Iq Ahu 01 1944 CFM D

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-01 Issue Date.
Revision No. 00 Revision Date NA
INSTALLATION QUALIFICATION
PROTOCOL OF
HEATING VENTILATION & AIR CONDITIONING
SYSTEM
FOR
SYSTEM ID.: AHU-01
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
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AND RESEARCH CENTRE

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 20
12.0 REFERENCE DOCUMENTS 21
13.0 OBSERVATION DEVIATION DURING INSTALLATION QUALIFICATION 22
14.0 RECOMMENDATION AND CONCLUSION AFTER INSTALLATION QUALIFICATION 23
15.0 POST APPROVAL 24
16.0 ABBREVIATIONS 25
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

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AND RESEARCH CENTRE

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)
2.0 PURPOSE
To provide the documentary evidences that the HVAC system (AHU-01) 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-01
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3.0 SCOPE
This qualification protocol is applicable to the HVAC system (AHU-01) 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 Packing Material sampling,
Airlock which meets the Class D.
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.
 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:
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 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.
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.
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 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).
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.
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 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.
7.0 SYSTEM DESCRIPTION
The following are the main features of the system:
This Air handling system having a supply air fan capacity of 1000 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.
 Four Rows deep DX Cooling coil.
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 2.86 TR condensing unit.

 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 HEPA Box with H-14 filter.
 Return Air Riser
 Nitrile rubber insulation with one side Al foil faced duct insulation.
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
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AHU Supply air

2. Visual Check
blower
DX Cooling
3. 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
9. Return Air Riser Visual Check
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 – 01
Type of unit Double skin sandwiched
Inside panel thick 0.6 mm thick. Plain GI
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Sr.
No.
Outside panel 0.6 mm Pre-coated GI
thick
Panel Thickness 47mm
Drain Pan
SS 304
material
Drain Pan Thick. 20 G
1.A Supply Decker
Capacity (CFM) 1000
Static pressure
125
(mmwg)
Length (mm) 2620
Width (mm) 900
Height (mm) 1700
2. FAN
Type Centrifugal Plug
Make Kruger
Model No. BNC P 355
Fan speed (RPM) 2762
Fan absorbed 1.67 KW

power
Serial No. To be recorded
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Sr.
No.
3. MOTOR
Make BBL/SIEMENS/CG
Type Non-Flame proof
KW/Pole 2.2 (2 Pole)
RPM 2900
4. DX COOLING COIL
Type DX Coil
Tube Material Copper
Tube Dia. 3/8 Inch
Fin material Aluminum
No. of fins 10-12 Fins per inch
Face area
381 X 483mm
(H x L)
Coil Area
1.97
(Sq. ft.)
Rows deep 4
Header material
Copper
& Size
5. PRE-FILTER
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AND RESEARCH CENTRE

Sr.
No.
Type Flange Type
Make Fine Airsys / Mechmaark

Size 508 x 508 x 51 mm-
(H x W x D) 1Nos.
Efficiency 90%
6. FRESH AIR FILTER
Type Flange Type
Make Fine Airsys / Mechmaark
Size (H x W x D) 250 x 250 x 30mm-1Nos.

250 x 250 x 30mm-1Nos.
Efficiency 90%
7. CONDENSING UNIT
Make Career
Unit 4 TR
Model 51MSG-048GSF
Qty. 1Nos.
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AND RESEARCH CENTRE

Sr.
No.
8. MICROVEE FILTER
Type Flange Type
Make Fine Airsys / Mechmark
Size (H x W x D) 508 x 508 x 300 mm-

1Nos.
Efficiency 95% (3µ)
9. PURGE AIR FILTER
Type Flange Type
Make Fine Airsys/ Mechmark
Size 250x250x30mm - 1Nos.
Efficiency 90%- (10µ)
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
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AND RESEARCH CENTRE

Sr. Acceptance
No. criteria
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
200 X 200 mm
(H x W)
Purge Air Damper
200 X 200 mm
(H x W)
Return Air
250 X 250 mm
Damper (H x W)
Supply Air
250 X 250 mm
Damper (H x W)
Bypass Air
100 X 500 mm
Damper (H x W)
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Sr. Acceptance
No. criteria
4. FIRE DAMPER
SA AIR /
Make RUSKIN TITUS /
CARYAIRE
MOC Galvanized Steel
Sheet
Size (H x W)
MM / Qty. 250 X 250 mm
(Supply)
Size (H x W)
MM / Qty. 250 X 250 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.
Qty.
6. DIFFERENTIAL PRESSURE ACROSS AHU FILTERS
Magnehelic
Instrument
gauges
Make Dwyer/Omicron
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AND RESEARCH CENTRE

Sr. Acceptance
No. criteria
0-25 mm of WC
(Pre Filter),
Range
0-50 mm WC
(Fine Filter)
7. SUPPLY AIR TERMINAL BOX

16 gauge
MOC aluminum anodized
extrusion
Make AAF
Perforated Sheet SS 304 18G
Sealant PU at 4 corners
SUPPLY AIR TERMINAL MODULE WITH HEPA FILTERS IN

