CS Yes Pass AF 18 APR 24

177°C
0 TO 177°C 0 TO Yes Pass AF 18 APR 24
__TCV-006_ SPIRAX SPIRAX CS CS
177°C
0 TO 177°C 0 TO 316L SS 316L SS Yes Pass AF 18 APR 24
__TT-001__ E&H E&H
177°C
0 TO 177°C 0 TO 316L SS 316L SS Yes Pass AF 18 APR 24
__TT-002__ E&H E&H
177°C
0 TO 177°C 0 TO 316L SS 316L SS Yes Pass AF 18 APR 24
__TT-003__ E&H E&H
177°C
0 TO 177°C 0 TO 316L SS 316L SS Yes Pass AF 18 APR 24
TT-004 E&H E&H
177°C

Comments: The stated range for the above was not provided in either the P&ID or URS. Therefore, the specified range above was
derived from P&ID 227 for tanks, as the temperature should not exceed these specifications.

Validation Peer Review

AISLING FIELD Aisling Field 18 APR 24

Print Name Signature Date

Maria Kaluzna Page 70

 QA Approval
Calvin Moore
CALVIN MOORE 18 APR 24
Print Name Signature Date

Sheet _2_ of _18_ ____ Installation Verification

Part-2: _Temperature__ Documentation Verification

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

__TCV-005__ Yes Yes See Comment Yes See Comment Yes See Comment Pass MK 18 APR 24
__TCV-006__ Yes Yes See Comment Yes See Comment Yes See Comment Pass MK 18 APR 24

__TT-001__ Yes Yes See Comment Yes See Comment Yes See Comment Pass MK 18 APR 24

__TT-002__ Yes Yes See Comment Yes See Comment Yes See Comment Pass MK 18 APR 24

__TT-003__ Yes Yes See Comment Yes See Comment Yes See Comment Pass MK 18 APR 24

TT-004 Yes Yes See Comment Yes See Comment Yes See Comment Pass MK 18 APR 24

Comments: Certs and check sheets can be found in the engineering library.

Validation Peer Review

Daniel Crandol 19 APR 24
DANIEL CRANDOL
Print Name Signature Date

QA Approval

Maria Kaluzna Page 71

 CALVIN MOORE Calvin Moore 19 APR 24
Print Name Signature Date

Sheet _3_ of __18 ___ Installation Verification

Part-3: _Temperature__ Installation Verification

Visually inspect, and subsequently verify, the correct installation of the instrument item in the field
Tag # Instrument item is installed as Instrument and cabling is Instrument orientated Verification Initials Date
per P&ID, is securely fitted and correctly tagged and details correctly and is accessible for (Pass/Fail)
is free from damage (Yes/No) conform to the design calibration and maintenance
specification (Yes/No) (Yes/No)
Yes Yes Yes Pass MK 22 MAY 24
_ TCV-005 ___
Yes Yes Yes Pass MK 22 MAY 24
__ TCV-006 __
Yes Yes Yes Pass MK 22 MAY 24
__ TT-001 __
Yes Yes Yes Pass MK 22 MAY 24
__ TT-002__
Yes Yes Yes Pass MK 22 MAY 24
__ TT-003__
Yes Yes Yes Pass MK 22 MAY 24
TT-004

Comments: N/A MK 22 MAY 24

Validation Peer Review

AISLING FIELD Aisling Field 23 MAY 24

Print Name Signature Date

QA Approval

Maria Kaluzna Page 72

 CALVIN MOORE CALVIN MOORE 24 MAY 24
Print Name Signature Date

Sheet _4_ of _18_ ___ Installation Verification

Part-1: _ Pressure __ Transmitter Description and Critical Design Features
Inspect the installed instrument item and the vendor’s documentation and verify correct specification conformance
Tag # Specified Actual Specified Range Actual Specified MOC Actual Loop Checked Verification Initials / Date
Manufacturer (Yes/No) (Pass/Fail)
_ PT-001 DWN DWN FV to 1Barg FV to 1Barg 316L SS 316L SS Yes Pass JW 04 JUN 24
___
__ PT- DWN DWN FV to 1Barg FV to 1Barg 316L SS 316L SS Yes Pass JW 04 JUN 24
002__
__ PI-004 DWN DWN FV to 1Barg FV to 1Barg 316L SS 316L SS Yes Pass JW 04 JUN 24
__
__ PI-005__ DWN DWN FV to 1Barg FV to 1Barg 316L SS 316L SS Yes Pass JW 04 JUN 24

__ PI-006__ DWN DWN FV to 1Barg FV to 1Barg 316L SS 316L SS Yes Pass JW 04 JUN 24

PI-007 DWN DWN FV to 1Barg FV to 1Barg 316L SS 316L SS Yes Pass JW 04 JUN 24

PI-008 DWN DWN FV to 1Barg FV to 1Barg 316L SS 316L SS Yes Pass JW 04 JUN 24

PRV-001 MANKENBERG MANKENBERG FV to 1Barg FV to 1Barg 316L SS 316L SS Yes Pass JW 04 JUN 24

PRV-002 MANKENBERG MANKENBERG FV to 1Barg FV to 1Barg 316L SS 316L SS Yes Pass JW 04 JUN 24

Comments: The stated range for the aforementioned parameters was not provided in either the P&ID or URS. Therefore, the specified range
mentioned above was derived from P&ID 227 for tanks, as the pressure range should not exceed these parameters.

Maria Kaluzna Page 73

 Validation Peer Review

DANIEL CRANDOL Daniel Crandol 05 JUN 24

Print Name Signature Date

QA Approval
Calvin Moore 05 JUN 24
CALVIN MOORE
Print Name Signature Date

Sheet _5_ of _18_ ____ Installation Verification

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

_ PT-001__ Yes Yes See Comment Yes See Comment Yes See Comment Pass MK 10 JUN 24
__ PT-002 __ Yes Yes See Comment Yes See Comment Yes See Comment Pass MK 10 JUN 24

__ PI-004 __ Yes Yes See Comment Yes See Comment Yes See Comment Pass MK 10 JUN 24

__ PI-005__ Yes Yes See Comment Yes See Comment Yes See Comment Pass MK 10 JUN 24

__ PI-006__ Yes Yes See Comment Yes See Comment Yes See Comment Pass MK 10 JUN 24

PI-007 Yes Yes See Comment Yes See Comment Yes See Comment Pass MK 10 JUN 24

PI-008 Yes Yes See Comment Yes See Comment Yes See Comment Pass MK 10 JUN 24

Maria Kaluzna Page 74

PRV-001 Yes Yes See Comment Yes See Comment Yes See Comment Pass MK 10 JUN 24

PRV-002 Yes Yes See Comment Yes See Comment Yes See Comment Pass MK 10 JUN 24

Comments: Certs and check sheets can be found in the engineering library.

Validation Peer Review

BRIAN ROCHE Brian Roche 10 JUN 24

Print Name Signature Date

QA Approval
11 JUN 24
CALVIN MOORE Calvin Moore
Print Name Signature Date

Sheet 6__ of _18_ ___ Installation Verification

Part-3: _ Pressure __ Installation Verification
Visually inspect, and subsequently verify, the correct installation of the instrument item in the field
Tag # Instrument item is installed as Instrument and cabling is Instrument orientated Verification Initials Date
per P&ID, is securely fitted and correctly tagged and details correctly and is accessible for (Pass/Fail)
is free from damage (Yes/No) conform to the design calibration and maintenance
specification (Yes/No) (Yes/No)
_PT-001__ Yes Yes Yes Pass MK 25 MAY 24
_PT-002__ Yes Yes Yes Pass MK 25 MAY 24

__PI-004__ Yes Yes Yes Pass MK 25 MAY 24

__PI-005__ Yes Yes Yes Pass MK 25 MAY 24

__PI-006__ Yes Yes Yes Pass MK 25 MAY 24

Maria Kaluzna Page 75

PI-007 Yes Yes Yes Pass MK 25 MAY 24

PI-008 Yes Yes Yes Pass MK 25 MAY 24

PRV-001 Yes Yes Yes Pass MK 25 MAY 24

PRV-002 Yes Yes Yes Pass MK 25 MAY 24

Comments: N/A MK 25 MAY 24

Validation Peer Review

BRIAN ROCHE Brian Roche 25 MAY 24

Print Name Signature Date

QA Approval

LAURA KEATING Laura Keating 25 MAY 24

Print Name Signature Date

Sheet _7_ of _18_ ___ Installation Verification

Part-1: _Flow __ Transmitter Description and Critical Design Features

Inspect the installed instrument item and the vendor’s documentation and verify correct specification conformance
Tag # Specified Actual Specified Range Actual Specified MOC Actual Loop Checked Verification Initials / Date
Manufacturer (Yes/No) (Pass/Fail)

Maria Kaluzna Page 76

__FT-001__ KRONE KRONE 2,500 TO 30,000 2,500 TO 316L SS 316L SS Yes Pass AF 13 JUN 24
L/HR 30,000 L/HR
__FT-002__ KRONE KRONE 2,500 TO 30,000 2,500 TO 316L SS 316L SS Yes Pass AF 13 JUN 24
L/HR 30,000 L/HR
_FT-003__ KRONE KRONE 2,500 TO 30,000 2,500 TO 316L SS 316L SS Yes Pass AF 13 JUN 24
L/HR 30,000 L/HR
__FT-004__ KRONE KRONE 2,500 TO 30,000 2,500 TO 316L SS 316L SS Yes Pass AF 13 JUN 24
L/HR 30,000 L/HR
_FS-005__ E&H E&H 2,500 TO 30,000 2,500 TO 316L SS 316L SS Yes Pass AF 13 JUN 24
L/HR 30,000 L/HR

Comments: N/A AF 13 JUN 24

Validation Peer Review

MARIA KALUZNA Maria Kaluzna 14 JUN 24

Print Name Signature Date

QA Approval

LAURA KEATING Laura Keating 14 JUN 24

Print Name Signature Date

Sheet __8 of __18 ____ Installation Verification

Part-2: __Flow_ Documentation Verification

Confirm that the vendor handover package is in place and contains correct material certificates

Maria Kaluzna Page 77

Tag # *Vendor Material Cert # Calibration Cert # Loop Checksheet # Verification Initials / Date
handover Certification is Certification Checksheet (Pass/Fail)
package is in available for is available is available
place wetted parts (Yes/No) (Yes/No)
(Yes/No) (Yes/No)

_ FT-001__ Yes Yes See Comment Yes See Comment Yes See Comment Pass 14 JUN 24
__FT-002__ Yes Yes See Comment Yes See Comment Yes See Comment Pass 14 JUN 24

__ FT-003__ Yes Yes See Comment Yes See Comment Yes See Comment Pass 14 JUN 24

__ FT-004__ Yes Yes See Comment Yes See Comment Yes See Comment Pass 14 JUN 24

__ FS-005__ Yes Yes See Comment Yes See Comment Yes See Comment Pass 14 JUN 24

Comments: Certs and check sheets can be found in the engineering library.

Validation Peer Review

MARIA KALUZNA Maria Kaluzna 17 JUN 24

Print Name Signature Date

QA Approval

LAURA KEATING Laura Keating 18 JUN 24

Print Name Signature Date

Sheet _9_ of _18_ ___ Installation Verification

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

Maria Kaluzna Page 78

 specification (Yes/No) (Yes/No)
__ FT-001__ Yes Yes Yes Pass MK 18 JUN 24
__ FT-002__ Yes Yes Yes Pass MK 18 JUN 24

__ FT-003__ Yes Yes Yes Pass MK 18 JUN 24

_ FT-004__ Yes Yes Yes Pass MK 18 JUN 24

__ FS-005__ Yes Yes Yes Pass MK 18 JUN 24

Comments: N/A MK 18 JUN 24

Validation Peer Review

AISLING FIELD Aisling Field 18 JUN 24

Print Name Signature Date

QA Approval

LAURA KEATING Laura Keating 18 JUN 24

Print Name Signature Date

Sheet __10 of _18_ ___ Installation Verification

Part-1: _ Conductivity __ Transmitter Description and Critical Design Features
Inspect the installed instrument item and the vendor’s documentation and verify correct specification conformance
Tag # Specified Actual Specified Range Actual Specified MOC Actual Loop Checked Verification Initials / Date
Manufacturer (Yes/No) (Pass/Fail)
* *
__ CT-001 _ HENKEL HENKEL 0 – 100 mS/cm 0 – 100 316L SS 316L SS Yes Pass JW 15 JUN 24

Maria Kaluzna Page 79

 mS/cm

__-__

Comments: Values not found Calibration Range: Factory Calibrated

0 to 99.99 μS/cm for cell constant 0.01
0 to 999.99 μS/cm for cell constant 0.1
0 to 9999.99 μS/cm for cell constant 1

Validation Peer Review

AISLING FIELD Aisling Field 20 JUN 24

Print Name Signature Date

QA Approval

LAURA KEATING Laura Keating 20 JUN 24

Print Name Signature Date

Sheet 11__ of _18_ ____ Installation Verification

Part-2: _Conductivity__ Documentation Verification

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

Maria Kaluzna Page 80

 (Yes/No)
__CT-001__ Yes Yes See Comment Yes See Comment Yes See Comment Pass JW 15 JUN
24
__-__

Comments: Certs and check sheets can be found in the engineering library.

