DQ Ahu 04-1944-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.
DESIGN QUALIFICATION OF
HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/DQ/AHU-04 Issue Date.
Revision No. 00 Revision Date N.A.
DESIGN QUALIFICATION
OF
HEATING VENTILATION & AIR CONDITIONING
SYSTEM
FOR
SYSTEM ID.: AHU-G04
PLANT
OF
M/S ENTRANCE PHARMACEUTICALS AND RESEARCH
CENTRE
NO.16, OKPOI, SPINTEX ROAD, ACCRA P.O.BOX CT 10805, SPINTEX ROAD,
GHANA.
BY
M/S. HVAX TECHNOLOGIES PVT. LTD. - MUMBAI
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CLIENT
AND RESEARCH CENTRE
GHANA.
TABLE OF CONTENTS
1.0 PRE-APPROVAL 3
2.0 OBJECTIVE 4
3.0 SCOPE 4
4.0 REASON FOR DESIGN QUALIFICATION 4
5.0 PRE-REQUISITES 4
6.0 DESIGN QUALIFICATION CRITERIA 5
7.0 SYSTEM DESCRIPTION 7
8.0 PRINCIPLE OF WORKING 8
9.0 AHU COMPONENT SPECIFICATION 9
10.0 TECHNICAL DATA OF ANCILLARY ITEMS 12
11.0 SAFTEY FEATURES & INTERLOCKS 12
12.0 REVIEW / EVALUATION OF VENDOR DESIGN AGAINST USER REQUIREMENTS 19
13.0 OBSERVED DEVIATION (IF ANY) 20
14.0 FINAL REPORT 21
15.0 REFERENCE DOCUMENTS 21
16.0 ABBREVIATIONS 22
17.0 POST APPROVAL: 24
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CLIENT
AND RESEARCH CENTRE
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1.0 PRE-APPROVAL
The Author signature indicates that this document has been prepared in accordance with 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 completely reflects
the tasks and deliverables necessary during the design phase required in the construction, equipping
of pharmaceutical facilities and/or the equipment used therein. 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.
Signature
Signatory Name Designation &
Date
Prepared by
M/S. HVAX Technology Pvt. Ltd.
Reviewed By
(QA Department)
M/S Entrance Pharmaceuticals
And Research Centre.
Approved By
(QA Head)
M/S Entrance Pharmaceuticals
And Research Centre.
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CLIENT
AND RESEARCH CENTRE
GHANA.
2.0 OBJECTIVE
The objective of DQ is to confirm that the design as offered by the system supplier is capable of
meeting the Intended Purpose of Use.
The main deliverable of this exercise is to summarize the Design Report, and conclude that it meets
the Intended Purpose of use.
3.0 SCOPE
This DQ is applicable to the HVAC system that will be installed at plant of M/S ENTRANCE
PHARMACEUTICALS AND RESEARCH CENTRE.
1.0 REASON FOR DESIGN QUALIFICATION
The reason for this DQ activity is:

Please click any one (or multiple) option(s) from the following ():
Purchase of new system 
Customization of existing equipment 
Other (Specify) 
2.0 PRE-REQUISITES
Sr. Availability
Prerequisite Ref Document Checked by
No. (Yes/No)
1. Room Data Sheet

AHU G.A. with Technical
2.
Specifications
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3.0 DESIGN QUALIFICATION CRITERIA
AHU design should be such that the following requirements are met:
6.1 AIR QUALITY REQUIRED:
AHU design should be such that the following requirements are met as per ‘USFDA and EU GMP
Annex 1 Differences in cleanroom’ specifications.
Maximum permitted
Maximum permitted number ISO Class
number of particles ≥
Grade of particles ≥ 0.5 µm/m3 At Rest/In
5µm/m3
Operation
At Rest In Operation At Rest In Operation
Set a limit
based on the
D 3520000 Not Defined 29000 8/-
risk
assessment
These counts are to be achieved as mentioned in above table.
6.2 AHU BASIS OF DESIGN

Areas catered by AHU-G04: Packing -2,Packing -1,Airlock
Equip. Room dimension ACPH
Room Name Occupancy Load Ht Class
Area Volume
HP Selected Design
(sq. ft.) (Mtr.) (Cu. Ft.)
PACKING-2 5.00 3.50 460.95 3.00 4,535.74 30.00 30.00 D

PACKING-1 5.00 3.50 459.86 3.00 4,525.00 30.00 30.00 D
AIR LOCK - - 33.70 3.00 331.65 30.00 30.00 D
TOTAL 954.51 9392.38
 Design Condition
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Design Relative
Room Name Design Temperature (°C)
Humidity (%)
PACKING-2 NMT 27 NMT 55
PACKING-1 NMT 27 NMT 55
AIR LOCK NMT 27 NMT 55
 Selected Capacity
Fresh Air CFM 322

Supply Air Quantity CFM 4696
Return Air quantity CFM 4530
Dehumidified Air quantity CFM 4518.72
Cooling Load TR 12
Heating Load KW 17
4.0 SYSTEM DESCRIPTION

The following are the main features of the system:
Page 6 of 26
CLIENT
AND RESEARCH CENTRE
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This Air handling system having a supply air fan capacity of 6750CFM 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.
 15 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.
5.0 PRINCIPLE OF WORKING
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CLIENT
AND RESEARCH CENTRE
GHANA.
HVAC System has been designed on the principle of minimum 10% fresh air and up to 90%
return air. The AHU blower draws the Fresh air from the service floor passing through 10µ pre
filter (efficiency 90%) and mixes it with the return air in the mixing box chamber. This stream
of fresh air and return air gets cooled through the cooling coils and after that it passes over the
heating coil for heating and passes through the 3µ fine filter (efficiency 95%). After passing
through the fine filter this steam of fresh and return air passes over the HEPA filter to achieve
the desired level of filtration. The air is then carried in the room via supply ducting through
supply air diffuser. Blower draws the room returns air from room via return duct through
return air diffuser. And this return air before enters into the AHU first passes through the bag
in and bag out filter (BIBO), terminally placed in the return air duct line. And after that, it
recirculates the same into the rooms by passing through the same above process. The AHU
sucks the return air from the respective rooms through the return air riser with filter (10µ).
Manually operated volume control damper is installed into the supply and return air mouth.
The fusible link fire damper is also installed into the supply and return air duct line. We
installed the magnehelic gauge across pre filter (0-25mmWG) , across the fine filter (0-50mmWG) and
HEPA filter (0-100mm WG).
Page 8 of 26
CLIENT
AND RESEARCH CENTRE
GHANA.
6.0 AHU COMPONENT SPECIFICATION

Sr. No. Description Unit Technical Details
1. GENERAL
System no. - AHU-04
Manufacturer - HVAX Technologies Pvt. Ltd.
Type of unit - Double skin panel with PUF
Inside panel thick mm 0.6 mm GI Plain
Outside panel thick mm 0.6 mm GI Pre-coated
Panel Thickness mm 47
Extrusion profile - Extruded Aluminum Thermal break Profile
Drain Pan material - S.S. 304
Insulation Nitrile Rubber
Drain Pan Thickness G 20
1.A AHU
Capacity CFM 6750
Static pressure mmWG 200

Length mm 2970
Width mm 1420
Height mm 2620
2. FAN
Type - Centrifugal PLG
Make - KRUGER/EQUV.
Blade Type - Backward Curved
Air quantity CFM 6750
Static pressure mmWG 200
Specification No / Model - BNC Q 500
Fan speed RPM 2520
Fan absorbed Power KW 9.24
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AND RESEARCH CENTRE
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3. MOTOR
Make - BBL/SIEMENS/CG/HM/EQUV
Type - Non Flame Proof
Motor KW 15
Motor Speed RPM 2900
Pole - 2
4. CHW COIL
Type - CHW coil
Coil Face Area Sq. ft. 11.45
Face area (H x L) mm 952 X 1117
Tube Material - Copper
Fin material - Aluminum
Coil Header Material - MS
Total Coil Capacity TR 19.29
Rows - 8
Tube Dia. Inch ½ inch
No. of fins / Thickness FPI 10-12 / 0.15mm
5. HW COIL
Type - HW Coil
Coil Face Area Sq. ft. 11.45
Face area (H x L) mm 952 X 1117
Tube Material - Copper
Fin material - Aluminum
Coil Header Material - MS
Total Coil Capacity Kw 23
Rows - 2
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Tube Dia. Inch ½ inch
No. of fins / Thickness FPI 10-12 / 0.15mm
6. PRE-FILTER
Type - Flange Type
Make - Fine Airsys / Mechmark
710 x 610 x 50-2
Size (H x W x D) mm
610 x 305 x 50-2
Efficiency - 90% - (10µ)
7. FRESH AIR FILTER

Type - Flange Type
Size (H x W x D) mm 350 x 350 x 30-1
Efficiency - 90% - (10µ)
8. MICROVEE FILTER
Supply Decker
Type - Flange Type
710 x 610 x 300-2
Size (H x W x D) mm
610 x 305 x 300-2
Efficiency - 95% (3µ)
9. HEPA FILTER
Type - Flange Type
710 x 610 x 300-2
Size (H x W x D) mm
610 x 305 x 300-2
Efficiency - 99.97% (0.3µ)
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CLIENT
AND RESEARCH CENTRE
GHANA.

10. PURGE AIR FILTER
Type - Flange Type
Make - Fine Airsys/Mechmark
Size (HxWxD) mm 350x350x30-01
Efficiency 90%- 10µ
11. BAG IN BAG OUT (BIBO)
Make - Fine Airsys
Type - Super HEPA filter (Box Type).
Capacity CFM 3000 each
Material - Aluminium
Initial Pressure Drop W.G 25mm
Final Pressure Drop W.G 75mm
Efficiency - 99.99% down to 0.3 microns
Media - Glass fibre filter paper media
Size mm 915x610x300
Qty. Nos. 2
7.0 TECHNICAL DATA OF ANCILLARY ITEMS

SR.NO. DESCRIPTION ACCEPTANCE CRITERIA
1. DUCTS
Material Of sheet Galvanized Steel
Thickness of Sheet 24G (0.6mm) & 22G (0.8mm)
Sizing & Construction 1220 x 2438 mm
Sealant Silicon sealant (white)
2. DUCT INSULATION
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CLIENT
AND RESEARCH CENTRE
GHANA.
Make Supreme
Material XLPE insulation with one side Al foil faced.
Density 28±3 Kg/m3
Thermal stability@90oC/24hrs ≤ 5%
Operating Temperature -40 °C to 115 °C
Supply insulation 19mm
Thickness
Return Insulation 13mm
3. DAMPERS
Make Fine Airsys / Mechmaark
Material Manually Operated Al. Damper
Fresh Air Damper (H x W) 300 X 300 mm- 01
Purge Air Damper (H x W) 300 X 300 mm- 01
Return Air Damper (H x W) 350 X 1000 mm-01
Supply Air Damper (H x W) 400 X 950mm-01
Bypass Air Damper (H x W) 100 X 500 mm-01
4. FIRE DAMPER
Make RUSKIN TITUS / CARYAIRE / SA AIR
MOC Galvanized Steel Sheet
Supply– 400 X 950 mm-01
Size Return– 350 X 1000 mm-01
5. ROOM PRESSURE
Instrument Magnehelic Gauges
Make Dwyer/Omicron
Location Entrance of the Room
Range 0-60 Pa
6. DIFFERENTIAL PRESSURE ACROSS AHU FILTERS
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CLIENT
AND RESEARCH CENTRE
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Instrument Magnehelic gauges

Make Dwyer/Omicron/Radix
0-25 mm of WC (Pre Filter),
0-50 mm of WC (Fine Filter)
Range
0-100mm of WC (HEPA Filter)
7. DIFFUSER WITH DAMPER FOR SUPPLY AIR

Aluminum powder coated 4 way diffuser with
MOC
VCD
Make SA AIR/RUSKIN TITUS
ROOM NAME SIZE (H x W ) QTY
PACKING-2 450 x 450mm 3
AIR LOCK 225 x 225mm 1
8. DIFFUSER WITH DAMPERS FOR RETURN AIR

Aluminum powder coated 4 way diffuser with
MOC
VCD
Make SA AIR/RUSKIN TITUS
ROOM NAME Size (H x W) QTY
AIR LOCK 225 x 225mm 1
PIPING AND MANIFOLD DETAILS:

9. CHILLED WATER MANIFOLD
Line size 50 mm
Insulation MOC Nitrile Rubber with Al foil
Make Armaflex/Armacell
Butterfly Valve Size 50 mm
Make Honeywell
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CLIENT
AND RESEARCH CENTRE
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MOC Carbon steel

Qty. 5 Nos
Y strainer Size 50 mm
Make Hammer
MOC Cast Iron
Qty. 1 No
Drain Valve Size 25 mm
Make Honeywell
MOC Brass Body
Qty. 2 No
Auto air Vent 15 mm
Make Anergy
MOC Brass
Qty. 1 No
Flanges ASME 16.5 # 150
Balancing Valve Size 50 mm
Insulation MOC Forged Brass to IS6912 Gr. FLB Body
Make Castle
Qty. 1 No
Three Way Control Valve 50 mm
MOC Ductile Iron ASTM 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
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CLIENT
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Ball Valve Size 20 mm

Make Honeywell
MOC Brass Body
Qty. 6 Nos
Y strainer Size 20 mm
Make Hammer
MOC Cast Iron
Qty. 1 No
Drain Valve Size 25 mm
Make Honeywell/KCR
MOC Brass Body
Qty. 2 No
Auto air Vent 15 mm
Make Anergy
MOC Brass
Qty. 1 No
Flanges ASME 16.5 # 150
Balancing Valve Size 20 mm
Insulation MOC Forged Brass to IS6912 Gr. FLB Body
Make Honeywell
Qty. 1 No
Three Way Control Valve 20 mm
MOC Ductile Iron ASTM A395 Grade 60-40-18
Make Honeywell
Qty. 1 No
11. TEMPERATURE CONTROLLER

Make. SELEC
Range 00 to 500C
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AND RESEARCH CENTRE
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Qty (Nos) 1
12. RH CONTROLLER
Make. SELEC
Range 0...100%
Qty (Nos) 1
13. VELOCITY SENSOR

Make OMICRON
Qty (Nos) 1
14. TEMPERATURE & RH SENSOR

Make. BELIMO
Qty (Nos) 1 SET
15. ELECTRICAL PANEL

Material C.R.C.A Sheet
Thickness Frame and door work- 16 SWG
Cable Entry Bottom Entry
Color Shade RAL 7035
Protection IP 54 for main Enclosure.
Gland Plate Thickness 14 SWG C.R.C.A Sheet
All Switchgear Make Schneider
Checked By:____________________ Date: ________________
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CLIENT
AND RESEARCH CENTRE
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8.0 SAFTEY FEATURES & INTERLOCKS:
Sr. No. ACTIVITY ACTION REMARK
Blower & Motor will be Interlock provision in

1. If Blower Service Door Open’s
‘OFF’ the Starter Panel.
Contractor will trip and Interlock provision in
2. Over load of Motor
Motor will be ‘OFF’ the Starter Panel.
3. In case of Fire in room Mechanical Fusible Interlock provision in
Link install in return the Starter Panel.
will melt at 74º C and
activates the limit
switch to close the
Page 18 of 26
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damper at Return Duct.
12.0 REVIEW / EVALUATION OF VENDOR DESIGN AGAINST USER REQUIREMENTS

Galaxy
Sr. Description of Acceptable
Pharmaceutical Vendor’s Offer Remarks
No. Requirement – Yes/No
requirement
Temperature: Temperature:
NMT 27 ͦ C NMT 27 C
Relative Humidity: Relative Humidity:
1. Room Condition NMT 55% NMT 55%
Differential
Differential Pressure:
Pressure:
As per design
As per design
2. System Capacity As per design. As per design.
Material of
3. GI GI
Construction
Filtration Scheme G4 G4
4.
F7 F7
Process Design and
5. As per URS As per URS
principle of working
To maintain the To maintain the
6. Functional Room condition as Room condition as
per ISO Class-8. per ISO Class-8.
a. Motor a. Motor
b. Blower b. Blower
c. Supply Air c. Supply Air
7. System Components control damper control damper
d. Volume control d. Volume control
damper damper
e. Fire Damper e. Fire Damper
Checked By:____________________ Date: ________________
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13.0 OBSERVED DEVIATION (IF ANY)
Details of deviation:
Corrective Action to Be Taken:
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Prepared By / Date
Checked By / Date
Approved By / Date
14.0 FINAL REPORT
Page 21 of 26
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AND RESEARCH CENTRE
GHANA.
Prepared By: ____________________ Date: ________________
15.0 REFERENCE DOCUMENTS
Sr. No. Title Document No.
1. Room Data Sheet 1944/HVAC/RDS/R0
2. AHU GA Drawing 1944-HVAC-AHU-04
3. Ducting layout 1944-HVAC-DL-FF-R00
4. RCP Layout 1944-HVAC-RCP & CP-FF-R00
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16.0 ABBREVIATIONS
ABBREVIATION DISCRIPTION
ACPH : Air Changes per hour
AHU : Air Handling Unit
Al : Aluminum
CFM : Cubic feet per minute
CFU : Colony forming unit
cGMP : Current Good Manufacturing Practices
°C : Degree Celsius
CHW Chilled Water
CMH : Cubic meter per hour
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DQ : Design Qualification
dB : Decibel
EU : Euro vent
FPM : Feet per minute
GA : General Arrangement
GI : Galvanized Iron
HEPA : High Efficiency Particulate Air
HVAC : Heating Ventilation and Air Conditioning
HW Hot Water
HZ : Hertz
ISO : International Standard Organization
KW : Kilowatts
mm : Millimeter
MOC : Material of construction
NB : Nominal bore
NC : Not Control
P&I : Process and instrument
QA : Quality Assurance
RPM : Rotation Per Minute
SMACNA : Sheet metal and air conditioning contractor’s national association.
TEFC : Totally Enclosed Fan Cooled
TR : Ton of refrigeration
URS : User Requirement Specification
VFD : Variable frequency drive
WC : Water column
WG : Water Gauge
% : Percentage
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17.0 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.
The approver’s signature indicates that the documentation and information contained herein
complies with applicable regulatory, corporate, divisional / departmental and cGMP
requirements.
Page 25 of 26
CLIENT
AND RESEARCH CENTRE
GHANA.
M/S ENTRANCE PHARMACEUTICALS AND RESEARCH CENTRE.

