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Design Qualification Document OF Air Handling Unit (Ahu-09)
Design Qualification Document OF Air Handling Unit (Ahu-09)
TABLE OF CONTENTS
1.0 PURPOSE 4
2.0 SCOPE 4
3.0 RESPONSIBILITY 5
II. DEHUMIDIFIER 11
7.2.6 DUCTING 14
10.0 ATTACHMENTS 23
11.0 ABBREVIATIONS 24
13.0 CONCLUSION 26
1.0 PURPOSE:
To Document & demonstrate that the AHU-09 is designed as per the approved specifications to
meet the respective area requirements and other regulatory guideline requirements.
To design and document the HVAC system of AHU-09 for manufacturing facility at .
The complete facility is to be designed as per regulatory requirement, comply with the following
cGMP critical parameters as prescribed in the URS:
1. Environmental conditions - Air Cleanliness Classification levels and Microbiological Levels
2. Non-Unidirectional air flow (Grade C & Grade D Area)
3. Temperature.
4. Relative humidity.
5. Differential pressure to provide assurance against contamination from lower grade
environments.
2.0 SCOPE:
Design, engineering, testing, validation and documentation of Low Side HVAC System comprising
of the following main equipments:
1. AHUs
2. Supply air Terminal Filters
3. Return air risers
4. Instrumentation and Controls including Room side –Digital Indicators to maintain – room
pressure differentials, Temperature & Relative Humidity.
5. Volume Control Dampers & Fire Dampers
6. GI Ducting, Duct thermal Insulation
7. CHW MS Piping and Insulation
8. Distribution of Chilled Water System comprising of piping valves, fittings.
DESIGN QUALIFICATION
SYSTEM NAME AIR HANDLING UNIT PAGE NO.
SYSTEM NUMBER AHU-09 5 of 28
DOCUMENT NO VEPL/HPPL/DQ/S09 REV NO: R0
3.0 RESPONSIBILITY:
3.1 VEPL
3.1.1 Design, Engineering & provide the complete technical details of the HVAC system
3.1.2 Documentation preparation.
3.1.3 To control work specification of sub contractor.
3.1.4 To control specification of all components.
3.1.5 Safety features & alarms.
3.1.6 Pre-installation requirements.
3.1.7 To ensure unauthorized or unrecorded design modification does not take place.
3.1.8 To confirm safe delivery of equipment to site.
3.1.9 Demonstration of design to comply with the requirement.
3.1.10 Project Manager / Project Engineer of VEPL are responsible for verifying the design specifications
and Execution of the project.
3.2 HPPL.
3.2.1 Project Engineer is responsible for checking of the qualification documents
3.2.2 Formulation/Analytical services is responsible for review of the qualification documents
3.2.3 Technical services is responsible for review & approval of the qualification documents
3.2.4 QA is responsible for review and authorization of reports/qualification documents.
4.1 The HVAC system shall be designed to provide Air-conditioning and Ventilation for the following
areas.
DESIGN QUALIFICATION
SYSTEM NAME AIR HANDLING UNIT PAGE NO.
SYSTEM NUMBER AHU-09 6 of 28
DOCUMENT NO VEPL/HPPL/DQ/S09 REV NO: R0
Non-walk able ceiling shall be provided above the classified process areas. All the cutouts done
for fixing HEPA filters shall be opened from clean room side for maintenance purpose. All the
AHU’s has been placed in 2nd floor service area in the specific planned locations to keep
minimum distance from usage area. Filtered and treated air from AHU-09 is fed to the air
conditioning space of that particular zone by means of GI ducting.
For all the classified areas, the supply air is provided from ceiling mounted HEPA filters, the
return air shall be picked up from return air risers/space between two panels and collected in
return air ducting and shall be taken back to the AHU-09. Supply air ducting shall be insulated
with 13mm thickness and as well as return air ducting shall be insulated with 9mm & 13mm
thickness (9mm Insulation for the ducts above ceiling, 13mm insulation for the ducts exposed to
environmental conditions) insulation & shall be laminated with Aluminum foil for the exposed
ducts in service area.
