Qright Pharma Private Limited

Puducherry

Title: User Requirement Specification Document No.:

Equipment Name: Air Handling Unit -1 Equipment Code: EI010
Format No.: QA012/F03-00 Department: Engineering Page No.: 1 of 11

Attachment# 1
1.0 Environment
This section gives a brief summary of the layout and physical condition of the proposed site of the AHU
system. This includes (but not limited to), the data sheet of the room where proposed equipment is to be
placed with proposed placement drawing showing room dimensions, design of rooms to be maintained by
the AHU system, drain locations, access route from outside, AHU supply/return grill locations, utility point
locations, etc.
S.No Parameter Specifications/Dimension
.
Area name Length Width Height Area Volume ACPH
m m m m2 m3
Men Entry 2.02 4.85 NLT 20
1.02 1.98 2.4
Air Lock sqm m3
1. Details of area to be Decartoning 16.18 38.83 NLT 20
3.54 4.57 2.4
supplied Room sqm m3
14.24 34.18 NLT 20
RM Day 3.11 4.58 2.4
m3
Store sqm

RM Entry 1.71 4.10 NLT 50

1.53 1.12 2.4
Air Lock 1 sqm m3
RM Entry 1.79 4.30 NLT 100
1.60 1.12 2.4
Air Lock 2 sqm m3

2. Available area for 1687x 600 x 8 m

installation ( L x W x H meter)
Location: Second Floor- Room no.: SF302
3. Expected size of Length: 3600 mm
equipment Width: 1180 mm
Height: 900 mm (Minimum)
4.  Fan capacity : 3000 CFM
Process fan detail
 Fan make : Kruger/ Blowtech
 Fan RPM : 2835
 Qright Pharma Private Limited
Puducherry

Title: User Requirement Specification Document No.:

Equipment Name: Air Handling Unit -1 Equipment Code: EI010
Format No.: QA012/F03-00 Department: Engineering Page No.: 2 of 11

 Fan Type : Centrifugal

 Static pressure: 1250 pa
 Motor make : Roto motive / Bharat Bijlie/ equivalent
 Motor RPM : 2830
 Motor type : IE2 single speed 2 pole
5. Temperature to be 23 ± 2 ºC
maintained in the area
6. Relative Humidity to NMT: 70%
be maintained in the
area
2.0 Functional Requirements of AHU System:
2.1 Functionality of the AHU System:
The desired functional requirements and how it shall operate are listed under this section.
S.No. Parameter Specifications

1. Design Double skinned

Panel external sheet : pre coated galvanized steel 0.6mm
Panel internal sheet : galvanized steel 0.6mm
CFM : 3000 CFM
CMH : 5100 CMH
2. Main motor Flame proof

3. No. of air changes per Should be NMT 20 Nos. / Hour for the Class of area ISO 8 at rest condition.
hour in cubicle
Should be NMT 50 Nos. / Hour for the Class of area ISO 7 at rest condition.

Should be NMT 100 Nos. / Hour for the Class of area ISO 6 at rest condition.
 Qright Pharma Private Limited
Puducherry

Title: User Requirement Specification Document No.:

Equipment Name: Air Handling Unit -1 Equipment Code: EI010
Format No.: QA012/F03-00 Department: Engineering Page No.: 3 of 11

4. Particulate matter Should meet the specifications of Class ISO 8 / Grade D area,
count
Class ISO 7 / Grade C area and Class ISO 6 / Grade B area.

Area 0.5 µ / m3 5.0 µ / m3

Men Entry Air Lock
At rest NMT 35,20,000 29,000
In operation NR * NR *
Decartoning Room
At rest NMT 35,20,000 29,000
In operation NR * NR *
RM Day Store
At rest NMT 35,20,000 29,000
In operation NR * NR *
RM Entry Air Lock-1
At rest NMT 3,52,000 2,900
In operation 35,20,000 29,300
RM Entry Air Lock-2
At rest NMT 3,520 29
In operation 3,52,000 2,930

Should meet the specifications of Class ISO 8 / Grade D, Class ISO 7 / Grade
C and Class ISO 6 / Grade B.

5. Microbial load
 Qright Pharma Private Limited
Puducherry

Title: User Requirement Specification Document No.:

Equipment Name: Air Handling Unit -1 Equipment Code: EI010
Format No.: QA012/F03-00 Department: Engineering Page No.: 4 of 11

These are average values.

Acceptance Criteria

Area Air Settle Contact Glove

sample plates dia plates dia points
Cfu / m3 90 mm 55 mm
Cfu/2 hrs Cfu/plate
Men Entry 500 100 50 -
Air Lock
(Class ISO 8 / Grade D)
Decartoning Room 500 100 50 -
(Class ISO 8 / Grade D)
RM Day Store 500 100 50 -
(Class ISO 8 / Grade D)
RM Entry Air Lock-1 100 50 25 -
(Class ISO 7 / Grade C)
RM Entry Air Lock-2 10 5 5 5
(Class ISO 6 / Grade B)
Bacterial Alert Limit: Action Limit:
count 60% of the specification 80 % of the specification
limit*. limit.
Fungal Alert Limit: Action Limit:
count 60% of the specification 80 % of the specification
limit#. limit.
* Specifications: NMT 100 CFU

# Specifications: NMT 100 CFU

6. Recovery / Clean up Should be achieved within 15 minutes.
period

Recovery for
7. Should be achieved within 30 minutes.
temperature and RH

The smoke should be diffused uniformly at supply air location to room and
8.
Air flow pattern
pass through return location. Also smoke should be passed from positive
pressure area to negative pressure area.

Pre Filter :( G4)

 Qright Pharma Private Limited
Puducherry

Title: User Requirement Specification Document No.:

Equipment Name: Air Handling Unit -1 Equipment Code: EI010
Format No.: QA012/F03-00 Department: Engineering Page No.: 5 of 11

Parameters Specifications
Filter Type Sliding, Box type Filter
MOC Frame / 0.1 mm GI / HDPE/Synthetic Fiber
MOC Media
Filter Size / 610 H x 610 W x 48 D 610 H x 305 Wx48 D mm
Qty mm / 1 No. / 1 No.
Eff:90% @ 10µm Eff:90% @ 10µm
Pre Filter :(F5)
9. Filter Detail Parameters Specifications
Filter Type Bag filter Box type
MOC Frame / 0.1 mm GI / HDPE/Synthetic Fiber
MOC Media
Filter Size / 610 H x 610 W x 300 D 305 Hx 610 Wx300 D mm
Qty mm /1 No. / 1 No.
Eff:95% @ 5µm Eff:95% @ 5µm
Fine Filter :( F7)
Parameters Specifications
Filter Type Flange type Filter
MOC Frame / 0.1 mm GI / Synthetic Fiber
MOC Media
Filter Size / 610 H x 610 W x 300 D 610 H x 305 Wx300 D mm
Qty mm /1 No. / 1 No.
Eff:97% @ 3µm Eff:97% @ 3µm

Fresh Air :(F5)

Parameters Specifications
Filter Type Pre filter box type
MOC Frame / 0.1 mm GI / Synthetic nonwoven Fiber
MOC Media
Filter Size / 285 H x 285 W x 50 D 215 Hx 215 Wx50 D mm /
Qty mm /1 No. 1 No.
Eff:90% @ 10 µm Eff:90% @ 10µm
PAO testing port should be provided for installed HEPA filter leak test and
installed HEPA filter should be leak tested at site. Access port / door should be
provided to allow HEPA filter integrity test on site.
 Qright Pharma Private Limited
Puducherry

Title: User Requirement Specification Document No.:

Equipment Name: Air Handling Unit -1 Equipment Code: EI010
Format No.: QA012/F03-00 Department: Engineering Page No.: 6 of 11

10. Electrical motor for Type: 3 phase induction motor. Motor should be compatible to run with VFD.
main supply blower Motor should be flame proof.
11. Valve control Controller and sensor should be provided after coil or in the area for actuation
of chilled water control valve.
Isolation valve should be provided at chilled water inlet and outlet.
Two ways balancing cum control valve for chilled water and three ways for hot
water should be provided.
12. Valves and strainers Strainer should be provided at chilled water inlet line.
Pressure gauge isolation valve should be provided.
a. Return air ducting:
Thickness: 0.6mm. Non soldered.
G.I. Sheet metal ducting – Prefabricated ducts 24G (0.6MM)/ 22G (0.8MM)/
20G (1.0MM).

Insulation:
MOC:
Nitrile rubber / closed cell polyethylene elastomeric foam insulation with
13. Ducting aluminum foil.
Thickness : 9mm

b. Supply air ducting :

Thickness: 0.6 mm. Non soldered.

Insulation:

MOC:
Nitrile rubber / closed cell polyethylene elastomeric foam insulation with
aluminum foil.

Thickness : 9 mm

All duct joints should be filled with sealant for zero leakages.

Volume control dampers should be used for the better air control.

Neoprene rubber gasket should be used between duct joints.

 Qright Pharma Private Limited
Puducherry

Title: User Requirement Specification Document No.:

Equipment Name: Air Handling Unit -1 Equipment Code: EI010
Format No.: QA012/F03-00 Department: Engineering Page No.: 7 of 11

Ducting Velocity sensor port should be provided in supply duct.

Individual damper for each supply and return of the room side should be
provided.

14. Duct leakages Should be less than 3 % of total volume handled by system.
VFD for supply
15. Suitable capacity of VFD to be provided.
blower
AHU cum dehumidifier should be operational through auto / manual switch
16. Operational feature and also compatible to run with VFD and BMS.
17. Fresh air Minimum 10%
18. Relief air Not more than ____NA______%
(if applicable) Not Applicable
All the filter banks, blower section, coil section should be facilitate with the
19 Filter section provision for the measurement of the differential pressure across the filters.
Low leakage aerofoil dampers should be provided.
Individual damper should be provided for supply, return, fresh air, relief air,
reactivation air etc.
20. Damper section Size:
Fresh air inlet damper: 215H x 215L mm 1no.
Return air damper : 650Hx 315 L mm no.1
Supply air outlet damper : 450Hx 315 L mm no.1
3.0 Instrumentation Requirements:
This section mentions in brief the minimum requirement for measuring instrumentation for controlling
and monitoring of process parameters. e.g. magnehelic gauge / manometer and etc.
S. No. Parameter Specifications

1. Differential magnehelic Magnehelic manometer should be provided across HEPA / Fine filter
gauge / manometer if bank. Manometer should have proper zero setting.
applicable. For room : 0 to 100 mm of WC
For AHU cum dehumidifier: 0 to 50 mm of WC.

4.0 Performance Features:

The parameters that are planned to be evaluated during performance qualification and validation
activities are mentioned.
 Qright Pharma Private Limited
Puducherry

Title: User Requirement Specification Document No.:

Equipment Name: Air Handling Unit -1 Equipment Code: EI010
Format No.: QA012/F03-00 Department: Engineering Page No.: 8 of 11

S.No. Parameter Specifications

1. Performance of the system The system is intended to be operated regularly 24 hours, 7 days per
according to operation. week.

2. Cleaning requirements Easy accessible for cleaning of parts and should be provided with
quick fixing arrangement.

5.0 Capacity:
S.No. Parameter Specifications
3000 CFM
1.
Capacity
Exhaust CFM: 90%
Required fresh air CFM: 10 %

6.0 Automation and Safety Features: The minimum required as well as desired automation and safety
features (alarms, interlocking, etc.) are listed in this section.
S.No. Parameter Specifications
Noise level Should be not more than 80 Db in 01 meter distance.
1.
Safety guards Safety guards should be provided to all moving parts.
2.
Limit switch Blower plenum should have limit switch which can switch OFF the
3.
blower when plenum door is opened.
Earthing connections Proper earthing to be provided.
4.
View lamp and view window FLP / NFLP view lamp should be provided in blower section with
5.
view glass on panel.
Indicator lamp Indication lamp for the process air blower, reactivation blower, bed
6.
motor, heater bank should be provided (If applicable).
Smoke detector Smoke detector should be provided in the return air duct of AHU
7.
(If applicable)
Emergency stop The system shall have an emergency stop mechanism
10.
Power failure and recovery The equipment should not function in case of power failure and starts
11.
only after operator intervention.
7.0 System Boundaries: Nil
 Qright Pharma Private Limited
Puducherry

Title: User Requirement Specification Document No.:

Equipment Name: Air Handling Unit -1 Equipment Code: EI010
Format No.: QA012/F03-00 Department: Engineering Page No.: 9 of 11

8.0 Material of Construction:

Specifications for material of construction of AHU system parts are listed here.
S.No. Parameters Specifications
1. AHU panel sheet YES
2. Process blower YES
3. Ducting YES

4. Damper Aluminium

5.

6. Hot water line Mild steel

7. Condensate collector tray SS-304

8. Control panel GI-with powder coated/ pre-wired electrical

9.0 Surface finish:

Specifications for surface finish of AHU system parts are listed here.

S.No. Parameter Specifications

There should be no welding burrs. Surface should be smooth
without crevices. All joints should be finished with silicon sealant
1. Surface of air contact part
and there should not be any gap for dust accumulating in the
joints.
10.0 cGxP considerations:
The requirements for electronic compliance of the AHU system in case of BMS.
S. No. Parameter Specifications

1. NA NA

11.0 Expected Documents and Drawings:

Requirement of documents to be delivered by the suppliers during the procurement life cycle. A
suggestive list (but not limited to), is as listed below:
S. No. Document room Required ( )


1. Design Specification
 Qright Pharma Private Limited
Puducherry

Title: User Requirement Specification Document No.:

Equipment Name: Air Handling Unit -1 Equipment Code: EI010
Format No.: QA012/F03-00 Department: Engineering Page No.: 10 of 11


2. Functional Specification

3. Alarm/ Interlock/ Safety/ Communication/

Power failure test procedures. 
4.

Piping and Instrumentation Diagram
(P&ID)


5. Instrument Listing


6. Control Schematics


7. Control panel assembly drawings


8. Machine Assembly Drawings


9. Bill of Material


10. Operator, Maintenance and Service Manual


11. Spare Parts List


12. MOC certificates


13. Calibration certificates of instruments


14. Test certificates of components/test devices


15. Weld certificates (if any)


16. ‘As-built’ P&ID


17. Isometric drawing (if any)


18. Electrical drawings


19. Component Cut Sheets (optional)

20. PLC Program Printouts and Disk File

(optional) 

21. HMI Configuration Printout and Disk File
(optional)


22.
Manufacture’s Quality Certificate
 Qright Pharma Private Limited
Puducherry

Title: User Requirement Specification Document No.:

Equipment Name: Air Handling Unit -1 Equipment Code: EI010
Format No.: QA012/F03-00 Department: Engineering Page No.: 11 of 11


23. Service and support details


24. Purchase order copy


25. Operation handbook


26. Calibration instructions


27. Maintenance instructions


28. Other (Specify)

12.0 Reference Documents: Nil.

Prepared by Approved by
Sign and Date: Sign and Date:

Department: Engineering Department: Production