DQ Ahu 03-1944-CFM-D

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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.
DESIGN QUALIFICATION OF
HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1944/HVAC/DQ/AHU-03 Issue Date.
Revision No. 00 Revision Date N.A.

DESIGN QUALIFICATION
OF
HEATING VENTILATION & AIR CONDITIONING
SYSTEM

FOR
SYSTEM ID.: AHU-G03
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

Page 1 of 28
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-03 Issue Date.
Revision No. 00 Revision Date N.A.

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

Page 2 of 28
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-03 Issue Date.
Revision No. 00 Revision Date N.A.

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.

Page 3 of 28
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-03 Issue Date.
Revision No. 00 Revision Date N.A.

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

Page 4 of 28
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-03 Issue Date.
Revision No. 00 Revision Date N.A.

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-G02: M-A/L, P-A/L, Compression-4
Equip. Room dimension ACPH
Room Name Occupancy Load Ht Class
Area Volume
HP Selected Design
(sq. ft.) (Mtr.) (Cu. Ft.)
2 2
M-A/L - - 5.96 3.00 55.47 30.00 45 D
1 1
P-A/L - - 8.44 3.00 81.45 30.00 127 D
14 1,3
COMPRESSION-4 2.00 7.00 2.11 3.00 98.40 30.00 43 D
TOTAL 186.52 1835.32

 Design Condition
Page 5 of 28
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-03 Issue Date.
Revision No. 00 Revision Date N.A.

Design Relative
Room Name Design Temperature (°C)
Humidity (%)

M-A/L NMT 27 NMT 40

P-A/L NMT 27 NMT 40

COMPRESSION-4 NMT 27 NMT 40

 Selected Capacity

Fresh Air CFM 563


Supply Air Quantity CFM 1579
Return Air quantity CFM 1016
Dehumidified Air quantity CFM 1237.72
Cooling Load TR 7
Heating Load KW 3

4.0 SYSTEM DESCRIPTION


The following are the main features of the system:

Page 6 of 28
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-03 Issue Date.
Revision No. 00 Revision Date N.A.

This Air handling system having a supply air fan capacity of 1700CFM 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.
 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 Box HEPA Box with H-13 filter.
 Return Air Riser with filter (10 µ)
 XLPE insulation with one side Al foil faced duct insulation.

5.0 PRINCIPLE OF WORKING

HVAC System has been designed on the principle of minimum 10% fresh air and up to 90% return air.
The AHU sucks the return air from the respective rooms through the return air riser with filter (10µ).
Page 7 of 28
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-03 Issue Date.
Revision No. 00 Revision Date N.A.
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%). The air is then carried in the room via supply ducting
filtered through 0.3µ HEPA filters (Efficiency 99.97%), terminally placed to achieve the desired level
of filtration before it enters into the room. Blower draws the room returns air from room via return duct
through return air grilles & return air risers (only applicable areas The AHU sucks the return air from
the respective rooms through the return air riser with filter 10µ). And after that, it recirculates the same
into the rooms by passing through the same above process. To maintain the required design temperature
and RH i.e. (Temp NMT 25%, RH 40%) we placed the dehumidifier and precooling coil. The return air
will be drawn into the AHU through dehumidifier. The dehumidifier is installed in the return air and
fresh air path. Some part of the return air and fresh air comes through this dehumidifier to maintain the
RH 40%. We installed the magnehelic gauge across pre filter (0-25mmWG) and across the fine filter
(0-50mmWG). Manually operated volume control damper installed at Fresh air, return air and supply
air mouth. Fusible Link fire damper is also installed at the supply and return air duct. Digital
Differential pressure transmitter is installed across the rooms. We also installed the 300CFM Dust
collector to extract the dust from the required room.

6.0 AHU COMPONENT SPECIFICATION


Sr. No. Description Unit Technical Details
1. GENERAL
Page 8 of 28
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-03 Issue Date.
Revision No. 00 Revision Date N.A.

