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LETAP PHARMACEUTICAL
LTD (Factory 2)
Site/Location: ACCRA, GHANA.
DESIGN QUALIFICATION OF
HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
DESIGN QUALIFICATION
OF
HEATING VENTILATION & AIR CONDITIONING
SYSTEM
FOR
SYSTEM ID: AHU-G18A
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 23
Client: M/s. LETAP PHARMACEUTICAL
LTD (Factory 2)
Site/Location: ACCRA, GHANA.
DESIGN QUALIFICATION OF
HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
TABLE OF CONTENTS
1.0 PRE-APPROVAL...............................................................................................................3
2.0 OVERVIEW........................................................................................................................4
3.0 PRE-REQUISITES.............................................................................................................4
12.0 ABBREVIATIONS...........................................................................................................21
Page 2 of 23
Client: M/s. LETAP PHARMACEUTICAL
LTD (Factory 2)
Site/Location: ACCRA, GHANA.
DESIGN QUALIFICATION OF
HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
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.
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 23
Client: M/s. LETAP PHARMACEUTICAL
LTD (Factory 2)
Site/Location: ACCRA, GHANA.
DESIGN QUALIFICATION OF
HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
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 HVAX/LP/AHU/122/2018-19
the vendor
Page 4 of 23
Client: M/s. LETAP PHARMACEUTICAL
LTD (Factory 2)
Site/Location: ACCRA, GHANA.
DESIGN QUALIFICATION OF
HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Page 5 of 23
Client: M/s. LETAP PHARMACEUTICAL
LTD (Factory 2)
Site/Location: ACCRA, GHANA.
DESIGN QUALIFICATION OF
HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Design Condition
Design Relative Design Temperature
Room Name
Humidity (%) (°C)
Selected Capacity
Page 6 of 23
Client: M/s. LETAP PHARMACEUTICAL
LTD (Factory 2)
Site/Location: ACCRA, GHANA.
DESIGN QUALIFICATION OF
HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
This Air handling system having a supply air fan capacity of 2480 CFM which supplies
the conditioned air to ISO Class 8 area.
Page 7 of 23
Client: M/s. LETAP PHARMACEUTICAL
LTD (Factory 2)
Site/Location: ACCRA, GHANA.
DESIGN QUALIFICATION OF
HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
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 riser with filter. 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
Terminal HEPA. Return air is sucked from respective rooms via return air ducts with insulation
on duct & through the return air Riser.
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.
Page 8 of 23
Client: M/s. LETAP PHARMACEUTICAL
LTD (Factory 2)
Site/Location: ACCRA, GHANA.
DESIGN QUALIFICATION OF
HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
7. SYSTEM DESCRIPTION:
7.1 Low side System:
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
Page 9 of 23
Client: M/s. LETAP PHARMACEUTICAL
LTD (Factory 2)
Site/Location: ACCRA, GHANA.
DESIGN QUALIFICATION OF
HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
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
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
G-18A 2480 4.7 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
Page 10 of 23
Client: M/s. LETAP PHARMACEUTICAL
LTD (Factory 2)
Site/Location: ACCRA, GHANA.
DESIGN QUALIFICATION OF
HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
2. FAN
Type - Centrifugal Plug Type Backward Curved
Make - NICOTRA
MOC - MS
Fan Pulley Size - NA
Page 11 of 23
Client: M/s. LETAP PHARMACEUTICAL
LTD (Factory 2)
Site/Location: ACCRA, GHANA.
DESIGN QUALIFICATION OF
HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
3. MOTOR
Make - SIEMENS
Type - NON FLP
Motor RPM RPM 2910
Motor KW KW 2.2
Serial Number - 1905 66 30699498
Pulley size - NA
Belt Size - NA
Motor mounting support Pair - 6
4. COOLING COIL
Make - Airco Engineering Works
Type - CHW COOLING COIL
Total Coil Capacity TR 4.7
Tube Material - Copper
Fin material - Aluminum
No. of fins - 10 - 12 Fins per inch 0.15mm
Coil Area Sqft. 4.95
Rows 6
Face area (H x L) mm 571 X 805
Header size mm 50
5. 5 PRE FILTER
Supply Decker
Type - EU 4 (Flange Type)
Make - FINE AIRSYS / MECHMAARK
610 X 610 X 50 – 1 NO,
Size(H x W x D) MM
610X305X50-1 NO
Efficiency - 90% down to 10µ
Filter serial No. - R-40808
MFIPL-PFC19-37466
Page 12 of 23
Client: M/s. LETAP PHARMACEUTICAL
LTD (Factory 2)
Site/Location: ACCRA, GHANA.
DESIGN QUALIFICATION OF
HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
6. MICROVEE FILTER
Supply Decker
Type - EU 7 (Flange Type)
Make - FINE AIRSYS / MECHMAARK
610 X 610 X300 –1 NO,
Size(H x W x D) MM
610X305X300-1 NO
Efficiency - 95% down to 5µ
MFIPL-FFB18-498
Filter serial No.
- R-40907
Media - Synthetic
Frame MOC - Aluminum
9. DRAIN DETAILS
MOC UPVC
Page 13 of 23
Client: M/s. LETAP PHARMACEUTICAL
LTD (Factory 2)
Site/Location: ACCRA, GHANA.
DESIGN QUALIFICATION OF
HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
2. DAMPERS
Make SA Air / Ruskin Titus
Material Manually Operated Al. Damper
Supply Air Damper (H x W) mm 350 X 450
Return Air Damper (H x W) mm 350 X 450
Fresh Air Damper (H x W) mm 200 X 200
Purge Air Damper (H x W) mm 200 X 200
Bypass Air Damper (H x W) mm NA
3. FIRE DAMPER
Make Carrier
MOC GI
Type Flange
Operating Fusible Link operated
Actuator Make NA
Supply 350 X 450 1 No
Size (H XW) Return 350 X 450 1 No
4. ROOM PRESSURE
Instrument Magnehelic Gauges
Make Omicron
Model H2300-10MM
Location Inside Room
Range -5 to +5 mm of WG
7. RISER
MOC 18 G GI
Make HVAX Technologies Pvt. Ltd.
ROOM NAME SIZE( H x W ) MM QTY (Nos.)
Compression Room - I 750 X 100 3
Page 15 of 23
Client: M/s. LETAP PHARMACEUTICAL
LTD (Factory 2)
Site/Location: ACCRA, GHANA.
DESIGN QUALIFICATION OF
HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
MOC MS Steel
Line size 32 mm
Insulation MOC Nitrile Rubber with Al foil
Make Armaflex/Armacell
Thickness 32 mm
Ball Valve Size 32 mm
Make Giacomini
MOC Carbon steel
Qty. 5 Nos
Type Wafer type
Location Supply/Return
Y strainer Size 32 mm
Make Sant/Hammer
MOC Rubber Gasket Body
Qty. 1 No
Type Y
Location Supply
MS Class C pipe 32 mm
Make Jindal
MOC MS steel
Auto air Vent 15 mm
Make Anergy/Honeywell
MOC Brass
Qty. 1 No
Flanges ASME 16.5 # 150
Location Return
Balancing Valve Size 32 mm
MOC Forged Brass to IS6912 Gr. FLB Body
Make Castle
Qty. 1 No
Location Return
Three Way Control Valve 25 mm
MOC Ductile Iron ASTM A395 Grade 60-40-18
Make Castle
Qty. 1 No
Actuator Size
Make Honeywell
Qty. 1
Page 16 of 23
Client: M/s. LETAP PHARMACEUTICAL
LTD (Factory 2)
Site/Location: ACCRA, GHANA.
DESIGN QUALIFICATION OF
HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Model CN7510A2001
Location Return
Temperature Gauge
Make TIC
Qty. 2
Location Supply and Return
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 2.2 KW
Frequency 50Hz ±10%
Serial No. 562302A239
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
Page 17 of 23
Client: M/s. LETAP PHARMACEUTICAL
LTD (Factory 2)
Site/Location: ACCRA, GHANA.
DESIGN QUALIFICATION OF
HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
RH % NMT 55
Duct Size 350X450 mm
Selected KW 9.0
Heater Bank 1.5Kw x 3 Nos x 2 Sets
AIRSTAT
Make Standard
Location Supply Duct line
Type AAA-11
Range 20-75
Location Supply duct
12. RH CONTROLLER
Make. SELEC
Range 0-99%
Qty (Nos) 1
Serial No. NA
Location Control panel
13. RH SENSOR
Make. BELIMO
Range 0-99%
Qty (Nos) 1
Serial No. 22DTH-13M
Location Return duct line
Page 18 of 23
Client: M/s. LETAP PHARMACEUTICAL
LTD (Factory 2)
Site/Location: ACCRA, GHANA.
DESIGN QUALIFICATION OF
HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Details of deviation:
________________
__________________
Prepared By / Date Checked By / Date
Page 19 of 23
Client: M/s. LETAP PHARMACEUTICAL
LTD (Factory 2)
Site/Location: ACCRA, GHANA.
DESIGN QUALIFICATION OF
HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
Page 20 of 23
Client: M/s. LETAP PHARMACEUTICAL
LTD (Factory 2)
Site/Location: ACCRA, GHANA.
DESIGN QUALIFICATION OF
HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
12.0 ABBREVIATIONS
Abbreviation Description
DQ : Design Qualification
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
Page 21 of 23
Client: M/s. LETAP PHARMACEUTICAL
LTD (Factory 2)
Site/Location: ACCRA, GHANA.
DESIGN QUALIFICATION OF
HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
REFERENCE DOCUMENTS
Page 22 of 23
Client: M/s. LETAP PHARMACEUTICAL
LTD (Factory 2)
Site/Location: ACCRA, GHANA.
DESIGN QUALIFICATION OF
HEATING VENTILATION AND AIR CONDITIONING (HVAC) SYSTEM
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
Engineer Head Signature Date
(M/s. LETAP PHARMACEUTICAL LTD.)
Reviewed By
QC Head Signature Date
(M/s. LETAP PHARMACEUTICAL LTD.)
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
(M/s. LETAP PHARMACEUTICAL LTD.)
Page 23 of 23