Signature &
Signatory Name
Date
Reviewed By
(Project / Engineering)
Approved By
(Project Head)
Approved By
(QA Head)
Page 26 of 26

DQ Ahu 04-1944-CFM-D

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CLIENT

M/S ENTRANCE PHARMACEUTICALS

1.0 REASON FOR DESIGN QUALIFICATION

The reason for this DQ activity is:

1. Room Data Sheet

3.0 DESIGN QUALIFICATION CRITERIA

6.1 AIR QUALITY REQUIRED:

These counts are to be achieved as mentioned in above table.

6.2 AHU BASIS OF DESIGN

PACKING-2 5.00 3.50 460.95 3.00 4,535.74 30.00 30.00 D

PACKING-2 NMT 27 NMT 55

PACKING-1 NMT 27 NMT 55

AIR LOCK NMT 27 NMT 55

Fresh Air CFM 322

4.0 SYSTEM DESCRIPTION

 Manually Operated Return Air Damper.

5.0 PRINCIPLE OF WORKING

6.0 AHU COMPONENT SPECIFICATION

Static pressure mmWG 200

Sr. No. Description Unit Technical Details

Sr. No. Description Unit Technical Details

7. FRESH AIR FILTER

Sr. No. Description Unit Technical Details

7.0 TECHNICAL DATA OF ANCILLARY ITEMS

SR.NO. DESCRIPTION ACCEPTANCE CRITERIA

6. DIFFERENTIAL PRESSURE ACROSS AHU FILTERS

SR.NO. DESCRIPTION ACCEPTANCE CRITERIA

Instrument Magnehelic gauges

7. DIFFUSER WITH DAMPER FOR SUPPLY AIR

8. DIFFUSER WITH DAMPERS FOR RETURN AIR

PIPING AND MANIFOLD DETAILS:

SR.NO. DESCRIPTION ACCEPTANCE CRITERIA

MOC Carbon steel

10. HOT WATER MANIFOLD

SR.NO. DESCRIPTION ACCEPTANCE CRITERIA

Ball Valve Size 20 mm

11. TEMPERATURE CONTROLLER

SR.NO. DESCRIPTION ACCEPTANCE CRITERIA

13. VELOCITY SENSOR

14. TEMPERATURE & RH SENSOR

15. ELECTRICAL PANEL

Checked By:____________________ Date: ________________

8.0 SAFTEY FEATURES & INTERLOCKS:

Sr. No. ACTIVITY ACTION REMARK

Blower & Motor will be Interlock provision in

damper at Return Duct.

12.0 REVIEW / EVALUATION OF VENDOR DESIGN AGAINST USER REQUIREMENTS

2. System Capacity As per design. As per design.

Checked By:____________________ Date: ________________

13.0 OBSERVED DEVIATION (IF ANY)

Corrective Action to Be Taken:

14.0 FINAL REPORT

Prepared By: ____________________ Date: ________________

15.0 REFERENCE DOCUMENTS

Sr. No. Title Document No.

1. Room Data Sheet 1944/HVAC/RDS/R0

2. AHU GA Drawing 1944-HVAC-AHU-04

3. Ducting layout 1944-HVAC-DL-FF-R00

4. RCP Layout 1944-HVAC-RCP & CP-FF-R00

17.0 POST APPROVAL:

M/S ENTRANCE PHARMACEUTICALS AND RESEARCH CENTRE.

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Checked By:____ Date:

Checked By:____ Date:

Prepared By: ____ Date: