Professional Documents
Culture Documents
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.
TABLE OF CONTENT
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.
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.
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.
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.
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
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.
Engineering:
Quality Assurance:
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.
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.
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.
This Air handling system having a supply air fan capacity of 1700CFM which supplies the
Conditioned air to Class ‘D’ Area.
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.
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
CHW Cooling
3. Visual Check
Coil
HW Cooling
4. Visual Check
Coil
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.
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
2. FAN
Sr.
Parameter Acceptance criteria Observation Checked By Remarks
No.
Static pressure 125 mm WG
3. MOTOR
BBL/SIEMENS/CG/
Make
HM/EQUV
Type Non-Flame proof
RPM 2900
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.
Sr.
Parameter Acceptance criteria Observation Checked By Remarks
No.
5. HW COIL
Type HW Coil
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
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.
Sr.
Parameter Acceptance criteria Observation Checked By Remarks
No.
Make Fine Airsys / Mechmaark
8. MICROVEE FILTER
Type Flange Type
Make Fine Airsys / Mechmark
9. DHU DETAILS:-
Make Rehoboth
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.
Sr.
Parameter Acceptance criteria Observation Checked By Remarks
No.
Fan Type Plug
Pole 2
Qty. 1
Qty. 1 Nos.
Motor Capacity 1 HP
Pole 2
Static Pressure 40 mm WG
Qty. 1 Nos.
Motor Capacity 40 W
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.
Sr.
Parameter Acceptance criteria Observation Checked By Remarks
No.
PRE AIR FILTER
Efficiency 90%-10µ
DAMPER DETAILS
Material Aluminium
Qty. 1Nos.
Material CRC
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.
Sr.
Parameter Acceptance criteria Observation Checked By Remarks
No.
Qty. 1 Nos.
HEATER DETAILS
Capacity 3KW
No. Of Heater
2Nos.
Bank
Total Capacity 18KW
Qty. 6Nos.
Controller PLC(GOC)
Make Mistubishi
Type Pre-Wired
Qty. 1Nos.
UNIT BASE
Make Rehoboth
Qty. 1 Nos.
AHU DETAILS
Make Rehoboth
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.
Sr.
Parameter Acceptance criteria Observation Checked By Remarks
No.
Frame Aluminium
Header MS
Tonnage 6 TR
Connection LHS
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.
Sr.
Parameter Acceptance criteria Observation Checked By Remarks
No.
Efficiency 90%- 10µ (EU 4)
Qty. 1Nos.
Material Aluminium
Qty 1 Nos.
UNIT BASE
Make Rehoboth
Size 50x100 mm
Qty. 1 Nos.
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.
Sr. Acceptance
Parameter Observation Checked By Remarks
No. criteria
1. DUCTS
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.
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.
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.
Sr. Acceptance
Parameter Observation Checked By Remarks
No. criteria
0-25 mm of WC
(Pre Filter),
Range
0-50 mm WC
(Fine Filter)
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.
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
Line size 32 mm
Nitrile Rubber with
Insulation MOC
Al foil
Make Armaflex/Armacell
Make Honeywell
Qty. 5 Nos.
Y strainer Size 32 mm
Make Hammer
Qty. 1 Nos.
Make Honeywell
Qty. 1 Nos.
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.
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
Qty. 1 Nos.
Line size 20 mm
Nitrile Rubber with
Insulation MOC
Al foil
Make Armaflex
Thickness 25 mm
Make Honeywell
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.
Sr. Acceptance
Parameter Observation Checked By Remarks
No. criteria
MOC Cast Iron Body
Qty. 1 Nos.
Make Honeywell/KCR
Qty. 1 Nos.
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
Qty. 1 Nos.
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.
Sr. Acceptance
Parameter Observation Checked By Remarks
No. criteria
Make. BELIMO
13. RH CONTROLLER
Make. SELEC
Range 0...100%
Qty (Nos) 1
Make Omicron
Qty (Nos) 1
11.0 SAFETY
Blower should be
mounted on bottom
Vibration Visual
2. channel frame
isolators Check
supported with
vibration isolators.
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.
2. AHU GA Annexure-II
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.
Investigation:
Acceptable Yes/No:
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.
Concluded By
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.
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
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.
4 DQ Design Qualification
5 GI Grey Iron
8 Mm Millimeter
9 NA Not applicable
11 TR Ton of Refrigeration
12 ͦ C Degree centigrade
13 % Percentage
Page 31 of 31