Iq Ahu 05 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-05 Issue Date.
Revision No. 00 Revision Date NA
INSTALLATION QUALIFICATION
PROTOCOL OF
HEATING VENTILATION & AIR CONDITIONING
SYSTEM
FOR
SYSTEM ID.: AHU-05
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 29
CLIENT
AND RESEARCH CENTRE

TABLE OF CONTENT
1.0 PROTOCOL APPROVAL SHEET 2
2.0 PURPOSE 3
3.0 SCOPE 4
4.0 RESPONSIBILITIES 4
5.0 DOCUMENTATION PROCEDURE 5
6.0 INSTALLATION QUALIFICATION PROCEDURE 6
7.0 SYSTEM DESCRIPTION 7
8.0 PHYSICAL VERIFICATION 8
9.0 INSPECTION CHECKLIST FOR AHU COMPONENTS 9
10.0 TECHNICAL DATA OF ANCILLARY ITEMS 14
11.0 SAFETY 23
12.0 REFERENCE DOCUMENTS 24
13.0 OBSERVATION DEVIATION DURING INSTALLATION QUALIFICATION 25
14.0 RECOMMENDATION AND CONCLUSION AFTER INSTALLATION QUALIFICATION 26
15.0 POST APPROVAL 27
16.0 ABBREVIATIONS 28
Page 2 of 29
CLIENT
AND RESEARCH CENTRE

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 29
CLIENT
AND RESEARCH CENTRE

2.0 PURPOSE
To provide the documentary evidences that the HVAC system (AHU-05) 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-05
3.0 SCOPE
This qualification protocol is applicable to the HVAC system (AHU-05) 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, De-Blistering, Packing-1,
De-Blistering,Packing-2, De-Blistering.
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 29
CLIENT
AND RESEARCH CENTRE

 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 29
CLIENT
AND RESEARCH CENTRE

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 29
CLIENT
AND RESEARCH CENTRE

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 29
CLIENT
AND RESEARCH CENTRE

7.0 SYSTEM DESCRIPTION
The following are the main features of the system:
This Air handling system having a supply air fan capacity of 6000CFM 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 200 mm WG static pressure.
 11 KW 3 phase non flame proof motor.
 F7 (3µ) flange type Fine filter.
 Flange type HEPA Filter(0.3µ)
 Magnehelic gauges mounted filters
 Ducting made of GI sheet.
 Terminal box with diffuser for Supply Air
 Terminal box with diffuser for Return air.
 XLPE insulation with one side Al foil faced duct insulation.
Page 8 of 29
CLIENT
AND RESEARCH CENTRE

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 29
CLIENT
AND RESEARCH CENTRE

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 – 05
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) 6000
Static pressure
200
(mmwg)
Length (mm) 2970
Width (mm) 1420
Height (mm) 2320
2. FAN
Type Centrifugal Plug
Make Kruger
Model No. BNC Q 450
Page 10 of 29
CLIENT
AND RESEARCH CENTRE

Sr. Checked
No. By
Air quantity 6000 CFM
Static pressure 200 mm WG

Fan absorbed 8.04 KW
Power
Fan speed (RPM) 2855
Serial No. To be recorded
3. MOTOR
Make BBL/SIEMENS/CG
Type Non-Flame proof
KW/Pole 11(2 Pole)
RPM 2900
4. CHW COOLING COIL
Type CHW coil
Coil Face Area 9.92 Sq.ft

Face area (H x
825 X 1117mm
L)
Tube Material Copper
Fin material Aluminum

Coil Header
MS
Material
Total Coil
21 TR
Capacity
Rows 8
Tube Dia. ½ inch

No. of fins / 10-12 / 0.15mm
Page 11 of 29
CLIENT
AND RESEARCH CENTRE

Sr. Checked
No. By
Thickness
5. HW COIL
Type HW Coil
Coil Face Area 9.92 Sq.ft

Face area (H x
825 X 1117mm
L)
Tube Material Copper
Fin material Aluminum

Coil Header
MS
Material
Total Coil
34 Kw
Capacity
Rows 2
Tube Dia. ½ inch

No. of fins /
10-12 / 0.15mm
Thickness
6. PRE-FILTER
Type Flange Type
Make Fine Airsys / Mechmaark
610 x 610 x 50mm-
Size 2Nos.
(H x W x D) 610 x 305 x 50mm-
2Nos.
Efficiency 90%
7. FRESH AIR FILTER
Page 12 of 29
CLIENT
AND RESEARCH CENTRE

Sr. Checked
No. By
Type Flange Type
Make Fine Airsys / Mechmaark
Size (H x W x D) 350 x 450 x 30mm-1
Efficiency 90%
8. MICROVEE FILTER
Type Flange Type
Make Fine Airsys / Mechmark
610 x 610 x 300mm-
Size (H x W x D) 2 Nos.
610 x 305 x 300mm-
2Nos.
Efficiency 95%
9. HEPA FILTER
Type Flange Type
Make Fine Airsys / Mechmark

610 x 610 x 300mm-2
Nos.
Size (H x W x D)
610 x 305 x 300mm-2
Nos.
Efficiency 99.97%
Serial No.
10. PURGE AIR FILTER
Page 13 of 29
CLIENT
AND RESEARCH CENTRE

Sr. Checked
No. By
Type Flange Type
Make Fine Airsys/Mechmark
Size (HXWXD) 350x350x30 mm-01
Efficiency 90% - (10µ)
Serial No.
11. BAG IN BAG OUT FILTER (BIBO)

Make Fine Airsys
Super HEPA filter (Box
Type
Type).
Capacity 3000 CFM
Material Aluminium
Initial Pressure
25mm
Drop
Final Pressure
75mm
Drop
99.99% down to 0.3
Efficiency
microns
Glass fibre filter paper
Media
media
Size 915 x 610 x 300 mm
Qty. 2
10.0 TECHNICAL DATA OF ANCILLARY ITEMS
Sr. Acceptance
Parameter Observation Checked By Remarks
No. criteria
1. DUCTS
Page 14 of 29
CLIENT
AND RESEARCH CENTRE

Sr. Acceptance
No. criteria
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
400 X 300 mm
(H x W)
Purge Air Damper
300 X 300 mm
(H x W)
Page 15 of 29
CLIENT
AND RESEARCH CENTRE

Sr. Acceptance
No. criteria
Return Air
350 X 950 mm
Damper (H x W)
Supply Air
400 X 900mm
Damper (H x W)
Bypass Air
100 X 1200 mm
Damper (H x W)
4. FIRE DAMPER
SA AIR / RUSKIN
Make TITUS /
CARYAIRE
MOC Galvanized Steel
Sheet
Size (H x W)
MM / Qty. 400 X 900 mm
(Supply)
Size (H x W)
MM / Qty. 350 X 950 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.
Page 16 of 29
CLIENT
AND RESEARCH CENTRE

Sr. Acceptance
No. criteria
6. DIFFERENTIAL PRESSURE ACROSS AHU FILTERS
Magnehelic
Instrument
gauges
Dwyer/Omicron/
Make
Radix
0-25 mm of WC
(Pre Filter),
0-50 mm WC (Fine
Range
Filter)
0-100mm of WC
(Hepa Filter)
7. DIFFUSER WITH DAMPER FOR SUPPLY AIR

Aluminum powder
MOC coated 4 way
diffuser with VCD
Make Caryaire
SIZE
7.1 ROOM NAME (H x W ) MM/
QTY (Nos.)
PACKING 450 x 450mm-3
DE-BLISTERING 300 x 300mm-1
PACKING-1 450 x 450mm-2
8. DIFFUSER WITH DAMPER FOR RETRUN AIR
Page 17 of 29
CLIENT
AND RESEARCH CENTRE

Sr. Acceptance
No. criteria
Aluminum powder
MOC coated 4 way
diffuser with VCD
Make Caryaire
RETURN AIR DIFFUSER

SIZE
ROOM NAME (H x W ) MM/
QTY (Nos.)
PACKING 450 x 450mm-2
PIPING AND MANIFOLD DETAILS:
9. CHILLED WATER MANIFOLD
Line size 50 mm
Insulation MOC Nitrile Rubber
Make Armaflex/Armacell
Butterfly Valve 50 mm
Make Honeywell
Page 18 of 29
CLIENT
AND RESEARCH CENTRE

Sr. Acceptance
No. criteria
MOC Brass
Qty. 5 Nos
Y strainer Size 50 mm
Make Hammer
MOC Cast Iron
Qty. 1 No
Drain Valve Size 25 mm
Make Honeywell
MOC Cast Iron Body
Qty. 2 No
Auto air Vent 15 mm
Make Anergy
MOC Brass
Qty. 1 No
Flanges ASME 16.5 # 150
Balancing Valve
50 mm
Size
Forged Brass to
Insulation MOC IS6912 Gr. FLB
Body
Make Castle
Qty. 1 No
Page 19 of 29
CLIENT
AND RESEARCH CENTRE

Sr. Acceptance
No. criteria
Three Way
50 mm
Control Valve
Ductile Iron ASTM
MOC A395 Grade 60-40-
18
Make Resideo Centra
Qty. 1 No
10. HOT WATER MANIFOLD
Line size 20 mm
Insulation MOC Nitrile Rubber
Make Armaflex/Armacell
Thickness 25 mm
Ball Valve Size 20 mm
Make Honeywell/KCR
MOC Brass
Qty. 5 Nos
Y strainer Size 20 mm
Make Hammer
Rubber Gasket
MOC
Body
Qty. 1 No
Drain Valve Size 25 mm
Page 20 of 29
CLIENT
AND RESEARCH CENTRE

Sr. Acceptance
No. criteria
Make Honeywell/KCR
MOC Brass
Qty. 1 No.
Auto air Vent 15 mm
Make Anergy/Honeywell
MOC Brass
Qty. 1 No.
Flanges ASME 16.5 # 150
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
Ductile Iron ASTM
MOC A395 Grade 60-40-
18
Make Resideo Centra
Qty. 1 No
11. TEMPERATURE CONTROLLER
Make. SELEC
Page 21 of 29
CLIENT
AND RESEARCH CENTRE

Sr. Acceptance
No. criteria
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
Page 22 of 29
CLIENT
AND RESEARCH CENTRE

Sr. Acceptance
No. criteria
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. 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 23 of 29
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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
Page 24 of 29
CLIENT
AND RESEARCH CENTRE

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:
Investigation:
Page 25 of 29
CLIENT
AND RESEARCH CENTRE

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 26 of 29
CLIENT
AND RESEARCH CENTRE

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 27 of 29
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
Page 28 of 29
CLIENT
AND RESEARCH CENTRE

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 29 of 29

Iq Ahu 05 1944 CFM D

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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 2

5.0 DOCUMENTATION PROCEDURE 5

6.0 INSTALLATION QUALIFICATION PROCEDURE 6

7.0 SYSTEM DESCRIPTION 7

8.0 PHYSICAL VERIFICATION 8

9.0 INSPECTION CHECKLIST FOR AHU COMPONENTS 9

10.0 TECHNICAL DATA OF ANCILLARY ITEMS 14

12.0 REFERENCE DOCUMENTS 24

13.0 OBSERVATION DEVIATION DURING INSTALLATION QUALIFICATION 25

14.0 RECOMMENDATION AND CONCLUSION AFTER INSTALLATION QUALIFICATION 26

15.0 POST APPROVAL 27

INSTALLATION QUALIFICATION PROTOCOL OF

Revision No. 00 Revision Date NA

1.0 PROTOCOL APPROVAL SHEET

Prepared By (M/s. HVAX Designation Signature Date

INSTALLATION QUALIFICATION PROTOCOL OF

Revision No. 00 Revision Date NA

Reference HVAC DQ Protocol No: - 1944/HVAC/DQ/AHU-05

 HVAX Technologies Pvt. Ltd.:

 To prepare qualification protocol cum report.

INSTALLATION QUALIFICATION PROTOCOL OF

Revision No. 00 Revision Date NA

 To review the qualification protocol cum report.

 To review the qualification protocol cum report.

 Engineering Head, GM Quality Assurance:

 To review and approve the qualification protocol and report.

INSTALLATION QUALIFICATION PROTOCOL OF

Revision No. 00 Revision Date NA

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

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

8.0 PHYSICAL VERIFICATION

AHU Supply air

5. Pre-filters Visual Check

6. Fine Filter Visual Check

INSTALLATION QUALIFICATION PROTOCOL OF

Revision No. 00 Revision Date NA

9.0 INSPECTION CHECKLIST FOR AHU COMPONENTS

Type of unit Double skin sandwiched

Inside panel thick 0.6 mm thick. Plain GI

Drain Pan Thick. 20 G

1.A Supply Decker

Width (mm) 1420

Height (mm) 2320

Model No. BNC Q 450

INSTALLATION QUALIFICATION PROTOCOL OF

Revision No. 00 Revision Date NA

Static pressure 200 mm WG