7581-pwg-fiq rev0

Factory Installation Qualification

Genesys Purified Water Generation Unit

Highly Purified Water System for

Deltaflex SDN BHD at

N.A.Z Medical Supplies SDN BHD Date: 13 May 2010 Ref: 7581-PWG-FIQ Rev: 0 of 44

Factory Installation Qualification (FIQ)

For the

Purified Water System

(Genesys Purified Water Generation Unit)

For

Deltaflex SDN BHD

At

N.A.Z Medical Supplies SDN, BHD

Author Job Title Name Signature Date

Puretech Process

Systems Ltd

Process

Engineer Lynne Haines

Reviewed By Job Title Name Signature Date

Puretech Process

Systems Ltd

Development

Director John Parks

Approved By Job Title Name Signature Date

Puretech Process

Systems Ltd Project Manager Dean Sanders

The following approvals must be completed prior to commencement of work detailed within this

document. Approval shows acceptance of this document.

Approval Company Job Title Name Signature Date






Revision Status:

Issue Date Description

P1 30 April 2010 Initial issue for internal review

0 13 May 2010 Internal comments incorporated, document issued for Client

review

Revision History

Issue Date Description

P1 30 April 2010 Initial issue for internal review

0 13 May 2010 Internal comments incorporated, document issued for Client

review

This document contains proprietary information belonging to Puretech Process Systems Ltd and shall

be used only for the purpose for which it was supplied. It shall not be copied reproduced or otherwise

used, nor shall such information be furnished in whole or in part to others.






Contents Page No.

1. Identification of Personnel ................................................................................................5

2. Introduction........................................................................................................................6

3. Objectives ...........................................................................................................................7

4. Responsibilities of Puretech ..............................................................................................7

4.1. Responsibilities of Person Executing Qualification ............................................................7

5. Equipment Description......................................................................................................8

5.1. Process Overview.................................................................................................................8

5.2. Materials of Construction ....................................................................................................8

5.3. System Scope .......................................................................................................................8

5.4. Connected Utilities ............................................................................................................10

5.5. Instrumentation ..................................................................................................................10

6. Associated Documentation ..............................................................................................12

6.1. Specifications.....................................................................................................................12

6.2. Maintenance Documentation .............................................................................................12

6.3. Procedures..........................................................................................................................12

6.4. Drawings ............................................................................................................................13

6.5. Engineering Data Book......................................................................................................13

7. Documentation Checks....................................................................................................14

7.1. Principal Components........................................................................................................14

7.2. Pipework and Line Fittings ................................................................................................16






7.3. Instruments.........................................................................................................................19

8. Installation Checks ..........................................................................................................21

8.1. Principal Components........................................................................................................21

8.2. P&ID Check (inc. Inline Items/Instruments) .....................................................................32

8.3. Electrical Checks ...............................................................................................................34

9. Instrument Calibration Certificate Check ....................................................................35

10. Non-Conformance List ....................................................................................................38

11. Results ...............................................................................................................................39

12. Conclusion ........................................................................................................................39

13. Interim Approvals............................................................................................................40

14. Final Approvals................................................................................................................40

15. Further Actions ................................................................................................................41

16. Appendices........................................................................................................................42






1. Identification of Personnel

In the table below enter details of the people involved in the execution of the Factory Installation

Qualification:

Personnel

Signatures Company/

Department Name

Sign Initial Date






2. Introduction

This is the Factory Installation Qualification (FIQ) of the Genesys Purified Water Generation Unit for

installation as part of the Highly Purified Water System for Deltaflex SDN BHD installed at N.A.Z

Medical Supplies SDN BHD.

The purpose of this FIQ is to document the Genesys Purified Water Generation Unit factory tests and to

reduce the scope of the site based Installation (IQ) so that only site specific testing is needed. The FIQ

will provide support to the site IQ activities.

The testing of the Genesys Purified Water Generation Unit will be carried out in 3 sections

Section 1: Factory Installation Qualification tests (FIQ)

Section 2: Factory Acceptance Test Specification (FAT2)

Section 3: Factory Operation Qualification tests (FOQ)

Note: Electrical Panel Testing (FAT1) and Hardware Acceptance Testing (HAT1) will have been

carried out prior the FIQ.

This document should be read in conjunction with the following Genesys Purified Water Generation

Unit documents:-

Genesys Purified Water Generation Unit P&ID ref 7581-X-0002

Genesys Purified Water Generation Unit FDS ref 7581-PWG-FDS

Genesys Purified Water Generation Unit Valve Schedule ref 7581-S-2001

Genesys Purified Water Generation Unit Equipment Schedule ref 7581-S-2002

Genesys Purified Water Generation Unit Instrument Schedule ref 7581-S-2003

Additional Evidence

In the event of testing being executed, where the engineer is required to attach additional sheets to the

test sheet, the following procedure should be followed:

• All additional sheets will have the test document reference and test number written at the

top right hand corner.

• An appendix number is taken from the appendix log (section 16)

• All additional sheets will have the appendix number, the page number and total number

of additional pages.

• All additional sheets will be signed and dated by the engineer.

• All additional sheets will be filed as an appendix, and the appendix log completed.






3. Objectives

The objectives of the Factory Installation Qualification for the Genesys Purified Water Generation Unit

are:-

• To provide documented evidence to demonstrate that all key aspects of installation (that can

be tested in the factory) adhere to client requirements and design intentions.

• To provide a summary of the test results with a conclusion and recommendations where

appropriate.

4. Responsibilities of Puretech

4.1. Responsibilities of Person Executing Qualification

• Ensuring that this document is fully approved and signed prior to starting the FIQ.

• Executing the FIQ in accordance with the Qualification.

• Recording the results of FIQ and any relevant comments in the FIQ document and its

appendices.

• Recording deviations discovered during execution of the Qualification in the non-

conformance section of this document.

Note, a resolution of non-conformances must be made by all parties.






5. Equipment Description

5.1. Process Overview

The Genesys Purified Water Generation Unit is designed to generate 3,000 l/hr purified water which as

a minimum will meet the Highly Purified Water requirements of the European Pharmacopeia (EP).

Parameter Specifiation

Appearance A clear colourless liquid

Conductivity < 1.1 µS/cm at 20°C

Total Organic Carbon < 500 ppb as C

Nitrates < 0.2 ppm

Babterial Endotoxins < 0.25 EU/ml

Total viable count < 10 CFU/100 ml

5.2. Materials of Construction

Wetted materials used on the Genesys Purified Water Generation Unit will be 316 stainless steel. Pre-

RO unit the material will be 316 descaled ID dairy tube, post RO will be pharmaceutical grade 316L

tube with internal finish mechanically polished to 0.5µm Ra. Valves post RO will be 316L

mechanically polished to 0.5µm Ra. Wetted/contact surfaces will be passivated. Valve diaphragm

material and tri-clover seals in contact with the purified water will be PTFE/EPDM (FDA compliant).

Permanent jointing of pipework will be closed head orbitally TIG welded, the number of manual welds

will be minimised. Weld samples, procedures, approvals and weld logs will be provided.

5.3. System Scope

The Genesys Purified Water Generation Unit is fed from a pretreated water supply. The Genesys

Purified Water Generation Unit is sized to feed 3,000l/hr to a Purified Water Storage Tank (TK201

supplied by Deltaflex) for distribution.

The Genesys Purified Water Generation Unit will comprise of a number of purification stages utilising

proprietary water purification equipment, the system will be operated from a central control panel

(CP01). The Genesys Purified Water Generation Unit will automatically fill the Purified Water Storage

Tank (TK201) when demanded and recirculate back to the Genesys Feed Water Storage Tank (TK01)

when the Purified Water Storage Tank is full, via valves V18 and V19 (valves free issued to Deltaflex

for installation) which are controlled by the Genesys, via volt free fill request signals from the

Distribution System.






The Genesys Purified Water Generation Unit comprises of the following main items of equipment:-

5 Micron Particulate Filter FH01

Feed Water Storage Tank TK01

RO Booster Pump PU01

Reverse Osmosis Units ROH01/02 (ROE01-ROE04)

Degasser DG01

Continuous Electro Deioniser CEDIA

Ultra Filtration Units UF01/02

The Genesys Purified Water Generation Unit will have 3 modes of operation, which will be selected via

the HMI on the Genesys Purified Water Generation Unit Control Panel (CP01)

• Normal Operation Mode

• Hot Water Sanitisation Mode

• CIP Mode

o CIP1 (RO Low Pressure Clean Sequence)

o CIP2 (RO High Pressure Clean Sequence)

o CEDI Clean Sequence

The Genesys Purified Water Generation Unit Control System will also interface with the following

panels:-

• PWD System Control Panel (CP201)

A complete description of the main control functions associated with the system is presented in the

following document:-

Genesys Purified Water Generation Unit Functional Design Specification 7581-PWG-FDS.






5.4. Connected Utilities

Utility Parameter Details Use

Pretreated Feed Water

Flowrate: 4,800 l/hr

Pressure: 2-6 barg

PH:6.5 - 9.0

Conductivity:<1000 µS/cm

Total Hardness:<5.0 ppm as CaC03

SDI:<5

Chlorine:<0.1 ppm

Temperature:≤ 20-25°C

Supply to Feed Water Storage

Tank TK01

Power 380V 3ph 50Hz Neutral + Earth, 63Amp Power to Genesys Control Panel

(CP01)

Instrument Air 50 l/min @ 6-7 barg Instrument Air to Genesys

Pneumatic Panel (CP02)

5.5. Instrumentation

In summary the system comprises of the following main instrument items:-

Inst Ref Parameter Monitored Function

PI01 Pre 5 Micron Particulate Filter

FH01 Local Indication

PI02 Post 5 Micron Particulate Filter

FH01 Local Indication

CL01/TT05 ORP (Chlorine)/Temperature Feedwater Chlorine/Temperature

Monitoring, Indication and Alarms

LT01 Feed Water Storage Tank Level Level Control with Indication and

Alarms

CT01/TT01 Feed Water Storage Tank Outlet

Conductivity and Temperature

Conductivity/Temp Monitoring,

Indication and Alarms

PT01 RO Feed Pressure Pressure Monitoring, Indication and

Alarms

CT02/TT02 RO Permeate Conductivity and

Temperature

Conductivity/Temp Monitoring,


FT01 Primary RO Permeate Flowrate Flow Monitoring, Indication and

Alarms

PT03 CEDIA Dilute Feed Pressure Pressure Monitoring, Indication and

Alarms






Inst Ref Parameter Monitored Function

FT04A CEDIA Concentrate Flowrate Flow Monitoring, Indication and

Alarms

PT04A CEDIA Concentrate Feed Pressure Pressure Monitoring, Indication and

Alarms

PI04 CEDIA Concentrate to Drain Pressure Local Indication

PT05 CEDIA Dilute Outlet Pressure Pressure Monitoring, Indication and

Alarms

CT03/TT03 Final Product Quality/Temperature Conductivity/Temp Monitoring,


TT04 Purified Water Return Temperature Temperature Monitoring, Indication

and Alarms

FT06 UF Retentate Flow Flow Monitoring, Indication and

Alarms

PT02 Primary RO Reject Pressure Pressure Monitoring, Indication and

Alarms

FT02 Primary RO Reject Drain Flowrate Flow Monitoring, Indication and

Alarms

FT03 Primary RO Reject to Recycle Flowrate Flow Monitoring, Indication and

Alarms

TT06 Primary RO Reject Drain Temperature Temperature Monitoring, Indication

and Alarms

FR01 Instrument Air Pressure to CP02 Local Indication

FR02 Instrument Air Pressure to Degasser

from CP02 Local Indication

FI01 Instrument Air Flow to Degasser from

CP02 Local Indication






6. Associated Documentation

Confirm that the following documentation is available for the Genesys Purified Water Generation Unit.

6.1. Specifications

Document Title Document Reference Rev Signed Date

Functional Design

Specification

7581-PWG-FDS

Genesys, O&M Manual ref

7581-PWG-O&M Book 1Section )

Genesys Valve

Schedule

7581-S-2001



Genesys Equipment

Schedule

7581-S-2002



Genesys Instrument

Schedule

7581-S-2003



Purified Water

Systems Utility

Schedule

7581-S-1004



6.2. Maintenance Documentation

Document Title Document Reference Signed Date

Manufacturer’s Technical

Information


7581-PWG-O&M Books 3 & 4

Spare Parts List Genesys, O&M Manual ref

7581-PWG-O&M Book 1

6.3. Procedures


System Operating

Description/Sanitisation Procedure


7581-PWG-O&M Book 1






6.4. Drawings

Drawing Title Drawing No. Rev Location Signed Date

P&I D –Genesys Purified

Water Generation Unit 7581-X-0002

Genesys, O&M

Manual ref

7581-PWG-O&M

Book 1

6.5. Engineering Data Book


Engineering Data Book 7581-PWG-EDB



Highly Purified Water System for Deltaflex SDN BHD at

N.A.Z Medical Supplies SDN BHD

Date: 13 May 2010 Ref: 7581-PWG-FIQ Rev: 0 of 44

7. Documentation Checks

7.1. Principal Components

The following plant items are included in the documentation checks of this qualification:

Acceptance Criteria: Signing the box confirms all the required documents for a given plant item are compiled in the supporting document file.

Material/Surface

Finish Certs:

Material Conformity Certificates, including seals and gaskets, surface finish certificates (refer to engineering data book section 11)

Test Certs: Test and Performance Certificates including pressure tests, manufacturer’s PED certification (refer to engineering data book section

11)

O&M Manuals: Operational and Maintenance Manuals

Tag

Number Description

Material/

Surface Finish

Certs

Test Certs O&M Manuals Comments Accepted

Yes/No Initial

FH01 5 Micron Particulate

Filter Not Required Not Required Book 3 Section 1.0

TK01 Feed Water Storage

Tank Not Required Water Fill Book 3 Section 2.0

SB01 TK01 Sprayball Not Required Not Required Book 3 Section 2.0

HT01 Feed Water Storage

Tank Heater Not Required Not Required Book 3 Section 3.0

Note 1

PU01 RO Booster Pump Not Required Not Required Book 3 Section 4.0






Tag

Number Description

Material/

Surface Finish

Certs

Test Certs O&M Manuals Comments Accepted

Yes/No Initial

ROH01/

02

Reverse Osmosis

Housings

Material

Certificates only Required Book 3 Section 5.0

ROE01/

04

Reverse Osmosis

Elements

Certificate of

Conformity Not Required Book 3 Section 6.0

DG01 Degasser Certificate of

Conformity

Not

Applicable Book 3 Section 7.0

CEDIA Continuous Electro

Deioniser

Certificate of

Conformity

Not

Available Book 3 Section 8.0

UF01/02 Ultrafilter Units Certificate of

Conformity Required Book 3 Section 9.0

Inspection Report Provided

GS01 Gas Separator Not Required Not Required Book 3 Section 10.0

Notes

1. Pressure test certificate available in the Engineering Data Book Section 11

Tested by: Date: Witnessed by: Date:






7.2. Pipework and Line Fittings

The following pipework and line fittings are included in the documentation checks of this qualification.

Acceptance Criteria: Signing the box confirms that all the required documents for the given pipework and fittings are compiled in the supporting

document file.

Material/Surface

Finish Certs:

Material Conformity Certificates, including seals and gaskets, surface finish certificates (refer to engineering data book section 5)

Valve Material/

Surface Finish

Valve Conformity Certificates, including diaphragms and seals, surface finish certificates (refer to engineering data book - section

12)

Weld Log: Weld Log Sheets, Weld Log Isometrics, Weld Procedures and Welder Approvals (refer to engineering data book sections 1 – 4)

NDT: Boroscopy (refer to engineering data book section 9)

Pressure Test

Certs:

Pressure Test Certificate –Pink copies will be attached as appendix to the FIQ (refer to engineering data book section 7)

Passivation

Certs:

Passivation Certificate (refer to engineering data book section 8)

Line

Terminations

Material/

Surface

Finish Certs

Valve

Material/

Surface

Finish

Weld Log NDT Pressure

Test Cert

Passivation

Cert Comments

Accepted

Yes/No Initial

TP01 to TK01

and TP04

Not

Required

Not

Required

Not

Required

Not

Required Required Required






Line

Terminations

Material/

Surface

Finish Certs

Valve

Material/

Surface

Finish


Test Cert

Passivation

Cert Comments

Accepted

Yes/No Initial

TK01 to PU01 Not

Required

Not

Required

Not

Required

Not


PU01 to

ROH01/02

Not

Required

Not

Required

Not

Required

Not


ROH01/02 to

DG01 Required Required Required Required Required Required

DG01 to CEDIA Required Required Required Required Required Required

CEDIA to

UF01/02 Required Required Required Required Required Required

UF01/02 to TP02 Required Required Required Required Required Required

TP04 to TK01 Required Required Required Required Required Required

ROH01/02 to

TK01, V06 and

Drain

Not

Required

Not

Required

Not

Required

Not


CEDIA to GS01 Not

Required

Not

Required

Not

Required

Not


GS01 Vent/Drain

Line

Not

Required

Not

Required

Not

Required

Not

Required

Not

Required

Not

Required

GS01 to TK01 Not

Required

Not

Required

Not

Required

Not







Line

Terminations

Material/

Surface

Finish Certs

Valve

Material/

Surface

Finish


Test Cert

Passivation

Cert Comments

Accepted

Yes/No Initial

UF01/02 to TK01 Not

Required

Not

Required

Not

Required

Not


TK01 Vent Line Not

Required

Not

Required

Not

Required

Not

Required

Not

Required

Not

Required

Drains to TP07 Not

Required

Not

Required

Not

Required

Not

Required

Not

Required

Not

Required

TP07 to Drain

Gulley

Not

Required

Not

Required

Not

Required

Not

Required

Not

Required

Not

Required

By Deltaflex - To be carried out

as part of SAT (7581-PWG-IQ)

Notes







7.3. Instruments

The following instruments are included in the documentation checks of this qualification. (For calibration refer to section 9 of this document)

Acceptance Criteria: Signing the box confirms that all the required documents, for a given plant item, are compiled in the supporting document

file.

Material Certs : Material Conformity Certificates (refer to engineering data book section 10)

Fill Fluid : Food Grade Fill Fluid (refer to engineering data book section 10)

Tag Number Description Material

Certs Fill Fluid Comments

Accepted

Yes/No Initial

CT02/TT02 RO Permeate

Quality/Temperature Required N/A

FT01 RO Permeate Flowrate Required N/A

PT03 CEDIA Dilute Feed Pressure Required Required

FT04A CEDIA Concentrate Flowrate Required N/A

PT04A CEDIA Concentrate Feed

Pressure Required Required

PT05 CEDIA Dilute Outlet Pressure Required Required

CT03/TT03 Final Product

Quality/Temperature Required N/A






Tag Number Description Material

Certs Fill Fluid Comments

Accepted

Yes/No Initial

TT04 Purified Water Return

Temperature Required N/A

Notes








8. Installation Checks

8.1. Principal Components

Inspect the principal components of the equipment to confirm they are as specified in the equipment

data sheet, installed correctly inline with the Manufacturer’s Technical Specification and accurately

documented on the individual checklists.

Tag Number. Principal Component Data Sheet Number Rev. No.

FH01 5 Micron Particulate Filter DS-7581-001

TK01 Feed Water Storage Tank DS-7581-002

HT01 Feed Water Storage Tank Heater DS-7581-003

PU01 RO Booster Pump DS-7581-004

ROH01/02

ROE01/04 Reverse Osmosis Units DS-7581-005 & 006

DG01 Degasser DS-7581-007

CEDIA Continuous Electro Deioniser DS-7581-008

UF01/02 Ultrafilter Units DS-7581-009

GS01 Gas Separator Unit DS-7581-010

CP01 Genesys Control Panel 7581-PWG-FDS

CP02 Genesys Pneumatic Panel Not Applicable

Completed by: Date:







5 Micron Particulate Filter Checklist FH01

Check List Items Comments Accepted

Yes/No Initial

Check conformation to P&ID 7581-

X-0002 and equipment data sheet ref:

DS-7581-001

Check filter vent and drains are fitted

Check plant tag number is on the

filter housing and is correct and

legible

Check nameplate is present and all

details are correct

Check process inlet and discharge

pipework is correctly connected and

aligned

Check no visual damage

Confirm correct filter element is

installed

Write the serial number in the

comments column

Tested by: Date:

Witnessed by: Date:







Feed Water Storage Tank TK01 Checklist


Yes/No Initial



DS-7581-002

Check Nameplate is fitted and all

details correct

Check plant tag number is fitted and

is correct and legible



comments column

Check sprayball SB01 fitted

Check for cleanliness internally and

externally ie visually inspect to

confirm that all fabrication marks

and dirt etc have been cleaned

off/out.

Tested by: Date:

Witnessed by: Date:







Tank Heater Checklist HT01


Yes/No Initial



DS-7581-003





details correct

Check heater is installed correctly

onto flange mounting.

Write serial number in comments

Tested by: Date:

Witnessed by: Date:







RO Booster Pump Checklist PU01


Yes/No Initial



DS-7581-004

Check nameplate is fitted and

contains CE mark and data/rating

information

Check plant tag number is on the

pump and is correct and legible



comments column

Check all securing bolts are in place

Check pump can be removed for

maintenance

Check for cleanliness

Tested by: Date:

Witnessed by: Date:







Reverse Osmosis Units Checklist ROH01-02 (ROE01-04)


Yes/No Initial



DS-7581-005 & 006




details correct


Write the manufacturing numbers in

the comments column

Confirm correct RO membranes are

installed (see sketch below)

Check for ease of

maintenance/removal of membranes

ROE04 Serial:- ROE03 Serial:-

ROE01 Serial:- ROE02 Serial:-

PU01

Tested by: Date:

Witnessed by: Date:







Degasser Checklist DG01


Yes/No Initial



DS-7581-007



Check Identification Nameplate is

present and all details correct



comments column

Tested by: Date:

Witnessed by: Date:







Continuous Electro Deioniser Checklist CEDIA


Yes/No Initial



DS-7581-008



Check model reference nameplate

and CE mark is present



comments column

Check for ease of maintenance

Check the unit is adequately earthed

Tested by: Date:

Witnessed by: Date:







Ultra filtration Units Checklist UF01/02


Yes/No Initial



DS-7581-009

Check plant tag numbers are on the

UF and is correct and legible

Check identification stickers are

present and details are correct

Check no visual damage exists

Write the serial numbers in the

comments column

Tested by: Date:

Witnessed by: Date:







Gas Separator Checklist GS01


Yes/No Initial



DS-7581-010




Check model reference nameplate is

present and details are correct

Check inlet and discharge pipework

is correctly connected.

Write the identification number in

the comments column

Tested by: Date:

Witnessed by: Date:







Genesys Control Panel Checklist CP01


Yes/No Initial

Check conformation to electrical

panel front drawing 7581-PWG-020

Note complete panel checks will be

carried out as part of HATS




Write installed software version

number in comments

Genesys Pneumatic Panel Checklist CP02


Yes/No Initial

Check conformation to pneumatic

panel front drawing 7581-PWG-035

Note complete panel checks will be

carried out as part of HATS




Tested by: Date:

Witnessed by: Date:







8.2. P&ID Check (inc. Inline Items/Instruments)

The following equipment, instruments, pipework and line fittings are to be checked to provide

assurance of:-

a. Tagging

b. Adequate support

c. Pipework route is correct, see P&ID acceptance criteria below

d. Pipe connections to equipment appear free from stress

e. Materials match specification

f. Pipeline is complete with all blank flanges, restrictor plates, valves, instruments

etc present

g. Notes on P&ID correctly incorporated

h. Valves and instruments installed in correct orientation and no clashes

i. Adequate operating and maintenance access

j. Check deadlegs no longer than 3 times pipe diameter

Use the following P&ID’, Valve, Equipment and Instrument Schedules to check the installation:-

Doc Number Doc Title Rev.

Used Signature Date

7581-X-0002 Genesys Purified Water

Generation Unit P&ID

7581-S-2001 Genesys Valve Schedule

7581-S-2002 Genesys Equipment Schedule

7581-S-2003 Genesys Instrument Schedule







Acceptance Criteria:-

i. If the installation is satisfactory the lines on the P&ID and items on the Valve, Equipment

and Instrument Schedules will be coloured green.

ii. An incomplete or unsatisfactory part of the installation will be coloured yellow on the

P&ID, Valve, Equipment and Instrument Schedules, and the deficiencies listed in the non

conformance section of this FIQ.

iii. Each person who completes any part of the FIQ will sign and date the appropriate area on

the P&ID, Valve, Equipment and Instrument Schedules

iv. The coloured P&ID, Valve, Equipment and Instrument Schedules will form part of this

installation report and will be attached in the appendices section of this FIQ.







8.3. Electrical Checks

Electrical testing will be carried out independently (Hardware Acceptance Tests HATS) and does not

form part of this FIQ document.

Checks will be carried out to verify the electrical installation and the HATS document will be provided

which will include the following tests:-

a) Electrical Continuity

b) Electrical Insulation

c) Cable Segregation

d) Earth Bonding and Continuity

e) Tagging






9. Instrument Calibration Certificate Check

Acceptance Criteria: Signing the box confirms that the required calibration certification is compiled in the supporting document file.

Calibration Certs: Calibration Certificates (refer to engineering data book section 10)

Tag No. Instrument Manufacturer Range Serial No. Calibration

Certification Comment

Accepted

Yes/No Initial

PI01 Pre FH01 Pressure Wika 0-7 barg Not Provided

PI02 Post FH01 Pressure Wika 0-7 barg Not Provided

CL01/TT05 ORP (Chlorine) /Temp Endress+

Hauser 0-1500 mV Yes

Note 1

CT01/TT01

Feed Water Tank

Outlet Conductivity

and Temperature

Endress+

Hauser

0-2000µS/cm

and 0-

100degC

Yes

Note 2

PT01 RO Feed Pressure Endress+

Hauser 0 – 40 barg Yes

CT02/TT02

RO Permeate

Conductivity and

Temperature

Endress+

Hauser

0-50µS/cm

and 0-

100degC

Yes

Note 2

FT01 RO Permeate Flowrate Burkert 0 –6000 l/hr Yes Note 3

PT03 CEDIA Dilute Feed

Pressure

Endress+









Accepted

Yes/No Initial

FT04A CEDIA Concentrate

Flowrate Burkert 0 –1000 l/hr Yes

Note 3

PT04A CEDIA Concentrate

pressure

Endress+


PT05 CEDIA Dilute Outlet

Pressure

Endress+


CT03/TT03 Final Product Quality/

Temperature

Endress+

Hauser

0-10µS/cm

and 0-

100degC

Yes

Note 2

TT04 Purified Water Return

Temperature

Endress+

Hauser 0 – 100 degC Yes

FT06 UF Retentate Flow Burkert 0 –1000 l/hr Note 3

PT02 RO Reject Pressure Endress+


FT02 RO Reject Drain


Note 3

FT03 RO Reject to Recycle


Note 3

TT06 RO Reject Drain

Temperature

Endress+

Hauser 0 – 100 degC Yes

PI04 CEDI-A Concentrate to

Drain Wika 0-7 barg Not Provided








Accepted

Yes/No Initial

FR01

(Pressure

Gauge)

Instrument Air feed to

CP02 Festo 0-7 barg Not Applicable Not Provided

FR02

(Pressure

Gauge)

Instrument Air feed to

Degasser Festo 0-7 barg Not Applicable Not Provided

FI01 Instrument Air Flow to

Degasser

Blue White,

IPS 0.5-4.5SCFM Not Applicable Not Provided

Notes:

1 ORP sensor is supplied with manufacturers certificate. Calibration/ranging of instrument is carried out during commissioning/SAT.

2 Conductivity sensors are supplied with a quality certificate.

3 Flowmeters are supplied with a flow simulation test.

Tested by: Date:

Witnessed by: Date:







10. Non-Conformance List

On identifying a non-conformance the responsible person will raise a non-conformance report and

record the number below. The non-conformance will then be categorised and a recommended course of

remedial action discussed, agreed and recorded on the NCR (non-conformance report). A copy of the

open NCR will be appended to this Qualification.

Upon completion of the required actions, the responsible person will sign below to confirm that the

non-conformance is now closed. A copy of the closed NCR will be appended to this Qualification.

Categorise each non-conformance as follows:

Fail: A non-conformance which either has a direct effect on product quality or has the

potential to delay validation progress.

Refer: A non-conformance that has little or no GMP impact and will not prevent validation

progress.

Record all non-conformances in the table below, giving a brief description of the non-conformance and

detailing the person responsible for its resolution.

Non Conformance

Report Number

Description

Person

Responsible

Complete

Sign/Date







11. Results

Summarise below the results of the Factory Installation Qualification including reference to any non-

conformances and their category. Also make reference to any further actions required to complete the

Factory Installation Qualification exercise:

12. Conclusion

Summarise below the conclusion of the Factory Installation Qualification based on the results obtained.

Include a statement regarding the result of the exercise and recommendations for progress of the

validation exercise or further actions where required:







13. Interim Approvals

All non-conformance “fails” in the non-conformance list have been considered and the corresponding

further actions completed. The Genesys Purified Water Generation Unit is ready for Factory

Operational Qualification.

Interim Approval

Name Title Sign Date

14. Final Approvals

The objectives listed in section 3 for the Genesys Purified Water Generation Unit have been achieved.

All remaining non-conformances have been considered and the corresponding follow up actions

completed. The Factory Installation Qualification is complete.

Final Approval

Name Title Sign Date







15. Further Actions

Record below any further actions required to complete the validation exercise:

Further

Action No. Description Ref. Section Complete Sign/Date







16. Appendices

Appendix

No. Description Test Ref No Pages

Confirm

Appended

1 Non Conformance Report Master N/A 1







Appendix 1

Non Conformance Report

(1 Page)







Non Conformance Report NCR No. Initial Date

Description of Non-Conformance: Test Reference:

Classification of Non-Conformance: □ Fail □ Refer

Justification:

Action taken (attach extra documentation if needed):

□ No Justification

□ Yes Description

Result (attach extra documentation if needed):

Recommendation (attach extra documentation if needed):

□ The Non-Conformance is accepted □ The Non-Conformance is not accepted

Justification (attach extra documentation if needed):

Approved By: Date:

7581-pwg-fiq rev0

Documents

deltaflex sdn bhd

purified water system

water generation unit

pwgfiq rev

installation checks

system scope

process overview

responsibilities of