Ever Cool Refrigerating &

Air Conditioning Co., Ltd.

Ever-Cool

Title: Installation Qualification (IQ) Protocol For HVAC Systems Of Penicillin

Page 1 of 58
Production Building

Document Number: EC/HVAC/IQ Version: 01 Effective Date:

INSTALLATION QUALIFICATION (IQ) PROTOCOL

FOR HVAC SYSTEMS
OF
PENICILLIN PRODUCTION BUILDING

AHU NO:
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Title: Installation Qualification (IQ) Protocol For HVAC Systems Of Penicillin

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Production Building

Document Number: EC/HVAC/IQ Version: 01 Effective Date:

PRE-APPROVAL

Prepared By Name Designation Signature Date

Ever-Cool, Hong Kong

Reviewed By Name Designation Signature Date

Opsonin Pharma Ltd.

Opsonin Pharma Ltd.

Opsonin Pharma Ltd.

Opsonin Pharma Ltd.

Approved By Name Designation Signature Date

Opsonin Pharma Ltd.

REVISION HISTORY
Description of the
Version Prepared by Effective Date
Changes
 Ever Cool Refrigerating &
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Title: Installation Qualification (IQ) Protocol For HVAC Systems Of Penicillin

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Production Building

Document Number: EC/HVAC/IQ Version: 01 Effective Date:

01 New
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Title: Installation Qualification (IQ) Protocol For HVAC Systems Of Penicillin

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Production Building

Document Number: EC/HVAC/IQ Version: 01 Effective Date:

TABLE OF CONTENT

1 INTRODUCTION 4
2 PURPOSE 4
3 SCOPE 4
4 QUALIFICTION APPROCH 21
5 REFERENCES 21
6 RESPONSIBILITIES 21
7 TRAINING 22
8 PERSONNEL IDENTIFICATION 22
9 ABBREVIATIONS AND DEFINITIONS 23
10 GENERAL INSTRUCTIONS 23
11 PRE-REQUISITES 24
12 PROCEDURE 25
12.1 Documentation Verification 26
12.2 AHU Specification Verification 27
12.3 Control and Instrumentation Verification 28
12.4 Air Terminals Verification. 29
12.5 Pipe Work Verification 30
12.6 Electrical Work Verification 31
12.7 Dehumidifier Verification 32
12.8 Bag-In Bag-Out Verification 33
13 DEVIATION HANDLING 34
14 ACCEPTANCE CRITERIA 34
15 INSTALLATION QUALIFICATION COMPLETION SUMMARY 35
16 APPENDICES 36
 Ever Cool Refrigerating &
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Title: Installation Qualification (IQ) Protocol For HVAC Systems Of Penicillin

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Document Number: EC/HVAC/IQ Version: 01 Effective Date:

1 INTRODUCTION
The HVAC system includes Air Handling Unit (AHU), Fan Coil Unit (FCU) and associated equipment are
installed in Penicillin Production Building, to provide required controlled environment as per design.

There will be equipped with Twenty-nine (29) numbers of AHU and Four (4) numbers of FCU to serve the
particular area on Penicillin Production Building. The fresh air-connecting unit of AHU/FCU is Outside Air
Unit (OA), which will be, installed twenty-four (24) numbers. The AHU/FCU is equipped with control panel
box.

This protocol defines a common concept the execution of Installation Qualification (IQ) which is to be
duplicating the original approval copy to perform qualification of particular AHU.

2 PURPOSE
The purpose of this protocol is to verify the correct installation of HVAC Systems complied with the
approved design, the manufacture’s recommendations and/or the user requirements.

3 SCOPE
This protocol is applicable for the following lists of AHU and main associated equipment.

AHU Name Serviced Room No. Room Name Clean Class

RECEIVING BAY CNC/NF

AHU-1CNC PEN 02

CORRIDOR CNC
AHU-1CNC PEN 04

REJECT STORE CNC

AHU-1CNC PEN 05

ENTRY/EXIT CNC
AHU-1CNC PEN 18
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Document Number: EC/HVAC/IQ Version: 01 Effective Date:

CHANGE ROOM (WAREHOUSE) CNC

AHU-1CNC PEN 20

AHU-1CNC PEN 21 PAL CNC

Room Name Clean Class

AHU Name Serviced Room No.

EMPTY GELATIN CAPSULE SHELL CNC

AHU-1CNC PEN 23

OFFICE CNC
AHU-1CNC PEN 26

MATERIAL STAGING CNC

AHU-1CNC PEN 38

SUGAR STAGING CNC

AHU-1CNC PEN 42

CHEANER`S CNC
AHU-1CNC PEN 42(A)

BOTILE WASH& DRY D

AHU-2D PEN 43

PAL D
AHU-2D PEN 45

CHEANER`S D
AHU-3D PEN 44
WASTE MATERIAL
D
AHU-3D PEN 47 AND NEUTRALIZATION

CORRIDOR D
AHU-3D PEN 49

IPQC D
AHU-3D PEN 50
DRY SYRUP GRANULATION D
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Document Number: EC/HVAC/IQ Version: 01 Effective Date:

AHU-4D PEN 54

BLENDING D
AHU-4D PEN 59

BOTTLE FILLING & SEALING D

AHU-4D PEN 60

BOTTLE STAGING D
AHU-5D PEN 46

AHU Name Serviced Room No. Room Name Clean Class

AHU-5D PEN 51 MATERIAL STAGING D

MAL D
AHU-5D PEN 52

CORRIDOR D
AHU-5D PEN 53

TOOLS ROOM D
AHU-5D PEN 55

UN CLEAN EQUIPMENT D
AHU-5D PEN 56

WASH D
AHU-5D PEN 57

CLEAN EQUIPMENT D
AHU-5D PEN 58

BIN WASH D
AHU-5D PEN 68

WIP D
AHU-5D PEN 69

OFFICE D
AHU-5D PEN 75
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Title: Installation Qualification (IQ) Protocol For HVAC Systems Of Penicillin

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Document Number: EC/HVAC/IQ Version: 01 Effective Date:

COATING D
AHU-6D PEN 67

TABLET COMPRESSION D
AHU-6D PEN 70

GRANULATION D
AHU-6D PEN 76

BLENDING D
AHU-6D PEN 81

CHANGE PARTS ROOM D

AHU-7D PEN 63

AHU Name Serviced Room No. Room Name Clean Class

BLISTER PACKER D
AHU-7D PEN 64

STRIP PACKER D
AHU-7D PEN 87

MAL OUT D
AHU-8D PEN 29

DISPENSING BOOTH D
AHU-8D PEN 30

PAL D
AHU-8D PEN 31

MAL IN D
AHU-8D PEN 32

PAL D
AHU-9.1D PEN 06

SAMPLING D
AHU-9.1D PEN 07

MAL OUT D
AHU-9.1D PEN 08
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Title: Installation Qualification (IQ) Protocol For HVAC Systems Of Penicillin

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Document Number: EC/HVAC/IQ Version: 01 Effective Date:

MAL IN D
AHU-9.1D PEN 09

MAL OUT D
AHU-9.2D PEN 12

MAL IN D
AHU-9.2D PEN 13

SAMPLING D
AHU-9.2D PEN 14

PAL D
AHU-9.2D PEN 15

AHU Name Serviced Room No. Room Name Clean Class

BROKEN BULK D
AHU-10D PEN 27

CORRIDOR D
AHU-10D PEN 28

CLEAN EQUIPMENT D
AHU-10D PEN 33

UN CLEAN EQUIPMENT D
AHU-10D PEN 34

WASH D
AHU-10D PEN 35

PAL D
AHU-10D PEN 36

MAL D
AHU-10D PEN 37

EMPTY BIN STORE D

AHU-10D PEN 39
MATERIAL STAGING ROOM D
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Title: Installation Qualification (IQ) Protocol For HVAC Systems Of Penicillin

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Document Number: EC/HVAC/IQ Version: 01 Effective Date:

AHU-10D PEN 40

SUGAR CRUSHING D
AHU-10D PEN 41

EMPTY BIN STORE D

AHU-11D PEN 84

ENCAPSULATION-2 D
AHU-11D PEN 85

CAPSULE SORTING/POLIS D
AHU-11D PEN 86

WIP TABLET/CAPSULE D
AHU-12D PEN 65

CLEAN EQUIPMENT D
AHU-12D PEN 71

TOOLS ROOM D
AHU-12D PEN 72

UN CLEAN EQUIPMENT D
AHU-12D PEN 73

WASH D
AHU-12D PEN 74
MATERIAL STAGING FOR
D
AHU-12D PEN 77 TABLET&CAPSULE

PASTE PREPARATION D
AHU-12D PEN 78

MAL D
AHU-12D PEN 79

CORRIDOR D
AHU-12D PEN 80

WIP D
AHU-12D PEN 82
BIN WASH D
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Title: Installation Qualification (IQ) Protocol For HVAC Systems Of Penicillin

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Document Number: EC/HVAC/IQ Version: 01 Effective Date:

AHU-12D PEN 83

BLISTER PACKER E
AHU-13.1 & 13.2E PEN 88

INSPECTION/LABELING E
AHU-13.1 & 13.2E PEN 89

QUARANTINE E
AHU-13.1 & 13.2E PEN 131

CHAING PARTS FOIL & FILM ROOM E

AHU-13.1 & 13.2E PEN 132

EXIT FROM PACKING HALL E

AHU-13.1 & 13.2E PEN 133

OFFICE E
AHU-13.1 & 13.2E PEN 134

CLEANERS E
AHU-13.1 & 13.2E PEN 135

CLEANERS E
AHU-13.1 & 13.2E PEN 144(A)

PACKING HALL E
AHU-13.1 & 13.2E PEN 145

AHU Name Serviced Room No. Room Name Clean Class

MAL E
AHU-13.1 & 13.2E PEN 150

OVER PRINTING E
AHU-13.1 & 13.2E PEN 151

LEAFLET FOLDING E
AHU-13.1 & 13.2E PEN 152

IPQC E
AHU-13.1 & 13.2E PEN 153
OFFICE E
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Document Number: EC/HVAC/IQ Version: 01 Effective Date:

AHU-13.1 & 13.2E PEN 154

NEUTRALIZATION E
AHU-13.1 & 13.2E PEN 155

WASTE MATERIAL COLLECTION E

AHU-13.1 & 13.2E PEN 156

RM QUARANTINE CNC
AHU-14CNC PEN 10

PRIMARY PM QUARANTINE CNC

AHU-14CNC PEN 11

PRIMARY PACKING WAREHOUSE CNC

AHU-14CNC PEN 16

RM QUARANTINE CNC
AHU-14CNC PEN 25

FILLING & SEALING B

AHU-15B PEN 91

WASHING&DEPYROGENATION TUNNEL C
AHU-16C PEN 92

MATERIAL TRANSFER C
AHU-16C PEN 93

WASH/LAUNDRY C
AHU-16C PEN 95

AHU Name Serviced Room No. Room Name Clean Class

AUTOCLAVE LOADING C
AHU-16C PEN 96

C' DRESS OFF/ON C

AHU-16C PEN 105

PAL C
AHU-16C PEN 106
AUTOCLAVE UNLOADING B
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Title: Installation Qualification (IQ) Protocol For HVAC Systems Of Penicillin

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Document Number: EC/HVAC/IQ Version: 01 Effective Date:

AHU-17B PEN 97

“B” CORRIDOR B
AHU-17B PEN 98

PAL IN B
AHU-17B PEN 99

B' DRESS ON B
AHU-17B PEN 100

C’ DRESS ON C
AHU-17B PEN 101
BUFFER ZONE
C
AHU-17B PEN 103 C’ DRESS ON

B' DRESS OFF B

AHU-17B PEN 104

D' DRESS OFF/ON D

AHU-18D PEN 102

D' CORRIDOR D
AHU-18D PEN 107
D' CHANGE
D
AHU-18D PEN 108 MALE

PAL D
AHU-18D PEN 108A

PAL D
AHU-18D PEN 109

AHU Name Serviced Room No. Room Name Clean Class

LAUNDRY D
AHU-18D PEN 110

D' CHANGE MANAGEMENT D

AHU-18D PEN 111
PAL D
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Title: Installation Qualification (IQ) Protocol For HVAC Systems Of Penicillin

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Document Number: EC/HVAC/IQ Version: 01 Effective Date:

AHU-18D PEN 111A

PAL D
AHU-18D PEN 112

PAL D
AHU-18D PEN 113

D' CHANGE MALE D

AHU-18D PEN 114

E' CORRIDOR E
AHU-19E PEN 115

STREET DRESS OFF(MALE) CNC

AHU-20CNC PEN 116

STREET DRESS OFF(MANAGEMENT) CNC

AHU-20CNC PEN 117

STREET DRESS OFF(FEMALE) CNC

AHU-20CNC PEN 118

PAL CNC
AHU-20CNC PEN 118A

E' CORRIDOR CNC

AHU-20CNC PEN 119

ENTRY LOBBY CNC

AHU-20CNC PEN 121

PAL CNC
AHU-20CNC PEN 123

MANAGEMENT TOILET CNC

AHU-20CNC PEN 124

AHU Name Serviced Room No. Room Name Clean Class

FEMALE TOILET CNC

AHU-20CNC PEN 125
PAL FEMALE CNC
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Title: Installation Qualification (IQ) Protocol For HVAC Systems Of Penicillin

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Document Number: EC/HVAC/IQ Version: 01 Effective Date:

AHU-20CNC PEN 126

PAL MALE CNC

AHU-20CNC PEN 127

MALE TOILET CNC

AHU-20CNC PEN 128

LOBBY CNC
AHU-20CNC PEN 129

ENTRY LOBBY (WAREHOUSE) CNC

AHU-21CNC PEN 136

CHANGE ROOM (WAREHOUSE) CNC

AHU-21CNC PEN 138

RECALL STORE CNC

AHU-21CNC PEN 139

REJECT GOODS STORE CNC

AHU-21CNC PEN 140

OFFICE CNC
AHU-21CNC PEN 141

FINISHED GOODS WAREHOUSE CNC

AHU-21CNC PEN 142

MAL CNC
AHU-21CNC PEN 143

RECEIVING/DISPATCH CNC
AHU-21CNC PEN 146

QUARANTINE CNC
AHU-21CNC PEN 148
SECONDARY PACKING MATERIAL
CNC
AHU-21CNC PEN 149 STORE

AHU Name Serviced Room No. Room Name Clean Class

E DRESS OFF/ON C
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Document Number: EC/HVAC/IQ Version: 01 Effective Date:

AHU-22C MB 10

C DRESS OFF/ON C
AHU-22C MB 11

PAL IN C
AHU-22C MB 12

BIO-BURDEN C
AHU-22C MB 13

ENTRY C
AHU-22C MB 14

CORRIDOR B
AHU-23B MB 16

STERILITY ROOM B
AHU-23B MB 17

STERILITY ROOM B
AHU-23B MB 18
B
PAL IN
AHU-23B MB 19

B DRESS ON B
AHU-23B MB 20

BUFFER ZONE B
AHU-23B MB 21

PAL OUT B
AHU-23B MB 22
B
B DRESS OFF
AHU-23B MB 23
B
E DRESS OFF
AHU-23B MB 24

PAL E
AHU-24E MB 01
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Document Number: EC/HVAC/IQ Version: 01 Effective Date:

AHU Name Serviced Room No. Room Name Clean Class

CHANGE ROOM E
AHU-24E MB 02

MEDIA STORE E
AHU-24E MB 03

GENERAL LAB E
AHU-24E MB 04 & 05

INCUBATION E
AHU-24E MB 06

WASH E
AHU-24E MB 07

MEDIA DESTRUCTION E
AHU-24E MB 08

INSTRUMENT ROOM E
AHU-24E MB 09

MEDIA PREP&STERILIZATION E
AHU-24E MB 25

OFFICE E
AHU-24E MB 26

DOCUMENTS ROOM E
AHU-24E MB 27

MICROLAB CORRIDOR E
AHU-24E MB 29

ENTRY/EXIT CNC
AHU-25CNC QC 01

CHANGE ROOM FO MALE CNC

AHU-25CNC QC 02

CHANGE ROOM FO FEMALE CNC

AHU-25CNC QC 05
SAMPLE RETENTION CNC
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Title: Installation Qualification (IQ) Protocol For HVAC Systems Of Penicillin

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Document Number: EC/HVAC/IQ Version: 01 Effective Date:

AHU-25CNC QC 06

AHU Name Serviced Room No. Room Name Clean Class

WASH E
AHU-24E MB 07

MEDIA DESTRUCTION E
AHU-24E MB 08

INSTRUMENT ROOM E
AHU-24E MB 09

MEDIA PREP&STERILIZATION E
AHU-24E MB 25

OFFICE E
AHU-24E MB 26

DOCUMENTS ROOM E
AHU-24E MB 27

MICROLAB CORRIDOR E
AHU-24E MB 29

ENTRY/EXIT CNC
AHU-25CNC QC 01

CHANGE ROOM FO MALE CNC

AHU-25CNC QC 02

CHANGE ROOM FO FEMALE CNC

AHU-25CNC QC 05

SAMPLE RETENTION CNC

AHU-25CNC QC 06

CHEMICAL LAB CNC

AHU-25CNC QC 07

WASH & DRY CNC

AHU-25CNC QC 08
GLASS WARW/REAGWNT STORE CNC
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Document Number: EC/HVAC/IQ Version: 01 Effective Date:

AHU-25CNC QC 10

PHYSICAL LAB CNC

AHU-25CNC QC 11

AHU Name Serviced Room No. Room Name Clean Class

INSTRUMENT LAB CNC

AHU-25CNC QC 12

IR ROOM CNC
AHU-25CNC QC 13

QA MANAGER'S OFFICE CNC

AHU-25CNC QC 14

SOLVENT STORE CNC

AHU-25CNC QC 15

DOCUMENTS ARCHIVE CNC

AHU-25CNC QC 16

WORK STATION CNC

AHU-25CNC QC 17

QC MANAGER'S OFFICE CNC

AHU-25CNC QC 18

CRS/WS ROOM CNC

AHU-25CNC QC 20

BALANCE CNC
AHU-25CNC QC 21

CLN CNC
AHU-25CNC QC 22

LOBBY CNC
AHU-26CNC PEN 22

STAIR CNC
AHU-26CNC ST-01
LIFT LOBBY CNC
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Document Number: EC/HVAC/IQ Version: 01 Effective Date:

AHU-26CNC PEN 301

CORRIDOR CNC
AHU-26CNC PEN 302

FUME CUPBOARD CNC

AHU FC QC 09
AHU TEF 1 &TSF 1 PEN 67A TECHNICAL AREA CNC

The Outside Air Unit (OA) that is part of AHU/FCU listed as below:

FCU Name Serviced Room No. Room Name Clean Class

LIFT LOBBY CNC

FCU 1/CAN ST 01(A)

LAUNDRY CNC
FCU 1/CAN CAN 04

FCU 1/CAN CAN 05 CLEAN GARMENT CNC

CORRIDOR
FCU 1/CAN CAN 06 CNC

MEETING ROOM
FCU 1/CAN CAN 07 CNC

FCU 1/CAN CAN 10 WASH

CNC

CAN 14 FOOD RECEIVING AREA CNC

FCU 1/CAN

CAN 15 DISH WASH CNC

FCU 1/CAN

CAN 16 STORE CNC

FCU 1/CAN

CAN 17 WASH CNC

FCU 1/CAN
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Document Number: EC/HVAC/IQ Version: 01 Effective Date:

CAN 18 PANTRY CNC

FCU 1/CAN

CAN 12 WORKER'S CANTEEN CNC

FCU 2/CAN

CAN 09 OFFICER'S CANTEEN CNC

FCU 3/CAN

CAN 02 FOOD ABLUTION CNC

FCU 4/CAN

FCU 4/CAN CAN 03 PRAYER HALL (MALE) CNC

OA No. Unit Connected to AHU No.

AHU1.OA 1 AHU 1CNC

AHU2.OA 1 AHU 2D

AHU3.OA 1 AHU 3D

AHU4.OA 1 AHU 4D

AHU5.OA 1 AHU 5D

AHU6.OA 1 AHU 6D

AHU7.OA 1 AHU 7D

AHU8.OA 1 AHU 8D

AHU9.OA 1 AHU 9.1D, AHU 9.2D

AHU10.OA 1 AHU 10D

AHU11.OA 1 AHU 11D

AHU12.OA 1 AHU 12D

AHU13.OA 1 AHU 13.1D, AHU 13.2D

AHU14.OA 1 AHU 14CNC

AHU15.OA 1 AHU 15B

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Document Number: EC/HVAC/IQ Version: 01 Effective Date:

AHU16.OA 1 AHU 16C

AHU17.OA 1 AHU 17B

AHU18.OA 1 AHU 18D

AHU19.OA 1 AHU 19E

AHU20.OA 1 AHU 20CNC

AHU21.OA 1 AHU 21CNC

AHU23.OA 1 AHU 22CNC, AHU 23B

AHU24.OA 1 AHU 24E

AHU25.OA 1 AHU 25CNC, AHU 26CNC

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Document Number: EC/HVAC/IQ Version: 01 Effective Date:

Main Associated Equipment ID No. Unit Serviced To

Dehumidifier DHF1/AHU4 1 AHU 4D

Dehumidifier DHF1/AHU5 1 AHU 5D

Dehumidifier DHF1/AHU6 1 AHU 6D

Dehumidifier DHF1/AHU7 1 AHU 7D

Dehumidifier DHF1/AHU8 1 AHU 8D

Dehumidifier DHF1/AHU9.1 1 AHU 9.1D

Dehumidifier DHF1/AHU11 1 AHU 11D

Dehumidifier DHF1/AHU12 1 AHU 12D

Dehumidifier DHF1/AHU15 1 AHU 15B

Dehumidifier DHF1/AHU17 1 AHU 17B

Bag-In Bag-Out Unit AHU 4D/BIBO 1 AHU 4D

Bag-In Bag-Out Unit AHU 5D/BIBO 1 AHU 5D

Bag-In Bag-Out Unit AHU 6D/BIBO 1 AHU 6D

Bag-In Bag-Out Unit AHU 7D/BIBO 1 AHU 7D

Bag-In Bag-Out Unit AHU 8D/BIBO 1 AHU 8D

Bag-In Bag-Out Unit AHU 9.1D/BIBO 1 AHU 9.1D

Bag-In Bag-Out Unit AHU 9.2D/BIBO 1 AHU 9.2D

Bag-In Bag-Out Unit AHU 11D/BIBO 1 AHU 11D

Bag-In Bag-Out Unit AHU 12D/BIBO 1 AHU 12D

Bag-In Bag-Out Unit AHU 15B/BIBO 1 AHU 15B

Bag-In Bag-Out Unit AHU 16C/BIBO 1 AHU 16C

Bag-In Bag-Out Unit AHU 17B/BIBO 1 AHU 17B

Bag-In Bag-Out Unit BB1/EF1.5 1 N/A

Bag-In Bag-Out Unit BB1/EF1.12 1 N/A

Bag-In Bag-Out Unit BB1/EF1.16 1 N/A

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Document Number: EC/HVAC/IQ Version: 01 Effective Date:

4 QUALIFICTION APPROCH
This protocol will take place at Penicillin Production Building. For all the activities will be performed by
Ever Cool Refrigerating and Air Conditioning Company Limited and witnessed/verified by a validation
team of Opsonin Pharma Ltd.

IQ Protocol: IQ protocol shall be pre-approved by authorized personnel before qualification approach. All
the test items there will have separate worksheets. Test methods are also listed and described with
acceptance criteria in separate worksheets which will be duly filled and signed during the execution of IQ.

IQ Test Methods and Acceptance Criteria: IQ protocol itself regulates test methods and evaluates
acceptance criteria. If some references for test method or acceptance criteria are required at actual
results, it should be as an attachment.

IQ Completion Summary: IQ completion verification will be generated after qualification execution. This
completion summary will carry and summarize the filled in photocopies of the worksheets of this protocol
along with relevant attachments and will be finally approved by Opsonin Pharma Ltd.

Deviation Handling: QA department & Engineering department will be informed immediately if any
deviations occur. Vendor will initiate deviation investigation, identify root cause, assess impact in IQ and
implement corrective action as needed.

5 REFERENCES
GMP & 21 CFR Part: 11

6 RESPONSIBILITIES
Job Items Roles Responsibilities
Prepares Installation Qualification
Compilation Ever Cool Refrigerating & Air Conditioning Co., Ltd.
Protocol
Performs Installation Qualification
Execution Ever Cool Refrigerating & Air Conditioning Co., Ltd.
Protocol
Review Opsonin Pharma Ltd. Reviews Installation Qualification
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Document Number: EC/HVAC/IQ Version: 01 Effective Date:

Protocol and Report

Approves Installation Qualification
Approval Opsonin Pharma Ltd.
Protocol and Report
7 TRAINING
All personnel engaged in the execution of this protocol require training which main target is how and
when to performance protocol qualification.

8 PERSONNEL IDENTIFICATION
Person involved in the execution of Installation Qualification (IQ) are listed in the following table.

Name Company Designation/Department Signature & Date

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Title: Installation Qualification (IQ) Protocol For HVAC Systems Of Penicillin

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Document Number: EC/HVAC/IQ Version: 01 Effective Date:

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Document Number: EC/HVAC/IQ Version: 01 Effective Date:

9 ABBREVIATIONS AND DEFINITIONS

Words Content/Description
URS User Requirement Specification
T&C Testing and Commissioning
OA Outside Air Unit
AHU Air Handling Unit
DC Dust Collector
DEH Dehumidifier
BMS Building Management System
EMS Environmental Monitoring System
DDC Direct Digital Control
HMI Human Machine Interface
CMH Cubic Meter Hour
CNC Controlled Not Classified
NMT Not More Than
NLT Not Less Than
N/A Not Applicable
DQ Design Qualification
IQ Installation Qualification
OQ Operational Qualification
PQ Performance Qualification

10 GENERAL INSTRUCTIONS

■ All data must be recorded using “Blue Pen” which is recognizable color if scan copy and be legible.

■ All blank spaces must be either completed as specified or lined out with an initial and a date.

■ Corrections are to be crossed out with a single line, given a reason, initialed, and dated.

■ Each data sheet is to be signed and dated by person(s) executing the protocol and a second
individual checking or verifying by the work.
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11 PRE-REQUISITES
Verify that commissioning activities of HVAC Systems have been successfully completed with all test
results. Installation Qualification (IQ) is ready to process after Commissioning is successfully completed.

Commissioning Completion Verification Completion Status

All parts of the total system are commissioned 口 Yes 口 No 口 Not Applicable
successfully.

Ducting air leakage testing and piping water pressure 口 Yes 口 No 口 Not Applicable
testing are completed successfully.

All deviations, if any, are closed and handled. 口 Yes 口 No 口 Not Applicable

This following table lists the instruments that will be necessary to perform the tests detailed in this protocol.
The calibration certificates for the instruments listed shall be included as an attachment.

Calibration Calibration Certificate

Instrument Name Serial No.
Certificate No. Due Date Available (Yes/No)
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Document Number: EC/HVAC/IQ Version: 01 Effective Date:

Name Designation Signature Date

Checked by
Reviewed by

12 PROCEDURE
This section provides the objectives and processes utilized to perform Installation Qualification (IQ).

■ Documentation Verification
■ AHU Specification Verification
■ Control and Instrumentation Verification
■ Air Terminals Verification
■ Pipe Work Verification
■ Electrical Work Verification
■ Dehumidifier Verification
■ Bag-In Bag-Out Verification
12.1 Documentation Verification

Objective
To verify the following documents are available.

Process
1. Check the following items are available for HVAC Systems installation.
■ User Requirement Specification
■ As-Built Drawing
■ Technical Specification of AHU
■ Data Sheet Checklist
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■ Operation and Maintenance Manual

■ Certification Record
■ Calibration Record

2. Record the document title and number of each listed item in Appendix-A: Documentation
Verification Form.

Acceptance Criteria
The documentation verification stated above must be met.
All information is recorded in Appendix-A: Documentation Verification Form.
12.2 AHU Specification Verification

Objective
Provide documented evidence to demonstrate that the AHU with associated equipment installed
complies with the approved design and manufacture’s recommendation.

Process
1. Verify the components are installed according to the Technical Specification of AHU.

2. Check and mark the drawings to confirm that it accurately reflects the installation as described by
the following colors.
■ Green (All OK)
■ Yellow (Information Missing)
■ Orange (Not Applicable)

3. Use Appendix-B; AHU Specification Verification Form to document the results.

Acceptance Criteria
The AHU specification verification stated above must be met.
All information is recorded in Appendix-B: AHU Specification Verification Form.
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12.3 Control and Instrumentation Verification

Objective
Provide documented evidence to demonstrate that the control and instrumentation installed complies
with the approved design and manufacture’s recommendation.

Process
1. Verify the components are installed according to the Data Sheet Checklist of Control and
Instrumentation.

2. Check and mark the drawings to confirm that it accurately reflects the installation as described by
the following colors.
■ Green (All OK)
■ Yellow (Information Missing)
■ Orange (Not Applicable)

3. Use Appendix-C: Control and Instrumentation Verification Form to document the results.

Acceptance Criteria
The control and instrumentation verification stated above must be met.
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All information is recorded in Appendix-C: Control and Instrumentation Verification Form.

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12.4 Air Terminals Verification.

Objective
Provide documented evidence to demonstrate that the air terminals installed complies with the
approved design and manufacture’s recommendation.

Process
1. Verify the components are installed according to the Data Sheet Checklist of Supply Air Diffuser.

2. Verify the components are installed according to the Data Sheet Checklist of Return Air Grille.

3. Verify the components if any terminal HEPA filters are installed in clean room according to the
Data Sheet Checklist of HEPA Box.

4. Check and mark the drawings to confirm that it accurately reflects the installation as described by
the following colors.
■ Green (All OK)
■ Yellow (Information Missing)
■ Orange (Not Applicable)

5. Use Appendix-D: Air Terminals Verification Form to document the results.

Acceptance Criteria
The air terminals verification stated above must be met.
All information is recorded in Appendix-D: Air Terminals Verification Form.
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12.5 Pipe Work Verification

Objective
Provide documented evidence to demonstrate that the pipe work installed complies with the approved
design and manufacture’s recommendation.

Process
1. Verify the components are installed according to the Data Sheet Checklist of Chilled Water Piping.

2. Verify the components are installed according to the Data Sheet Checklist of Hot Water Piping.

3. Verify the components are installed according to the Data Sheet Checklist of Drain Water Piping.

4. Check and mark the drawings to confirm that it accurately reflects the installation as described by
the following colors.
■ Green (All OK)
■ Yellow (Information Missing)
■ Orange (Not Applicable)

5. Use Appendix-E: Pipe Work Verification Form to document the results.

Acceptance Criteria
The pipe work verification stated above must be met.
All information is recorded on the Appendix-E: Pipe Work Verification Form.
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12.6 Electrical Work Verification

Objective
Provide documented evidence to demonstrate that the electrical work installed complies with the
approved design and manufacture’s recommendation.

Process
1. Verify the components are installed according to the Data Sheet Checklist of Electrical
Component.

2. Check and mark the drawings to confirm that it accurately reflects the installation as described by
the following colors.
■ Green (All OK)
■ Yellow (Information Missing)
■ Orange (Not Applicable)

3. Use Appendix-F: Electrical Work Verification Form to document the results.

Acceptance Criteria
The electrical work verification stated above must be met.
All information is recorded in Appendix-F: Electrical Work Verification Form.
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12.7 Dehumidifier Verification

Objective
Provide documented evidence to demonstrate that the dehumidifier installed complies with the
approved design and manufacture’s recommendation.

Process
1. Check and mark the drawings to confirm that it accurately reflects the installation as described by
the following colors.
■ Green (All OK)
■ Yellow (Information Missing)
■ Orange (Not Applicable)

2. Use Appendix-G: Dehumidifier Verification Form to document the results.

Acceptance Criteria
The dehumidifier verification stated above must be met.
All information is recorded in Appendix-G: Dehumidifier Verification Form.
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12.8 Bag-In Bag-Out Verification

Objective
Provide documented evidence to demonstrate that the Bag-In Bag-Out installed complies with the
approved design and manufacture’s recommendation.

Process
3. Check and mark the drawings to confirm that it accurately reflects the installation as described by
the following colors.
■ Green (All OK)
■ Yellow (Information Missing)
■ Orange (Not Applicable)

4. Use Appendix-H: Bag-In Bag-Out Verification Form to document the results.

Acceptance Criteria
The dehumidifier verification stated above must be met.
All information is recorded in Appendix-H: Bag-In Bag-Out Verification Form.
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13 DEVIATION HANDLING
Purpose
To check and record any deviation or unexpected situation observed during the execution of protocol.

Test Method
1. Use Appendix-I: Deviation List to record deviations.
2. Use Appendix-J: Deviation Report to settle deviations.

Acceptance Criteria
All the information is recorded if any in Appendix-I: Deviation List.
All the information is handled if any in Appendix-J: Deviation Report.

14 ACCEPTANCE CRITERIA

■ All the information required are complete, correct and accurate.

■ List of all the drawings are the current version and posted in the verification documents.
■ All the utilities must be verified to meet the manufacturer’s specifications.
■ The information captured in the form is complete, correct, accurate and signed.
■ Inspection items confirmed match with the acceptance criteria of forms.
■ All the deviations are closed and attached.
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15 INSTALLATION QUALIFICATION COMPLETION SUMMARY

Summarize and verify the results of this IQ protocol in accordance with acceptance criteria.
Signature /
Acceptance Criteria Results Acceptable
Initial &Date

All actions with execution of Installation Qualification (IQ) for 口 Acceptable

AHU No. 口 Not Acceptable
__________________is successfully completed. 口 Not Applicable

All the deviations related to Installation Qualification (IQ) for 口 Acceptable

AHU No. 口 Not Acceptable
________________if attached are investigated and closed. 口 Not Applicable

口 Acceptable
Referring to AHU No. __________________of HVAC Systems
口 Not Acceptable
is ready to process Operational Qualification (OQ).
口 Not Applicable

Comments:

Name Designation Signature Date

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Checked by
Reviewed by

16 APPENDICES

■ Appendix-A: Documentation Verification Form

■ Appendix-B: AHU Specification Verification Form
■ Appendix-C: Control and Instrumentation Verification Form
■ Appendix-D: Air Terminals Verification Form
■ Appendix-E: Pipe Work Verification Form
■ Appendix-F: Electrical Work Verification Form
■ Appendix-G: Dehumidifier Verification Form
■ Appendix-H: Bag-In Bag-Out Verification Form
■ Appendix-I: Deviation List
■ Appendix-J: Deviation Report
■ Appendix-K: Attachment Sheet
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Document Number: EC/HVAC/IQ Version: 01 Effective Date:

POSTAPPROVAL
Reviewed By Name Designation Signature Date

Opsonin Pharma Ltd.

Opsonin Pharma Ltd.

Opsonin Pharma Ltd.

Approved By Name Designation Signature Date

Opsonin Pharma Ltd.

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APPENDIX-A Documentation Verification Form

Items Name Document Content/Description Document No. Ver. Available
User
Requirement 口 Yes 口 No
Specification

As-Built Drawing HVAC Serviced Drawing 口 Yes 口 No

Technical
Specification of Technical Specification of AHU HVAC/IQ/TS/AHU 01 口 Yes 口 No
AHU
Data Sheet Checklist of Control and
HVAC/IQ/DS/CI 01 口 Yes 口 No
Instrumentation
Data Sheet Checklist of Supply Air
HVAC/IQ/DS/SD 01 口 Yes 口 No
Diffuser
Data Sheet Checklist of Return Air
HVAC/IQ/DS/RG 01 口 Yes 口 No
Grille

Data Sheet Checklist of HEPA Box HVAC/IQ/DS/HB 01 口 Yes 口 No

Data Sheet
Checklist Data Sheet Checklist of Chilled Water
HVAC/IQ/DS/CHW 01 口 Yes 口 No
Piping
Data Sheet Checklist of Hot Water
HVAC/IQ/DS/HW 01 口 Yes 口 No
Piping
Data Sheet Checklist of Drain Water
HVAC/IQ/DS/DRNP 01 口 Yes 口 No
Piping
Data Sheet Checklist of Electrical
HVAC/IQ/DS/ELEC 01 口 Yes 口 No
Component
Operation and Please find the attachment folder
Maintenance N/A N/A 口 Yes 口 No
Manual #__________________________

Please find the attachment folder

Certification
N/A N/A 口 Yes 口 No
Record #__________________________

Please find the attachment folder

Calibration
N/A N/A 口 Yes 口 No
Record #__________________________
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APPENDIX-A Documentation Verification Form (Cont.)

Deviations: YES 口 NO 口 Acceptance Meet Criteria: YES 口 NO 口
Attachment (If any):

Comments:

Checked by: Signature & Date:

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Verified by: Signature & Date:

APPENDIX-B AHU Specification Verification Form
AHU Name:
Confirmation
Inspection Items
Yes No N/A
1. The unit should be horizontally levelled in designated
口 口 口
location.
2. General appearance/orientation/construction of the
口 口 口
installed units should beeper design.
3. Pre-filters and Final filters should be installed properly and
口 口 口
fitted without any damage per design.

4. Fan & Motor should be coupled. 口 口 口

5. Edges of the housing should be sealed with silicon

口 口 口
sealant.
6. Cooling Coil if any installed should be properly connected
口 口 口
to Chilled water system with proper insulation.
7. Heating Coil if any installed should be properly connected
口 口 口
to Heating Hot water system with proper insulation.
8. Electric Heater if any installed should be properly
口 口 口
connected to Terminal Box with proper insulation.
9. Condensate drain connections should be completed with
口 口 口
proper insulation.
10. Electrical wiring and connections should be completed.
Power supply should be: 380-415V, 3Ph, 50Hz with earth 口 口 口
points.

11. Air Inlet/Outlet ducts should be connected as per design. 口 口 口

12. The AHU and all associated components if any appended

口 口 口
should be properly labelled.
Acceptance Meet Criteria: YES 口 NO
Deviations: YES 口 NO 口
口
Comments:

Checked by: Signature & Date:

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APPENDIX-C Control and Instrumentation Verification Form

AHU Name:
Serving Area Room No.

Confirmation
Inspection Items
Yes No N/A
1. Mechanical installation should be completed in the correct
口 口 口
location as per design without any visual damage.
2. All items should be correctly and clearly tagged with
口 口 口
identification number.

3. All items should be located to facilitate maintenance. 口 口 口

4. Calibration or certification record should be available for

口 口 口
each piece of controls and instruments.
Deviations: YES 口 NO 口 Acceptance Meet Criteria: YES 口 NO 口

Comments:

Checked by: Signature & Date:

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Verified by: Signature & Date:

APPENDIX-D Air Terminals Verification Form

AHU Name:
Serving Area Room No.

Confirmation
Inspection Items
Yes No N/A

1. Mechanical installation should be completed in the correct

口 口 口
location as per design without any visual damage.

2. The tag with identification number should be correct and

口 口 口
clear.

Deviations: YES 口 NO 口 Acceptance Meet Criteria: YES 口 NO 口

Comments:

Checked by: Signature & Date:

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Document Number: EC/HVAC/IQ Version: 01 Effective Date:

Verified by: Signature & Date:

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APPENDIX-E Pipe Work Verification Form

AHU Name:
Piping No. (Supply): Piping No. (Return):

Confirmation
Inspection Items
Yes No N/A
1. Mechanical installation should be completed in the
correct location as per design without any visual 口 口 口
damage.
2. The tag with identification number should be
口 口 口
correct and clear.
Deviations: YES 口 NO 口 Acceptance Meet Criteria: YES 口 NO 口

Comments:

Checked by: Signature & Date:

Verified by: Signature & Date:

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APPENDIX-F Electrical Work Verification Form

AHU Name:
Confirmation
Inspection Items
Yes No N/A
1. Physical installation of all the electrical components shall
be completed in the correct location within the AHU and 口 口 口
Electrical Panel Board per design.
2. All the cable trays and control panels should be properly
口 口 口
installed per design location.
3. All the incoming cables should be installed per the design
口 口 口
layout and size list.
4. All the terminations are connected per designed electrical
口 口 口
drawings.
5. Visual examinations should reveal that there is no damage
to each of electrical components, wirings and other 口 口 口
installation.
6. All electrical components and wirings need to be correctly
口 口 口
tagged including the numbering at each location.

7. All safety checks have been completed prior to trial run. 口 口 口

8. All the accessories if appended are place to put properly. 口 口 口

Deviations: YES 口 NO 口 Acceptance Meet Criteria: YES 口 NO 口

Comments:

Checked by: Signature & Date:

Verified by: Signature & Date:

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APPENDIX-G Dehumidifier Verification Form

AHU Name:
Confirmation
Inspection Items
Yes No N/A

1. Installation included assembly parts and electrical

口 口 口
components shall be in the correct location as per design.

2. All safety visual checks without leakage or damage have

口 口 口
been successfully completed prior to trial run.
3. The tag with identification number should be correct and
口 口 口
clear.

4. All the accessories if any appended are place to put properly. 口 口 口

Deviations: YES 口 NO 口 Acceptance Meet Criteria: YES 口 NO 口

Comments:

Checked by: Signature & Date:

Verified by: Signature & Date:

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APPENDIX-H: Bag-In Bag-Out Verification Form

AHU Name:
Confirmation
Inspection Items
Yes No N/A

1. Installation included assembly parts and electrical

口 口 口
components shall be in the correct location as per design.

2. All safety visual checks without leakage or damage have been

口 口 口
successfully completed prior to trial run.

3. The tag with identification number should be correct and clear. 口 口 口

4. All the accessories if any appended are place to put properly. 口 口 口

Deviations: YES 口 NO 口 Acceptance Meet Criteria: YES 口 NO 口

Comments:
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Document Number: EC/HVAC/IQ Version: 01 Effective Date:

Signature & Date:

Checked by:

Verified by: Signature & Date:

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APPENDIX-I Deviation List

Deviation
Brief Description Initiated By/Date Action Taken Date Closed
Report No.
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APPENDIX-J Deviation Report

Description of Deviation

Classification 口 Major 口 Minor

Required Action

Target Date for Completion of Action

Retest Required

Sign & Date:

Action Completed

Retest Result
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Document Number: EC/HVAC/IQ Version: 01 Effective Date:

Sign & Date:

Action Approved By (Sign & Date):

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APPENDIX-K Attachment Sheet

Initial to Confirm
Item Number Title/Description Reference Section
Available
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Document Number: EC/HVAC/IQ Version: 01 Effective Date: