Ahu Design Qualification Document

DESIGN QUALIFICATION SYSTEM NAME

AIR HANDLING UNIT

SYSTEM NUMBER

AHU-09

DOCUMENT NO

VEPL/HPPL/DQ/S09

PAGE NO. 1 of 28 REV NO: R0

DESIGN QUALIFICATION DOCUMENT OF AIR HANDLING UNIT (AHU-09)

DESIGN QUALIFICATION SYSTEM NAME

AIR HANDLING UNIT

SYSTEM NUMBER

AHU-09

DOCUMENT NO

VEPL/HPPL/DQ/S09

PAGE NO. 2 of 28 REV NO: R0

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

 LOW SIDE SYSTEM

10

 EQUIPMENTS – I. AIR HANDLING UNIT

10

 II. DEHUMIDIFIER

11

 III. PRE COOLING COIL

12

7.2 7.2.1

DESIGN QUALIFICATION SYSTEM NAME

AIR HANDLING UNIT

SYSTEM NUMBER

AHU-09

DOCUMENT NO

VEPL/HPPL/DQ/S09

PAGE NO. 3 of 28 REV NO: R0

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

DESIGN QUALIFICATION

1.0

SYSTEM NAME

AIR HANDLING UNIT

SYSTEM NUMBER

AHU-09

DOCUMENT NO

VEPL/HPPL/DQ/S09

PAGE NO. 4 of 28 REV NO: R0

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

SYSTEM NUMBER

AHU-09

DOCUMENT NO

VEPL/HPPL/DQ/S09

3.0

RESPONSIBILITY:

3.1

VEPL

PAGE NO. 5 of 28 REV NO: R0

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.

DESIGN QUALIFICATION SYSTEM NAME

AIR HANDLING UNIT

SYSTEM NUMBER

AHU-09

DOCUMENT NO

VEPL/HPPL/DQ/S09

PAGE NO. 6 of 28 REV NO: R0



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-AHUZONEAHU-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)

c)

Horizontal Centrifugal Pumps for clear, cold & fresh water

IS 1520-1980

d)

Mild steel tubes, tubular & other wrought steel fittings

IS 1239-1990 Part I & II

e)

Galvanized Sheet Steel

IS 277-1992

f)

Metal Air Ducts fabrication and construction

SMACNA

DESIGN QUALIFICATION

g)

SYSTEM NAME

AIR HANDLING UNIT

SYSTEM NUMBER

AHU-09

DOCUMENT NO

VEPL/HPPL/DQ/S09

Dimension of 3 phase foot mounted induction motors

PAGE NO. 7 of 28 REV NO: R0 IS 1231-1974

6.0

BASIS OF DESIGN PARAMETERS:

6.1

AREAS COVERED, ROOM AREA, HEIGHT & ROOM VOLUME: Room Name

6.2

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

OUT SIDE CONDITIONS

Season

6.3

Dry Bulb

Temperature Wet Bulb

Dew Point

Relative Humidity

Summer

96°F

78°F

71°F

45%

Monsoon

82°F

78°F

76°F

82%

Winter

58°F

54°F

51°F

78%

DESIGNED IN SIDE CONDITIONS:

DESIGN QUALIFICATION SYSTEM NAME

AIR HANDLING UNIT

SYSTEM NUMBER

AHU-09

DOCUMENT NO

VEPL/HPPL/DQ/S09

Room Name

PAGE NO. 8 of 28 REV NO: R0

Temperature

R.H. %

22±20 c

NMT 45

GRANULATION MATERIAL IN MATERIAL OUT STAFF ENTRY

6.4

OCCUPANCY, EQUIPMENT LOAD, AREA CLASSIFICATION, DESIGN AIR CHANGES, ROOM AIR QUANTITY, TOTAL AIR QUANTITY & TOTAL COOLING LOAD REQUIREMENTS:

Room Name

Occupancy

Equip. Load

Number

KW

1

20

GRANULATION MATERIAL IN

6.5

Class

100K

MATERIAL OUT STAFF ENTRY

Area Classification

1

Design ACPH Number

Room Selected Total Cooling wise Air AHU Load Qty Capacity CFM TR CFM

30

3093

30

198

30

222

30

173

10TR

5050

DIFFERENTIAL ROOM PRESSURE GRADIENT: Sr. No.