ROOMS
Type Bottom Loading

Mechmark filtech
Make india private
limited
Imported
Filter Media Submicronic Glass
fiber paper
Initial Pressure 25±10% mm of
Drop WG
Final Pressure
60 mm of WG
Drop
Filter grade H-14
99.999% down to
Efficiency
0.3µ
Sealant Silica Gel
Serial No.
7.1 ROOM NAME SIZE
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AND RESEARCH CENTRE

Sr. Acceptance
No. criteria
(H x W x D) MM/
QTY (Nos.)
PACKING
610 X 610 X
MATERIAL
81mm-1
SAMPLING
300 X 300 X
AIRLOCK
105mm-1
8. RETURN AIR RISER IN ROOMS
RETURN AIR RISER

SIZE
ROOM NAME (H x W ) MM/
QTY (Nos.)
PACKING
MATERIAL 300 X 100mm-1
SAMPLING
AIRLOCK 300 X 100mm-1
CONDENSING DRAIN TRAY DETAILS
9. CONDENSING DRAIN TRAY
MOC S.S 304
Thickness 20 G
Insulation
19 mm
Thickness
Drain Socket Size 40 mm Dia
10. TEMPERATURE CONTROLLER
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Sr. Acceptance
No. criteria
Make. SELEC
Range 00 to 500C
Qty (Nos) 1
11. TEMPERATURE & RH SENSOR
Make. BELIMO
Qty (Nos) 1 SET
Serial Number
12. RH CONTROLLER
Make. SELEC
Range 0...100%
Qty (Nos) 1
13. VELOCITY SENSOR
Make Omicron
Qty (Nos) 1
Serial Number
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Sr. Acceptance
No. criteria
14. 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
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.
2. Vibration Blower should be Visual

isolators mounted on bottom Check
channel frame
supported with
vibration isolators.
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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
5. Fan Curve Annexure-V
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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:
Acceptable Yes/No:
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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
Conclusion after Installation Qualification
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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 23 of 25
CLIENT
AND 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
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
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11 TR Ton of Refrigeration
12 ͦ C Degree centigrade
13 % Percentage
14 RCP Room Ceiling Partition
Page 25 of 25

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CLIENT

M/S ENTRANCE PHARMACEUTICALS

INSTALLATION QUALIFICATION PROTOCOL OF

Revision No. 00 Revision Date NA

INSTALLATION QUALIFICATION PROTOCOL OF

Revision No. 00 Revision Date NA

1.0 PROTOCOL APPROVAL SHEET 3

1.0 PROTOCOL APPROVAL SHEET

Prepared By (M/s. HVAX Designation Signature Date

INSTALLATION QUALIFICATION PROTOCOL OF

Revision No. 00 Revision Date NA

Technologies Pvt. Ltd.)

Reference HVAC DQ Protocol No: - 1944/HVAC/DQ/AHU-01

INSTALLATION QUALIFICATION PROTOCOL OF

Revision No. 00 Revision Date NA

 HVAX Technologies Pvt. Ltd.:

 To prepare qualification protocol cum report.

 To review the qualification protocol cum report.

INSTALLATION QUALIFICATION PROTOCOL OF

Revision No. 00 Revision Date NA

 To review the qualification protocol cum report.

 Engineering Head, GM Quality Assurance:

 To review and approve the qualification protocol and report.

5.0 DOCUMENTATION PROCEDURE

INSTALLATION QUALIFICATION PROTOCOL OF

Revision No. 00 Revision Date NA

6.0 INSTALLATION QUALIFICATION PROCEDURE

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

INSTALLATION QUALIFICATION PROTOCOL OF

Revision No. 00 Revision Date NA

 Document initial and date after each observation in respective column.

7.0 SYSTEM DESCRIPTION

The following are the main features of the system:

 Manually Operated Return Air Damper.

INSTALLATION QUALIFICATION PROTOCOL OF

Revision No. 00 Revision Date NA

 2.86 TR condensing unit.

8.0 PHYSICAL VERIFICATION

INSTALLATION QUALIFICATION PROTOCOL OF

Revision No. 00 Revision Date NA

AHU Supply air

5. Pre-filters Visual Check

6. Fine Filter Visual Check

9. Return Air Riser Visual Check

9.0 INSPECTION CHECKLIST FOR AHU COMPONENTS

System No. AHU – 01

Type of unit Double skin sandwiched

Inside panel thick 0.6 mm thick. Plain GI

INSTALLATION QUALIFICATION PROTOCOL OF

Revision No. 00 Revision Date NA

Panel Thickness 47mm

Drain Pan Thick. 20 G

1.A Supply Decker

Capacity (CFM) 1000

Length (mm) 2620

Width (mm) 900

Height (mm) 1700

Type Centrifugal Plug

Model No. BNC P 355

Fan speed (RPM) 2762

Fan absorbed 1.67 KW

Serial No. To be recorded

INSTALLATION QUALIFICATION PROTOCOL OF