The AHU Service area located at 2nd floor level. The Fresh Air for AHU-09 shall be taken from
ambient.
5.0 STANDARDS & GUIDELINES
Room Name Room Area in Ft2 False Ceiling Height Ft Room Volume in Ft3
GRANULATION 273.44 8.69 2377
MATERIAL IN 50.32 7.87 396
MATERIAL OUT 56.51 7.87 445
STAFF ENTRY 43.86 7.87 345
Temperature
Season Relative Humidity
Dry Bulb Wet Bulb Dew Point
Summer 96°F 78°F 71°F 45%
Monsoon 82°F 78°F 76°F 82%
Winter 58°F 54°F 51°F 78%
6.4 OCCUPANCY, EQUIPMENT LOAD, AREA CLASSIFICATION, DESIGN AIR CHANGES, ROOM AIR
QUANTITY, TOTAL AIR QUANTITY & TOTAL COOLING LOAD REQUIREMENTS:
Area Room Selected
Equip. Design Total Cooling
Room Name Occupancy Classification wise Air AHU
Load ACPH Load
Qty Capacity
Number KW Class Number CFM TR CFM
GRANULATION 1 20 30 3093
MATERIAL IN 30 198
100K 10TR 5050
MATERIAL OUT 30 222
STAFF ENTRY 1 30 173
Temperature Control: Temperature Control is achieved by Cooling. Sensible & latent heat
is removed from the Air Stream by the Chilled Water Cooling Coil in the AHU.
Relative Humidity: Relative Humidity is achieved by providing Dehumidifier connected to
AHU-09, part of humidified air coming from return air duct passing through dehumidifier,
get dehumidified and dehumidified air will pass through AHU and respective rooms.
Reduction of moisture content in air stream take place through chilled water cooling coil
and dehumidifier, the conditioned air is delivered to the respective clean rooms through the
insulated ducting system.
floor by means of actuator installed at the stem of valve and actuated by return air
temperature sensor installed at return Air duct, which senses temperature of return Air. If
the temperature inside process room goes above required design temperature it energize the
motor inside the actuator that pulls the rod and open the orifice of the valve making
direction of flow in such a way that chilled water circulates from AHU coils occurring more
heat absorption and temperature reduction.
Now if the temperature lowers down below required conditioned limits due to continuous
heat absorption return air sensor sense and de energize the motor inside actuator which
again push the rod and disc and closing the circuit of cooling coil, restricts the flow of
chilled water from cooling coil and making the flow from bypass line which is connected
between inlet and out let manifolds of the AHU. This chilled water then enters in to
balancing valve that regulates pressure differential in the outlet line. Balancing valve consist
of threaded stem, disc, one port before disc and another after disc. The purpose of
balancing Valve is to regulate the chilled water flow rate across chilled water piping as per
designed water flow rate with respect to cooling load requirement, ensuring adequate water
flow across the pipe line. This chilled water then returns back to the chiller for further
chilling process. This circulation of chilled water repeated through closed loop pipe network.
Parameters Specifications
Capacity 5050 CFM@160 mm of wc Static Pressure.
Over all Dimension 5239 L X 1450 W X 1150H in mm.
BLOWER
Parameters Specifications
Type / Model BDB355T DRAUGHT FAN
DESIGN QUALIFICATION
SYSTEM NAME AIR HANDLING UNIT PAGE NO.
SYSTEM NUMBER AHU-09 11 of 28
DOCUMENT NO VEPL/HPPL/DQ/S09 REV NO: R0
Parameters Specifications
Rating/Pole 7.5 KW / 2 Pole
Speed in RPM 2916 RPM
COOLING COIL
Parameter Specification
Type Chilled Water Cooling Coil
Coil Header Size 1.5” NB Copper Tube with M S End Connection
Coil Size and Face Area 1.1m x 0.92m & 10.89 Sqft.
No of Rows 8 Rows
Temp at inlet (+) 7 + 1 °C
Temp at outlet (+) 12 + 1 °C
Parameters Specifications
FRESH AIR CAPACITY 184 CFM
DIMENSIONS 600x600x550MM
MOC CASING ALUMINUN PROFILES WITH 2MM THK
OUTER SKIN 0.63 MM PRE COATED & PRE PLASTIC
DESIGN QUALIFICATION
SYSTEM NAME AIR HANDLING UNIT PAGE NO.
SYSTEM NUMBER AHU-09 13 of 28
DOCUMENT NO VEPL/HPPL/DQ/S09 REV NO: R0
(REFER ATTACHED DE-HUMIDIFIER G.A DRAWING, PRE-COOLING COIL G.A DRAWING WITH
TECHNICAL SPECIFICATIONS SHEET ATTCHED WITH THIS DOCUMENT.)
Parameter Specification
Return air- humidified air is being sucked in to the mixing chamber of AHU, where it is mixed
with Fresh air. Fresh air is meant for makeup and to maintain indoor air quality. Mixed air is
filtered thru pre filter (EU-4) and passed thru cooling coil, BDB355T DRAUGHT FAN blower is
to be used for supplying air. Make up air changes for each room is considered according to
the Room Data Sheet and AHU wise Airflow Schematic Drawing.
In the HVAC system AHU (Air Handling Unit), dehumidified and filtered air supplied to
maintaining required environment condition in the various area thru GSS ducting. Air
distribution is enabled by Factory Fabricated GSS supply and return air ducts. The supply air
duct joints are sealed with silicon sealant. Flange joints are provided with min 5mm thick
Neoprene gasket Treated conditioned air is supplied in the room through HEPA filter /
Diffuser installed at terminal in the Non-Walk able Ceiling. Airflow through each HEPA
Filters/Diffusers is controlled by volume control damper. This circulation of airflow repeated
continuously.
DESIGN QUALIFICATION
SYSTEM NAME AIR HANDLING UNIT PAGE NO.
SYSTEM NUMBER AHU-09 15 of 28
DOCUMENT NO VEPL/HPPL/DQ/S09 REV NO: R0
7.2.6 DUCTING:
Parameter Specification
G.I. Sheet metal Ducting – Prefabricated ducts
MOC
24G (0.6MM), 22G (0.8MM), 20G (1.0MM)
Fabrication SMACNA standards
Duct Sizing Design Duct Sizing Design done based on Air Velocity Method.
Duct size As per duct layout attached.
Duct Leak Test Through Smoke test at site
Pressure
Application For distribution of conditioned air from air handling unit to
The designated areas.
Joint Sealing:
Flange joints Rubbers gasket & RTV sealant.
Leak Testing Air supply with blower is to be blown in the duct & leak
testing to be done by the duct smoke testing
The deflection of transverse joints should be within specified limit for rectangular duct
deflection as given in SMACNA. Reinforcement of ducts shall be achieved by either cross
breaking or straight beading depending on length of ducts.
Parameter Specification
Nitrile Rubber / closed cell polyethylene elastomeric
MOC
foam insulation with aluminum foil.
Thickness of supply duct 13MM
Thickness of return duct 9MM/13MM
Thermal conductivity 0.029 to 0.035 W/m K at 230 C
Density 25 to 30 Kg/m3
Moisture absorption Non hydroscopic
Temperature Range -40°C to +115°C
Parameter Specification
Body 16 G Aluminum sheet
Louvers 16 G Aluminum sheet
Bush ALUMINUM
Size / Qty 300 Hx300 L mm –9 No.
Type Opposed blade
the frame head providing maximum air passage and preventing passing air current from creating
noise chatter. The blades shall be held in position through fusible links.
The thrust of the suddenly released tension shall instantly drive the blades down and keep it down
without the use of springs, weights or other devices subject to failure. Fire damper sleeves and
access doors shall be provided within the ducts in accordance with the manufacturer’s
recommendations.
Parameters Specifications
Body 18 G GI sheet
Louvers 18 G GI sheet
Fire Rating 90 Minutes
Size/Qty (for return) 550L x 550W mm– 1 No
Type Opposed blade
Parameters Specifications
Location Air Handling Unit
Range 0-50 MM WC
Quantity 2 Nos.
Housing Die cast aluminum case and bezel with acrylic cover
Accuracy (+/-)2% of F.S
Dial size 4"
Process connection 1/8" NPT Female
Parameters Specifications
Location IN AIR CONDITIONED AREA
Range 0 to 10mm WC
Quantity 1 Nos.
Power 24 Volts D.C Typical
Accuracy ±0.5% of F.S
DESIGN QUALIFICATION
SYSTEM NAME AIR HANDLING UNIT PAGE NO.
SYSTEM NUMBER AHU-09 18 of 28
DOCUMENT NO VEPL/HPPL/DQ/S09 REV NO: R0
Parameters Specifications
Location IN AIR CONDITIONED AREA
Range for Differential Pressure 0 to 10mm WC
Range for Temperature 0 to +50 OC
Range for RH 0.0 to 100.0 %RH
Quantity 3 Nos.
Power 24 Volts D.C Typical (250 Ma)
Accuracy for Differential Pressure ±0.5% of F.S
Accuracy for Temperature ±0.5 OC of F.S
Accuracy for RH ±1.8% for 10 to 95 %RH For Relative Humidity indicator
Communication Isolated RS485 RTU Modbus Protocol
Spacing of pipe supports shall not be more than that specified below:
Nominal Pipe Size (mm) Spacing (m)
12 and 15 1.25
20 and 25 2.00
32, 40, 50 and 65 2.50
80, 100 and 125 2.50
DESIGN QUALIFICATION
SYSTEM NAME AIR HANDLING UNIT PAGE NO.
SYSTEM NUMBER AHU-09 19 of 28
DOCUMENT NO VEPL/HPPL/DQ/S09 REV NO: R0
Spacing of pipe supports shall not be more than that specified below:
150 and above 3.00
Extra support shall be provided at the bends and heavy fittings like valves to avoid undue
stresses on the pipes. Pipe hangers shall be fixed on walls and ceiling by means of metallic
or expansion fasteners. Vertical risers shall be parallel to walls and column lines and shall be
straight and plump. Risers passing from floor to floor shall be supported at each floor by
clamp or collars attached to pipe with a 12 mm thick rubber pad. Risers shall also have
suitable elbow or concrete pipe support at the lowest point.
Pipe sleeves of 50 mm or larger diameter shall be provided wherever pipes pass through walls
and the annular space filled with felt and finished with retaining rings.
Insulated piping shall be supported in such a manner as not to put undue pressure on the
insulation. All pipes using screwed fittings shall be accurately cut to the required sizes and
threaded in accordance with IS: 554 and burrs removed before laying. Open ends of the
piping shall be blocked to avoid entrance of foreign matter. Wherever reducers are to be
made in horizontal runs, eccentric reducers shall be used. If the piping is to drain freely in
other locations, concentric reducers may be used.
Flanged inspection pieces 1.5 meters long, with bolted flanges on both ends, shall be
provided not more than 30 meter centres, to facilitate future cleaning of all welded pipes.
All buried pipes shall be cleaned and coated with zinc chromate primer and bitumen paint,
then wrapped with three layers of fibreglass felt, each layer laid in bitumen.
In General pressure tests shall be applied to piping only before connection of equipment and
appliances. In no case shall piping, equipment or appliances be subjected to pressures
exceeding their test ratings. Tests shall be completed and approved before any insulation is
applied. After tests have been completed, the system shall be drained and cleaned of all dust
and foreign matter all strainers, valves and fittings shall be cleaned of all dirt, filings and
debris.
HYDROSTATIC PRESSURE TEST – CHILLED WATER PIPING
All water piping shall be tested and proven tight under hydro statistic pressure of 1.5 times of
design pressure in Kg/cm². Unless stated otherwise in the specifications the prescribed
pressure shall be maintained for four hours.
The section sets out the general requirements for design, standards of workmanship, supply,
at site, installation of pipes, pipe fittings and valves application, testing and balancing of all
galvanised and steel water piping system for air-conditioning application. All piping inclusive
of fittings and valves shall follow the applicable Indian Standards.
a) BALL VALVES
Parameter Specification
Application Flow Isolation
Size Ø40 MM
DESIGN QUALIFICATION
SYSTEM NAME AIR HANDLING UNIT PAGE NO.
SYSTEM NUMBER AHU-09 20 of 28
DOCUMENT NO VEPL/HPPL/DQ/S09 REV NO: R0
Quantity 5 Nos.
Ball OTTONE CW617N UNI EN 12165
b) BALANCING VALVES
Parameter Specification
Make Advance valves
MOC Cast Gun metal (IS 318 Gr. LTB2)
Application Flow control
Size / Quantity Ø40 MM / 1 No.
Hand Wheel Nylon Gr. 66
Bonnet IS 319 Brass
Stem IS 319 Brass
End Connection Type BSP Screwed End
c) Y- STRAINERS
Parameter Specification
Body/Cover Cast Iron
Connecting Studs/Nuts A-307,Grade B
Filter Screen Stainless Steel Perforated Screen of 2-3mm Perforation X 24G
Flanges Drilled As Per BS-10, ANSI,ASA Standards
Drain Plug Stainless Steel -410
Size / Qty Ø40 MM / 1 No
Application Removal of solids/suspended particles in the main stream
d) DRAIN VALVES
Parameter Specification
M.O.C Brass
Size & Quantity Ø25 MM & 1 No.
Application Removal of water condensate from drain line
Parameter Specification
Body OTTONE/BRASS CW 617 N
Float Polyethylene Resin
DESIGN QUALIFICATION
SYSTEM NAME AIR HANDLING UNIT PAGE NO.
SYSTEM NUMBER AHU-09 21 of 28
DOCUMENT NO VEPL/HPPL/DQ/S09 REV NO: R0
Ring NBR
Maximum Working
110°C
Temperature
Maximum Working Pressure 10 bar
Threads ISO228
Application Removal of air in main stream
Size / Quantity Ø20 MM / 1 No.
Parameter Specification
MOC Brass
Operating voltage at power
AC 24V +/-20%
supply of AC 230V
Operating Frequency 50Hz
Degree of protection of
IP 54
actuator
Size Ø32 MM
Quantity 1 No.
Application Flow control for temperature modulation
Parameter Specification
Pipe size Ø40 MM
Pipe MOC MS A Class Piping
Quantity 1 Nos.
Parameter Specification
Pipes are insulated with k-flex and aluminum
M.O.C outer layer.
DESIGN QUALIFICATION
SYSTEM NAME AIR HANDLING UNIT PAGE NO.
SYSTEM NUMBER AHU-09 22 of 28
DOCUMENT NO VEPL/HPPL/DQ/S09 REV NO: R0
Latest edition shall be followed for testing and acceptance of the system. Following tests
(minimum) shall be performed during system qualification.
ROOM TEMPERATURE
Room temperature shall be controlled and monitored in the individual as per the room book
data. It shall be monitored in the system.
RELATIVE HUMIDITY
Relative humidity shall be controlled in the individual as per the room book data. It shall be
monitored in the system.
DIFFERENTIAL PRESSURE
Differential pressure shall be controlled in the individual as per the room book data. It shall
be monitored in the system.
ACPH
Room ACPH shall be calculated based on the individual filter CFM achieved. ACPH of
individual room shall be as per the room book data.
FILTER INTEGRITY TEST
Individual filter shall be checked as per the ISO 14644-3.
AIRBORNE PARTICULATE TESTING (NON-VIABLE PARTICLE COUNT)
RECOVERY TEST
Area required conditions shall be achieved within 15-20 minutes.
10.0 ATTACHMENTS
11.0 ABBREVIATION
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DESIGN QUALIFICATION
SYSTEM NAME AIR HANDLING UNIT PAGE NO.
SYSTEM NUMBER AHU-09 27 of 28
DOCUMENT NO VEPL/HPPL/DQ/S09 REV NO: R0
13.0 CONCLUSION: -
Concluded By: -
Name: Name:
Sign: Sign:
Date: Date:
DESIGN QUALIFICATION
SYSTEM NAME AIR HANDLING UNIT PAGE NO.
SYSTEM NUMBER AHU-09 28 of 28
DOCUMENT NO VEPL/HPPL/DQ/S09 REV NO: R0
HPPL