Sr. No. Description Unit Technical Details


System no. - AHU-03
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 (Double skin sandwiched)
AHU panel Frame - Extruded Aluminum Thermal break Profile
Drain Pan material - S.S. 304
Insulation Nitrile Rubber
Drain Pan Thickness G 20
1.A AHU
Capacity CFM 1700

Static pressure mmWG 125


Length mm 2520
Width mm 1000
Height mm 1800
2. FAN
Type - Centrifugal Plug
Make - KRUGER/EQUV.
Blade Type - Backward Curved
Air quantity CFM 1700
Static pressure mmWG 125
Specification No / Model - BNC P355
Fan speed RPM 2788
Fan absorbed Power KW 1.78

3. MOTOR

Page 9 of 28
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-03 Issue Date.
Revision No. 00 Revision Date N.A.

Sr. No. Description Unit Technical Details


Make - BBL/SIEMENS/CG/HM/EQUV
Type - Non Flame Proof
Motor KW 2.2
Motor Speed RPM 2900
Pole - 2

4. CHW COIL

Type - CHW coil

Coil Face Area Sq. ft. 4.55


Face area (H x L) mm 667 X 634

Tube Material - Copper

Fin material - Aluminum

Coil Header Material - MS


Total Coil Capacity TR 7.77

Rows - 8

Tube Dia. Inch ½ inch

No. of fins / Thickness FPI 10-12 / 0.15mm

Coil Face Velocity FPM 500

5. HW COIL
Type - HW Coil
Coil Face Area Sq. ft. 4.55
Face area (H x L) mm 667 X 634
Tube Material - Copper
Fin material - Aluminum

Page 10 of 28
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-03 Issue Date.
Revision No. 00 Revision Date N.A.

Sr. No. Description Unit Technical Details


Coil Header Material - MS
Total Coil Capacity Kw 3
Rows - 2
Tube Dia. Inch ½ inch
No. of fins / Thickness FPI 10-12 / 0.15mm
Coil Face Velocity FPM 500

6. PRE-FILTER
Type - Flange Type
Make - Fine Airsys / Mechmark
Size (H x W x D) mm 610 x 610 x 50
Efficiency - 90% (10µ)
Qty. Nos. 1

7. FRESH AIR FILTER


Type - Flange Type
Make - Fine Airsys / Mechmark
Size (H x W x D) mm 350 x 400 x 30
Efficiency - 90% ( 10µ)
Qty. Nos. 1

8. MICROVEE FILTER
Supply Decker
Type - Flange Type
Make - Fine Airsys / Mechmark
Size (H x W x D) mm 610 x 610 x 300
Efficiency - 95% (3µ)
Qty. Nos. 1

Page 11 of 28
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-03 Issue Date.
Revision No. 00 Revision Date N.A.

Sr. No. Description Unit Technical Details


9. DHU DETAILS:-
Make - Rehoboth
Capacity CFM 900
Unit Type - Floor Mounted
Frame - 1.2mm Thick CRC
Type - Single Skinned
Color - White (RAL 9002)
Inner and Outer Skin - 1.2mm thick CRC Powder Coated.
Qty. Nos. 1
PROCESS FAN AND MOTOR DETAILS
Fan Capacity CFM 900
Fan Model - R63-250-19
Fan Type - Plug
Fan Make - Rosenberg
Motor Capacity HP 1.5
Pole - 2
Static Pressure mmWg 50
Motor Type - Flange
Qty. Nos. 1
REACTIVATION FAN AND MOTOR DETAILS
Fan Capacity CFM 300
Fan Type - SISW
Fan Make - Rehoboth
Qty. Nos. 1
Motor Capacity HP 1
Pole - 2
Static Pressure mmWg 40

Page 12 of 28
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-03 Issue Date.
Revision No. 00 Revision Date N.A.

Sr. No. Description Unit Technical Details


Motor Type - Flange
Qty. Nos. 1
BED DRIVE MOTOR DETAILS
Motor Capacity W 40
Connection - Single Phase
Motor Type - Flange
Motor Make - Rehoboth
Qty. Nos. 1
FILTER DETAILS
PRE AIR FILTER
Filter Make - Tharma/Freude
Filter Type - Aluminium
Efficiency - 90%-10µ
Filter Material - CRC
Filter Size (HxWxD) mm 305x610x50
Qty. Nos. 1
REACTIVATION AIR FILTER DETAILS
Filter Make - Rehoboth
Filter Type - Box
Efficiency - 90%- 10µ
Filter Material - CRC
Filter Size (HxWxD) - 280x335x30
Qty. Nos. 1
DAMPER DETAILS
SUPPLY AIR OUT DAMPER
Damper Make - Rehoboth
Material - Aluminium

Page 13 of 28
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-03 Issue Date.
Revision No. 00 Revision Date N.A.

Sr. No. Description Unit Technical Details


Damper Size - 250x250
Qty. Nos. 1
REACTIVATION AIR OUT DAMPER
Damper Make - Rehoboth
Material - CRC
Damper Size - 150x150
Qty. Nos. 1
HEATER DETAILS
Heater Type - SS Tubular
Heater Make - Rehoboth
Capacity KW 3
No. Of Heater Bank Nos. 2
Total Capacity KW 18
Qty. Nos. 6
CONTROL PANEL DETAILS:
Controller - PLC(GOC)
Make - Mistubishi
Type - Pre-Wired
Qty. Nos. 1
UNIT BASE
Material - 3mm CRC
Make - Rehoboth
Qty. Nos. 1
10. PRE COOLING COIL
AHU DETAILS
Make - Rehoboth
AHU Capacity CFM 563

Page 14 of 28
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-03 Issue Date.
Revision No. 00 Revision Date N.A.

Sr. No. Description Unit Technical Details


Profile - Thermal Break
Unit Type - Floor Mount
Frame - Aluminium
Insulation - Puff (40kg/m³)
Panel Thickness - 45mm±0.5
Color - White (RAL-9002)
Inner and Outer Skin - 0.8mm thick CRC Powder Coated.
Type - Double Skinned
PRE-COOLING COIL DETAILS
Face Sq.Ft 2.17
Coil Type - CHW
Casing - GI-16/18 SWG
Header - MS
Tonnage TR 6
Fins - Aluminium (12-13 FPI)
Drain Pipe Inch 1”
Drain Tray - SS 304 (140mm deep with puff insulation)
Tube - Copper
Connection - LHS
Header Size Inch 2”
No. of Rows - 8 Rows Deep
Coil Size (HTxLT) mm 450x450
FILTER DETAILS
FRESH AIR FILTER
Filter Make - Mechmaark
Filter Type - Flange
Efficiency - 90%- 10µ (EU 4)

Page 15 of 28
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-03 Issue Date.
Revision No. 00 Revision Date N.A.

Sr. No. Description Unit Technical Details


Filter Material - Aluminium
Filter Size (HxWxD) - 350x350x50
Qty. Nos. 1
FRESH AIR DAMPER DETAILS
Damper Make - Rehoboth
Material - Aluminium
Damper Size mm 310x310
Qty Nos. 1
UNIT BASE
Material - 1.2mm CRC
Make - Rehoboth
Size mm 50x100
Qty. Nos. 1
11. DUST COLLECTOR
Make - Pilani Envirotech Pvt Ltd.
Capacity CFM 300
Qty Nos. 1

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)

Page 16 of 28
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-03 Issue Date.
Revision No. 00 Revision Date N.A.

SR.NO. DESCRIPTION ACCEPTANCE CRITERIA

2. DUCT INSULATION
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) 350 X 300 mm
Purge Air Damper (H x W) -
Return Air Damper (H x W) 300 X 350 mm
Supply Air Damper (H x W) 300 X 350mm
Bypass Air Damper (H x W) 150 X 650 mm

4. FIRE DAMPER
Make RUSKIN TITUS / CARYAIRE / SA AIR
MOC Galvanized Steel Sheet
Supply– 300 X 350 mm
Size Return– 300 X 350 mm

5. ROOM PRESSURE
Instrument Magnehelic Gauges
Make Dwyer/Omicron

Location Entrance of the Room

Range 0-60 Pa

Page 17 of 28
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-03 Issue Date.
Revision No. 00 Revision Date N.A.

SR.NO. DESCRIPTION ACCEPTANCE CRITERIA

6. DIFFERENTIAL PRESSURE ACROSS AHU FILTERS

Instrument Magnehelic gauges

Make Dwyer/Nextech

0-25 mm of WC (Pre Filter),


Range
0-50 mm WC (Fine Filter)

7. SUPPLY AIR FILTER BOX IN ROOMS


Frame Aluminium Anodizes
Make Mechmaark Fitech India Pvt Ltd.
Imported Subnicronic Fiber Glass Paper Pleated
Filter Media
with corrogated aluminium separators.
Initial Pressure Drop 25mm WG

Final Pressure Drop 60mm WG

Filter grade H-13

Efficiency 99.97% down to 0.3 microns particles.

Gasket Food Grade

ROOM NAME SIZE (H x LxW) QTY


M-A/L 310 x 310x300mm 1
P-A/L 310 x 310x300mm 1

8. RETURN AIR RISERS


ROOM NAME Size (H x W) QTY
M-A/L 360 x 360mm 1
P-A/L 360 x 360mm 1
Compression -04 900 x 80 1

PIPING AND MANIFOLD DETAILS


9. CHILLED WATER MANIFOLD

Page 18 of 28
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-03 Issue Date.
Revision No. 00 Revision Date N.A.

SR.NO. DESCRIPTION ACCEPTANCE CRITERIA

Line size 32 mm
Insulation MOC Nitrile Rubber with Al foil
Make Armaflex/Armacell
Ball Valve Size 32 mm
Make Honeywell
MOC Brass Body
Qty. 5 Nos.
Y strainer Size 32 mm
Make Hammer
MOC Cast Iron Body
Qty. 1 Nos.
Drain Valve Size 25 mm
Make Honeywell
MOC Brass Body
Qty. 1 Nos.
Auto air Vent 15 mm
Make Anergy
MOC Brass
Qty. 1 No
Balancing Valve Size 32 mm
MOC Forged Brass to IS6912 Gr. FLB Body
Make Honeywell
Qty. 1 No
Three Way Control Valve 32 mm
MOC Cast Iron Body
Make Resedeo Centra
Qty. 1 Nos.

7. HOT WATER MANIFOLD

Page 19 of 28
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-03 Issue Date.
Revision No. 00 Revision Date N.A.

SR.NO. DESCRIPTION ACCEPTANCE CRITERIA

Line size 20 mm
Insulation MOC Nitrile Rubber with Al foil
Make Armaflex
Thickness 25 mm
Ball Valve Size 20 mm
Make Honeywell
MOC Carbon steel
Qty. 5 Nos
Y strainer Size 20 mm
Make Hammer
MOC Cast Iron Body
Qty. 1 Nos.
Drain Valve Size 20 mm
Make Honeywell/KCR
MOC Cast Iron Body
Qty. 1 Nos.
Auto air Vent 15 mm
Make Anergy
MOC Brass
Qty. 1 No
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 Cast Iron Body
Make Resedeo Centra
Qty. 1 Nos.

Page 20 of 28
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-03 Issue Date.
Revision No. 00 Revision Date N.A.

SR.NO. DESCRIPTION ACCEPTANCE CRITERIA

8. TEMPERATURE CONTROLLER
Make. SELEC
Range 00 to 500C
Qty (Nos) 1

9. RH CONTROLLER
Make. SELEC
Range 0...100%
Qty (Nos) 1

10. VELOCITY SENSOR


Make Omicron
Qty (Nos) 1

11. TEMPERATURE & RH SENSOR


Make. BELIMO
Qty (Nos) 1 SET

12. 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

Page 21 of 28
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-03 Issue Date.
Revision No. 00 Revision Date N.A.

Checked By:____________________ Date: ________________

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.
Mechanical Fusible
Link install in return
will melt at 74º C and
Interlock provision in
3. In case of Fire in room activates the limit
the Starter Panel.
switch to close the
damper at Return Duct.

Page 22 of 28
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-03 Issue Date.
Revision No. 00 Revision Date N.A.

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 40% NMT 40%
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: ________________

Page 23 of 28
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-03 Issue Date.
Revision No. 00 Revision Date N.A.

13.0 OBSERVED DEVIATION (IF ANY)

Details of deviation:

Corrective Action to Be Taken:

Prepared By / Date

Checked By / Date

Approved By / Date

Page 24 of 28
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-03 Issue Date.
Revision No. 00 Revision Date N.A.

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-02

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

Page 25 of 28
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-03 Issue Date.
Revision No. 00 Revision Date N.A.

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

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
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

Page 26 of 28
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-03 Issue Date.
Revision No. 00 Revision Date N.A.

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

Page 27 of 28
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-03 Issue Date.
Revision No. 00 Revision Date N.A.

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.

M/S ENTRANCE PHARMACEUTICALS AND RESEARCH CENTRE.


Signature &
Signatory Name
Date
Reviewed By
(Project / Engineering)

Approved By
(Project Head)

Approved By
(QA Head)

Page 28 of 28

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