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CLIENT

M/S ENTRANCE PHARMACEUTICALS


AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF


HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-03 Issue Date.

Revision No. 00 Revision Date NA

INSTALLATION QUALIFICATION
PROTOCOL OF
HEATING VENTILATION & AIR CONDITIONING
SYSTEM

FOR
SYSTEM ID.: AHU-03

PLANT OF
M/S ENTRANCE PHARMACEUTICALS AND RESEARCH
CENTRE
NO.16, OKPOI, SPINTEX ROAD, ACCRA P.O.BOX CT 10805, SPINTEX ROAD,
GHANA.
TABLE OF CONTENTS

BY
M/S. HVAX TECHNOLOGIES PVT. LTD. - MUMBAI

Page 1 of 31
CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF


HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-03 Issue Date.

Revision No. 00 Revision Date NA

TABLE OF CONTENT

1.0 PROTOCOL APPROVAL SHEET 3


2.0 PURPOSE 4
3.0 SCOPE 4
4.0 RESPONSIBILITIES 4
5.0 DOCUMENTATION PROCEDURE 6
6.0 INSTALLATION QUALIFICATION PROCEDURE 7
7.0 SYSTEM DESCRIPTION 8
8.0 PHYSICAL VERIFICATION 9
9.0 INSPECTION CHECKLIST FOR AHU COMPONENTS 10
10.0 TECHNICAL DATA OF ANCILLARY ITEMS 19
11.0 SAFETY 26
12.0 REFERENCE DOCUMENTS 27
13.0 OBSERVATION DEVIATION DURING INSTALLATION QUALIFICATION 28
14.0 RECOMMENDATION AND CONCLUSION AFTER INSTALLATION QUALIFICATION 29
15.0 POST APPROVAL 30
16.0 ABBREVIATIONS 31

Page 2 of 31
CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF


HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-03 Issue Date.

Revision No. 00 Revision Date NA

1.0 PROTOCOL APPROVAL SHEET

The Author signature indicates that this document has been prepared in accordance with existing
cGMP standards and adequately reflects the tasks and deliverables necessary during the design phase
in the construction and equipping of pharmaceutical facilities and/or the equipment used therein.

Prepared By (M/s. HVAX Designation Signature Date


Technologies Pvt. Ltd.)

The reviewer’s signature indicates that, this document has been reviewed and it accurately and
completely reflects the tasks and deliverables necessary during the design phase in the construction and
equipping of pharmaceutical facilities and/or the equipment used therein, and that the documentation
and information included complies with applicable regulatory, corporate, divisional / departmental and
cGMP requirements.
The approver’s signature indicates that the documentation and information contained herein complies
with applicable regulatory, corporate, divisional/departmental & cGMP requirements.

Reviewed By
(M/S.Entrance Pharmaceuticals Designation Signature Date
And Research Centre)

Approved By
(M/S.Entrance Pharmaceuticals Designation Signature Date
And Research Centre)

Page 3 of 31
CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF


HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-03 Issue Date.

Revision No. 00 Revision Date NA

2.0 PURPOSE

To provide the documentary evidences that the HVAC system (AHU-03) installed at of M/S. Entrance
Pharmaceuticals and Research Centre is installed as per design specification.

Reference HVAC DQ Protocol No: - 1944/HVAC/DQ/AHU-03

3.0 SCOPE

This qualification protocol is applicable to the HVAC system (AHU-03) for M/S. Entrance
Pharmaceuticals and Research Centre. This was designed & checked by M/S. HVAX
TECHNOLOGIES PVT. LTD.

This document is applicable for HVAC System and catering Areas are M-A/L, P-A/L, Compression-4.

4.0 RESPONSIBILITIES

 HVAX Technologies Pvt. Ltd.:

 To prepare qualification protocol cum report.


 To submit qualification protocol M/S. Entrance Pharmaceuticals and Research Centre for
approval.
 To record the observation along M/S. Entrance Pharmaceuticals and Research Centre during
execution of the protocol.
 To submit final qualification report to M/S. Entrance Pharmaceuticals and Research Centre for
approval.
 To install the HVAC system as per approved designed specification and at designated place.

Page 4 of 31
CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF


HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-03 Issue Date.

Revision No. 00 Revision Date NA

 Engineering:

 To review the qualification protocol cum report.


 To get the system installed as per the design specification.
 To provide utilities and supportive services for qualification. (As mentioned in DQ)
 To arrange for the calibration of the instruments for qualification study.
 To assist quality assurance / quality control while qualification study.

 Quality Assurance:

 To review the qualification protocol cum report.


 To record the observation along with engineering & M/S. HVAX TECHNOLOGIES PVT. LTD. as
per designed protocol.
 To verify the compliance of qualification activity as per protocol.

 Engineering Head, GM Quality Assurance :

 To review and approve the qualification protocol and report.

Page 5 of 31
CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF


HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-03 Issue Date.

Revision No. 00 Revision Date NA

5.0 DOCUMENTATION PROCEDURE

 All documentation work shall be completed concurrently during execution of the qualification.
However, the protocol does not define the sequence of the documentation to be carried out.
 Use indelible blue ink for the recording of observations. (Or as per Client)
 Fill out complete information in the format provided.
 Do not leave any blank space. Enter “N/A” in space that is not applicable.
 Correct the wrong entry by drawing single line through incorrect data, recording the correct data and
then signing and dating the change.
 If any deviation occurred during execution of the protocol, it shall be handled through predefined
procedure.
 After protocol execution, report shall be prepared with following details.
1. Discussion of all studies in observation column.
2. Qualification is successfully completed or not.
3. Conclusion.
4. Recommendation, (if any).

Page 6 of 31
CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF


HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-03 Issue Date.

Revision No. 00 Revision Date NA

6.0 INSTALLATION QUALIFICATION PROCEDURE

 Ensure that the HVAC is installed at the designated place.


 Check the material of construction (MOC) of all the critical parts.
 Ensure that all safety features are installed.
 Check other details as per the specifications of this protocol and enter the observations.
 Check the Installation Qualification parameters against their specification during installation of the
HVAC as given in the table and record the same.
 Document initial and date after each observation in respective column.
 In case of any deviation, document in “Remarks” column and immediately inform to the department
head for necessary action.
 Document the deviation details in observed deviation section.
 Quality assurance head and department head shall decide whether deviation is acceptable or not.
 If deviation is acceptable and it does not have any potential to impact on operation, initiate for
operation qualification.
 If deviation is not acceptable then inform to M/S. Entrance Pharmaceuticals and Research Centre
Engineering department head for necessary action for attending problems to complete installation
qualification.

Page 7 of 31
CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF


HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-03 Issue Date.

Revision No. 00 Revision Date NA

7.0 SYSTEM DESCRIPTION

The following are the main features of the system:

This Air handling system having a supply air fan capacity of 1700CFM which supplies the
Conditioned air to Class ‘D’ Area.

 Manually Operated Return Air Damper.


 Manually Operated Fresh Air Damper.
 G4 (10µ) flange type Pre filter.
 Eight Rows deep Cooling coil.
 Two Rows deep hot water coil
 Plug type blower having 125 mm WG static pressure.
 2.2 KW 3 phase non flame proof motor.
 F7 (3µ) flange type Fine filter.
 Magnehelic gauges mounted filters
 Ducting made of GI sheet.
 Supply Air Terminal Box HEPA Box with H-13 filter.
 Return Air Riser with filter (10 µ)
 XLPE insulation with one side Al foil faced duct insulation.

Page 8 of 31
CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF


HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-03 Issue Date.

Revision No. 00 Revision Date NA

8.0 PHYSICAL VERIFICATION

Perform the physical verification of each component as mentioned below after receipt of the site for
any damages or dent while transporting.
Acceptance Criteria: Should be no physical damage and dents.

Method of
Sr. No. Items Name Observation Checked By Remarks
Verification

Main AHU
1. Visual Check
Body

AHU Supply air


2. Visual Check
blower

CHW Cooling
3. Visual Check
Coil

HW Cooling
4. Visual Check
Coil

5. Pre-filters Visual Check

6. Fine Filter Visual Check

Volume control
7. dampers Visual Check
(VCDs)
Supply Air
8. Terminal Visual Check
box

Return Air
9. Visual Check
terminal Box

Page 9 of 31
CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF


HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-03 Issue Date.

Revision No. 00 Revision Date NA

9.0 INSPECTION CHECKLIST FOR AHU COMPONENTS

Sr.
Parameter Acceptance criteria Observation Checked By Remarks
No.
1. GENERAL
HVAX Technologies
Manufacturer
Pvt. Ltd.
System No. AHU – 03
Double skin panel with
Type of unit
PUF
Inside panel thick 0.6 mm thick. Plain GI
Outside panel 0.6 mm Pre-coated GI
thick
Panel Thickness 47mm
AHU panel Extruded Aluminum
Frame Thermal break Profile
Drain Pan
SS 304
material
Insulation Nitrile Rubber

Drain Pan Thick. 20 G

1.A Supply Decker

Capacity (CFM) 1700


Static pressure
125
(mmwg)
Length (mm) 2520

Width (mm) 1000

Height (mm) 1800

2. FAN

Type Centrifugal Plug

Make Kruger/ Equivalent

Model No. BNC P 355

Air quantity 1700 CFM


Page 10 of 31
CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF


HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-03 Issue Date.

Revision No. 00 Revision Date NA

Sr.
Parameter Acceptance criteria Observation Checked By Remarks
No.
Static pressure 125 mm WG

Fan speed (RPM) 2788

Serial No. To be recorded

3. MOTOR
BBL/SIEMENS/CG/
Make
HM/EQUV
Type Non-Flame proof

KW/Pole 2.2 (2 Pole)

RPM 2900

Serial No. To be recorded

4. CHW COOLING COIL

Type CHW coil

Coil Face Area 4.55 Sq.ft


Coil Face
500 fpm
Velocity
Face area (H x
667 X 634mm
L)
Tube Material Copper

Fin material Aluminum


Coil Header
MS
Material
Total Coil
7.77 TR
Capacity
Rows 8

Tube Dia. ½ inch


No. of fins /
10-12 / 0.15mm
Thickness

Page 11 of 31
CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF


HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-03 Issue Date.

Revision No. 00 Revision Date NA

Sr.
Parameter Acceptance criteria Observation Checked By Remarks
No.

5. HW COIL

Type HW Coil

Coil Face Area 4.55 Sq.ft


Face area (H x
667 X 634mm
L)
Tube Material Copper

Fin material Aluminum


Coil Header
MS
Material
Total Coil
3 Kw
Capacity
Rows 2

Tube Dia. ½ inch


No. of fins /
10-12 / 0.15mm
Thickness
Coil Face
500 FPM
Velocity

6. PRE-FILTER
Type Flange Type
Make Fine Airsys / Mechmaark
Size
610 x 610 x 50 mm-1
(H x W x D)
Efficiency 90% (10µ)
Serial No. To be recorded

7. FRESH AIR FILTER

Type Flange Type

Page 12 of 31
CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF


HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-03 Issue Date.

Revision No. 00 Revision Date NA

Sr.
Parameter Acceptance criteria Observation Checked By Remarks
No.
Make Fine Airsys / Mechmaark

Size (H x W x D) 350 x 400 x 30mm-


1Nos.
Efficiency 90%(10µ)
Serial No. To be recorded

8. MICROVEE FILTER
Type Flange Type
Make Fine Airsys / Mechmark

Size (H x W x D) 610 x 610 x 300 mm-


1Nos.
Efficiency 95% (3µ)
Serial No. To be recorded

9. DHU DETAILS:-

Make Rehoboth

Capacity 900 CFM

Unit Type Floor Mounted

Frame 1.2mm Thick CRC

Type Single Skinned

Color White (RAL 9002)


Inner and Outer 1.2mm thick CRC
Skin Powder Coated.
Qty. 1 Nos.

PROCESS FAN AND MOTOR DETAILS

Fan Capacity 900 CFM

Fan Model R63-250-19

Page 13 of 31
CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF


HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-03 Issue Date.

Revision No. 00 Revision Date NA

Sr.
Parameter Acceptance criteria Observation Checked By Remarks
No.
Fan Type Plug

Fan Make Rosenberg

Motor Capacity 1.5 HP

Pole 2

Static Pressure 50 mmWG

Motor Type Flange

Qty. 1

REACTIVATION FAN AND MOTOR DETAILS

Fan Capacity 300 CFM

Fan Type SISW

Fan Make Rehoboth

Qty. 1 Nos.

Motor Capacity 1 HP

Pole 2

Static Pressure 40 mm WG

Motor Type Flange

Qty. 1 Nos.

BED DRIVE MOTOR DETAILS

Motor Capacity 40 W

Connection Single Phase

Motor Type Flange

Motor Make Rehoboth

Qty. 1 Nos.

FILTER DETAILS

Page 14 of 31
CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF


HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-03 Issue Date.

Revision No. 00 Revision Date NA

Sr.
Parameter Acceptance criteria Observation Checked By Remarks
No.
PRE AIR FILTER

Filter Make Tharma/Freude

Filter Type Aluminium

Efficiency 90%-10µ

Filter Material CRC


Filter Size
305x610x50 mm
(HxWxD)
Qty. 1 No.

REACTIVATION AIR FILTER DETAILS

Filter Make Rehoboth

Filter Type Box

Efficiency 90%- 10µ

Filter Material CRC


Filter Size
280x335x30
(HxWxD)
Qty. 1 Nos.

DAMPER DETAILS

SUPPLY AIR OUT DAMPER

Damper Make Rehoboth

Material Aluminium

Damper Size 250x250

Qty. 1Nos.

REACTIVATION AIR OUT DAMPER

Damper Make Rehoboth

Material CRC

Damper Size 150x150 mm

Page 15 of 31
CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF


HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-03 Issue Date.

Revision No. 00 Revision Date NA

Sr.
Parameter Acceptance criteria Observation Checked By Remarks
No.
Qty. 1 Nos.

HEATER DETAILS

Heater Type SS Tubular

Heater Make Rehoboth

Capacity 3KW
No. Of Heater
2Nos.
Bank
Total Capacity 18KW

Qty. 6Nos.

CONTROL PANEL DETAILS:

Controller PLC(GOC)

Make Mistubishi

Type Pre-Wired

Qty. 1Nos.

UNIT BASE

Material 3mm CRC

Make Rehoboth

Qty. 1 Nos.

10. PRE COOLING COIL

AHU DETAILS

Make Rehoboth

AHU Capacity 563 CFM

Profile Thermal Break

Unit Type Floor Mount

Page 16 of 31
CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF


HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-03 Issue Date.

Revision No. 00 Revision Date NA

Sr.
Parameter Acceptance criteria Observation Checked By Remarks
No.
Frame Aluminium

Insulation Puff (40kg/m³)

Panel Thickness 45mm±0.5

Color White (RAL-9002)


Inner and Outer 0.8mm thick CRC
Skin Powder Coated.
Type Double Skinned

PRE-COOLING COIL DETAILS

Face 2.17 Sq.ft

Coil Type CHW

Casing GI-16/18 SWG

Header MS

Tonnage 6 TR

Fins Aluminium (12-13 FPI)

Drain Pipe 1”Inch


SS 304 (140mm deep
Drain Tray
with puff insulation)
Tube Copper

Connection LHS

Header Size 2”Inch

No. of Rows 8 Rows Deep


Coil Size
450x450 mm
(HTxLT)
FILTER DETAILS

FRESH AIR FILTER

Filter Make Mechmaark

Filter Type Flange

Page 17 of 31
CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF


HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-03 Issue Date.

Revision No. 00 Revision Date NA

Sr.
Parameter Acceptance criteria Observation Checked By Remarks
No.
Efficiency 90%- 10µ (EU 4)

Filter Material Aluminium


Filter Size
350x350x50
(HxWxD)
Serial No.

Qty. 1Nos.

FRESH AIR DAMPER DETAILS

Damper Make Rehoboth

Material Aluminium

Damper Size 310x310

Qty 1 Nos.

UNIT BASE

Material 1.2mm CRC

Make Rehoboth

Size 50x100 mm

Qty. 1 Nos.

11. DUST COLLECTOR

Make Pilani Envirotech Pvt Ltd.

Capacity 300 CFM

Qty 1Nos.

Page 18 of 31
CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF


HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-03 Issue Date.

Revision No. 00 Revision Date NA

10.0 TECHNICAL DATA OF ANCILLARY ITEMS

Sr. Acceptance
Parameter Observation Checked By Remarks
No. criteria
1. DUCTS

Material Of sheet Galvanized Steel


24G (0.6mm)
Thickness of Sheet
22G(0.8mm)
Sizing &
1220 x 2438 mm
Construction
Silicon sealant
Sealant
(white)

2. DUCT INSULATION

Make Supreme
XLPE insulation
Material with one side Al
foil faced.
Density 28±3 Kg/m3
Thermal
stability@90oC/24 ≤ 5%
hrs
Operating
-40 °C to 115 °C
Temperature
Supply insulation
19mm
Thickness
Return Insulation
13mm

3. DAMPERS
Fine Airsys /
Make
Mechmaark
Manually Operated
Material
Al. Damper
Fresh Air Damper
350 X 300 mm
(H x W)
Purge Air Damper
-
(H x W)
Return Air 300 X 350 mm
Page 19 of 31
CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF


HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-03 Issue Date.

Revision No. 00 Revision Date NA

Sr. Acceptance
Parameter Observation Checked By Remarks
No. criteria
Damper (H x W)
Supply Air
300 X 350mm
Damper (H x W)
Bypass Air
150 X 650 mm
Damper (H x W)

4. FIRE DAMPER
SA AIR /
Make RUSKIN TITUS /
CARYAIRE
MOC Galvanized Steel
Sheet
Size (H x W)
MM / Qty. 300 X 350 mm
(Supply)
Size (H x W)
MM / Qty. 300 X 350 mm
(Return)

5. ROOM PRESSURE
Magnehelic
Instrument
Gauges
Dwyer/Omicron/
Make
Radix
Entrance of the
Location
Room
Range 0-60 Pa

To be recorded
Serial No.

6. DIFFERENTIAL PRESSURE ACROSS AHU FILTERS

Magnehelic
Instrument
gauges

Make Dwyer/Nextech

Page 20 of 31
CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF


HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-03 Issue Date.

Revision No. 00 Revision Date NA

Sr. Acceptance
Parameter Observation Checked By Remarks
No. criteria
0-25 mm of WC
(Pre Filter),
Range
0-50 mm WC
(Fine Filter)

7. SUPPLY AIR FILTER BOX IN ROOMS


Aluminium
Frame
Anodizes
Mechmaark Fitech
Make
India Pvt Ltd.
Imported
Subnicronic Fiber
Glass Paper Pleated
Filter Media
with corrogated
aluminium
separators.
Initial Pressure
25mm WG
Drop
Final Pressure
60mm WG
Drop
Filter grade H-13
99.97% down to 0.3
Efficiency
microns particles.
Gasket Food Grade
SIZE
7.1 ROOM NAME (H x W x L ) MM/
QTY (Nos.)
310 x 310x300mm-
M-A/L
1 Nos.
310 x 310x300mm-
P-A/L
1 Nos.

8. RETURN AIR RISERS


360 x 360mm-1
M-A/L
Nos.
360 x 360mm-1
P-A/L
Nos.
Compression-04 900 x 80mm-1 Nos.

Page 21 of 31
CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF


HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-03 Issue Date.

Revision No. 00 Revision Date NA

Sr. Acceptance
Parameter Observation Checked By Remarks
No. criteria
SIZE
8.1 ROOM NAME (H x W ) MM/
QTY (Nos.)
M-A/L 360 x 360mm-1

P-A/L 360 x 360mm-1

Compression-04 900 x 80mm-2

PIPING AND MANIFOLD DETAILS:

9. CHILLED WATER MANIFOLD

Line size 32 mm
Nitrile Rubber with
Insulation MOC
Al foil
Make Armaflex/Armacell

Ball Valve Size 32 mm

Make Honeywell

MOC Brass Body

Qty. 5 Nos.

Y strainer Size 32 mm

Make Hammer

MOC Cast Iron Body

Qty. 1 Nos.

Drain Valve Size 25 mm

Make Honeywell

MOC Brass Body

Qty. 1 Nos.

Auto air Vent 15 mm

Page 22 of 31
CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF


HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-03 Issue Date.

Revision No. 00 Revision Date NA

Sr. Acceptance
Parameter Observation Checked By Remarks
No. criteria
Make Anergy

MOC Brass

Qty. 1 No
Balancing Valve
32 mm
Size
Forged Brass to
MOC IS6912 Gr. FLB
Body
Make Honeywell

Qty. 1 No
Three Way
32 mm
Control Valve
MOC Cast Iron Body

Make Resedeo Centra

Qty. 1 Nos.

10. HOT WATER MANIFOLD

Line size 20 mm
Nitrile Rubber with
Insulation MOC
Al foil
Make Armaflex

Thickness 25 mm

Ball Valve Size 20 mm

Make Honeywell

MOC Carbon steel

Qty. 5 Nos

Y strainer Size 20 mm

Make Hammer

Page 23 of 31
CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF


HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-03 Issue Date.

Revision No. 00 Revision Date NA

Sr. Acceptance
Parameter Observation Checked By Remarks
No. criteria
MOC Cast Iron Body

Qty. 1 Nos.

Drain Valve Size 20 mm

Make Honeywell/KCR

MOC Cast Iron Body

Qty. 1 Nos.

Auto air Vent 15 mm

Make Anergy

MOC Brass

Qty. 1 No
Balancing Valve
20 mm
Size
Forged Brass to
Insulation MOC IS6912 Gr. FLB
Body
Make Honeywell

Qty. 1 No
Three Way
20 mm
Control Valve
MOC Cast Iron Body

Make Resedeo Centra

Qty. 1 Nos.

11. TEMPERATURE CONTROLLER

Make. SELEC

Range 00 to 500C

Qty (Nos) 1

Page 24 of 31
CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF


HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-03 Issue Date.

Revision No. 00 Revision Date NA

Sr. Acceptance
Parameter Observation Checked By Remarks
No. criteria

12. TEMPERATURE & RH SENSOR

Make. BELIMO

Qty (Nos) 1 SET

Serial Number To be recorded

13. RH CONTROLLER

Make. SELEC

Range 0...100%

Qty (Nos) 1

14. VELOCITY SENSOR

Make Omicron

Qty (Nos) 1

Serial Number To be recorded

15. ELECTRICAL PANEL

Material C.R.C.A Sheet


Frame and door work-
Thickness
16 SWG
Cable Entry Bottom Entry

Color Shade RAL 7035


IP 54 for main
Protection
Enclosure.
Gland Plate
14 SWG C.R.C.A Sheet
Thickness
All Switchgear
Schneider
Make
Page 25 of 31
CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF


HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-03 Issue Date.

Revision No. 00 Revision Date NA

11.0 SAFETY

Sr. Method of Checked


Parameter Acceptance criteria Verification Observation Remarks
No. By

Should not be more


As per
1. Noise level than 90dB at a
Certificates
distance of 1 meter.

Blower should be
mounted on bottom
Vibration Visual
2. channel frame
isolators Check
supported with
vibration isolators.

Earthing Motor earthing Visual


3.
connections should be providing. Check

12.0 REFERENCE DOCUMENTS

Sr.
Annexure / Documents Annexure No. Checked By
No.

Page 26 of 31
CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF


HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-03 Issue Date.

Revision No. 00 Revision Date NA

1. Room Data Sheet Annexure-I

2. AHU GA Annexure-II

3. Filter test certificates Annexure-III

4. Motor Certificate Annexure-IV

5. Fan Curve Annexure-V

6. Coil Certificate Annexure-VI

7. AHU Location Layout Annexure-VII

8. Ducting Layout Annexure-VIII

9. RCP Layout Annexure-IX

13.0 OBSERVATION DEVIATION DURING INSTALLATION QUALIFICATION

Details of deviation:

Page 27 of 31
CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF


HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-03 Issue Date.

Revision No. 00 Revision Date NA

Investigation:

Corrective Action Taken:

Acceptable Yes/No:

Justification for Acceptance:

Deviation Investigated by:

Deviation Approved By (If any):

Department Head / Date Quality Assurance Head/ Date

14.0 RECOMMENDATION AND CONCLUSION AFTER INSTALLATION QUALIFICATION

Recommendation after Installation Qualification

Page 28 of 31
CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF


HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-03 Issue Date.

Revision No. 00 Revision Date NA

Conclusion after Installation Qualification

Concluded By

15.0 POST APPROVAL

It is hereby certified by the following functionaries that the system stands qualified for Design Qualification
and the system may be released to the next level of qualification activity.

Page 29 of 31
CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF


HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-03 Issue Date.

Revision No. 00 Revision Date NA

The reviewer’s signature indicates that this document has been reviewed and it accurately and completely
reflects that the tasks and deliverables necessary for validation of the system have been completed
successfully and that the documentation and information included complies with applicable regulatory,
corporate, divisional/ departmental and cGMP requirements.

Reviewed By
(M/S. Entrance Pharmaceuticals And Signature Date
Research Centre.)

The approver’s signature indicates that the documentation and information contained herein complies
with applicable regulatory, corporate, divisional / departmental and cGMP requirements.

Approved By
(M/S. Entrance Pharmaceuticals And Signature Date
Research Centre.)

16.0 ABBREVIATIONS

Sr. No. Abbreviation Description

Page 30 of 31
CLIENT
M/S ENTRANCE PHARMACEUTICALS
AND RESEARCH CENTRE
NO.16, OKPOI GONNO, SPINTEX ROAD, ACCRA
P.O.BOX CT 10805, SPINTEX ROAD, GHANA.

INSTALLATION QUALIFICATION PROTOCOL OF


HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/IQ/AHU-03 Issue Date.

Revision No. 00 Revision Date NA

1 AHU Air Handling Unit

2 CFM Cubic feet per minute

3 cGMP Current Good Manufacturing Practice

4 DQ Design Qualification

5 GI Grey Iron

6 HVAC Heating Ventilation & Air conditioning

7 HEPA High Efficiency Particulate Air

8 Mm Millimeter

9 NA Not applicable

10 URS User Requirement specification

11 TR Ton of Refrigeration

12 ͦ C Degree centigrade

13 % Percentage

14 RCP Room Ceiling Partition

Page 31 of 31

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