Validation Peer Review

AISLING FIELD Aisling Field 20 JUN 24

Print Name Signature Date

QA Approval

LAURA KEATING Laura Keating 20 JUN 24

Print Name Signature Date

Sheet _12_ of _18_ ___ Installation Verification

Part-3: __Conductivity_ Installation Verification

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

Maria Kaluzna Page 81

_ CT-001 __ Yes Yes Yes Pass JW 15 JUN 24
__-__

Comments: N/A JW 15 JUN 24

Validation Peer Review

AISLING FIELD Aisling Field 20 JUN 24

Print Name Signature Date

QA Approval

LAURA KEATING Laura Keating 20 JUN 24

Print Name Signature Date

Sheet _13_ of _18_ ___ Installation Verification

Part-1: _Level__ Transmitter Description and Critical Design Features

Inspect the installed instrument item and the vendor’s documentation and verify correct specification conformance
Tag # Specified Actual Specified Range Actual Specified MOC Actual Loop Checked Verification Initials / Date
Manufacturer (Yes/No) (Pass/Fail)
_ LS-003 __ E&H E&H 0 TO 6000 L 0 TO 6000 L 316L SS 316L SS Yes Pass JW 15 JUN 24
__ LS-004__ E&H E&H 0 TO 6000 L 0 TO 6000 L 316L SS 316L SS Yes Pass JW 15 JUN 24

Maria Kaluzna Page 82

__ LS-005_ E&H E&H 0 TO 6000 L 0 TO 6000 L 316L SS 316L SS Yes Pass JW 15 JUN 24

__ LT-001__ E&H E&H 0 TO 6000 L 0 TO 6000 L 316L SS 316L SS Yes Pass JW 15 JUN 24

__ LT-002__ E&H E&H 0 TO 6000 L 0 TO 6000 L 316L SS 316L SS Yes Pass JW 15 JUN 24

Comments: N/A JW 15 JUN 24

Validation Peer Review

MARIA KALUZNA Maria Kaluzna 21 JUN 24

Print Name Signature Date

QA Approval

LAURA KEATING Laura Keating 21 JUN 24

Print Name Signature Date

Sheet _14_ of __18 ____ Installation Verification

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

Maria Kaluzna Page 83

 (Yes/No)
__ LS-003__ Yes Yes See Comment Yes See Comment Yes See Comment Pass MK 19 JUN 24
__ LS-004_ Yes Yes See Comment Yes See Comment Yes See Comment Pass MK 19 JUN 24

__ LS-005_ Yes Yes See Comment Yes See Comment Yes See Comment Pass MK 19 JUN 24

__ LT-001_ Yes Yes See Comment Yes See Comment Yes See Comment Pass MK 19 JUN 24

_ LT-002__ Yes Yes See Comment Yes See Comment Yes See Comment Pass MK 19 JUN 24

Comments: Certs and check sheets can be found in the engineering library.

Validation Peer Review

AISLING FIELD Aisling Field 21 JUN 24

Print Name Signature Date

QA Approval

LAURA KEATING Laura Keating 21 JUN 24

Print Name Signature Date

Sheet _15_ of __18 ___ Installation Verification

Part-3: Level ___ Installation Verification

Visually inspect, and subsequently verify, the correct installation of the instrument item in the field
Tag # Instrument item is installed as Instrument and cabling is Instrument orientated Verification Initials Date
per P&ID, is securely fitted and correctly tagged and details correctly and is accessible for (Pass/Fail)
is free from damage (Yes/No) conform to the design calibration and maintenance
specification (Yes/No) (Yes/No)
__ LS-003__ Yes Yes Yes Pass MK 19 JUN 24

__LS-004__ Yes Yes Yes Pass MK 19 JUN 24

Maria Kaluzna Page 84

__ LS-005__ Yes Yes Yes Pass MK 19 JUN 24

__ LT-001__ Yes Yes Yes Pass MK 19 JUN 24

__ LT-002__ Yes Yes Yes Pass MK 19 JUN 24

Comments: N/A MK 19 JUN 24

Validation Peer Review

AISLING FIELD Aisling Field 21 JUN 24

Print Name Signature Date

QA Approval

LAURA KEATING Laura Keating 21 JUN 24

Print Name Signature Date

Sheet 16 of 18 Instrument Installation Verification

Part-1: Valves Transmitter Description and Critical Design Features

Inspect the installed instrument item and the vendor’s documentation and verify correct specification conformance
Tag # Specified Actual Specified Actual Specified Actual Loop Verification Initials /
Manufacturer Range MOC Checked (Pass/Fail) Date
(Yes/No)
XV- MS ARMATUREN MS N/A N/A 316L SS 316L SS Yes Pass MK 27 May
003 ARMATUREN 24
XV- MS ARMATUREN MS N/A N/A 316L SS 316L SS Yes Pass MK 27 May
24

Maria Kaluzna Page 85

 004 ARMATUREN
XV- HABONIM HABONIM N/A N/A 316L SS 316L SS Yes Pass MK 27 May
008 24

Maria Kaluzna Page 86

17.

XV-009 HABONIM HABONIM N/A N/A 316L SS 316L SS Yes Pass MK 27 May 24
XV-001 GEA TUCHENHAGEN GEA TUCHENHAGEN N/A N/A 316L SS 316L SS Yes Pass MK 27 May 24

Sheet 17
XV-002 ofTUCHENHAGEN
GEA 18 GEA TUCHENHAGEN Instrument
N/A Installation
N/A Verification
316L SS 316L SS Yes Pass MK 27 May 24

XV-005 GEA TUCHENHAGEN GEA TUCHENHAGEN N/A N/A 316L SS 316L SS Yes Pass MK 27 May 24

XV-006 GEA TUCHENHAGEN GEA TUCHENHAGEN N/A

Part-2: Valves
N/A
Documentation Verification
316L SS 316L SS Yes Pass MK 27 May 24

XV-007 GEA TUCHENHAGEN GEA TUCHENHAGEN N/A handover package

N/A is in place316L SS 316Lmaterial
SS Yes Pass MK 27 May 24
Confirm that the vendor and contains correct certificates
Tag # *Vendor handover Material Cert # Calibration Cert # Loop Check Check sheet # Verif icati on Initials / Date
package is in Certification is Certification is sheet is (Pas s/Fai l)
place available for available available
(Yes/No) wetted parts (Yes/No) (Yes/No)
(Yes/No)
Comments:
N/A MK 27 May 24
XV-003 Yes Yes See Comment Yes See Comment Yes See Comment Pass MK 27 May 24

XV-004 Yes Yes See Comment Yes See Comment Yes See Comment Pass MK 27 May 24

XV-008 Yes Yes See Comment Yes See Comment Yes See Comment Pass MK 27 May 24

XV-009 Yes Yes See Comment Yes See Comment Yes See Comment Pass MK 27 May 24

Validation Peer Review

AISLING FIELD Aisling Field 21 JUN 24

Print Name Signature Date

QA Approval

LAURA KEATING
Laura Keating 21 JUN 24
Print Name Signature Date

XV-001 Yes Yes See Comment Yes See Comment Yes See Comment Pass MK 27 May 24

MariaXV-002
Kaluzna Yes Yes Page 87 See Comment Yes See Comment Yes See Comment Pass MK 27 May 24

XV-005 Yes Yes See Comment Yes See Comment Yes See Comment Pass MK 27 May 24

XV-006 Yes Yes See Comment Yes See Comment Yes See Comment Pass MK 27 May 24

XV-007 Yes Yes See Comment Yes See Comment Yes See Comment Pass MK 27 May 24
 Comments:
Validation Certs and check sheets can be found in the engineering library.
Peer Review
AISLING FIELD Aisling Field 21 JUN 24
Print Name Signature Date

QA Approval
LAURA KEATING Laura Keating 21 JUN 24
Print Name Signature Date

Sheet 18 of 18 Instrument Installation Verification

Part-3: Valve Installation Verification

Visually inspect, and subsequently verify, the correct installation of the instrument item in the field
Tag # Instrument item is installed as Instrument and cabling is Instrument orientated Verification Initials Date
per P&ID, is securely fitted and correctly tagged and details correctly and is accessible for (Pass/Fail)
is free from damage (Yes/No) conform to the design calibration and maintenance
specification (Yes/No) (Yes/No)
XV-003 Yes Yes Yes Pass MK 17 JUN 24
XV-004 Yes Yes Yes Pass MK 17 JUN 24

XV-008 Yes Yes Yes Pass MK 17 JUN 24

XV-009 Yes Yes Yes Pass MK 17 JUN 24

XV-001 Yes Yes Yes Pass MK 17 JUN 24

Maria Kaluzna Page 88

18.

XV-002 Yes Yes Yes Pass MK 17 JUN 24

XV-005 Yes Yes Yes Pass MK 17 JUN 24

XV-006 Yes Yes Yes Pass MK 17 JUN 24

XV-007 Yes Yes Yes Pass MK 17 JUN 24

Comments:N/A MK 17 JUN 24
Validation Peer Review
AISLING FIELD Aisling Field 21 JUN 24
Print Name Signature Date

QA Approval

LAURA KEATING Laura Keating 21 JUN 24

Print Name Signature Date

Maria Kaluzna Page 89

16.2.4. Piping Installation Verification
Sheet 1 of 6 Piping Installation Verification

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

50-PUW1-S6-147-IH *a S6 See Comment Yes See Comment Yes See Comment Yes Pass MK 19 JUN 24

50-PUW1-S6-148-IH *b S6 See Comment Yes See Comment Yes See Comment Yes Pass MK 19 JUN 24

80-DETERGENT-S6-149-IH S6 See Comment Yes See Comment Yes See Comment Yes Pass MK 19 JUN 24
*c

80-DETERGENT-S6-150-IH S6 See Comment Yes See Comment Yes See Comment Yes Pass MK 19 JUN 24
*d

80-DETERGENT-S6-151-IH S6 See Comment Yes See Comment Yes See Comment Yes Pass MK 19 JUN 24
*e

65-DETERGENT-S6-152-IH S6 See Comment Yes See Comment Yes See Comment Yes Pass MK 19 JUN 24
*f

65-DETERGENT-S6-153-IH S6 See Comment Yes See Comment Yes See Comment Yes Pass MK 19 JUN 24
*g
*Weld Log collates material-of-construction certificates and weld inspection certificates **Construction Dossier collates slope-check documentation

Comments: Weld log, Pressure test pack and Construction Dossier documents can be found in the engineering library.
Inline component *: a. XV-009, b. XV-008, c.XV-002, XV-004, XV-007, d.V-008, e.V-009, f.V-011, g.V-010, PI-004, V-012
Validation Peer Review
JONATHAN WALSH Jonathan Walsh 21 JUN 24
Print Name Signature Date

QA Approval

LAURA KEATING Laura Keating 21 JUN 24

Print Name Signature Date

Maria Kaluzna Page 90

 Sheet 2 of 6 Piping Installation Verification
Tag # MOC *Weld *Weld Log Pressure Test Pressure Test Construction **Slopes Verification Initials / Date
Log # Complete Pack-# Complete Dossier # Checked (Pass/Fail)
(Yes/No) (Yes/No) (Yes/No)
65-DETERGENT-SS1-154- SS1 See Comment Yes See Comment Yes See Comment Yes Pass MK 19 JUN 24
IH *a
80-PUW2-S6-155-IH *b S6 See Comment Yes See Comment Yes See Comment Yes Pass MK 19 JUN 24

80-PUW2-S6-156-IH *c S6 See Comment Yes See Comment Yes See Comment Yes Pass MK 19 JUN 24

80-PUW2-S6-157-IH *d S6 See Comment Yes See Comment Yes See Comment Yes Pass MK 19 JUN 24

65-PUW2-S6-158-IH *e S6 See Comment Yes See Comment Yes See Comment Yes Pass MK 19 JUN 24

65-PUW2-S6-159-IH *f S6 See Comment Yes See Comment Yes See Comment Yes Pass MK 19 JUN 24

65-PUW2-S6-160-IH *g S6 See Comment Yes See Comment Yes See Comment Yes Pass MK 19 JUN 24

25-PROCESS-S6-161-NI S6 See Comment Yes See Comment Yes See Comment Yes Pass MK 19 JUN 24
*h
*Weld Log collates material-of-construction certificates and weld inspection certificates **Construction Dossier collates slope-check documentation

Comments: Weld log, Pressure test pack and Construction Dossier documents can be found in the engineering library.
Inline component *: a.V-042,V-014 b.XV-001,XV-003 c.XV-001 d.V-002, e.V-004, f.V-003,PI-003, V-005 g.V-007, V-041 h.V-036

Validation Peer Review

JONATHAN WALSH Jonathan Walsh 21 JUN 24
Print Name Signature Date

QA Approval

LAURA KEATING Laura Keating 21 JUN 24

Print Name Signature Date

Maria Kaluzna Page 91

 Sheet 3 of 6 Piping Installation Verification
Tag # MOC *Weld Log *Weld Log Pressure Test Pressure Test Construction **Slopes Verification Initials / Date
Comments: Weld log, Pressure test pack
# and Construction
Complete Dossier documents
Pack-# canComplete
be found in the engineering
Dossier # library. Checked (Pass/Fail)
(Yes/No)
(Yes/No) c.V-043,XV-005,PRV-001, d.V-032,SG-006 e.V-033,SG-007
(Yes/No)
Inline component *: a.V-034,V-040 b.V-044,XV-006,PRV-002
25-PROCESS-S6-162- NI S6 See Comment Yes See Comment Yes See Comment Yes Pass MK 21 JUN 24
*a
65-DETERGENT-S6- S6 See Comment Yes See Comment Yes See Comment Yes Pass MK 21 JUN 24
163-IH *b
65-PUW2-S6-164-IH S6 See Comment Yes See Comment Yes See Comment Yes Pass MK 21 JUN 24
*c
100-VENTS6-166-NI S6 See Comment Yes See Comment Yes See Comment Yes Pass MK 21 JUN 24

25-DRAIN-S6-167-NI S6 See Comment Yes See Comment Yes See Comment Yes Pass MK 21 JUN 24
*d
100-VENTS6-168-NI S6 See Comment Yes See Comment Yes See Comment Yes Pass MK 21 JUN 24
25-DRAIN-S6-169-NI S6 See Comment Yes See Comment Yes See Comment Yes Pass MK 21 JUN 24
*e
50-DRAIN-S6-170-NI S6 See Comment Yes See Comment Yes See Comment Yes Pass MK 21 JUN 24
*Weld Log collates material-of-construction certificates and weld inspection certificates **Construction Dossier collates slope-check documentation
Validation Peer Review
JONATHAN WALSH Jonathan Walsh 21 JUN 24
Print Name Signature Date

QA Approval

LAURA KEATING Laura Keating 21 JUN 24

Print Name Signature Date

Sheet 4 of 6 Piping Installation Verification

Maria Kaluzna Page 92

Tag # MOC *Weld Log *Weld Log Pressure Test Pressure Test Construction **Slopes Verification Initials / Date
# Complete Pack-# Complete Dossier # Checked (Pass/Fail)
(Yes/No) (Yes/No) (Yes/No)
50-DRAIN-S6-171-NI S6 See Comment Yes See Comment Yes See Comment Yes Pass MK 21 JUN 24
25-VENT-S6-172-NI S6 See Comment Yes See Comment Yes See Comment Yes Pass MK 21 JUN 24
*a
25-VENT-S6-173-NI S6 See Comment Yes See Comment Yes See Comment Yes Pass MK 21 JUN 24
*b
50-DRAIN-S6-174-NI S6 See Comment Yes See Comment Yes See Comment Yes Pass MK 21 JUN 24
50-DRAIN-S6-175-NI S6 See Comment Yes See Comment Yes See Comment Yes Pass MK 21 JUN 24
80-DRAIN-S6-176-NI S6 See Comment Yes See Comment Yes See Comment Yes Pass MK 21 JUN 24
15-DRAIN-S6-177-NI S6 See Comment Yes See Comment Yes See Comment Yes Pass MK 21 JUN 24
*c
15-DRAIN-S6-178-NI S6 See Comment Yes See Comment Yes See Comment Yes Pass MK 21 JUN 24
*d
*Weld Log collates material-of-construction certificates and weld inspection certificates **Construction Dossier collates slope-check documentation

Maria Kaluzna Page 93

 Comments: Weld log, Pressure test pack and Construction Dossier documents can be found in the engineering library.
Inline component *: a.PSV-002 b.PSV-001 c.V-030 d.V-031.

Validation Peer Review

JONATHAN WALSH Jonathan Walsh 21 JUN 24
Print Name Signature Date

QA Approval

LAURA KEATING Laura Keating 21 JUN 24

Print Name Signature Date

Maria Kaluzna Page 94

 Sheet 5 of 6 Piping Installation Verification
Tag # MOC *Weld Log *Weld Log Pressure Test Pressure Test Construction **Slopes Checked Verification Initials / Date

# Complete Pack-# Complete (Yes/No) Dossier # (Yes/No) (Pass/Fail)

(Yes/No)
15-DRAIN-179-S6-NI *a S6 See Comment Yes See Comment Yes See Comment Yes Pass AF 27 MAY 24

15-DRAIN-180-S6-NI *b S6 See Comment Yes See Comment Yes See Comment Yes Pass AF 27 MAY 24

50-DRAIN-181-S6-NI *c SS1 See Comment Yes See Comment Yes See Comment Yes Pass AF 27 MAY 24

50-DRAIN-182-S6-NI *d SS1 See Comment Yes See Comment Yes See Comment Yes Pass AF 27 MAY 24

65-PLANT STEAM-CS5- CS5 See Comment Yes See Comment Yes See Comment Yes Pass AF 27 MAY 24
183-IH *e
15-PLANT STEAM-CS5- CS5 See Comment Yes See Comment Yes See Comment Yes Pass AF 27 MAY 24
184-IH *f
20-CONDENSTATE-CS5- CS5 See Comment Yes See Comment Yes See Comment Yes Pass AF 27 MAY 24
185-IH
40-CONDENSTATE-CS5- CS5 See Comment Yes See Comment Yes See Comment Yes Pass AF 27 MAY 24
186-IH *7
*Weld Log collates material-of-construction certificates and weld inspection certificates **Construction Dossier collates slope-check documentation

Comments: Weld log, Pressure test pack and Construction Dossier documents can be found in the engineering library.
Inline component *: a.V-028 b.V-029 c.V-006 d.V-013 e.TCV-006,V-019,TCV-005,V-020 f.V-021,ST-001,SG-003,V-022,V-023 7.ST-002,SG-005,V-024,V- 025

Maria Kaluzna Page 95

 Validation Peer Review
Maria Kaluzna 28 MAY 24
MARIA KALUZNA
Print Name Signature Date

QA Approval
CALVIN MOORE Calvin Moore 28 MAY 24
Print Name
Signature Date

Sheet 6 of 6 Piping Installation Verification

Tag # MOC *Weld Log *Weld Log Pressure Test Pressure Test Construction **Slopes Verification Initials / Date

# Complete Pack-# Complet Dossier # Checked (Pass/Fail)

e
(Yes/No) (Yes/No)
(Yes/No)
40-CONDENSTATE-CS5- CS5 See Comment Yes See Comment Yes See Comment Yes Pass AF 27 MAY 24
187-IH *a

100-PLANT STEAM-CS5- CS5 See Comment Yes See Comment Yes See Comment Yes Pass AF 27 MAY 24
241-IH *b

80-CONDENSTATE-CS5- CS5 See Comment Yes See Comment Yes See Comment Yes Pass AF 27 MAY 24
242-IH
40-COMPRESSED AIR- SS1 See Comment Yes See Comment Yes See Comment Yes Pass AF 27 MAY 24
SS1-502-NI *c
*Weld Log collates material-of-construction certificates and weld inspection certificates **Construction Dossier collates slope-check documentation

Maria Kaluzna Page 96

 Validation Peer Review
Maria Kaluzna 28 MAY 24
MARIA KALUZNA
Print Name Signature Date

QA Approval
CALVIN MOORE Calvin Moore 28 MAY 24

Print Name Signature Date

Maria Kaluzna Page 97

 Pharmaceutical Equipment Stainless Steel Sanitary Grade Welded Pipe/Tube - China Stainless Steel Sanitary Tube, Stainless Steel Tube | Made-in-

China.com

https://tedisteel.en.made-in-china.com/product/YJSROBPClWVN/China-Pharmaceutical-Equipment-Stainless-Steel-Sanitary-Grade-Welded-Pipe-Tube.html

Maria Kaluzna Page 98

16.2.5. Calibration Program Verification

https://www.getreskilled.com/validation/validation-protocol/

Maria Kaluzna Page 99

 Page _1__ of __1_

CALIBRATION PROGRAM VERIFICATION FORM

No. Steps Yes/No Verified By Date

Critical component list attached and cross referenced from commissioning
1
documents
Yes MK 01 JUN 24
2 Calibration list attached and cross referenced from site calibration program Yes MK 01 JUN 24
All critical components confirmed to be entered into the site calibration 01 JUN 24
3
program
Yes MK
Deviation Report Required (Yes/No) : No
Acceptance Criteria Met: (Yes/No): Yes
Comments: N/A MK 01 JUN 24

Reviewed By: Date: 02 JUN 24

Validation
Daniel Crandol
Approved By: Date: 02 JUN 24
(QA)
Calvin Moore

Maria Kaluzna Page 100

16.2.6. Preventative Maintenance Program Verification
Page _1__ of __2_

Preventative Maintenance Program Verification Form

No. Description Verified By / Date

Component: Pumps (P-207,P-209,P-415,P-417,P-223)

1 Centrifugal pumps: P-207,P-209,P-415,P-417 Metering pump: P-223 MK 03 JUN 24

PM#:1 001-1004, Location: Hot Detergent / PUW Effective Date:
1007 Skid, Reactor cleaning. 03 JUN 24
Component: Heat Exchangers (HX-211,HX-411)
Detergent Plate Heat Exchanger: HX-211, PUW2 Plate Heat Exchanger: HX-411
Location: Cleaning Skid System,
Hot Detergent / PUW Skid.
2 Isolate one process circulation loop from
Effective Date: MK 04 JUN 24
another. The hot detergent solution supply
PM#: 994 temperature is maintained by a closed loop control 04 JUN 24
system, which modulates steam flow to the heat
exchanger HX-211. The PUW2 hot process water
supply temperature is maintained by a closed loop
control system, which modulates steam flow to the
heat exchanger HX-411.

Component: Filters (FL-399,FL-401)

3 Inline filters: Detergent Cartridge Filter FL-399, PUW2 Cartridge Filter FL-401 MK 05 JUN 24
Location: Hot Detergent / PUW Effective Date:
PM#: 876
Skid, Reactor cleaning. 05 JUN 24
4 Component: Pressure Safety Valves (PSV-002,PSV-001) MK 03 JUN 24
PUW2 Sanitary Pressure Relief Valve PSV-001, Detergent Sanitary Pressure Relief Valve
PSV-002

Maria Kaluzna Page 101

 Location: PSV-001 in HX-411 Effective Date: Page _2_ of __2_
Outlet, PSV-002 in HX-211 03 JUN 24
PM#: 1024
Outlet;
Cleaning Skid System.
Component: Temperature Indicator (TI-007,TI-008)
Bimetalic Temperature indicators
Location: TI-007-T-411
5
thermowell, TI-008-T-211
MK 03 JUN 24
Effective Date:
PM#: 007 thermowell. Hot Detergent and
03 JUN 24
Hot PUW Skid.

Component: Level Transmitter (LT-001,LT-002)

Hydrostatic Pressure type level Transmitters
6
Location: Hot Detergent and Hot
MK 03 JUN 24
Effective Date:
PM#: 409 PUW Skid.
04 JUN 24
LT-001-T-411, LT-002-T-211.
Comments: N/A MK 05 JUN 24

Reviewed By: 03 JUN 24

Validation
Daniel Crandol Date:
Approved By: 03 JUN 24
(QA)
Calvin Moore Date:

Maria Kaluzna Page 102

16.2.7. Draft SOP Verification
Page _1 __ of _ 2_

Standard Operating Procedure Verification Form

No. Description Verified By / Date

Title: Operation of the Hot detergent system

1 AF 15 MAR 24

SOP #: 11302 Revision #: 1 Date: 15 MAR 24

Title: Operation of the Hot PUW2 system

2 MK 03 FEB 24

SOP #: 11303 Revision #: 0 Date: 03 FEB 24

Title Cleaning the Hot PUW2 and Hot Detergent system

3 MK 16 FEB 24

SOP #: 11304 Revision #: 0 Date: 16 FEB 24

Examine the attachments and connections on the Hot detergent and hot PUW generation and distribution skid.
Title:

4 AF 08 APR 24

SOP #: 11325 Revision #: 2 Date: 08 APR 24

Assembling and disassembling the Hot detergent and hot PUW generation and distribution skid
Title:

5 AF 20 APR 24

SOP #: 11330 Revision #: 3 Date: 20 APR 24

Title: Operation and maintenance of CIP wash tanks

6 MK 12 JAN 24

Maria Kaluzna Page 103

 Date: 12 JAN 24
SOP #: SOP-235 Revision #: 12 Page _2_ of __2_
Title: CIP procedures for bioreactors

7 MK 08 JAN 24

SOP #: SOP-157 Revision #: 4.3 Date: 08 JAN 24

Title: Operation and maintenance of steam supply line

8 MK 30 APR 24

SOP #: SOP-1002 Revision #: 6.7 Date: 30 APR 24

Title: Operational maintenance of hot detergent line

9 FR 22 JAN 24

SOP #: SOP-645 Revision #: 15.6 Date: 22 JAN 24

Title: Operational maintenance of PUW1 supply line

10 FR 17 APR 24

SOP #: SOP-880 Revision #: 3.9 Date: 17 APR 24

Title: Operation and maintenance of pumps in generation and distribution system

11 MK 30 APR 24

SOP #: SOP-184 Revision #: 1.7 Date: 30 APR 24

Comments:

Reviewed By: 30 APR 24

Daniel Crandol Date:
Validation
Approved By: 30 APR 24
Calvin Moore_ Date:
(QA)

Maria Kaluzna Page 104

16.2.8. Test-Instrument Calibration Verification
Page _1 _ of _2 __

Test Instrument Calibration Verification Form

Objective: To document all test instruments used in the execution of this protocol.
Identification Calibration
Test Instrument Description Calibration Date Verified By / Date
Number Due Date
Steam Temperature control valve TCV-005 21 JUN 24 20 DEC 24 MK 21 JUN 24
Steam Temperature control valve TCV-006 21 JUN 24 20 DEC 24 MK 21 JUN 24

3 wire RTD Temperature transmitters TT-001 21 JUN 24 20 DEC 24 MK 21 JUN 24

3 wire RTD Temperature transmitters TT-002 21 JUN 24 20 DEC 24 MK 21 JUN 24

3 wire RTD Temperature transmitters TT-003 21 JUN 24 20 DEC 24 MK 21 JUN 24

3 wire RTD Temperature transmitters TT-004 21 JUN 24 20 DEC 24 MK 21 JUN 24

Sanitary Diaphragm type Pressure Indicating transmitters PT-001 21 JUN 24 20 DEC 24 MK 21 JUN 24

Sanitary Diaphragm type Pressure Indicating transmitters PT-002 21 JUN 24 20 DEC 24 MK 21 JUN 24

Magnetic flow Transmitter FT-001 21 JUN 24 20 DEC 24 MK 21 JUN 24

Magnetic flow Transmitter FT-002 21 JUN 24 20 DEC 24 MK 21 JUN 24

Magnetic flow Transmitter FT-003 21 JUN 24 20 DEC 24 MK 21 JUN 24

Magnetic flow Transmitter FT-004 21 JUN 24 20 DEC 24 MK 21 JUN 24

Conductivity transmitter CT-001 21 JUN 24 20 DEC 24 MK 21 JUN 24

Bimetalic Temperature indicator TI-007 21 JUN 24 20 DEC 24 MK 21 JUN 24

Bimetalic Temperature indicator TI-008 21 JUN 24 20 DEC 24 MK 21 JUN 24

Bimetalic Temperature indicator TI-009 21 JUN 24 20 DEC 24 MK 21 JUN 24

Maria Kaluzna Page 105

 Bimetalic Temperature indicator TI-010 21 JUN 24 20 DEC 24 MK 21 JUN 24

Hydrostatic Pressure type level Transmitter LT-001 21 JUN 24 20 DEC 24 MK 21 JUN 24

Hydrostatic Pressure type level Transmitter LT-002 21 JUN 24 20 DEC 24 MK 21 JUN 24

Actuated Sanitary Ball Valve XV-008 21 JUN 24 20 DEC 24 MK 21 JUN 24

Actuated Sanitary Ball Valve XV-009 21 JUN 24 20 DEC 24 MK 21 JUN 24
High Level Switch (Tuning fork type) LS-004 21 JUN 24 20 DEC 24 MK 21 JUN 24
High Level Switch (Tuning fork type) LS-006 21 JUN 24 20 DEC 24 MK 21 JUN 24
Comment:

N/A MK 21 JUN 24

Reviewed By:
Maria Kaluzna Date: 21 JUN 24
Validation

Calvin Moore Date: 21 JUN 24

Approved By: (QA)

Maria Kaluzna Page 106

 Calibration of instruments in pharmaceutical industry - How to perform calibration

Maria Kaluzna Page 107

 Master Pressure Calibrators: Precision Tools for Accurate Pressure Instrument Calibration

Maria Kaluzna Page 108

16.3. Appendix C: OQ GMP check-sheets

16.3.1. Hot Detergent System – Level Control

Test Pass / Date
Operational Test Step Description Expected Result Actual Result Initials
Step # Fail (dd/mmm/yyyy)
Confirm the initial level in the hot detergent tank LT-002 = 0 0 PASS GPC 11/Feb/2020
1

Fill the hot detergent tank from the PUW1 water loop until LT-002 = 5775 litres ± 5% 5775 PASS GPC 11/Feb/2020
2
it stops filling automatically.
Open the drain valve and the tank should automatically LT-002 = 5775 litres ± 5% 5775 PASS GPC 11/Feb/2020
3 start filling again from the PUW1 water loop to remain
full.
Close the drain valve and check that the level in the tank LT-002 = 5775 litres ± 5% 5775 PASS GPC 11/Feb/2020
4 remains full in normal operation mode for a further 30-
minutes
Print out the associated trends for level LT-002 the test Trends attached Trends attached PASS GPC 11/Feb/2020
5
period and append to this test section.

Aisling Field 13/Feb/2024

Reviewed By (Validation Peer Review) Date

Calvin Moore 13/Feb/2024

Approved By (Quality Assurance) Date

Maria Kaluzna Page 109

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 Time Expected Actual Date

Pass / Fail Initials
minutes HH/MM LT-002 (Litres) LT-002 (Litres) (dd/mmm/yyyy)
t0-min 13:00 0 0 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

Maria Kaluzna 14 FEB 2024

Reviewed By (Validation Peer Review) Date

Calvin Moore 14 FEB 2024

Approved By (Quality Assurance) Date

Maria Kaluzna Page 110

Time Time Expected Actual Date
Pass / Fail Initials
minutes HH/MM LT-002 (Litres) LT-002 (Litres) (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

Comments: N/A MK 14 FEB 24

14 FEB 24
Aisling Field
Reviewed By (Validation Peer Review) Date

Calvin Moore 14 FEB 24

Approved By (Quality Assurance) Date

Maria Kaluzna Page 111

16.3.2. Hot Detergent System – Flow Control
Test Pass / Date
Operational Test Step Description Expected Result Actual Result Initials
Step # Fail
1 Start the hot detergent pump circulating FT-002 = 25,000 litres/hr ±5% FT-002 = 25,000 litres/hr PASS GPC 11/Feb/2020
FT-004 = 25,000 litres/hr ±5°C FT-004 = 25,000 litres/hr

2 Confirm the initial flow reading of FT-002 and FT-002 = 25,000 litres/hr ±5% FT-002 = 25,000 litres/hr PASS GPC 11/Feb/2020
FT-004 FT-004 = 25,000 litres/hr ±5% FT-004 = 25,000 litres/hr

3 Open the transfer valves to RE-119 and RE-140 LT-119 = 5,500 Litres LT-119 = 5,500 litres PASS GPC 11/Feb/2020
and transfer 5,500 litres into each vessel, LT-140 = 5,500 Litres LT-140 = 5,500 litres
confirming the level reading on LT-119 and LT-
140 (this will take approximately 30-minutes). FT-002 = 25,000 litres/hr ±5% FT-002 = 25,000 litres/hr
Confirm the flow readings FT-002 and FT-004 FT-004 = 3,000 litres/hr ±5% FT-004 = 3,000 litres/hr
4 After the transfer stops, maintain the hot detergent FT-002 = 25,000 litres/hr ±5% FT-002 = 25,000 litres/hr PASS GPC 11/Feb/2020
system in normal recirculation mode for a further FT-004 = 25,000 litres/hr ±5% ±5%
30-minutes with no further drawdown. FT-004 = 25,000 litres/hr
±5%
5 Print out the associated trends for level LT-119 Trends attached Trends attached PASS GPC 11/Feb/2020
and LT-140, flow FT-002 and FT-004 during the
test period and append to this test section.

Maria Kaluzna
Maria Kaluzna Page 112
 14 FEB 24
Reviewed By (Validation Peer Review) Date

Calvin Moore 14 FEB 24

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 Time Expected Actual Actual Expected Expected Actual Actual Pass / Initials Date
Mins HH/MM Flow FT-002 / FT-004 FT-002 FT-004 LT-119 LT-140 LT-119 LT-140 Fail (dd/mmm/yyyy)
Litres/hr Litres/hr Litres/hr Litres Litres (Litres) (Litres)
t0-min 13:00 FT-002 25,000 ± 5% 25,490 25,490 0 0 0 0 PASS GPC 11/Feb/2020
FT-004 25,000 ± 5%
t5-min 13:05 FT-002 25,000 ± 5% 24,966 24,966 0 0 0 0 PASS GPC 11/Feb/2020
FT-004 25,000 ± 5%
t10-min 13:10 FT-002 25,000 ± 5% 25,019 25,019 0 0 0 0 PASS GPC 11/Feb/2020
FT-004 25,000 ± 5%
t15-min 13:15 FT-002 25,000 ± 5% 24,699 24,699 0 0 0 0 PASS GPC 11/Feb/2020
FT-004 25,000 ± 5%
t20-min 13:20 FT-002 25,000 ± 5% 25,243 25,243 0 0 0 0 PASS GPC 11/Feb/2020
FT-004 25,000 ± 5%
t25-min 13:25 FT-002 25,000 ± 5% 24,699 24,699 0 0 0 0 PASS GPC 11/Feb/2020
FT-004 25,000 ± 5%
t30-min 13:30 FT-002 25,000 ± 5% 25,243 25,243 0 0 0 0 PASS GPC 11/Feb/2020
FT-004 25,000 ± 5%
t35-min 13:35 FT-002 25,000 ± 5% 24,446 2,917 <5,500 <5,500 1,000 1,000 PASS GPC 11/Feb/2020
FT-004 3,000 ± 5%
t40-min 13:40 FT-002 25,000 ± 5% 25,009 3,109 <5,500 <5,500 2,000 2,000 PASS GPC 11/Feb/2020
Maria Kaluzna Page 113
 FT-004 3,000 ± 5%

Maria Kaluzna 15 FEB 24

Reviewed By (Validation Peer Review) Date

Calvin Moore 16 FEB 24

Approved By (Quality Assurance) Date

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

Maria Kaluzna Page 114

t70-min 14:10 FT-002 25,000 ± 24,255 24,255 5,500± 5% 5,500± 5% 5,500 5,500 PASS GPC 11/Feb/2020
5%
FT-004 25,000 ±
5%
t75-min 14:15 FT-002 25,000 ± 25,245 25,245 5,500± 5% 5,500± 5% 5,500 5,500 PASS GPC 11/Feb/2020
5%
FT-004 25,000 ±
5%
t80-min 14:20 FT-002 25,000 ± 25,457 25,457 5,500± 5% 5,500± 5% 5,500 5,500 PASS GPC 11/Feb/2020
5%
FT-004 25,000 ±
5%
t85-min 14:25 FT-002 25,000 ± 25,189 25,189 5,500± 5% 5,500± 5% 5,500 5,500 PASS GPC 11/Feb/2020
5%
FT-004 25,000 ±
5%

Comments:

15 FEB 24
Maria Kaluzna
Reviewed By (Validation Peer Review) Date

Calvin Moore 16 FEB 24

Approved By (Quality Assurance) Date

Maria Kaluzna Page 115

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

Aisling Field 17 MAR 24

Reviewed By (Validation Peer Review) Date

Laura Keating 19 MAR 24

Approved By (Quality Assurance) Date

Maria Kaluzna Page 116

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 Time Expected Actual Actual Expected Actual Actual Pass / Initials Date
minutes HH/MM TT-002 and TT-002 TT-004 LT-119 LT-119 LT-140 Fail (dd/mmm/yyyy)
TT-004 (°C) (°C) LT-140 (Litres) (Litres)
(°C) (Litres)
t0-min 13:00 <80°C 25°C 25°C 0 0 0 PASS GPC 11/Feb/2020
t5-min 13:05 <80°C 40°C 40°C 0 0 0 PASS GPC 11/Feb/2020
t10-min 13:10 <80°C 60°C 60°C 0 0 0 PASS GPC 11/Feb/2020
t15-min 13:15 <80°C 75°C 75°C 0 0 0 PASS GPC 11/Feb/2020
t20-min 13:20 80°C ±5°C 80°C 80°C 0 0 0 PASS GPC 11/Feb/2020
t25-min 13:25 80°C ±5°C 81°C 80°C 0 0 0 PASS GPC 11/Feb/2020
t30-min 13:30 80°C ±5°C 78°C 83°C 0 0 0 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

19 MAR 24
Aisling Field
Reviewed By (Validation Peer Review) Date

Laura Keating 19 MAR 24

Approved By (Quality Assurance) Date

Maria Kaluzna Page 117

Time Time Expected Actual Actual Expected LT-119 LT-140 Pass / Initials Date
minutes HH/MM TT-002 TT-002 TT-004 LT-119 (Litres) (Litres) Fail (dd/mmm/yyyy)
TT-004 (°C) (°C) LT-140
(°C) (Litres)
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

Comments:
N/A AF 19 MAR 24

Aisling Field 19 MAR 24

Reviewed By (Validation Peer Review) Date

Laura Keating 19 MAR 24

Approved By (Quality Assurance) Date

Maria Kaluzna Page 118

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

20 MAR 24
Aisling Field
Reviewed By (Validation Peer Review) Date

Laura Keating 29 MAR 24

Approved By (Quality Assurance) Date

Maria Kaluzna Page 119

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 Time Expected Actual Expected Actual Actual Expected LT-119 LT-140 Pass / Initials Date
minutes HH/ CT-001 CT-001 TT-002 TT-002 TT-004 LT-119 (Litres) (Litres) Fail (dd/mmm/
MM μScm-1 μScm-1 TT-004 (°C) (°C) LT-140 yyyy)
(°C) (Litres)
t0-min 13:00 <500 100 μScm-1 80°C ±5°C 80°C 80°C 0 0 0 PASS GPC 11/Feb/2020
t5-min 13:05 <500 200 μScm-1 80°C ±5°C 81°C 80°C 0 0 0 PASS GPC 11/Feb/2020
t10-min 13:10 <500 300 μScm-1 80°C ±5°C 80°C 80°C 0 0 0 PASS GPC 11/Feb/2020
t15-min 13:15 <500 400 μScm-1 80°C ±5°C 84°C 82°C 0 0 0 PASS GPC 11/Feb/2020
t20-min 13:20 500 μScm-1 ± 5% 499 μScm-1 80°C ±5°C 80°C 79°C 0 0 0 PASS GPC 11/Feb/2020
t25-min 13:25 500 μScm-1 ± 5% 502 μScm-1 80°C ±5°C 83°C 80°C 0 0 0 PASS GPC 11/Feb/2020
t30-min 13:30 500 μScm-1 ± 5% 500 μScm-1 80°C ±5°C 78°C 83°C 0 0 0 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

20 MAR 24
Aisling Field
Reviewed By (Validation Peer Review) Date

Laura Keating 29 MAR 24

Approved By (Quality Assurance) Date

Maria Kaluzna Page 120

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

Comments: N/A AF 20 MAR 24

20 MAR 24
Aisling Field
Reviewed By (Validation Peer Review) Date

Maria Kaluzna Page 121

Laura Keating 29 MAR 24
Approved By (Quality Assurance) Date

16.3.5. Hot PUW System – Level Control

Test Operational Test Step Description Expected Result Actual Result Pass / Initials Date
Step # Fail (dd/mmm/yyyy)
1 Confirm the initial level in the Hot PUW2 tank LT-001 = 0 0 PASS MK 29/May/2024

2 Fill the hot PUW2 tank from the PUW1 water loop until it LT-001 = 5775 litres ± 5% 5775 PASS MK 29/May/2024
stops filling automatically.
3 Open the drain valve and the tank should automatically start LT-001 = 5775 litres ± 5% 5775 PASS MK 29/May/2024
filling again from the PUW1 water loop to remain full.
4 Close the drain valve and check that the level in the tank LT-001 = 5775 litres ± 5% 5775 PASS MK 29/May/2024
remains full in normal operation mode for a further 30-
minutes
5 Print out the associated trends for level LT-001 the test Trends attached Trends attached PASS MK 29/May/2024
period and append to this test section.

Aisling Field 29 MAY 24

Reviewed By (Validation Peer Review) Date

Calvin Moore 29 MAY 24

Approved By (Quality Assurance) Date

Maria Kaluzna Page 122

 In the following table, at successive 5-minute intervals record the level in the Hot PUW2 tank of the level transmitter LT-001. Ensure that during the time
period the values are recorded correspond to the following:

 The 30-minutes for filling the hot PUW2 tank (starting at t0-min) [INSERT INFORMATION]
 Automatic filling during the draining of the hot PUW2 tank
 The 30-minutes following the closing of the valve
Time Time Expected Actual Pass / Fail Initials Date
minutes HH/MM LT-001 (Litres)_ LT-001 (Litres) (dd/mmm/yyyy)
t0-min 13:00 0 0 Pass MK 26/May/2024
t5-min 13:05 <5,775 914 Pass MK 26/May/2024
t10-min 13:10 <5,775 1833 Pass MK 26/May/2024
t15-min 13:15 <5,775 2752 Pass MK 26/May/2024
t20-min 13:20 <5,775 3666 Pass MK 26/May/2024
t25-min 13:25 <5,775 4582 Pass MK 26/May/2024
t30-min 13:30 5,775 ± 5% 5775 Pass MK 26/May/2024
t35-min 13:35 5,775 ± 5% 5775 Pass MK 26/May/2024
t40-min 13:40 5,775 ± 5% 5775 Pass MK 26/May/2024

29 MAY 24
Aisling Field
Reviewed By (Validation Peer Review) Date

Calvin Moore 29 MAY 24

Approved By (Quality Assurance) Date

Maria Kaluzna Page 123

 Time Time Expected Actual Pass / Fail Initials Date
minutes HH/MM LT-001 (Litres)_ LT-001 (Litres) (dd/mmm/yyyy)
t45-min 13:45 5,775 ± 5% 5775 Pass MK 29/May/2024
t50-min 13:50 5,775 ± 5% 5775 Pass MK 29/May/2024
t55-min 13:55 5,775 ± 5% 5775 Pass MK 29/May/2024
t60-min 14:00 5,775 ± 5% 5775 Pass MK 29/May/2024
t65-min 14:05 5,775 ± 5% 5775 Pass MK 29/May/2024
t70-min 14:10 5,775 ± 5% 5775 Pass MK 29/May/2024
t75-min 14:15 5,775 ± 5% 5775 Pass MK 29/May/2024
t80-min 14:20 5,775 ± 5% 5775 Pass MK 29/May/2024
t85-min 14:25 5,775 ± 5% 5775 Pass MK 29/May/2024

Comments: N/A MK 26 MAY 24

Aisling Field 29 MAY 24

Reviewed By (Validation Peer Review) Date

Calvin Moore 29 MAY 24

Approved By (Quality Assurance) Date

Maria Kaluzna Page 124

16.3.6. Hot PUW System – Flow Control

Test Operational Test Step Description Expected Result Actual Result Pass / Initials Date
Step # Fail (dd/mmm/yyyy)
1 Start the hot PUW2 pump circulating FT-001 = 25,000 litres/hr ±5% FT-002 = 25,000 Pass AF 30/May/24
FT-003 = 25,000 litres/hr litres/hr
±5°C FT-004 = 25,000
litres/hr
2 Confirm the initial flow reading of FT-002 and FT-004 FT-001 = 25,000 litres/hr ±5% FT-002 = 25,000 Pass AF 30/May/24
FT-003 = 25,000 litres/hr ±5% litres/hr
FT-004 = 25,000
litres/hr
3 Open the transfer valves to RE-119 and RE-140 and transfer LT-119 = 5,500 LT-119 = 5,500 Pass AF 30/May/24
5,500 litres into each vessel, confirming the level reading on LT- Litres LT-140 = litres LT-140 =
119 and LT-140 (this will take approximately 30-minutes). 5,500 Litres 5,500 litres
Confirm the flow readings FT-001 and FT-003
FT-001 = 25,000 litres/hr ±5% FT-002 = 25,000
FT-003 = 3,000 litres/hr ±5% litres/hr
FT-004 = 3,000 litres/hr
4 After the transfer stops, maintain the hot detergent system in FT-001 = 25,000 litres/hr ±5% FT-002 = 25,000 Pass AF 30/May/24
normal recirculation mode for a further 30-minutes with no further FT-003 = 25,000 litres/hr ±5% litres/hr ±5%
drawdown. FT-004 = 25,000
litres/hr ±5%
5 Print out the associated trends for level LT-119 and LT-140, Trends attached Trends attached Pass AF 30/May/24
flow FT-001 and FT-003 during the test period and append to
this test
section.

Maria Kaluzna 30 MAY 24

Reviewed By (Validation Peer Review) Date

Calvin Moore 30 MAY 24

Maria Kaluzna Page 125

Approved By (Quality Assurance) Date

Maria Kaluzna Page 126

 In the following table, at successive 5-minute intervals record the online indicator values of of flow transmitters FT-001 and FT-003 and Level
transmitters LT-119 and LT-140. [INSERT INFORMATION].
Ensure that during the time period the values are recorded correspond to the following:
 The 30-minutes before the transfer from the hot PUW2 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 Time Expected Actual Actual Expected Expected Actual LT- Actual Pass / Fail Initials Date
minutes HH/MM FT-001 / FT-003 FT-001 FT-003 LT-119 LT-140 119 LT- 140 (dd/mmm/yy
Litres/hr Litres/ Litres/hr (Litres) (Litres) (Litres) (Litres) yy)
hr
t0-min 14:00 FT-002 25,000 ± 5% 25,491 25,491 0 0 0 0 Pass AF O2/Jun/2024
FT-004 25,000 ± 5%
t5-min 14:05 FT-002 25,000 ± 5% 24,967 24,967 0 0 0 0 Pass AF O2/Jun/2024
FT-004 25,000 ± 5%
t10-min 14:10 FT-002 25,000 ± 5% 25,020 25,020 0 0 0 0 Pass AF O2/Jun/2024
FT-004 25,000 ± 5%
t15-min 14:15 FT-002 25,000 ± 5% 24,700 24,700 0 0 0 0 Pass AF O2/Jun/2024
FT-004 25,000 ± 5%
t20-min 14:20 FT-002 25,000 ± 5% 25,244 25,244 0 0 0 0 Pass AF O2/Jun/2024
FT-004 25,000 ± 5%
t25-min 14:25 FT-002 25,000 ± 5% 24,698 24,698 0 0 0 0 Pass AF O2/Jun/2024
FT-004 25,000 ± 5%
t30-min 14:30 FT-002 25,000 ± 5% 25,243 25,243 0 0 0 0 Pass AF O2/Jun/2024
FT-004 25,000 ± 5%
t35-min 14:35 FT-002 25,000 ± 5% 24,446 2,919 <5,500 <5,500 1,000 1,000 Pass AF O2/Jun/2024
FT-004 3,000 ± 5%
t40-min 14:40 FT-002 25,000 ± 5% 25,009 3,111 <5,500 <5,500 2,000 2,000 Pass AF O2/Jun/2024
FT-004 3,000 ± 5%

