DQ Ahu G01

Client: M/s.
LETAP PHARMACEUTICAL
LTD (Factory 2)
Site/Location: ACCRA, GHANA.
DESIGN QUALIFICATION OF
HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Document No. 1820/HVAC/DQ/LET/AHU-G01 Effective Date. 30/10/2023
AHU No. G01 Next Revision As Required
DESIGN QUALIFICATION
OF
HEATING VENTILATION & AIR CONDITIONING
SYSTEM
FOR
SYSTEM ID: AHU-G01
PLANT OF
M/S. LETAP PHARMACEUTICAL LTD.
– ACCRA, GHANA
PROJECT EXECUTED BY
M/S. HVAX TECHNOLOGIES PVT. LTD. - MUMBAI
601,6th FLOOR,Lodha Supremus,
I think Techno Campus,
Kanjurmarg-E,Mumbai-400042,India.
Phone no-9102249739447
Page 1 of 24
Client: M/s. LETAP PHARMACEUTICAL
LTD (Factory 2)
TABLE OF CONTENTS
1.0 PRE-APPROVAL...............................................................................................................3
2.0 OVERVIEW........................................................................................................................4
3.0 PRE-REQUISITES.............................................................................................................4
4.0 DESIGN QUALIFICATION CRITERIA........................................................................5
5.0 SYSTEM FEATURES........................................................................................................7
6.0 PRINCIPLE OF WORKING.............................................................................................8
7.0 SYSTEM DESCRIPTION..................................................................................................9
8.0 AHU COMPONENT SPECIFICATION........................................................................11
9.0 TECHNICAL DATA OF ANCILLARY ITEMS................................................11 To 19
10.0 OBSERVED DEVIATION (IF ANY).............................................................................20
11.0 FINAL REPORT...............................................................................................................21
12.0 ABBREVIATIONS...........................................................................................................22
13.0 DOCUMENTS ENCLOSED............................................................................................23
14.0 POST APPROVAL:..........................................................................................................24
Page 2 of 24
LTD (Factory 2)
1.0 PRE-APPROVAL
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.
Name Department Designation Signature Date
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.
Page 3 of 24
LTD (Factory 2)
2.0 OVERVIEW
2.1 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.
2.2 Scope
This DQ is applicable to the HVAC system that will be installed at Plant of M/s. LETAP
PHARMACEUTICAL LTD.
2.3 Responsibilities:
 HVAX Technology Pvt Ltd.
 Preparation of protocol
 Coordination with user department, Engineering and quality assurance for execution
of protocol
 User department
 Review of protocol
 Engineering
 Review and approval of protocol
 To ensure that the design is as per user requirement specification.
 Quality Assurance
Approval of protocol by site Quality Head
3.0 PRE-REQUISITES
Sr. Availability
Prerequisite Ref Document Checked by
No. (Yes/No)
Room Data Sheet provided
1. Yes 1820/HVAC/RDS/R0
by the vendor
AHU G.A. with Technical
2. Specifications provided by Yes Refer AHU GAD
the vendor
4.0 DESIGN QUALIFICATION CRITERIA

AHU design should be such that the following requirements are met:
Page 4 of 24
LTD (Factory 2)
4.1 AIR QUALITY REQUIRED:

AHU design should be such that the following requirements are met:
Class Maximum Particles per m3 at Rest

ISO 9 (CNC) 0.1 µ 0.2µ 0.3µ 0.5µ 1µ 5µ
CUMT - - - 35200000 8320000 293000
These counts are to be achieved in the ‘At Rest’ state as mentioned in above table.
4.2 DATA FOR DESIGN OF HVAC
Ambient Out Side Air Conditions:
Summer Mansoon
Dry Bulb Wet Bulb Dry Bulb Wet Bulb
Temperature (0C) Temperature (0C) Temperature (0C) Temperature (0C)
4.3 AHU BASIS OF DESIGN

Areas catered by AHU-G01 are Approved Raw Material Store, Under Test RM Store, Reject,
Dedusting, Clean Pallet Area, Wash, and Cold Room
Equip. Room dimension
Room Occu Load No of Air
Area Area (sq. Height Volume Class
No pancy Changes
HP ft.) (Mtr.) (Cu. Ft.)
Approved Raw
W-018 2 - 6452.48 5 105820.68 5 CNC
Material Store
Under Test RM CNC
W-004 1 - 1562.56 5 25626.05 5
Store
- - 272.65 5 4471.47 5 CNC
- - 238.05 5 3904.05 5 CNC
W-002 Reject - - 277.78 3 2733.40 5 CNC
W-001 Dedusting - 2.68 1090.95 3 10734.97 5 CNC
W-012 Dedusting - 2.68 240.74 3 2368.93 5 CNC
Clean Pallet 5 CNC
W-035 - - 422.81 3 4160.45
Area
W-49 Wash - - 83.63 3 822.89 5 CNC
W-022 Cold Room 10 418.45 3 4117.51 5 CNC
157.24 3 1547.28 5 CNC
TOTAL 11217.36 166307.69
 Design Condition
Page 5 of 24
LTD (Factory 2)
Design Relative Design Temperature

Room Name
Humidity (%) (°C)
Approved Raw Material Store NMT 55% 25+/-2 C

Under Test RM Store NMT 55% 25+/-2 C
Reject NMT 55% 25+/-2 C
Dedusting NMT 55% 25+/-2 C
Dedusting NMT 55% 25+/-2 C
Clean Pallet Area NMT 55% 25+/-2 C
Wash NMT 55% 25+/-2 C
Cold Room NMT 55% 25+/-2 C
 Selected Capacity
Fresh Air CFM 0

Supply Air Quantity CFM 15018
Return Air quantity CFM 16694
Dehumidified Air quantity CFM 13490
Cooling Load TR 27.18
Heating Load KW 19.69
5.0 SYSTEM FEATURES

;
Page 6 of 24
LTD (Factory 2)
The following are the main features of the system:
This Air handling system having a supply air fan capacity of 17970 CFM which supplies the
Conditioned air to ISO Class 9 (CNC ) Area.
 Manually Operated Return Air Damper.

 Manually Operated Fresh Air Damper with 10µ Filter.
 EU4 (10µ) flange type Pre filter.
 Six Row CHW Cooling coil.
 Centrifugal DIDW type Backward Curved Blower having 65 mm WG static Pressure.
 11 KW 3 phase Non Flame proof motor.
 EU7 (5µ) flange type Microvee filter.
 Manually Operated Bleed Air Damper with 20µ Filter.
 Fire Damper.
 Magnehelic gauges across the AHU mounted filter (EU7 and EU4)
 Ducting made of galvanized iron sheet.
 Chemically Cross Linked closed cell Polyethylene Foam Insulation for Ducting.
 Supply/ Return air Diffuser with room operated volume control damper
 Supply/ Return air Diffuser with room operated volume control damper
6.0 PRINCIPLE OF WORKING
Page 7 of 24
LTD (Factory 2)
The air supply into the room is through draw through type recirculation Air Handling unit. These
systems are provided with double skin construction. The AHU sucks the return air from the
respective rooms through the return air Diffusers/ Grills. This return air mixes with the fresh air
in mixing chamber and after that passes on through Pre filter (EU-4). Further this filtered air
passes through the CHW coil to maintain the required condition. Then this conditioned air is fed
through the backward Curve blower to the intermediate Microvee filter (EU-7).
This air is then fed to the respective rooms via supply air ducts with Insulation on ducts &
through the supply air Diffusers/ Grills. Return air is sucked from respective rooms via return air
ducts with insulation on duct & through the return air Diffusers/ Grills.
AHU will take fresh air from atmosphere through the GI damper at the fresh air module with
EU-4 filter and fed to the mixing chamber. Condensed water collected at the base of AHU is
drained through the drain water pipeline. One manual operated type Volume controlled damper
at return side and one manual operated type Volume controlled damper at supply air side is
provided to control the Airflow.
Magnehelic gauges are mounted across the Pre filter, Microvee filter to indicate the pressure
difference.
7. SYSTEM DESCRIPTION:
7.1 Low side System:
Page 8 of 24
LTD (Factory 2)
In low side system AHUs, piping, Valves, Ducting, Diffusers/Terminal boxes, HEPA filters,
Return Air risers, Insulation, Electrical instrumentation etc. Shall be provided.
7.1.1 Equipment’s: Air Handling Unit
The air handling unit is horizontal skid mounted unit. The unit mainly comprises of double
skin ,coil section of cooling coil section having set of filters, fan section along with backward curved
blower and motor.
7.1.2 Air Distribution
In the HVAC system dehumidified and filtered air is supplied to maintain required environments
condition in the various area through pre insulated with aluminum foil fabricated ducts. Duct joints
are provided with PVC flanges & sealed with silicon sealant. Fresh air from service floor area is
being sucked into the AHU.Air is filtered through combination(EU-4) pre filter & (EU-7) fine filter
a plug type fans are used for pressurizing the air to overcome pressure drop across filters. Provided
in area for classified areas.
Treated conditioned air is supplied into the process areas through Terminal HEPA filters and
unclassified area through diffusers/four-way type diffuser. Required airflow through HEPA Filters
shall be carried out during the operational qualification. Leakage acceptable shall be less than
0.01%.Air quantity supplied in individual room with details of infiltration, exfiltration is mentioned
in AHU air flow air flow diagram.
Duct Work Details:
a) Standards.
b) Material of Construction.
c) Construction details.
d) Dampers.
e) Diffusers, grills, Terminal boxes and Louvers.
f) Return Air Risers.
a) Standards:
Construction, erection, testing and performance of the ducting system shall confirm to the
SMACNA standards.
b) Material of Construction:
All ducting shall be fabricated as per Smart Pre-insulated-PIR (Polyisocyanurate Rigid)
20mm thick, panel with side plain Aluminum and other sides Embossed aluminum foil of 80
micron thickness and close cell not less than 95% rigid cellular foam insulation of thickness
as specified below and material shall be class O as per BS 476Part 6 & Part 7,with density of
28 ± 3 kg/m3 and should have thermal conductivity 0.019 W/mk.Water absorption shall be
not more than 0.03% as per EN 13403 standard. The Transvers duct work should be capable
of handling pressure upto2000 Pascale. The joint between the duct shall be done by means of
Page 9 of 24
LTD (Factory 2)
polymer side in type joint between ducts with gasket bayonet and connecting flanges to be
used for branches, Collar and dropper connection for negligible leakage. Duct supports to be
provided at the regular intervals.
c) Construction Details:
All ductwork tapers, elbows, branches shoes pieces, collars, terminal boxes and other
transformation pieces are site fabricated.
d) Dampers:
Dampers for supply air branch ducts, if any & HEPA Dropper shall be with a leakage G.I
section and blades. The linkage shall be of plated still blade brackets and galvanized steel rod
construction. Each damper shall be provided with an indicating device for damper position.
e) Terminal Boxes and Diffuser:
Diffuser shall be extruded aluminum powder coated finish with removable core. The louvers
shall be made of aluminum sheet. The diffuser shall also have collar damper.
CRCA (18G) powder coted terminal boxes with perforated sheet of 18 G.S.s will be provided
for classified areas.
f) Return Air Riser:
1. R.A Riser will be made in CRP panel front panel of R.A. riser shall be made from
S.S.304 Grill & shall be removable / Openable type for proper cleaning.
2. R.A.Riser will be made in 20 G.I front panel of R.A riser shall be made from S.S.304
Grill and shall be removable / Openable type for proper cleaning.
7.1.3. Condensing Unit Details:
AHU No. CFM Cond Unit Refrigerant
TR
G01 17970 26.2 NA
7.1.3.1 Refrigerant Piping & Insulation:
Soft and hard copper refrigerant piping for liquid /suction line with nitrile rubber
insulation of 19 mm thick.
Drain Pipe-Rigid PVC.
7.1.4 Electrical Details:
Each AHU shall be provided with common electrical panels with manual lock
provision. Panel required for the AHU, Cabling & Earthlings from electrical panels to
AHU
7.1.4.1 Electrical Panels:
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LTD (Factory 2)
The MCC & AHU electrical panels are fabricated out of 14 G CRCA sheet. The casing is
totally dust and vermin proof conforming to degree of protection IP-54.Control panel
should have all necessary interlocking arrangements. Each panel shall be provided with a
trifoliate or engraved metal name plates mentioning the unit number. Control panel shall
be totally enclosed, completely dust proof, with hinged doors, neoprene gasket and
suitable locking arrangement.
7.1.4.2. Cabling and Cable Tray:
All power and control cables for use on medium/high voltage shall be heavy –duty type,
with aluminum/copper conductor, PVC/XLPE insulated, inner sheathed, armored and
overall PVC sheathed. All cable tray shall be in 16/18 SWG with and suitable support
arrangements
8.0 AHU COMPONENT SPECIFICATION
Sr. No. Description Unit Technical Details

1. GENERAL
System no. - AHU-G01
Manufacturer - HVAX TECHNOLOGIES PVT. LTD.
Type of unit - Double skin construction Floor mounted
Inside panel thick mm 24G (0.6) mm Plain GI -White
Outside panel thick mm 24G (0.6) mm Pre-coated GI
Panel Thickness mm 47
Extrusion profile - Extruded Aluminum with Thermal break
Drain Pan material - S.S. 304
Insulation Nitrile Rubber
Drain Pan Thickness G 18
Drain Pan insulation details-Nitrile rubber insulation
Socket size mm 40
1.A Supply Decker
Capacity CFM 17970
Static pressure mmwg 65
Length mm 4510
Width mm 2080
Height mm 2080
2. FAN
Type - Centrifugal DIDW type
Make - NICOTRA
MOC
Page 11 of 24
LTD (Factory 2)

Fan Pulley Size 2A-315-50
Serial Number - BF19070173
Location - Fan selection
Air quantity CFM 17970
Static pressure mmwg 65
Model - RDH 800 K
Fan speed RPM 873
3. MOTOR
Make - SIEMENS
Type - NON FLP
Motor RPM RPM 1460
Motor KW KW 11
Serial Number - 1904 66 30682082
Pulley size - 2A-180-42
Belt Size - SPA 2880
Motor mounting support - 6
4. COOLING COIL
Make - Airco Engineering Works
Type - CHW COOLING COIL
Total Coil Capacity TR 26.2
Tube Material - Copper
Fin material - Aluminum
No. of fins - 10 - 12 Fins per inch 0.15mm
Coil Area Sq. ft.
26
Rows 6
Face area (H x L) mm 1365 X 1770
Header mm 60
5. PRE FILTER
Supply Decker
Type - EU 4 (Flange Type)
Make - FINE AIRSYS / MECHMAARK
Size(H x W x D) MM 610 X 610 X 50 – 9 NOS
Efficiency - 90% down to 10µ
Media - Synthetic
MOC - Aluminum
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LTD (Factory 2)

MFIPL-PFJ19-21274
MFIPL-PFJ19-24441
MFIPL-PFJ19-21276
MFIPL-PFJ19-21275
Filter serial No. MFIPL-PFJ19-21272
MFIPL-PFJ19-21273
MFIPL-PFJ19-21259
MFIPL-PFK19-24439
- MFIPL-PFK19-24440
6. MICROVEE FILTER
Supply Decker
Size(H x W x D) MM 610 X 610 X 300 – 9 NOS
Media - Synthetic
MOC - Aluminum
MFIPL-FFI20-3565
MFIPL-FFI20-3572
MFIPL-FFI20-3554
MFIPL-FFI20-3573
Filter serial No. - MFIPL-FFI20-3574
MFIPL-FFI20-3555
MFIPL-FFI20-3564
MFIPL-FFI20-3557
MFIPL-FFI20-3567
7. FRESH AIR FILTER

Supply Decker
Size(H x W x D) MM 400 X 950 X 30 – 1 NO
Media - Synthetic
MOC - Aluminum
Filter serial No. - R-14163
Page 13 of 24
LTD (Factory 2)
8. BLEED AIR FILTER

Supply Decker
Size(H x W x D) MM 400 X 950 X 30 – 1 NO
Media - Synthetic
MOC - Aluminum
Filter serial No. - R-10785
9. DRAIN DETAILS
MOC - Upvc
Drain Socket size mm 40
Insulation thickness mm 9
Drain Line size mm 40
9.0 TECHNICAL DATA OF ANCILLARY ITEMS
SR.NO. DESCRIPTION ACCEPTANCE CRITERIA

1. DUCTS
Manufacture of sheet ASAWA Insulation
Material Of sheet PIR ducting sheet
Zinc coating thickness As Per SMACNA Standards
Flange MOC PVC
Sealant Non Acidic Vulcanizing
2. DAMPERS
Make SA Air / Ruskin Titus
Material Aluminium Damper
Operation mode Manually Operated Al. Damper
Supply Air Damper (H x W) mm 750 X 1400
Return Air Damper (H x W) mm 550 X 1980
Fresh Air Damper (H x W) mm 350 X 900
Purge Air Damper (H x W) mm 350 X 900
Bypass Air Damper (H x W) mm 460 X 1760 mm
Page 14 of 24
LTD (Factory 2)

3. FIRE DAMPER
Make Carrier
MOC GI
Location Supply and Return duct
Type Flange
Operating Fusible Link operated
Supply 750 X 1400 1 No
Size (H XW) Return 550 X 1980 1 No
4. ROOM PRESSURE
Instrument Magnehelic Gauges
Make Omicron
Model H2300-10MM
Location Inside Room
Range -5 to +5 mm of WG
5. DIFFERENTIAL PRESSURE ACROSS AHU FILTERS

Instrument Magnehelic gauges
Model No H2000-25mmwc
H2000-50mmwc
Make OMICRON
0-25 mm of WC (Pre Filter),
Range
0-50 mm WC (Fine Filter)
6. SUPPLY/ RETURN AIR DIFFUSER WITH ROOM OPERATED VOLUME

CONTROL DAMPER
7.1 SUPPLY AIR DIFFUSER
MOC Al Powder Coated
Make SA Air / Ruskin
QTY
ROOM NAME
NECK SIZE(H x W) MM (Nos.)
Reject 225 X 225 2
Dedusting 275 X 275 3
Receiving Bay 300 X 300 3
Clean Pallet Area 225 X 225 3
Wash 225 X 225 1
Cold Storage Room 300 X 300 2
7.2 RETURN AIR DIFFUSER

Page 15 of 24
LTD (Factory 2)

QTY
ROOM NAME
NECK SIZE(H x W) MM (Nos.)
Reject 225 X 225 2
Receiving Bay 300 X 300 3
Clean Pallet Area 225 X 225 3
Wash 225 X 225 1
Cold Storage Room 300 X 300 2
7. SUPPLY/ RETURN AIR GRILLES WITH ROOM OPERATED VOLUME

CONTROL DAMPER
7.1 SUPPLY AIR GRILL
ROOM NAME SIZE( H x W ) MM QTY (Nos.)
Approved Raw Material Store 450 X 450 17
Under Test RM Store 375 X 375 6
7.2 RETURN AIR GRILL

ROOM NAME SIZE( H x W ) MM QTY (Nos.)
Approved Raw Material Store 450 X 450 18
Under Test RM Store 375 X 375 7
8. PIPPING AND MANIFOLD DETAILS:

CHILLED WATER MANIFOLD
Pipe size 65mm
Pipe Class C
Make Jindal
MOC MS Steel
Line size 65 mm
Insulation MOC Nitrile Rubber with Al foil
Make Armaflex/Armacell
Thickness 32 mm
Butterfly Valve Size 65 mm
Make Honeywell
MOC Carbon steel
Page 16 of 24
LTD (Factory 2)

Qty. 5 Nos
Type Wafer type
Location Supply/Return
Y strainer Size 65 mm
Make Sant/Hammer
MOC Rubber Gasket Body
Qty. 1 No
Location Supply
Drain Valve Size 15 mm
Make Honeywell/KCR
MOC Brass Body
Qty. 1 No
Auto air Vent 15 mm
Make Anergy/Honeywell
MOC Brass
Qty. 1 No
Flanges ASME 16.5 # 150
Location Return
Balancing Valve Size 65 mm
MOC Forged Brass to IS6912 Gr. FLB Body
Make Castle
Qty. 1 No
Location Return
Three Way Control Valve 50 mm
MOC Ductile Iron ASTM A395 Grade 60-40-18
Make Honeywell
Qty. 1 No
Actuator Size
Make Honeywell
Qty. 1
Model CN7510A2001
Location Return
Temperature Gauge
Make TIC
Qty. 2
Location Supply and Return
Page 17 of 24
LTD (Factory 2)

Pressure Gauge
Make GL
Qty. 2
Location Supply and Return
9. ELECTRICAL PANEL
MOC CRCA Sheet
Make HVAX Technologies Pvt. Ltd.
Body Thickness – 1.6 mm
Thickness
Door Thickness – 1.6 mm
Cable Entry / Protection Top Entry / IP54
9.1 VFD
Make Danfoss (FC360)
Rating 11 KW
Frequency 50Hz ±10%
Serial No. 6514024A229
9.2 LOCAL PUSH BUTTON
Make Schneider
1 Nos. for on condition.
Control push button
1 Nos. for emergency stop condition.
Control supply 230V AC 50Hz
Location Near AHU
9.3 LIMIT SWITCH WITH MARINE LIGHT
Make Standard
Quantity 01
Location Inside AHU
Marine Light quantity 01
Watt 9
10. HEATER & AIRSTAT

Type Strip Heaters
CFM 17970
RH % NMT 55
Duct Size 750 X 1400
Selected KW 18
Heater Bank 6 Kw x 3 Nos.
AIRSTAT
Make Standard
Supply Supply Duct line
Type AAA-11
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LTD (Factory 2)
Range 20-75
Location Supply duct
11. TEMPERATURE CONTROLLER

Make. SELEC
Range 0-50 deg C
Serial No. NA
Location Control Panel
Qty (Nos) 1
12. RH CONTROLLER
Make. SELEC
Range 0-99%
Serial No. NA
Location Control Panel
Qty (Nos) 1
13. RH SENSOR
Make. BELIMO
Range 0-99%
Qty (Nos) 1
Serial No. 22DTH-13M
Location Return Duct Line
14. TEMPERATURE SENSOR

Make. BELIMO
Range 0-99%
Qty (Nos) 1
Serial No. 22DTH-13M
Location Return Duct Line
15. AIR VELOCITY

Make. NA
Range NA
Serial No. NA
Location NA
Qty (Nos) NA
Page 19 of 24
LTD (Factory 2)
Checked By:____________________ Date: _____________
10.0 OBSERVED DEVIATION (IF ANY)
Details of deviation:
Corrective Action to Be Taken:
_____________________ ___________________
Prepared By / Date Checked By / Date
Page 20 of 24
LTD (Factory 2)
11.0 FINAL REPORT
Prepared By: ____________________ Date: ________________
12.0 ABBREVIATIONS
Abbreviation Description
DQ : Design Qualification
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LTD (Factory 2)
AHU : Air Handling Unit

P&I : Process and instrument
QA : Quality Assurance
URS : User Requirement Specification
CGMP : Current Good Manufacturing Practices
HVAC : Heating Ventilation and Air Conditioning
ISO : International Standard Organization
EU : Euro vent
HEPA : High Efficiency Particulate Air
RPM : Rotation Per Minute
ACPH : Air Changes per hour
CFM : Cubic feet per minute
FPM : Feet per minute
WC : Water column
CMH : Cubic meter per hour
TR : Ton of refrigeration
MOC : Material of construction
HZ : Hertz
VFD : Variable frequency drive
KW : Kilowatts
NB : Nominal bore
CFU : Colony forming unit
SMACNA : Sheet metal and air conditioning contractor’s national
association.
GA : General Arrangement
GI : Galvanized Iron
Al : Aluminum
TEFC : Totally Enclosed Fan Cooled
WG : Water Gauge
°C : Degree Celsius
% : Percentage
Mm : Millimeter
dB : Decibel
NC : Not Control
NMT Not More than
PIR Pre Insulated Duct
REFERENCE DOCUMENTS
Page 22 of 24
LTD (Factory 2)
Sr. No. Title Document No

1 Room Data Sheet 1820/HVAC/RDS
2 AHU General Arrangement Drawing Refer AHU GAD
13.0 DOCUMENTS ENCLOSED:
Following documents are provided with DQ
Sr.No. Documents Checked By

1. AHU Zoning
2. Pressure Zoning
3. Ducting Layouts
4. RCP
5. AHU GA Drawings
6. Technical data sheet of fan
7. Blower performance curve
8. Hydro test Report
9. Electrical drawing
10. Leak Test report
All Type of instruments/devices
11.
test report
14.0 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.
Page 23 of 24
LTD (Factory 2)
Prepared By
Signature Date
(HVAX TECHNOLOGEIS PVT LTD.)
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
Engineering Head Signature Date
(M/s. LETAP PHARMACEUTICAL LTD.)
Reviewed By
QC Head Signature Date
The approver’s signature indicates that the documentation and information contained herein
complies with applicable regulatory, corporate, divisional / departmental and cGMP
requirements.
Approved By
QA Head Signature Date
Page 24 of 24

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Document No. 1820/HVAC/DQ/LET/AHU-G01 Effective Date. 30/10/2023

AHU No. G01 Next Revision As Required

Document No. 1820/HVAC/DQ/LET/AHU-G01 Effective Date. 30/10/2023

AHU No. G01 Next Revision As Required

4.0 DESIGN QUALIFICATION CRITERIA........................................................................5

5.0 SYSTEM FEATURES........................................................................................................7

6.0 PRINCIPLE OF WORKING.............................................................................................8

7.0 SYSTEM DESCRIPTION..................................................................................................9

8.0 AHU COMPONENT SPECIFICATION........................................................................11

9.0 TECHNICAL DATA OF ANCILLARY ITEMS................................................11 To 19

10.0 OBSERVED DEVIATION (IF ANY).............................................................................20

11.0 FINAL REPORT...............................................................................................................21

13.0 DOCUMENTS ENCLOSED............................................................................................23

14.0 POST APPROVAL:..........................................................................................................24

Document No. 1820/HVAC/DQ/LET/AHU-G01 Effective Date. 30/10/2023

AHU No. G01 Next Revision As Required

Name Department Designation Signature Date

Name Department Designation Signature Date

Document No. 1820/HVAC/DQ/LET/AHU-G01 Effective Date. 30/10/2023

AHU No. G01 Next Revision As Required

4.0 DESIGN QUALIFICATION CRITERIA

Document No. 1820/HVAC/DQ/LET/AHU-G01 Effective Date. 30/10/2023

AHU No. G01 Next Revision As Required

4.1 AIR QUALITY REQUIRED:

Class Maximum Particles per m3 at Rest

4.3 AHU BASIS OF DESIGN

Document No. 1820/HVAC/DQ/LET/AHU-G01 Effective Date. 30/10/2023

AHU No. G01 Next Revision As Required

Design Relative Design Temperature

Approved Raw Material Store NMT 55% 25+/-2 C

Fresh Air CFM 0

5.0 SYSTEM FEATURES

Document No. 1820/HVAC/DQ/LET/AHU-G01 Effective Date. 30/10/2023

AHU No. G01 Next Revision As Required

The following are the main features of the system:

 Manually Operated Return Air Damper.

6.0 PRINCIPLE OF WORKING

Document No. 1820/HVAC/DQ/LET/AHU-G01 Effective Date. 30/10/2023

AHU No. G01 Next Revision As Required

Document No. 1820/HVAC/DQ/LET/AHU-G01 Effective Date. 30/10/2023

AHU No. G01 Next Revision As Required

Document No. 1820/HVAC/DQ/LET/AHU-G01 Effective Date. 30/10/2023

AHU No. G01 Next Revision As Required

7.1.4.1 Electrical Panels:

Document No. 1820/HVAC/DQ/LET/AHU-G01 Effective Date. 30/10/2023

AHU No. G01 Next Revision As Required

8.0 AHU COMPONENT SPECIFICATION

Sr. No. Description Unit Technical Details

Document No. 1820/HVAC/DQ/LET/AHU-G01 Effective Date. 30/10/2023

AHU No. G01 Next Revision As Required

Sr. No. Description Unit Technical Details

Document No. 1820/HVAC/DQ/LET/AHU-G01 Effective Date. 30/10/2023

AHU No. G01 Next Revision As Required

Sr. No. Description Unit Technical Details

7. FRESH AIR FILTER

Document No. 1820/HVAC/DQ/LET/AHU-G01 Effective Date. 30/10/2023

AHU No. G01 Next Revision As Required

Sr. No. Description Unit Technical Details

8. BLEED AIR FILTER

SR.NO. DESCRIPTION ACCEPTANCE CRITERIA

Document No. 1820/HVAC/DQ/LET/AHU-G01 Effective Date. 30/10/2023

AHU No. G01 Next Revision As Required

Checked By:________ Date: _

Prepared By: ____ Date: