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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-02 Issue Date.

Revision No. 00 Revision Date NA

INSTALLATION QUALIFICATION
PROTOCOL OF
HEATING VENTILATION & AIR CONDITIONING
SYSTEM

FOR
SYSTEM ID.: AHU-02

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-02 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 14
11.0 SAFETY 24
12.0 REFERENCE DOCUMENTS 25
13.0 OBSERVATION DEVIATION DURING INSTALLATION QUALIFICATION 26
14.0 RECOMMENDATION AND CONCLUSION AFTER INSTALLATION
QUALIFICATION 27
15.0 POST APPROVAL 28
16.0 ABBREVIATIONS 29

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-02 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 Designation Signature Date
Pharmaceuticals And Research
Centre)

Approved By
(M/S.Entrance Designation Signature Date
Pharmaceuticals 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-02 Issue Date.

Revision No. 00 Revision Date NA

2.0 PURPOSE

To provide the documentary evidences that the HVAC system (AHU-02) 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-02

3.0 SCOPE

This qualification protocol is applicable to the HVAC system (AHU-02) 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, Capsule Filling.

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-02 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-02 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-02 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-02 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 2000 CFM 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.
 5.5 KW 3 phase 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-14 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-02 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-02 Issue Date.

Revision No. 00 Revision Date NA

9.0 INSPECTION CHECKLIST FOR AHU COMPONENTS

Sr. Checked
Parameter Acceptance criteria Observation Remarks
No. By
1. GENERAL
HVAX Technologies
Manufacturer
Pvt. Ltd.
System No. AHU – 02

Type of unit Double skin sandwiched

Inside panel thick 0.6 mm thick. Plain GI


Outside panel 0.6 mm Pre-coated GI
thick
Panel Thickness 47mm
Extruded Aluminum
Extrusion profile
Thermal break Profile
Drain Pan
SS 304
material
Insulation Nitrile Rubber

Drain Pan Thick. 20 G

1.A Supply Decker


Capacity (CFM) 2000
Static pressure
125
(mmwg)
Length (mm) 2520

Width (mm) 1100

Height (mm) 1990

2. FAN
Type Centrifugal PLG

Make Kruger

Blade Type Backward Curved

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-02 Issue Date.

Revision No. 00 Revision Date NA

Sr. Checked
Parameter Acceptance criteria Observation Remarks
No. By
Model No. BNC P 255

Air quantity 2000 CFM

Static pressure 125 mm WG

Fan speed (RPM) 2836

Serial No. To be recorded

3. MOTOR
Make BBL/SIEMENS/CG

Type Non-Flame proof

KW/Pole 3.7 (2 Pole)

RPM 2900

Serial No. To be recorded

4. CHW COOLING COIL

Type CHW coil

Coil Face Area 5.63 Sq.ft


Face area (H x
711 X 737mm
L)
Tube Material Copper

Fin material Aluminum


Coil Header
MS
Material
Total Coil
8.92 TR
Capacity
Rows 8

Tube Dia. ½ inch

No. of fins / 10-12 / 0.15mm


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-02 Issue Date.

Revision No. 00 Revision Date NA

Sr. Checked
Parameter Acceptance criteria Observation Remarks
No. By
Thickness

5. HW COIL
Type HW Coil

Coil Face Area 5.63 Sq.ft


Face area (H x
711 X 737mm
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

6. DEHUMIDIFIER
Rehoboth Envirosystem
Make
Pvt Ltd
Model RFD 150

PROCESS FAN & MOTOR DETAIL

Fan Capacity 900 CFM

Fan Model R-63-250-19

Fan Type Plug

Fan Make Rosenberg

Motor Type Flange


Motor Capacity/ 1/2 HP
Pole
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-02 Issue Date.

Revision No. 00 Revision Date NA

Sr. Checked
Parameter Acceptance criteria Observation Remarks
No. By
Static Pressure 50 mmWG

REACTIVATION FAN & MODEL DETAIL

Fan Capacity 300 CFM

Fan Type SISW

Fan Make Rehoboth


Motor
1/2 HP
Capacity /Pole
Motor Type Flange

BED DRIVE MOTOR DETAILS

Motor Capacity 40 W

Connection Single Phase

Motor Type Flange

Motor Make Rehoboth

FILTER DETAILS

PRE AIR FILTER DETAILS

Filter Make Tharma/fruede

Filter Type Aluminum

Efficiency 90%- 10µ

Filter Material CRC


Filter Size
305x610x50 mm
(HxWxD)
Serial No. To be recorded

Qty 1 Nos.

REACTIVATION AIR FILTER

Filter Make Rehoboth

Filter Type Box

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-02 Issue Date.

Revision No. 00 Revision Date NA

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

Filter Material CRC


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

DAMPER DETAILS

SUPPLY AIR OUT DAMPERS

Damper Make Rehoboth

Damper Material Aluminium

Damper Size 250x250 mm

Qty 1Nos.

REACTIVATION AIR OUT DAMPER

Damper Make Rehoboth

Material Aluminium

Damper Size 250x250 mm

Qty 1Nos.

HEATER DETAILS

Heater Type SS tubular

Heater Make Rehoboth

Capacity / Nos. 3/6 KW


No. of Heater
3Nos.
Bank
Total Capacity 18 KW

CONTROL PANEL DETAILS

Controller PLC

Make Mitsubishi

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-02 Issue Date.

Revision No. 00 Revision Date NA

Sr. Checked
Parameter Acceptance criteria Observation Remarks
No. By
Type Pre-Wired

Qty 1Nos.

UNIT BASE

Material 3mm CRC

Make Rehoboth

Size 30x1200mm

Qty 1 Nos.

7. PRE-COOLING COIL DETAILS (AHU)

Profile Thermal Break

Unit Type Floor Mount

Frame Aluminium

Insulation Puff (40kg/m3)

Panel Thickness 45mm±0.5

Colour White (RAL-9002)


Inner skin and
0.8mm CRC Powder
outer skin
Coated
thickness
Type Doubled Skin

PRE COOLING COIL DETAILS

Face Area 2.17 Sq.ft

Coil Type CHW

Casing GI-16/18SWG

Header MS

Tonnage 6 TR

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-02 Issue Date.

Revision No. 00 Revision Date NA

Sr. Checked
Parameter Acceptance criteria Observation Remarks
No. By
Fins 12-13 FPI (Aluminium)

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

Coil Size (H)x(L) 450x450 mm

FILTER DETAILS

FRESH AIR FILTER

Filter Make Mechmark

Filter type Flange

Efficiency 90% -10µ(EU4)

Filter Material Aluminium


Filter Size
350x350x50 mm
(HxWxD)
Serial No. To be recorded.

Qty 1Nos.

DAMPER DETAILS

Damper Make Rehoboth

Material Aluminium

Damper Size 310x310 mm

Qty. 1Nos.

8. PRE-FILTER (AHU)

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-02 Issue Date.

Revision No. 00 Revision Date NA

Sr. Checked
Parameter Acceptance criteria Observation Remarks
No. By
Type Flange Type

Make Fine Airsys / Mechmark

Size (H x W x D) 610 x 610 x 50 mm

Qty. 1Nos.

Serial No. To be recorded

Efficiency 90% (10µ)

9. FRESH AIR FILTER (AHU)

Type Flange Type

Make Fine Airsys / Mechmark

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

Qty. 1 Nos.

Serial No. To be recorded

Efficiency 90% (10µ).

10. MICROVEE FILTER (AHU)


Supply Decker

Type Flange Type

Make Fine Airsys / Mechmark

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

Qty. 1Nos.

Serial No. To be recorded

Efficiency 95%, (3µ).

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-02 Issue Date.

Revision No. 00 Revision Date NA

Sr. Checked
Parameter Acceptance criteria Observation Remarks
No. By
11. DUST COLLECTOR
Pilani Envirotech Pvt
Make
Ltd.
Capacity 300 CFM

Qty 1 Nos.

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
Thickness Supply insulation
19mm
Return Insulation
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-02 Issue Date.

Revision No. 00 Revision Date NA

Sr. Acceptance
Parameter Observation Checked By Remarks
No. criteria
13mm

3. DAMPERS
Fine Airsys /
Make
Mechmaark
Manually Operated
Material
Al. Damper
Fresh Air Damper
300 X 300 mm
(H x W)
Purge Air Damper
-
(H x W)
Return Air
350 X 400 mm
Damper (H x W)
Supply Air
350 X 400mm
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. 350 X 400 mm
(Supply)
Size (H x W)
MM / Qty. 350 X 400 mm
(Return)

5. ROOM PRESSURE
Magnehelic
Instrument
Gauges
Dwyer/Omicron/
Make
Radix
Location Entrance of the
Room
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-02 Issue Date.

Revision No. 00 Revision Date NA

Sr. Acceptance
Parameter Observation Checked By Remarks
No. criteria
Range 0-60 Pa

To be recorded
Serial No.

6. DIFFERENTIAL PRESSURE ACROSS AHU FILTERS


Magnehelic
Instrument
gauges
Make Nextech
0-25 mm of WC
(Pre Filter),
Range
0-50 mm WC
(Fine Filter)

7. TERMINAL HEPA FILTER


Aluminium
FRAME
Anodized
Mechmark Filtech
Make
India Pvt Ltd.
Imported
submicronic filter
fiber glass paper
Filter Media
pleated corrugated
aluminium
separators.
Initial Pressure
Drop
25mm of WC
Final Pressure
60mm of WC
Drop
Eurovent Class EU-13
99.97 % down to
Efficiency
0.3 micron particles
Gasket Food Grade
SIZE
7.1 ROOM NAME (H x W x L )
MM/ QTY (Nos.)
M-A/L 310x310x300mm –
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-02 Issue Date.

Revision No. 00 Revision Date NA

Sr. Acceptance
Parameter Observation Checked By Remarks
No. criteria
1 Nos.
310x310x300mm –
P-A/L
1 Nos.

8. RETURN AIR RISERS


SIZE
ROOM NAME (H x W ) MM/
QTY (Nos.)
CAPSULE
900 x 80mm-2 Nos.
FILLING-2

PIPING AND MANIFOLD DETAILS:

9. CHILLED WATER MANIFOLD

Line size 25 mm

Insulation MOC Nitrile Rubber

Make Armaflex/Armacell

Thickness 25 mm

Ball Valve Size 25 mm

Make Honeywell

MOC Brass Body.

Qty. 5 Nos

Y strainer Size 25 mm

Make Hammer

MOC Cast Iron

Qty. 1 No

Drain Valve Size 25 mm

Make Honeywell

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-02 Issue Date.

Revision No. 00 Revision Date NA

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

Qty. 1 No

Auto air Vent 15 mm

Make Anergy

MOC Brass

Qty. 1 No

Flanges ASME 16.5 # 150


Balancing Valve
25 mm
Size
Forged Brass to
Insulation MOC IS6912 Gr. FLB
Body
Make Castle

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

Make Resideo centra

Qty. 1 No

10. HOT WATER MANIFOLD

Line size 20 mm

Insulation MOC Nitrile Rubber

Make K-flex

Thickness 25 mm

Ball Valve Size 20 mm

Make Honeywell

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-02 Issue Date.

Revision No. 00 Revision Date NA

Sr. Acceptance
Parameter Observation Checked By Remarks
No. criteria
MOC Brass

Qty. 5 Nos

Y strainer Size 20 mm

Make Hammer

MOC Cast Iron

Qty. 1 No

Drain Valve Size 25 mm

Make Honeywell

MOC Brass

Qty. 1 No

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 Castle

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

Make Resedio centra

Qty. 1 No

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-02 Issue Date.

Revision No. 00 Revision Date NA

Sr. Acceptance
Parameter Observation Checked By Remarks
No. criteria
11. TEMPERATURE CONTROLLER

Make. SELEC

Range 00 to 500C

Qty (Nos) 1

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

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-02 Issue Date.

Revision No. 00 Revision Date NA

Sr. Acceptance
Parameter Observation Checked By Remarks
No. criteria
Color Shade RAL 7035
IP 54 for main
Protection
Enclosure.
Gland Plate
14 SWG C.R.C.A Sheet
Thickness
All Switchgear
Schneider
Make

11.0 SAFETY

Sr. Acceptance Method of Checked


Parameter Verification Observation Remarks
No. criteria 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. isolators
channel frame
Check
supported with
vibration isolators.

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-02 Issue Date.

Revision No. 00 Revision Date NA

Earthing Motor earthing Visual


3. connections should be providing. Check

12.0 REFERENCE DOCUMENTS

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

1. Room Data Sheet Annexure-I

2. AHU GA Annexure-II

3. Filter test certificates Annexure-III

4. Motor Certificate Annexure-IV

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-02 Issue Date.

Revision No. 00 Revision Date NA

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:

Investigation:

Corrective Action Taken:

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-02 Issue Date.

Revision No. 00 Revision Date NA

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-02 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.

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.)

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-02 Issue Date.

Revision No. 00 Revision Date NA

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

1 AHU Air Handling Unit

2 CFM Cubic feet per minute

3 cGMP Current Good Manufacturing Practice

4 DQ Design Qualification

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-02 Issue Date.

Revision No. 00 Revision Date NA

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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