03 JUN 24
Maria Kaluzna
Reviewed By (Validation Peer Review) Date

Maria Kaluzna Page 127

Calvin Moore 03 JUN 24
Approved By (Quality Assurance) Date

Time Time Expected Actual Actual Expected Expected Actual Actual Pass / Initials Date
minutes HH/ FT-001 / FT-003 FT-001 FT-003 LT-119 LT-140 LT- LT-140 Fail (dd/mm/yyyy)
MM Litres/hr Litres/hr Litres/hr (Litres) (Litres) 119 (Litres)
(Litres)
t45-min 14:45 FT-002 25,000 ± 5% 25,224 2,954 <5,500 <5,500 3,500 3,500 Pass AF O2/Jun/2024
FT-004 3,000 ± 5%
t50-min 14:50 FT-002 25,000 ± 5% 24,765 3,149 <5,500 <5,500 4,500 4,500 Pass AF O2/Jun/2024
FT-004 3,000 ± 5%
t55-min 14:55 FT-002 25,000 ± 5% 24,459 3,005 <5,500 <5,500 5,500 5,500 Pass AF O2/Jun/2024
FT-004 3,000 ± 5%
t60-min 15:00 FT-002 25,000 ± 5% 25,809 2,959 5,500± 5% 5,500± 5,500 5,500 Pass AF O2/Jun/2024
FT-004 3,000 ± 5% 5%
t65-min 15:05 FT-002 25,000 ± 5% 24,924 24,924 5,500± 5% 5,500± 5,500 5,500 Pass AF O2/Jun/2024
FT-004 25,000 ± 5% 5%
t70-min 15:10 FT-002 25,000 ± 5% 24,255 24,255 5,500± 5% 5,500± 5,500 5,500 Pass AF O2/Jun/2024
FT-004 25,000 ± 5% 5%
t75-min 15:15 FT-002 25,000 ± 5% 25,245 25,245 5,500± 5% 5,500± 5,500 5,500 Pass AF O2/Jun/2024
FT-004 25,000 ± 5% 5%
t80-min 15:20 FT-002 25,000 ± 5% 25,457 25,457 5,500± 5% 5,500± 5,500 5,500 Pass AF O2/Jun/2024
FT-004 25,000 ± 5% 5%
t85-min 15:25 FT-002 25,000 ± 5% 25,189 25,189 5,500± 5% 5,500± 5,500 5,500 Pass AF O2/Jun/2024
FT-004 25,000 ± 5% 5%

Comments: N/A AF 03 JUN 24

Maria Kaluzna Page 128

Maria Kaluzna 03 JUN 24
Reviewed By (Validation Peer Review) Date

Calvin Moore 05 JUN 24

Approved By (Quality Assurance) Date

16.3.7. Hot PUW System – Temperature Control

Test Operational Test Step Description Expected Result Actual Result Pass / Initials Date
Step # Fail (dd/mmm/yyyy)
1 Start heating up the recirculating water loop in the hot TT-001 = 80°C±5°C TT-001 = 73°C Fail MK 05/Jun/24
PUW2 system to a steady 80°C ±5°C and confirm the TT-003 = 71°C
temperature on TT-001 and TT-003. TT-003 = 80°C±5°C
2 Open the transfer valves to reactors RE-119 and reactor LT-119 > 5,500 Litres LT-119 = 5,500L Pass MK 05/Jun/24
RE-140, and transfer 5,500 litres into both reactors, LT-140 > 5,500 Litres LT-140 = 5,500L
noting the level on LT-119 and LT-140. Confirm that TT-001 = 80°C±5°C TT-001 = 81°C
the temperature of the hot detergent system maintains TT-003 = 80°C±5°C TT-003 = 78°C
80°C ±5°C during the transfer on TT-001 and TT-003
3 Following the transfer, maintain the hot detergent No drawdown No drawdown Pass MK 05/Jun/24
system in normal circulation mode for a further 30-
minutes with no further drawdown.
4 Print out the associated trends for temperature Trends attached Trends attached Pass MK 05/Jun/24
transmitters TT-001 and TT-003, and level-
transmitters LT-119 and LT-140 during the test period
and append
to this test section.

Maria Kaluzna Page 129

Daniel Crandol 05 JUN 24
Reviewed By (Validation Peer Review) Date

Calvin Moore 05 JUN 24

Approved By (Quality Assurance) Date

Maria Kaluzna Page 130

In the following table, at successive 5-minute intervals record the online indicator values of temperature transmitters TT-001 and TT-003, and level-
transmitters LT-119 and LT-140 [INSERT INFORMATION].

• The 30-minutes before the transfer from the hot PUW2 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 Time Expected Actual Actual Expected Actual Actual Pass / Initials Date
minutes HH/MM TT-001 TT- TT-001 TT-003 LT-119 LT- LT-140 Fail (dd/mmm/yyyy)
003 (°C) (°C) LT-140 119 (Litres)
(°C) (Litres) (Litres)
t0-min 14:30 80°C ±5°C 81°C 82°C <5,500 3,000 3,500 Pass MK 11/Jun/2024
t5-min 14:35 80°C ±5°C 79°C 82°C <5,500 4,000 4,000 Pass MK 11/Jun/2024
t10-min 14:40 80°C ±5°C 82°C 80°C <5,500 5,000 5,000 Pass MK 11/Jun/2024
t15-min 14:45 80°C ±5°C 81°C 83°C 5,500± 5% 5,500 5,500 Pass MK 11/Jun/2024
t20-min 14:50 80°C ±5°C 80°C 78°C 5,500± 5% 5,500 5,500 Pass MK 11/Jun/2024
t25-min 14:55 80°C ±5°C 80°C 81°C 5,500± 5% 5,500 5,500 Pass MK 11/Jun/2024
t30-min 15:00 80°C ±5°C 79°C 85°C 5,500± 5% 5,500 5,500 Pass MK 11/Jun/2024
t35-min 15:05 80°C ±5°C 80°C 78°C 5,500± 5% 5,500 5,500 Pass MK 11/Jun/2024
t40-min 15:10 80°C ±5°C 81°C 80°C 5,500± 5% 5,500 5,500 Pass MK 11/Jun/2024

21 JUN 24
Brian Roche
Reviewed By (Validation Peer Review) Date

Calvin Moore 21 JUN 24

Approved By (Quality Assurance) Date

Maria Kaluzna Page 131

Time Time Expected Actual Actual Expected LT-119 LT-140 Pass / Initials Date
minutes HH/MM TT-001 TT-001 TT-003 LT-119 (Litres) (Litres) Fail (dd/mmm/yyyy)
TT-003 (°C) (°C) LT-140
(°C) (Litres)
t45-min 11:45 80°C ±5°C 82°C 80°C <5,500 3,000 3,000 Pass MK 11/Jun/2024
t50-min 11:50 80°C ±5°C 82°C 80°C <5,500 4,000 4,000 Pass MK 11/Jun/2024
t55-min 11:55 80°C ±5°C 82°C 80°C <5,500 5,000 5,000 Pass MK 11/Jun/2024
t60-min 12:00 80°C ±5°C 82°C 80°C 5,500± 5% 5,500 5,500 Pass MK 11/Jun/2024
t65-min 12:05 80°C ±5°C 82°C 80°C 5,500± 5% 5,500 5,500 Pass MK 11/Jun/2024
t70-min 12:10 80°C ±5°C 82°C 80°C 5,500± 5% 5,500 5,500 Pass MK 11/Jun/2024
t75-min 12:15 80°C ±5°C 82°C 80°C 5,500± 5% 5,500 5,500 Pass MK 11/Jun/2024
t80-min 12:20 80°C ±5°C 82°C 80°C 5,500± 5% 5,500 5,500 Pass MK 11/Jun/2024
t85-min 12:25 80°C ±5°C 82°C 80°C 5,500± 5% 5,500 5,500 Pass MK 11/Jun/2024

Comments: N/A MK 11 JUN 24

Brian Roche 21 JUN 24

Reviewed By (Validation Peer Review) Date

Calvin Moore 21 JUN 24

Approved By (Quality Assurance) Date

Maria Kaluzna Page 132

16.3.8. Approved SOP Verification
Page _ 1__ of _ 2__

Standard Operating Procedure Verification Form

No. Description Verified By / Date

Title: Operation of the Hot detergent system

1 AF 15 MAR 24

SOP #: 11302 Revision #: 1 Date: 15 MAR 24

Title: Operation of the Hot PUW2 system

2 MK 03 FEB 24

SOP #: 11303 Revision #: 0 Date: 03 FEB 24

Title Cleaning the Hot PUW2 and Hot Detergent system

3 MK 16 FEB 24

SOP #: 11304 Revision #: 0 Date: 16 FEB 24

Examine the attachments and connections on the Hot detergent and hot PUW generation and distribution skid.
Title:

4 AF 08 APR 24

SOP #: 11325 Revision #: 2 Date: 08 APR 24

Assembling and disassembling the Hot detergent and hot PUW generation and distribution skid
Title:

5 AF 20 APR 24

SOP #: 11330 Revision #: 3 Date: 20 APR 24

Title: Operation and maintenance of CIP wash tanks

6 MK 12 JAN 24

SOP #: SOP-235 Revision #: 12 Date: 12 JAN 24

7 Title: CIP procedures for bioreactors MK 08 JAN 24

Maria Kaluzna Page 133

 Page _2_ of __2_
SOP #: SOP-157 Revision #: 4.3 Date: 08 JAN 24

Title: Operation and maintenance of steam supply line

8 MK 30 APR 24

SOP #: SOP-1002 Revision #: 6.7 Date: 30 APR 24

Title: Operational maintenance of hot detergent line

9 FR 22 JAN 24

SOP #: SOP-645 Revision #: 15.6 Date: 22 JAN 24

Title: Operational maintenance of PUW1 supply line

10 FR 17 APR 24

SOP #: SOP-880 Revision #: 3.9 Date: 17 APR 24

Title: Operation and maintenance of pumps in generation and distribution system

11 MK 20 APR 24

SOP #: SOP-184 Revision #: 1.7 Date: 30 APR 24

Comments:

Reviewed By: 14 JUN 24

Daniel Crandol Date:
Validation
Approved By: 18 JUN 24
Calvin Moore_ Date:
(QA)

Maria Kaluzna Page 134

16.4. Appendix D: Deviation log
Deviation Date Approved Related
Deviation # Deviation Summary Statement Resolved Date Verified Change #
(YES / No) (if applicable)
1 The PUW2 system is not achieving the Yes 25MAR24 27MAR24 1
stated temperature of 80°C ±5°C, instead it
only reaches a recirculation temperature of
72°C to 73°C.

2 The GPC Validation engineer failed to Yes 29 MAY 24 06 JUN 24 N/A

provide their signature in the protocol's CAPA-
signature log. corrective and
preventative
method-
additional
training
3 There is no existing documentation/ record Yes 10 JUN 24 10 JUN 24 N/A
for LT-002. Error in the specific test steps. Repeated tests
taken in
consideration.

Comments: N/A MK 12 JUN 24

Reviewed By: Daniel Crandol Date: 25 MAY 24

(Validation)
*Reviewed By: Calvin Moore Date: 27 MAY 24
(QA)

Maria Kaluzna Page 135

*Must be approved by QA if any deviations are deemed a ‘Direct Impact System’

What are the many forms of deviation in the pharmaceutical industry?

A deviation refers to an undesirable occurrence that deviates from the authorised methods, procedures, instructions, specifications, or established
norms. Deviation may arise at various stages of drug product production, including manufacture, packing, sampling, and testing. There exist
three categories of deviations: crucial, significant, and minor.

Maria Kaluzna Page 136

16.5. Appendix E: Deviation Form
Deviation Details Deviation# 1
Building / Area Drug Product Equipment / System Hot detergent & hot PUW2
Protocol Section # 16.3.7 Protocol Test Descriptor Operational testing
Deviation Category 2
(Please Circle)
1 3 *4 *5

DEVIATION DESCRIPTION
Upon initial operation, the hot PUW2 system only achieves a recirculation temperature ranging from 72°C to 73°C after 30 minutes, instead of
the specified range of 80°C ±5°C.

2. Impact Assessment of Deviation

System GMP Category Component GMP Category
(Please Circle) (Please Circle)
*Direct Indirect No Impact Critical Non-Critical
Affected Items Yes/No Affected Items Yes/No
User Requirement No Functional or Detailed Design Specifications No
Testing Already Completed No System Documentation No
Testing Protocols No Drawings No
Validation Plan No Standard Operating Procedures No
Training No Other No
Details of Affected Items: N/A

REFERENCES (AFFECTED ITEMS)

Document # Revision

MK 25/MAR/24

Maria Kaluzna Page 137

 3. Resolution Description

See change control #1

4. Resolution Verification
Verified By: (Originator) Maria Kaluzna Date: 25MAR24
Approved By: (Validation) Daniel Crandol Date: 25MAR24
*Approved By: (QA) Calvin Moore Date: 27MAR24

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

Maria Kaluzna Page 138

 Deviation Details Deviation# 2
Building / Area BDS Equipment / System Hot Detergent System
Hot Detergent System – Flow
Protocol Section # 13.2.6.3 Protocol Test Descriptor Control. Expected results and
Actual results.
Deviation Category 1 2 3 *4 *5
(Please Circle)
DEVIATION DESCRIPTION

GPC Validation engineer did not sign signature log of protocol upon completion of test.

2. Impact Assessment of Deviation

System GMP Category Component GMP Category
(Please Circle) (Please Circle)
No Impact
Non-Critical
*Direct Indirect Critical
Affected Items Yes/No Affected Items Yes/No
User Requirement No Functional or Detailed Design Specifications No
Testing Already Completed No System Documentation No
Testing Protocols No Drawings No
Validation Plan No Standard Operating Procedures No
Training No Other Yes

Details of Affected Items: Signature log not completed unable to identify initials. (Potential problems for audit). Affected item-documentations.

REFERENCES (AFFECTED ITEMS)

Document # Title / Description Revision
5555 The system involves the production and distribution of hot detergent and hot PUW2. 2

Maria Kaluzna Page 139

 3. Resolution Description

Company reached out to the vendor in order to ascertain the identity of the validation engineer who will be responsible for finalising the
signature log. Other comparable test results used- optionally.

4. Resolution Verification
Verified By: (Originator) Frank Roche Date: 07 JUN 24
Approved By: (Validation) Daniel Crandol Date: 08 JUN 24
*Approved By: (QA) Calvin Moore Date: 09 JUN 24

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

Maria Kaluzna Page 140

Deviation Details Deviation# 2
Building / Area BDS Equipment / System Hot detergent tank
Hot Detergent System – Flow Control.–
Protocol Section # 13.2.5.6, 13.3.5.1, 13.4.5.1 Protocol Test Descriptor Detergent Dosing Control- Temperature
Control. Specific Test Steps.
Deviation Category 1 2 3 *4 *5
(Please Circle)
DEVIATION DESCRIPTION
There is no existing documentation/record of LT-002. The specific test protocols indicate that the level in the hot detergent tank must be
maintained at 5775 litres during the transfer process. Hydrostatic Pressure type level Transmitter.

2. Impact Assessment of Deviation

System GMP Category Component GMP Category
*
Direct
(Please Circle) (Please Circle)
Indirect No Impact Critical Non-Critical
Affected Items Yes/No Affected Items Yes/No
User Requirement No Functional or Detailed Design Specifications No
Testing Already Completed No System Documentation No
Testing Protocols Yes Drawings No
Validation Plan No Standard Operating Procedures No
Training No Other No
Details of Affected Items: The testing technique is erroneous, needs to be revised as it requires confirmation that the level in the hot detergent
tank must be maintained at 5775 litres. Testing protocol incorrect as it asks to confirm that level in hot detergent tank must maintain at 5775
litres.

Maria Kaluzna Page 141

REFERENCES (AFFECTED ITEMS)
Document # Title / Description Revision
The system involves the generation and distribution of hot detergent and hot PUW2.
2222 1

3. Resolution Description

Maybe check what are the possibilities when the manufacturer and senior engineer – what happens when the level is lower and higher than
5775L in tank. . eventually use other comparable tests.

4. Resolution Verification
Verified By: (Originator) Nick Walsh Date: 12 JUN 24
Approved By: (Validation) Daniel Crandol Date: 15 JUN 24
*Approved By: (QA) Laura Keating Date: 16 JUN 24

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

Deviation Details Deviation#

Maria Kaluzna Page 142

 Building / Area Equipment / System
Protocol Section # Protocol Test Descriptor
Deviation Category
1 2 3 *4 *5
(Please Circle)
DEVIATION DESCRIPTION

2. Impact Assessment of Deviation

System GMP Category Component GMP Category
(Please Circle) (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

Maria Kaluzna Page 143

 3. Resolution Description

4. Resolution Verification
Verified By: (Originator) Date:
Approved By: (Validation) Date:
*Approved By: (QA Date:

Maria Kaluzna Page 144

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

1 Hot The Plate Heat Exchangers HX211 Direct 20/MAR/2024 25/MAR/2024 21/JUN/2024
Detergent and HX-411 are both to be
& Hot replaced with units that have a
PUW2 rating of 650KW.

2. CC-10389 P&ID-227 Additional equipment has been Direct 22 JUN 24 23 JUN 24 In progress
incorporated/added into the hot
detergent and hot PUW2
generation and distribution system.

MK 21/JUN/24

COMMENTS: N/A

Maria Kaluzna Page 145

 Reviewed By: Daniel Crandol Date: 10JUN24
(Validation Engineering)

16.7. Appendix G: Change Control Form

Change Control Form

Project Title: Reactor cleaning CHANGE #: 1

Project No: 24-RC-0001 P&ID / System: Hot detergent & Hot PUW2
Attachments (Yes/No): Yes Date: 26 MAR 24
SECTION 1: OBSERVATIONS AND PROPOSED CHANGE (to be completed by 1Project Engineer)

ORIGINAL DESIGN: PROPOSED CHANGE:

Plate Heat Exchangers HX-211 and HX411 rated 569.4KW Both Plate Heat Exchangers, HX-211 and HX-411, are
scheduled for replacement with units rated at 650KW.

Maria Kaluzna Page 146

 2
HAZOP TO BE UPDATED (Yes / No) No

SECTION 2: IMPACT ASSESSMENT (to be completed by 1Engineering Validation)

AFFECTED APPROVED ITEMS Yes/No AFFECTED APPROVED ITEMS Yes/No

3
3 Project URS
Validation Plan No No

3 3
System Level URS No System Impact Assessment No

3 3, 4
Component Impact Assessment No Qualification Protocol(s) Yes
4 4
Commissioning Protocol(s) Yes Other Yes
3, 5 5 5
DIRECT INDIRECT NO IMPACT
3
SYSTEM IMPACT Yes (/ No) Yes /( No) (Yes /) No

Maria Kaluzna Page 147

 How to Troubleshoot a Plate Heat Exchanger?
How to tell if a plate heat exchanger is bad?
The most common symptoms are the following:
1. Increased pressure drop from inlet to outlet.
2. Loss of heat transfer efficiency.
3. Loss of flow and performance.
4. Process fluid leakage.

https://academy.paulmueller.com ›.

Maria Kaluzna Page 148

SECTION 2 (Continued): IMPACT ASSESSMENT (to be completed by 1Engineering Validation)
3, 5 3, 5 5
OPER. CRITICAL PRODUCT CONTACT NON CRITICAL
3
COMPONENT IMPACT No Yes No

5 5 3, 5
CONSTRUCTION COMMISSIONING QUALIFICATION
PROJECT PHASE No No Yes

SECTION 3: TESTING REQUIRED (to be completed by 1Engineering Validation)

4 4
TESTING REQUIRED DOCUMENT UPDATES REQUIRED
A. Create a nw/fresh test script, attach it, and save it in the file along with this A. Commissioning Protocol
change control. B. Qualification Protocol
B. End the current qualification protocol's tests and grant approval for the
remaining ones.
C. Equipment Specification
C. Using this change control as a reference, close out deviations for the failed D. P&ID for Hot Detergent & Hot PUW2
tests.

Number of Test Pages Attached

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

6 6
COST OF CHANGE €4,262.15 IMPACT ON SCHEDULE (time) 3 months

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

PROJECT ENGINEER FRANK ROCHE Frank Roche 07JUN24

PROJECT MANAGER JOHN ROBERTS John Roberts 14JUN24

EHS KATHY MC DONALD Kathy McDonald 14JUN24

Maria Kaluzna Page 149

VALIDATION DANIEL CRANDOL Daniel Crandol 10JUN24

QA CALVIN MOORE Calvin Moore 12JUN24

SECTION 6: REJECT CHANGE

PRINT NAME SIGNATURE DATE

CHANGE REJECTED BY N/A N/A N/A

REASON FOR REJECTING CHANGE

N/A MK08JUN24

Maria Kaluzna Page 150

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

3 3
System Level URS N/A System Impact Assessment N/A

3
Component Impact Assessment N/A 3, 4
Qualification Protocol(s) Yes

4
Commissioning Protocol(s) Yes 4
Other Yes

2
HAZOP UPDATED (Yes / No) Yes

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

PRINT NAME SIGNATURE DATE

VERIFIED BY MARIA KALUZNA Maria Kaluzna 07JUN4

SECTION 9: POST-CHANGE APPROVALS

PROJECT DISCIPLINE PRINT NAME SIGNATURE DATE

PROJECT ENGINEER FRANK ROCHE Frank Roche 07JUN24

PROJECT MANAGER JOHN ROBERTS John Roberts 14JUN24

EHS KATHY MC DONALD Kathy McDonald 14JUN24

VALIDATION DANIEL CRANDOL Daniel Crandol 10JUN24

Maria Kaluzna Page 151

 QA CALVIN MOORE Calvin Moore 12JUN24

ADDITIONAL COMMENTS

N/A

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

Change Control Form

New equipment added to the hot detergent CC-10389
Project Title: and hot PUW2 generation and distribution CHANGE #:
system
Project No: 1 P&ID / System: P&ID 227
Attachments (Yes/No): No Date: 18 APR 24
SECTION 1: OBSERVATIONS AND PROPOSED CHANGE (to be completed by 1Project Engineer)
ORIGINAL DESIGN: PROPOSED CHANGE:
No Hot detergent and hot PUW2 generation and distribution system onsite The suggested modification involves the installation of a hot detergent
and hot PUW2 generating and distribution system in accordance with
P&ID-227.

2
HAZOP TO BE UPDATED (Yes / No) Yes
SECTION 2: IMPACT ASSESSMENT (to be completed by 1Engineering Validation)
AFFECTED APPROVED ITEMS Yes/No AFFECTED APPROVED ITEMS Yes/No
3 3
Validation Plan Yes Project URS Yes
3 3
System Level URS Yes System Impact Assessment Yes
3 3, 4
Component Impact Assessment Yes Qualification Protocol(s) Yes

4 4
Commissioning Protocol(s) Yes Other N/A
3, 5 5 5
DIRECT INDIRECT NO IMPACT
3
SYSTEM IMPACT Yes No No

Maria Kaluzna Page 152

 SECTION 2 (Continued): IMPACT ASSESSMENT (to be completed by 1Engineering Validation)
3, 5 3, 5 5
OPER. CRITICAL PRODUCT CONTACT NON CRITICAL
3
COMPONENT IMPACT Yes Yes No

5 5 3, 5
CONSTRUCTION COMMISSIONING QUALIFICATION
PROJECT PHASE Yes Yes Yes

SECTION 3: TESTING REQUIRED (to be completed by 1Engineering Validation)

4 4
TESTING REQUIRED DOCUMENT UPDATES REQUIRED
Hot detergent system – Level control SOP #: 11302 Operation of the Hot detergent system Revision 1
Hot detergent system – Flow control SOP #: 11303 Operation of the Hot PUW2 system Rev/0
Hot detergent system – Temperature control SOP #: 11304 Cleaning the Hot PUW2 and Hot Detergent system Rev.0
Hot detergent system – Detergent control SOP #: 11325 Examine the attachments and connections on the Hot detergent and hot PUW
generation and distribution skid. Rev.2
PUW2 – Level control SOP #: 11330 Assembling and disassembling the Hot detergent and hot PUW generation and
PUW2 – Flow control distribution skid Rev.3
PUW2 – Temperature SOP-235 Operation and maintenance of CIP wash tanks Revision.12
control PUW2 – Detergent SOP-157 CIP procedures for bioreactors Rev.4.3
control SOP-1002 Operation and maintenance of steam supply line Rev.6.7
SOP-645 Operational maintenance of hot detergent line Rev. 15.6
SOP-880 Operational maintenance of PUW1 supply line Rev. 3.9
SOP-184 Operation and maintenance of pumps in generation and distribution system Rev. 1.7

Number of Test Pages Attached 98

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

6 6
COST OF CHANGE €5000 IMPACT ON SCHEDULE (time) 4 months

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

PROJECT ENGINEER DANIEL CRANDOL Daniel Crandol 03 MAY 24

Maria Kaluzna Page 153

 PROJECT MANAGER FRANK ROCHE Frank Roche 10 MAY 24

EHS KATHY MC DONALD Kathy McDonald 11 MAY 24

Maria Kaluzna Page 154

 VALIDATION AISLING FIELD Aisling Field 12 MAY 24

QA LAURA KEATING Laura Keating 13 MAY 24

SECTION 6: REJECT CHANGE

PRINT NAME SIGNATURE DATE

CHANGE REJECTED BY

REASON FOR REJECTING CHANGE: N/A

Maria Kaluzna Page 155

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

3 3
System Level URS Yes System Impact Assessment Yes

3
Component Impact Assessment Yes 3, 4
Qualification Protocol(s) Yes
4 4 N/A
Commissioning Protocol(s) Yes Other
2
HAZOP UPDATED (Yes / No) Yes

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

PRINT NAME SIGNATURE DATE

VERIFIED BY DANIEL CRANDOL Daniel Crandol 15 MAY 24

SECTION 9: POST-CHANGE APPROVALS

PROJECT DISCIPLINE PRINT NAME SIGNATURE DATE

PROJECT ENGINEER DANIEL CRANDO Daniel Crandol 15-May-24

PROJECT MANAGER FRANK ROCHE Frank Roche 15-May-24

EHS KATHY MC DONALD Kathy McDonald 20 MAY 24

VALIDATION JONATHAN WALSH Jonathan Walsh 15-May-24

QA CALVIN MOORE Calvin Moore 24-May-22

ADDITIONAL COMMENTS: N/A

Maria Kaluzna Page 156

 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

Maria Kaluzna Page 157

16.8. Appendix H: Component Impact Assessment

Equipment Components
Critical Non-Critical
Tag Description Operational Product Contact
Critical Critical
T-211 Hot Detergent Tank No Yes No
T-411 Hot PUW2 Tank No Yes No
P-207 Detergent Centrifugal Transfer Pump Yes Yes No
P-209 Detergent Centrifugal Transfer Pump Yes Yes No
P-415 PUW2 Centrifugal Transfer Pump Yes Yes No
P-417 PUW2 Centrifugal Transfer Pump Yes Yes No
P-223 Detergent Metering Pump Yes Yes No
HX-211 Detergent Plate Heat Exchanger Yes Yes No
HX-411 PUW2 Plate Heat Exchanger No Yes No
FL-399 Detergent Cartridge Filter No Yes No
FL-401 PUW2 Cartridge Filter No Yes No
PSV-001 PUW2 Sanitary Pressure Relief Valve No Yes No
PSV-002 Detergent Sanitary Pressure Relief Valve No Yes No

Maria Kaluzna Page 158

Instrument Components
Critical Non-Critical
Tag Description Operational Product Contact
Critical Critical
TCV-005 Steam Temperature control valve Yes No No
TCV-006 Steam Temperature control valve Yes No No
TT-001 3 wire RTD Temperature transmitters Yes Yes No
TT-002 3 wire RTD Temperature transmitters Yes Yes No
TT-003 3 wire RTD Temperature transmitters Yes Yes No
TT-004 3 wire RTD Temperature transmitters Yes Yes No
PT-001 Sanitary Diaphragm type Pressure Indicating transmitters No No Yes
PT-002 Sanitary Diaphragm type Pressure Indicating transmitters Yes No No
PI-007 Local pressure indicators c/w bourdon type gauges No No Yes
FT-001 Magnetic flow Transmitter Yes Yes No
FT-002 Magnetic flow Transmitter Yes Yes No
FT-003 Magnetic flow Transmitter Yes Yes No
FT-004 Magnetic flow Transmitter Yes Yes No
FS-005 Low Flow switch Yes No No
CT-001 Conductivity transmitter Yes Yes No
PI-003 Diaphragm type pressure indicator Yes No No
PI-004 Diaphragm type pressure indicator Yes No No
PI-005 Diaphragm type pressure indicator No No Yes
PI-006 Diaphragm type pressure indicator Yes No No
PI-008 Diaphragm type pressure indicator Yes No No
TI-007 Bimetalic Temperature indicator Yes Yes Yes
TI-008 Bimetalic Temperature indicator Yes No No
TI-009 Bimetalic Temperature indicator Yes No No
TI-010 Bimetalic Temperature indicator Yes No No

Maria Kaluzna Page 159

 Critical Non-Critical
Tag Description Operational Product Contact
Critical Critical
LS-003 Low Level Switch (Tuning fork type) Yes Yes No
LS-004 Low Level Switch (Tuning fork type) Yes Yes No
LS-005 High Level Switch (Tuning fork type) Yes Yes No
LS-006 High Level Switch (Tuning fork type) Yes Yes No
LT-001 Hydrostatic Pressure type level Transmitter Yes No No
LT-002 Hydrostatic Pressure type level Transmitter Yes No No
XV-003 Actuated Sanitary Butterfly Valve No Yes No
XV-004 Actuated Sanitary Butterfly Valve No Yes No
XV-008 Actuated Sanitary Ball Valve No Yes No
XV-009 Actuated Sanitary Ball Valve No Yes No
XV-001 Actuated Tuchenhagen Multiport divert Valves. No Yes No
XV-002 Actuated Tuchenhagen Multiport divert Valves. No Yes No
XV-005 Actuated Tuchenhagen Multiport divert Valves. No Yes No
XV-006 Actuated Tuchenhagen Multiport divert Valves. No Yes No
XV-007 Actuated Tuchenhagen Multiport divert Valves. No Yes No
PRV-001 Back Pressure Regulating Valve No Yes No
PRV-002 Back Pressure Regulating Valve No Yes No

Maria Kaluzna Page 160

Piping Components
Critical Non-Critical
Tag Description Operational Product Contact
Critical Critical
50-PUW1-S6-147-IH From LN-486 To T-211 No Yes No
50-PUW1-S6-148-IH From LN-486 To T-411 No Yes No
80-DETERGENT-S6-149-IH From T-211 To FL-399 No Yes No
80-DETERGENT-S6-150-IH From FL-399 To P-207 No Yes No
80-DETERGENT-S6-151-IH From LN-150 To P-209 No Yes No
65-DETERGENT-S6-152-IH From P-209 To LN-153 No Yes No
65-DETERGENT-S6-153-IH From P-207 To HX-211 No Yes No
From HX-211 To XV-021 @
65-DETERGENT-SS1-154-IH No Yes No
DETERGENT change-over valves
80-PUW2-S6-156-IH From FL-401 To P-415 No Yes No
80-PUW2-S6-157-IH From LN-156 To P-417 No Yes No
65-PUW2-S6-158-IH- From P-417 To LN-159 No Yes No
65-PUW2-S6-159-IH- From P-415 To HX-411 No Yes No
From HX-411 To XV-016 @ PUW2
65-PUW2-SS1-160-IH- No Yes No
change-over valves
From Conc. Detergent Dosing System
25-PROCESS-S6-161-NI No Yes No
To P-223
25-PROCESS-S6-162-NI From P-223 To LN-149 No Yes No
From XV-018 @ DETERGENT change-
65-DETERGENT-SS1/S6-163-IH No Yes No
over valves To T-211
From XV-013 @ PUW2 change-over
65-PUW2-SS1/S6-164-IH No Yes No
valves To T-411
100-VENT-S6-166-NI From T-211 To Safe Area No No Yes
25-DRAIN-S6-167-NI From LN-166 To LN-176 No No Yes
100-VENT-S6-168-NI From T-411 To Safe Area No No Yes
25-DRAIN-S6-169-NI From LN-168 To LN-176 No No Yes

Maria Kaluzna Page 161

 Critical Non-Critical
Tag Description Operational Product Contact
Critical Critical
50-DRAIN-S6-170-NI From XV-002 @ T-211 outlet to LN-176 No No Yes
50-DRAIN-S6-171-NI From XV-001 @ T-411 outlet to LN-176 No No Yes
25-VENT-S6-172-NI From PSV-002 To LN-176 No No Yes
25-VENT-S6-173-NI From PSV-001 To LN-176 No No Yes
50-DRAIN-S6-174-NI From XV-006 @ T-211 inlet to LN-176 No No Yes
50-DRAIN-S6-175-NI From XV-005 @ T-411 inlet to LN-176 No No Yes
80-DRAIN-SS1-176-NI From Drain Lines to Drain Header No No Yes
15-DRAIN-S6-177-NI From P-207 To Drain No No Yes
15-DRAIN-S6-178-NI From P-209 To Drain No No Yes
15-DRAIN-S6-179-NI From P-415 To Drain No No Yes
15-DRAIN-S6-180-NI From P-417 To Drain No No Yes
50-DRAIN-SS1-181-NI From T-411 Pump Discharge To Drain No No Yes
50-DRAIN-SS1-182-NI From T-211 Pump Discharge To Drain No No Yes
65-PLANT STEAM-CS5-183-IH From LN-241 To HX-211 / HX-411 No No Yes
15-PLANT STEAM-CS5-184-IH From LN-241 To LN-185 No No Yes
20-CONDENSATE-CS5-185-IH From LN-184 To LN-242 No No Yes
40-CONDENSATE-CS5-186-IH From HX-211 To LN-242 No No Yes
40-CONDENSATE-CS5-187-IH From HX-411 To LN-242 No No Yes
From Existing Steam Header Level 2
100-PLANT STEAM-CS5-241-IH No No Yes
To Cleaning generation Skid
From Cleaning Generation Skid To
80-CONDENSATE-CS5-242-IH No No Yes
Existing Condensate Header Level 4
40-COMPRESSED AIR-SS1-502-NI From V-39 To Pneumatic Control No No Yes

Maria Kaluzna Page 162

16.9. Appendix I: Traceability Matrix

Testing Traceability Matrix

Hot Detergent and Hot PUW Generation and Distribution
1 Plant Throughputs for Hot Detergent and Hot PUW Generation System

URS User Requirement Description Testing Comment

Item
Numbe
r
The Hot Detergent system shall be capable of  Operational / Functional  Conduct test during
achieving and maintaining defined flowrates, at Test – Hot Detergent simultaneous maximum
steady state conditions, e.g. maximum flow of 25,000 System - Flow Control Hot Detergent drawdown
1.1 kg/hr ±5%, minimum flow of 3,000 kg/hr ±5% etc.  Procedure section 13.2 into reactor RE-119 and
&13.3 [Insert #] reactor RE-140
 Check sheet 16.3.2 &16.3.3
The Hot PUW system shall be capable of achieving  Operational / Functional  Conduct test during
and maintaining defined flowrates, at steady state Test - Hot PUW System – simultaneous maximum
conditions, e.g. maximum flow of 25,000 kg/hr ±5%, Flow Control Hot PUW drawdown into
1.2 minimum flow of 3,000 kg/hr ±5% etc.  Procedure Section 13.6 reactor RE-119 and
&13.3 reactor RE-140
 Check sheet 16.3.6 &16.3.3

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2 Skid Configuration
URS User Requirement Description Testing Comment
Item
Numb
er
The Skid shall consist of the following equipment  Equipment Installation Test  Conduct a P&ID walkdown
items. The detailed design specifications for these  Procedure 11.2 and Equipment and Piping
equipment items are outlined in Appendix 1.  Checksheet 16.2.2 & Installation Tests for the
16.2.2.1 to Checksheet CIP Skid.
Process water tank 1 16.2.2.13
2.1
Detergent solution tank 1
Centrifugal recirculation pumps 4  Piping Installation Test
Detergent dosing pump 1  Procedure 11.4 &11.1
Heat exchangers 2  Checksheet 16.2.4&16.2.1

Instrumentation as illustrated on the P&ID-227 shall be  Instrument Installation Test  Conduct a P&ID walkdown
supplied with the skid.  Procedure 11.3 and Instrumentation
2.2  Checksheet 16.2.4 & Installation Test for the CIP
16.2.3.1 to Checksheet SKID
16.2.3.12

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3 Hot Detergent Solution Operation
URS User Requirement Description Testing Comment
Item
Numb
er
The Hot Detergent Tank shall be fed directly from the  Operational / Functional  Conduct test during
25°C PUW1 water loop and shall maintain the level in Test - Hot Detergent simultaneous maximum Hot
the tank during maximum drawdown into the reactors System – Level Control Detergent drawdown into
3.1 being washed.  Procedure section 13.1 & reactor RE-119 and reactor
13.4 RE-140
 Checksheet 16.3.1 & 16.3.4

 The system shall have the facility to automatically  Operational / Functional  Conduct test during
dose concentrated detergent to the required Test - “Detergent Dosing simultaneous maximum Hot
concentration (2% ±0.05%) during drawdown into Control Detergent drawdown into
3.5
the 2 reactors.  Procedure 13.4 &13.1 reactor RE-119 and reactor
 Online conductivity measurement shall be provided  Checksheet 16.3.4 &16.3.1 RE-140
to verify the detergent concentration.

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4 Hot PUW Solution Operation
URS User Requirement Description Testing Comment
Item
Numb
er
 The Hot PUW supply temperature shall be  Operational / Functional Conduct test during
maintained by a closed loop control system, which Test - Hot PUW System – simultaneous maximum Hot
modulates steam flow to the heat exchanger. Temperature Control PUW drawdown into reactor
4.4  The control system shall be capable of controlling  Procedure13.7 &13.5 RE-119 and reactor RE-140
the supply temperature to within ±5°C of the  Checksheet 16.3.7 & 16.3.5
setpoint (80°C) during maximum drawdown of the
Hot PUW for the 2 reactors.

PUW Generation PW and WFI storage and distribution systems. The pharmaceutical water distribution system

https://cm-systems.pl/en/products-and-services/storage-distribution-systems
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