Room Designation

Standard DP Range In mm wc 0.5-1.5 mm

From (High Pressure)

To (Low Pressure)

1

CORRIDOR-4

MATERIAL IN

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

DESIGN QUALIFICATION

6.6

SYSTEM NAME

AIR HANDLING UNIT

SYSTEM NUMBER

AHU-09

DOCUMENT NO

VEPL/HPPL/DQ/S09

PAGE NO. 9 of 28 REV NO: R0

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

DESIGN QUALIFICATION SYSTEM NAME

AIR HANDLING UNIT

SYSTEM NUMBER

AHU-09

DOCUMENT NO

VEPL/HPPL/DQ/S09

PAGE NO. 10 of 28 REV NO: R0

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 Parameters

Specifications

Type / Model

BDB355T DRAUGHT FAN

DESIGN QUALIFICATION SYSTEM NAME

AIR HANDLING UNIT

SYSTEM NUMBER

AHU-09

DOCUMENT NO

VEPL/HPPL/DQ/S09

M.O.C

PAGE NO. 11 of 28 REV NO: R0

Blower is made of G.I sheet

Capacity

5050 CFM

Static Pressure

160 mm WG Static Pressure

Speed

2874 RPM

MOTOR 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

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) Parameters Filter Type MOC Frame / MOC Media Filter Size / Qty

Specifications Pocket Filter Aluminum / Synthetic Fiber 595Lx 595Wx400H mm / 2 No, 595Lx287Wx400H mm /2 No

FINE FILTER :( F8) Parameters

Specifications

Filter Type

Bag Filter

MOC Frame / MOC Media

Aluminum / Synthetic Fiber 595Lx 595Wx400H mm / 2 No, 595Lx287Wx400H mm /2 No

Filter Size / Qty

DESIGN QUALIFICATION SYSTEM NAME

AIR HANDLING UNIT

SYSTEM NUMBER

AHU-09

DOCUMENT NO

VEPL/HPPL/DQ/S09

PAGE NO. 12 of 28 REV NO: R0

II. DE-HUMIDIFIER SPECIFICATIONS: Parameters

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 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

SYSTEM NUMBER

AHU-09

DOCUMENT NO

VEPL/HPPL/DQ/S09

PAGE NO. 13 of 28 REV NO: R0

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: Parameter

Specification

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: Parameter

Specification

MOC – Filter Frame / Media

Aluminum Anodized / Micro Glass Fiber Media

Type

Hooded type Mini pleat HEPA Filter in TM RSC module

DESIGN QUALIFICATION SYSTEM NAME

AIR HANDLING UNIT

SYSTEM NUMBER

AHU-09

DOCUMENT NO

VEPL/HPPL/DQ/S09

PAGE NO. 14 of 28 REV NO: R0

Location Room No / Room Name

At Room Ceiling 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: Parameter

Specification

MOC – Filter Frame / Media

Aluminum Anodized / Micro Glass Fiber Media

Type

Hooded type Mini pleat HEPA Filter in TM RSC module

Location Room No / Room Name

At Room Ceiling 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.

DESIGN QUALIFICATION

7.2.6

SYSTEM NAME

AIR HANDLING UNIT

SYSTEM NUMBER

AHU-09

DOCUMENT NO

VEPL/HPPL/DQ/S09

REV NO: R0

DUCTING: Parameter

Specification

Fabrication

G.I. Sheet metal Ducting – Prefabricated ducts 24G (0.6MM), 22G (0.8MM), 20G (1.0MM) SMACNA standards

Duct Sizing Design

Duct Sizing Design done based on Air Velocity Method.

Duct size

As per duct layout attached.

Duct Leak Test Pressure Application

Through Smoke test at site

MOC

Joint Sealing:  Flange joints  Leak Testing

7.2.7

PAGE NO. 15 of 28

For distribution of conditioned air from air handling unit to The designated areas.  Rubbers gasket & RTV sealant.  Air supply with blower is to be blown in the duct & leak testing to be done by the duct smoke testing

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.

DESIGN QUALIFICATION SYSTEM NAME

AIR HANDLING UNIT

SYSTEM NUMBER

AHU-09

DOCUMENT NO

VEPL/HPPL/DQ/S09

PAGE NO. 16 of 28 REV NO: R0

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 Parameter

Specification Nitrile Rubber / closed cell polyethylene elastomeric foam insulation with aluminum foil.

MOC 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.

Parameter Body Louvers Bush Size / Qty Type

Specification 16 G Aluminum sheet 16 G Aluminum sheet ALUMINUM 300 Hx300 L mm –9 No. 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

DESIGN QUALIFICATION SYSTEM NAME

AIR HANDLING UNIT

SYSTEM NUMBER

AHU-09

DOCUMENT NO

VEPL/HPPL/DQ/S09

PAGE NO. 17 of 28 REV NO: R0

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

7.2.10 MAGNEHELIC GAUGES: 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

7.2.11 TEMPERATURE, RELATIVE HUMIDITY & DIFFERENTIAL PRESSURE, INDICATORS

DIFFERENTIAL PRESSURE INDICATOR 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

SYSTEM NUMBER

AHU-09

DOCUMENT NO

VEPL/HPPL/DQ/S09

Communication

PAGE NO. 18 of 28 REV NO: R0

Isolated RS485 Modbus RTU Protocol

DIFFERENTIAL PRESSURE, TEMPERATURE & RH INDICATOR 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

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

DESIGN QUALIFICATION SYSTEM NAME

AIR HANDLING UNIT

SYSTEM NUMBER

AHU-09

DOCUMENT NO

VEPL/HPPL/DQ/S09

PAGE NO. 19 of 28 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. III VALVES & FITTINGS a) BALL VALVES Parameter

Specification

Application

Flow Isolation

Size

Ø40 MM

DESIGN QUALIFICATION SYSTEM NAME

AIR HANDLING UNIT

SYSTEM NUMBER

AHU-09

DOCUMENT NO

VEPL/HPPL/DQ/S09

PAGE NO. 20 of 28 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 M.O.C Size & Quantity Application

Specification Brass Ø25 MM & 1 No. Removal of water condensate from drain line

e) AIR VENT VALVES Parameter

Specification

Body

OTTONE/BRASS CW 617 N

Float

Polyethylene Resin

DESIGN QUALIFICATION SYSTEM NAME

AIR HANDLING UNIT

SYSTEM NUMBER

AHU-09

DOCUMENT NO

VEPL/HPPL/DQ/S09

PAGE NO. 21 of 28 REV NO: R0

Ring

NBR

Maximum Working Temperature

110°C

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 Parameter

Specification

MOC

Brass

Operating voltage at power supply of AC 230V

AC 24V +/-20%

Operating Frequency

50Hz

Degree of protection of actuator

IP 54

Size

Ø32 MM

Quantity

1 No.

Application

Flow control for temperature modulation

7.2.13 CHILLED WATER PIPING - DRAIN U TRAP Parameter Pipe size Pipe MOC

Specification Ø40 MM

Quantity

1 Nos.

MS A Class Piping

7.2.14 CHILLED WATER PIPING INSULATION Parameter

Specification

M.O.C

Pipes are insulated with k-flex and aluminum outer layer.

DESIGN QUALIFICATION SYSTEM NAME

AIR HANDLING UNIT

SYSTEM NUMBER

AHU-09

DOCUMENT NO

VEPL/HPPL/DQ/S09

Maximum & Minimum Surface Temperature

PAGE NO. 22 of 28 REV NO: R0

-40°C to +85°C

Fire

Euroclass B-s3, d0

Thermal Conductivity at +20° C

≤ 0.035 W/(m-K)

7.2.15 CHW PIPING PRESSURE GAUGES: Parameter Specification BAUMER Make 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

Quantity

2 Nos. (1 No. Each in Supply & Return header of CHW Manifold)

7.2.16 CHW PIPING TEMPERATURE GAUGES: Temperature gauge BAUMER MAKE 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.

9.0

8.1 open.

There are limit switches in the AHUs to make the system off when access doors are

8.2

All the electrical equipment grounded properly to prevent electrical shocks.

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.

DESIGN QUALIFICATION SYSTEM NAME

AIR HANDLING UNIT

SYSTEM NUMBER

AHU-09

DOCUMENT NO

VEPL/HPPL/DQ/S09

PAGE NO. 23 of 28 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) Sr. No.

ISO Classification

0.5µ/m3

5µ/m3

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

At Rest

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

DESIGN QUALIFICATION SYSTEM NAME

AIR HANDLING UNIT

SYSTEM NUMBER

AHU-09

DOCUMENT NO

VEPL/HPPL/DQ/S09

PAGE NO. 24 of 28 REV NO: R0



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

DESIGN QUALIFICATION SYSTEM NAME

AIR HANDLING UNIT

SYSTEM NUMBER

AHU-09

DOCUMENT NO

VEPL/HPPL/DQ/S09

PAGE NO. 25 of 28 REV NO: R0

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 practices

VEPL

Vindair Engineers Pvt. Ltd.

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 filter

MS

Mild Steel

MOC

Material Of Construction

FS

Full Scale

DESIGN QUALIFICATION

12.0

SYSTEM NAME

AIR HANDLING UNIT

SYSTEM NUMBER

AHU-09

DOCUMENT NO

VEPL/HPPL/DQ/S09

PAGE NO. 26 of 28 REV NO: R0

SUMMARY REPORT:

………………………………………………………………………………………………………………................................... ....................................................................................................................... ....................................................................................................................... ....................................................................................................................... ....................................................................................................................... ....................................................................................................................... ....................................................................................................................... ....................................................................................................................... .......................................................................................... ....................................................................................................................... ....................................................................................................................... ....................................................................................................................... ....................................................................................................................... ....................................................................................................................... ....................................................................................................................... ....................................................................................................................... ....................................................................................................................... ....................................................................................................................... ....................................................................................................................... ....................................................................................

DESIGN QUALIFICATION SYSTEM NAME

AIR HANDLING UNIT

SYSTEM NUMBER

AHU-09

DOCUMENT NO

VEPL/HPPL/DQ/S09

PAGE NO. 27 of 28 REV NO: R0

13.0 CONCLUSION: -

Concluded By: For VEPL

For HPPL

Name:

Name:

Sign:

Sign:

Date:

Date:

DESIGN QUALIFICATION SYSTEM NAME

AIR HANDLING UNIT

SYSTEM NUMBER

AHU-09

DOCUMENT NO

VEPL/HPPL/DQ/S09

PAGE NO. 28 of 28 REV NO: R0

14.0 AHU DESIGN QUALIFICATION APPROVAL SHEET VEPL Name

Designation

Signature

Date

Designation

Signature

Date

HPPL Name