Ahu Design Qualification Document

DESIGN QUALIFICATION
SYSTEM NAME AIR HANDLING UNIT PAGE NO.

SYSTEM NUMBER AHU-09 1 of 28
DOCUMENT NO VEPL/HPPL/DQ/S09 REV NO: R0
DESIGN QUALIFICATION DOCUMENT

OF
AIR HANDLING UNIT (AHU-09)
TABLE OF CONTENTS
SL.NO DESCRIPTION PAGE NO
1.0 PURPOSE 4
2.0 SCOPE 4
3.0 RESPONSIBILITY 5
4.0 FACILITY DESCRIPTION 5
5.0 STANDARDS & GUIDELINES 6
6.0 BASIS OF DESIGN PARAMETERS 7
6.1  AREAS COVERED, ROOM AREA, HEIGHT & ROOM VOLUME 7
6.2  OUTISDE CONDITIONS 7
6.3  DESIGNED INSIDE CONDITIONS 7
6.4  OCCUPANCY, EQUIPMENT LOAD, AREA CLASSIFICATION, DESIGN AIR 8

CHANGES, ROOM AIR QUANTITY, TOTAL AIR QUANTITY & TOTAL
COOLING LOAD REQUIREMENTS.
6.5  ROOM DIFFERENTIAL PRESSURE GRADIENT 8
6.6  TEMPERATURE & HUMIDITY CONTROL 8
7.0 HVAC SYSTEM DESCRIPTION & TECHNICAL SPECIFICATIONS 9
7.1  HIGH SIDE SYSTEM 9
7.1.1  CHILLED WATER GENERATION SYSTEM 9
7.1.2  CHILLED WATER DISTRIBUTION 9
7.2  LOW SIDE SYSTEM 10
7.2.1  EQUIPMENTS – I. AIR HANDLING UNIT 10
 II. DEHUMIDIFIER 11
 III. PRE COOLING COIL 12

TABLE OF CONTENTS CONTINUED...
7.2.2  TERMINAL HEAP MODULES WITH PERFORATED GRILLS 13
7.2.3  TERMINAL MINIPLEAT HEPA FILTERS 13
7.2.4  RETURN RISERS GRILLS WITH FILTERS 13
7.2.5  AIR DISTRIBUTION 14
7.2.6  DUCTING 14
7.2.7  DUCT WORK DETAILS 14
7.2.8  DUCT INSULATION 15
7.2.9  VOLUME CONTROL DAMPERS & FIRE DAMPERS 15
7.2.10  MAGNEHELIC GAUGES 16
7.2.11  TEMPERATURE, RH & DIFFERENTIAL PRESSURE INDICATORS 17
7.2.12  CHILLED WATER PIPING & VALVE FITTINGS 17
7.2.13  CHILLED WATER DRAIN U TRAP 20
7.2.14  CHILLED WATER INSULATION 21
7.2.15  PRESSURE GAUGES 21
7.2.16  TEMPERATURE GAUGES 21
8.0 SAFETY CONSIDERATION 21
9.0 PERFORMANCE TESTING 22
10.0 ATTACHMENTS 23
11.0 ABBREVIATIONS 24
12.0 SUMMARY REPORT 25
13.0 CONCLUSION 26
14.0 AHU DESIGN QUALIFICATION APPROVAL SHEET 27

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.
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.
4.0 FACILITY DESCRIPTION
4.1 The HVAC system shall be designed to provide Air-conditioning and Ventilation for the following
areas.
 GRANULATION  MATERIAL OUT
 MATERIAL IN  STAFF ENTRY

HVAC System AHU-09 is positioned in the Services Area, to cater conditioned and Filtered Air
to GRANULATION, MATERIAL IN, MATERIAL OUT & STAFF ENTRY located in first Floor.
Consideration is made to group rooms to form different zones to eliminate the possibility of
cross contamination between different classes of clean zones. Each AHU shall cater to
specified areas and the same is explained in the AHU zoning drawing (VEPL-HPPL-AHUZONE-
AHU-09).
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
a) Centrifugal fans IS 4894-1987 (Reaffirmed 1991)

b) Propeller type A/C Ventilation Fans IS 2312-1967 (Reaffirmed 1991)
Horizontal Centrifugal Pumps for clear,
c) IS 1520-1980
cold & fresh water
Mild steel tubes, tubular & other wrought
d) IS 1239-1990 Part I & II
steel fittings
e) Galvanized Sheet Steel IS 277-1992
Metal Air Ducts fabrication and
f) SMACNA
construction
Dimension of 3 phase foot mounted

g) IS 1231-1974
induction motors
6.0 BASIS OF DESIGN PARAMETERS:

6.1 AREAS COVERED, ROOM AREA, HEIGHT & ROOM VOLUME:
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
6.2 OUT SIDE CONDITIONS
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%
6.3 DESIGNED IN SIDE CONDITIONS:

Room Name Temperature R.H. %

GRANULATION
MATERIAL IN
22±20 c NMT 45
MATERIAL OUT
STAFF ENTRY
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
6.5 DIFFERENTIAL ROOM PRESSURE GRADIENT:

Room Designation Standard DP
Sr.
Range In mm
No. From (High Pressure) To (Low Pressure) wc
1 CORRIDOR-4 MATERIAL IN 0.5-1.5 mm
2 CORRIDOR-4 MATERIAL OUT 0.5-1.5 mm
3 CORRIDOR-4 STAFF ENTRY 0.5-1.5 mm
4 STAFF ENTRY GRANULATION 0.5- 1.5 mm
6.6 TEMPERATURE AND HUMIDITY CONTROL: -
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.
7.0 HVAC SYSTEM DESCRIPTION WITH TECHNICAL SPECIFICATION

7.1 HIGH SIDE SYSTEM
All AC space in first floor shall be air conditioned by providing chilled water from a central
chilling plant which generates chilling water at NMT (+) 7 °C temperature. The further
network of the chilling line distribution shall be done at respective user points within
proposed facility.
7.1.1 CHILLED WATER GENERATION SYSTEM
Existing Chiller shall be used for this facility.
7.1.2 CHILLED WATER DISTRIBUTION

To maintain the room temperature and RH, chilled Water is required to be supplied in all
AHUs. Chilled Water from AHU returns back through pumps, strainers and butterfly valve to
the chiller at a temperature 12°C and get cooled by rejecting its sensible heat to the
refrigerant circulating in chillers and come out at the conditioned state of temperature at
(+) 7 °C. This chilled water then circulated to AHU’s as per the load requirements.
Circulation of Chilled Water from chiller to AHU’s is done through MS ‘C’ class IS–1239 piping.
Chilled Water from chiller enters in to the AHU through butterfly valve/Ball Valve and Y
strainer where dust / dirt particles are removed. This chilled water circulates through
cooling coil of AHU made up of copper and gets hot by taking latent and sensible heat of the
Return Air and Fresh Air entering in the AHU. This chilled water then enters to three ways
mixing valve installed at the out let of AHU. The function of three way mixing valve is to
regulate the flow of chilled water according to the temperature required inside the process
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.
7.2 LOW SIDE SYSTEM

In low side system, Air Handling Units, ventilation/exhaust units, piping, valves, Duct works,
grilles/diffusers, HEPA filters, return air risers, insulation, instrumentation etc. shall be
provided.
7.2.1 EQUIPMENTS
AIR HANDLING UNIT TYPE
The Air Handling Unit shall be double skin construction comprising of various sections such as
mixing box, filter sections with filters, coil section with chilled water, supply air dampers,
return air dampers, fresh air dampers, exhaust air dampers, blower section with imported
blowers, pre filter, fine filter plenum, purge Pre filter plenum, discharge plenum with
openings etc. as applicable.
AHU HOUSING / CASING
Parameters Specifications
Capacity 5050 CFM@160 mm of wc Static Pressure.
Over all Dimension 5239 L X 1450 W X 1150H in mm.
BLOWER
Type / Model BDB355T DRAUGHT FAN
Blower is made of G.I sheet

M.O.C
Capacity 5050 CFM

Static Pressure 160 mm WG Static Pressure
Speed 2874 RPM
MOTOR
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
CONDENSATE DRAIN DESCRIPTION:

Condensate coming from cooling coil shall be collected in duly insulated SS drain pan and taken
out of the AHU thru a Class ‘A’ GI piping to the nearest drain trap at service floor. A ‘U’ trap is
provided in the drain circuit AHU to prevent air in/out from AHU thru drainpipe. A minimum of
1:100 slopes is maintained to ensure gravity flow of drain water.
PRE FILTER :( G4)
Filter Type Pocket Filter
MOC Frame / MOC Media Aluminum / Synthetic Fiber
595Lx 595Wx400H mm / 2 No,
Filter Size / Qty
595Lx287Wx400H mm /2 No
FINE FILTER :( F8)
Filter Type Bag Filter
MOC Frame / MOC Media Aluminum / Synthetic Fiber
595Lx 595Wx400H mm / 2 No,
Filter Size / Qty
595Lx287Wx400H mm /2 No
II. DE-HUMIDIFIER SPECIFICATIONS:

DH MODULE CCR – 100
CAPACITY 600 CFM
APPROX. DIMENSIONS 1470x1020x1130 MM
FRAME CRCA POWDER COATED
PROCESS AIR FLOW 600 CFM
PROCESS MOTOR MAKE SIEMENS
PROCESS MOTOR RATING/CURRENT 0.5 HP / 1.12 Amps.
PROCESS MOTOR SPEED 1400 RPM
PROCESS FILTER 470x280x75 MM – 10 MICRONS
REACTIVATION AIR FLOW 200 CFM
REACT. MOTOR MAKE SIEMENS
REACT. MOTOR RATING/CURRENT 180 WATTS / 0.8 Amps.
REACT. MOTOR SPEED 2550 rpm
REACT. FILTER 260x250x75 MM – 10 MICRONS
DESICCANT ROTOR 470 DIA x 200 MM
HUMIDITY & TEMP. SENSOR GALLTEC, GERMANY
PLC & HMI MISTSUBISHI
LIMIT SWITCH TECHNIC MAKE
PRESSURE SWITCH RANGE (1 – 10 M BAR)
THERMOSTAT MAKE ELCON 50 – 300 ◦ C
ELECTRICAL HEATERS 1.2KW x 12 Nos.
III. PRE - COOLING COIL TECHNICAL SPECIFICATIONS
FRESH AIR CAPACITY 184 CFM
DIMENSIONS 600x600x550MM
MOC CASING ALUMINUN PROFILES WITH 2MM THK
OUTER SKIN 0.63 MM PRE COATED & PRE PLASTIC
INNE SKN 0.63 MM PLAIN GI

INSULATION PUFF WITH 23±2MM THK
PRE-COOLING COIL SIZE 10” x 10” x 8 ROW
COIL TUBE MOC/DIA COOPER / 3/8” DIA
FIN MATERIAL ALUMINUN 0.15MM THK
FILTER MAKE / TYPE / MEDIA/SIZE AAF/ FLANGED / HDPE+NONOWEN+AL.MESH /305x305x75
EU CLASSIFATION / EFFICIENCY EU 4 / 90% DOWN TO 10 MICRON
PRESSURE DROP 4-5 MM OF WC
FINAL PRESSURE DROP 12MM OF WC
DRAIN PAN MOC /THK/INSULATION SS 304 / 1MM/12MM TORCELIN
DRAIN PIPE SS 304 / DIA 25 MM
DAMPER MOC GI POWDER COATING
DAMPER SIZE 9” x 9”
(REFER ATTACHED DE-HUMIDIFIER G.A DRAWING, PRE-COOLING COIL G.A DRAWING WITH
TECHNICAL SPECIFICATIONS SHEET ATTCHED WITH THIS DOCUMENT.)
7.2.2 TERMINAL HEPA FILTERMODULES WITH PERFORATED GRILLS:
M.O.C HOUSING/GRILLS Extruded Aluminum / SS 304

Room No/Name Housing Size/Qty, Grill Size/Qty
GRANULATION 610Lx610Wx175Hmm/06 No’s, 680Lx680W mm/06 No’s
MATERIAL IN 610Lx610Wx175H mm/01 No’s, 680Lx680W mm/01 No’s

MATERIAL OUT 610Lx 610Wx 175H mm / 01 No’s, 680Lx680W mm/01 No’s
AIR LOCK 610Lx 610Wx 175H mm / 01 No’s, 680Lx680W mm/01 No’s
7.2.3 TERMINAL MINIPLEAT HEPA FILTERS:

MOC – Filter Frame / Media Aluminum Anodized / Micro Glass Fiber Media
Type Hooded type Mini pleat HEPA Filter in TM RSC module
Location At Room Ceiling

Room No / Room Name Size/Quantity
GRANULATION 580Lx580Wx124H mm / 06 No’s
MATERIAL IN 580Lx580Wx124H mm / 01 No’s
MATERIAL OUT 580Lx580Wx124H mm / 01 No’s
AIR LOCK 580Lx580Wx124H mm / 01 No’s
7.2.4 RETURN RISERS GRILLS WITH FILTERS:

MOC – Filter Frame / Media Aluminum Anodized / Micro Glass Fiber Media
Type Hooded type Mini pleat HEPA Filter in TM RSC module
Location At Room Ceiling
Room No / Room Name Size/Quantity
GRANULATION 780Wx380H mm/06 No’s, 745Wx345H mm/06 No’s,
MATERIAL IN 630Wx380H mm/01 No’s, 595Wx345H mm/01 No’s
MATERIAL OUT 630Wx380H mm/01 No’s, 595Wx345H mm/01 No’s
AIR LOCK 630Wx380H mm/01 No’s, 595Wx345H mm/01 No’s
7.2.5 AIR DISTRIBUTION

Each Air Handling Unit shall consist of Return air damper, pre filter, and supply air fan with
V-belt drive motor, cooling coil, fine filter, drain tray, supply air damper, return air
damper, limit switch and other ancillaries.
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.
7.2.6 DUCTING:
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
7.2.7 DUCT WORK DETAILS

I. STANDARDS:
Unless otherwise specified here, the construction, erection, testing and performance of the
ducting system shall conform to the SMACNA-1995 standards (“HVAC Duct Construction
Standards – Metal and Flexible – Second Edition – 1995”-SMACNA).
II. CONSTRUCTION DETAILS:
All ductwork including straight sections, tapers, elbows, branches, shoe pieces, collars,
terminal boxes and other transformation pieces must be factory-fabricated. Equivalency
will require fabrication by utilizing the following machines and processes to provide the
requisite quality of ducts and speed of supply:
Coil lines to ensure location of longitudinal seams at corners/folded edges only to obtain
the required duct rigidity and low leakage characteristics. No longitudinal seams permitted
along any face side of the duct.
All ducts, transformation pieces and fittings to be made on CNC profile cutters for required
accuracy of dimensions, location and dimensions of notches at the folding lines.
All edges to be machine treated using lock formers, flanges and roller for turning up edges.
The fabricated duct dimensions should be as per approved drawings and all connecting
sections are dimensionally matched to avoid any gaps. Ducts shall be straight and smooth
on the inside. Longitudinal seams shall be airtight and at corners only, which shall be either
Pittsburgh as per SMACNA practice, to ensure air tightness.
Changes in dimensions and shape of ducts shall be gradual (between 1:4 and 1:7). Turning
vanes or air splitters shall be installed in all bends and duct collars designed to permit the
air to make the turn without appreciable turbulence.
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.
7.2.8 DUCT INSULATION
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
Fire Performance/rating Class 0 or Class 1
7.2.9 VOLUME CONTROL DAMPERS & FIRE DAMPERS:

I. VOLUME CONTROL DAMPERS
The dampers shall be zero leakage airfoil having thick extruded Aluminium frame sections and
blades minimum 1.2 mm thick extruded aluminium airfoil. The bearing having heavy duty moulded
nylon/bronze. The linkage shall be plated steel blade brackets, brass rollers and galvanised steel
rods. Neoprene Rubbers Seals at tips of blades shall be provided. Stops shall be aluminium at
head and sill. The motorised dampers shall be provided with motors and electrical wiring as
required. Every damper shall have an indicating device clearly showing the damper position at all
times.
Body 16 G Aluminum sheet
Louvers 16 G Aluminum sheet
Bush ALUMINUM
Size / Qty 300 Hx300 L mm –9 No.
Type Opposed blade
II. FIRE DAMPERS

Return air duct in air handling units in main duct shall be provided with approved fire dampers of
at least 90 minutes fire rating. Fire damper blades shall be one piece folded high strength
galvanised steel construction. In normal position, these blades shall be gathered and stacked at
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.
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
7.2.10 MAGNEHELIC GAUGES:
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
7.2.11 TEMPERATURE, RELATIVE HUMIDITY & DIFFERENTIAL PRESSURE, INDICATORS
DIFFERENTIAL PRESSURE INDICATOR
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
Communication Isolated RS485 Modbus RTU Protocol
DIFFERENTIAL PRESSURE, TEMPERATURE & RH INDICATOR
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
7.2.12 M.S. PIPING – CHILLED WATER:

I MATERIAL OF CONSTRUCTION
All chilled brine and hot water piping shall be MS C class as per IS 1239.
II FABRICATION DETAILS
The proper additional precautions shall be taken for vibration isolation of piping, passing
through sensitive areas. Piping shall be properly supported or suspended from stands,
clamps, hanger’s etc. as required. Each support will be isolated from supported pipe or
fittings by anti-vibration springs or non-deteriorating and durable lines of rubber or
neoprene.
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
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.
III VALVES & FITTINGS
a) BALL VALVES
Application Flow Isolation
Size Ø40 MM
Quantity 5 Nos.
Ball OTTONE CW617N UNI EN 12165
b) BALANCING VALVES
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
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
M.O.C Brass
Size & Quantity Ø25 MM & 1 No.
Application Removal of water condensate from drain line
e) AIR VENT VALVES
Body OTTONE/BRASS CW 617 N
Float Polyethylene Resin
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.
f) 3 WAY MODULATING MIXING VALVES WITH ACTUATOR
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
7.2.13 CHILLED WATER PIPING - DRAIN U TRAP
Pipe size Ø40 MM
Pipe MOC MS A Class Piping
Quantity 1 Nos.
7.2.14 CHILLED WATER PIPING INSULATION
Pipes are insulated with k-flex and aluminum
M.O.C outer layer.
Maximum & Minimum Surface

-40°C to +85°C
Temperature
Fire Euroclass B-s3, d0
Thermal Conductivity at +20° C ≤ 0.035 W/(m-K)
7.2.15 CHW PIPING PRESSURE GAUGES:

Make BAUMER
MOC-Case ANSI 304 SS
Range/Connection Size 0 to 10 Kg/Cm2 / 3/8 ” BSP
Size 4’(100 mm) dial type
Accuracy +/- 1.0% of F.S
2 Nos. (1 No. Each in Supply & Return header of CHW
Quantity
Manifold)
7.2.16 CHW PIPING TEMPERATURE GAUGES:

Temperature gauge
MAKE BAUMER
MOC-Case ANSI 304 SS
Range 0-50 Deg0C
Size 4’(100 mm) dial type
Accuracy Class 1 as per EN-13190 : 1999
Quantity 2 Nos. (1 No. Each in Supply & Return header of CHW Manifold)
8.0 SAFETY CONSIDERATION:

For Personnel Protection, there are following provisions.
8.1 There are limit switches in the AHUs to make the system off when access doors are
open.
8.2 All the electrical equipment grounded properly to prevent electrical shocks.
9.0 PERFORMANCE TESTING

Performance of system shall be demonstrated at rest conditions. Non-viable counts shall
be as per ISO standards 14644-Clean Room & Associated Controlled Environment. Viable
counts shall be as per EU GMP & US FDA guidelines.
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)
ISO 0.5µ/m3 5µ/m3

Sr. No.
Classification At Rest
2. ISO 5 3,520 29
3. ISO 6 3,5200 293
4. ISO 7 352,000 2,930
5. ISO 8 3,520,000 29,300
 RECOVERY TEST
Area required conditions shall be achieved within 15-20 minutes.
 AIRFLOW VISUALIZATION TEST

Airflow Visualization of non unidirectional clean rooms shall be performed through digital
Videography of Airflow direction of individual clean rooms
10.0 ATTACHMENTS
 G.A. DRAWING FOR AHU

 HVAC ROOM DATA SHEET
 AIR FLOW SCHEMATIC DIAGRAM
 DUCT LAYOUT & AHU LOCATION LAY OUT
 PIPING MANIFOLD DIAGRAM (CHILLED WATER) WITH DRAIN PIPING
 TEMPERATURE, ROOM PRESSURE & AREA CLASSIFICATION ZONING
 G.A DRAWING FOR DE-HUMIDIFIER
 G.A DRAWING FOR PRE-COOLING COIL
 TECHNICAL CALCULATION SHEET FOR DEHUMIDIFIER
11.0 ABBREVIATION
Abbreviation Description Abbreviation Description

AHU Air Handling Unit MM WG Millimeter Water gauge
CHW Chilled Water NA Not Applicable
MM WC Millimeter Water Column HPPL HIGHER PHARMATECH PVT. LTD.
cGMP Current Good manufacturing VEPL Vindair Engineers Pvt. Ltd.

practices
DQ Design Qualification Pa Pascal
DP Differential Pressure QA Quality Assurance
DWG. Drawing. RH Relative Humidity
TR Tonnage Refrigeration URS User Requirement Specification
CS Carbon Steel S.A Supply air
GI Galvanized Iron R.A Return air
VCD Volume Control Damper PTFE Poly Tetra Fluoro Ethylene
HEPA High Efficiency Particulate Air MS Mild Steel

filter
MOC Material Of Construction FS Full Scale

12.0 SUMMARY REPORT:
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13.0 CONCLUSION: -
Concluded By: -
For VEPL For HPPL
Name: Name:
Sign: Sign:
Date: Date:
14.0 AHU DESIGN QUALIFICATION APPROVAL SHEET

VEPL
Name Designation Signature Date
HPPL
Name Designation Signature Date

Ahu Design Qualification Document

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DESIGN QUALIFICATION

SYSTEM NAME AIR HANDLING UNIT PAGE NO.

DESIGN QUALIFICATION DOCUMENT

SL.NO DESCRIPTION PAGE NO

4.0 FACILITY DESCRIPTION 5

5.0 STANDARDS & GUIDELINES 6

6.0 BASIS OF DESIGN PARAMETERS 7

6.1  AREAS COVERED, ROOM AREA, HEIGHT & ROOM VOLUME 7

6.2  OUTISDE CONDITIONS 7

6.3  DESIGNED INSIDE CONDITIONS 7

6.4  OCCUPANCY, EQUIPMENT LOAD, AREA CLASSIFICATION, DESIGN AIR 8

6.5  ROOM DIFFERENTIAL PRESSURE GRADIENT 8

6.6  TEMPERATURE & HUMIDITY CONTROL 8

7.0 HVAC SYSTEM DESCRIPTION & TECHNICAL SPECIFICATIONS 9

7.1  HIGH SIDE SYSTEM 9

7.1.1  CHILLED WATER GENERATION SYSTEM 9

7.1.2  CHILLED WATER DISTRIBUTION 9

7.2  LOW SIDE SYSTEM 10

7.2.1  EQUIPMENTS – I. AIR HANDLING UNIT 10

 III. PRE COOLING COIL 12

TABLE OF CONTENTS CONTINUED...

7.2.2  TERMINAL HEAP MODULES WITH PERFORATED GRILLS 13

7.2.3  TERMINAL MINIPLEAT HEPA FILTERS 13

7.2.4  RETURN RISERS GRILLS WITH FILTERS 13

7.2.5  AIR DISTRIBUTION 14

7.2.7  DUCT WORK DETAILS 14

7.2.8  DUCT INSULATION 15

7.2.9  VOLUME CONTROL DAMPERS & FIRE DAMPERS 15

7.2.10  MAGNEHELIC GAUGES 16

7.2.11  TEMPERATURE, RH & DIFFERENTIAL PRESSURE INDICATORS 17

7.2.12  CHILLED WATER PIPING & VALVE FITTINGS 17

7.2.13  CHILLED WATER DRAIN U TRAP 20

7.2.14  CHILLED WATER INSULATION 21

7.2.15  PRESSURE GAUGES 21

7.2.16  TEMPERATURE GAUGES 21

8.0 SAFETY CONSIDERATION 21

9.0 PERFORMANCE TESTING 22

12.0 SUMMARY REPORT 25

14.0 AHU DESIGN QUALIFICATION APPROVAL SHEET 27

4.0 FACILITY DESCRIPTION

 GRANULATION  MATERIAL OUT

 MATERIAL IN  STAFF ENTRY

a) Centrifugal fans IS 4894-1987 (Reaffirmed 1991)

Dimension of 3 phase foot mounted

6.0 BASIS OF DESIGN PARAMETERS:

6.2 OUT SIDE CONDITIONS

6.3 DESIGNED IN SIDE CONDITIONS:

Room Name Temperature R.H. %

6.5 DIFFERENTIAL ROOM PRESSURE GRADIENT:

6.6 TEMPERATURE AND HUMIDITY CONTROL: -

7.0 HVAC SYSTEM DESCRIPTION WITH TECHNICAL SPECIFICATION

7.1.1 CHILLED WATER GENERATION SYSTEM

Existing Chiller shall be used for this facility.

7.1.2 CHILLED WATER DISTRIBUTION

7.2 LOW SIDE SYSTEM

Blower is made of G.I sheet

Capacity 5050 CFM

CONDENSATE DRAIN DESCRIPTION:

II. DE-HUMIDIFIER SPECIFICATIONS:

III. PRE - COOLING COIL TECHNICAL SPECIFICATIONS

INNE SKN 0.63 MM PLAIN GI

7.2.2 TERMINAL HEPA FILTERMODULES WITH PERFORATED GRILLS:

M.O.C HOUSING/GRILLS Extruded Aluminum / SS 304