Design Qualification

DOC.
NO:
ACV/TEVA/DQ-01
CLIENT
: TEVA API INDIA LIMITED
PROJECT
: HVAC WORK FOR MPP BUILDING
March 8, 2010
CONTRACTOR : ACV SYSTEMS PRIVATE LIMITED
Page 1 of 15
DESIGN QUALIFICATION FOR AHU, AW & EXHAUST FAN

TABLE OF CONTENTS:
SR. NO.
0
DESCRIPTION
PAGE
NO.
Table of Contents
1.0
Design Qualification Protocol Approval
2.0
Objective
3.0
Scope
4.0
Responsibilities
5.0
Pre-Requisites
6.0
References
7.0
Equipment / System Description
8.0
Basis of Equipment / System Design
9.0
Design Data (Detailed Specifications for Major Components)
10.0
Documentation
12
11.0
Post Construction Review (For any kind of deviation, if any) &

Discussions
13
12.0
Design Qualification Summary and Conclusion
13
13.0
Design Qualification Approval
14
14.0
Abbreviations
15
Enclosure - 1
Bill Of Quantity
16
Enclosure - 2
G.A. Drawing of AHU & Duct Layout Drawing
17
Enclosure 3
Enclosure - 4
Room Data Sheet

Technical Specifications
4 - 10
11
11-12
18
19
DOC. NO:
ACV/TEVA/DQ-01
CLIENT
PROJECT
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Page 2 of 15
1.0
DESIGN QUALIFICATION PROTOCOL APPROVAL
PREPARED BY:
NAME
DESIGNATION
ORGANISATION
MR. Rahul.
AGGARWAL
TECHNICAL
DIRECTOR
ACV SYSTEMS PVT.

LTD.
SIGNATURE
DATE
SIGNATURE
DATE
SIGNATURE
DATE
APPROVED BY:
NAME
DESIGNATION
ORGANISATION
TEVA API INDIA
LIMITED
CHECKED BY:
NAME
DESIGNATION
ORGANISATION
TEVA API INDIA
LIMITED
CLIENT
PROJECT
DOC. NO:
ACV/TEVA/DQ-01
March 8, 2010
Page 3 of 15
2.0
3.0
OBJECTIVE
(a)
To prepare detailed specifications (design data) for HVAC System and its
major components, to ensure that the User Requirement Specifications, as
described in URS are achieved.
(b)
To design the system in conjunction with the design data in order to provide
basis for the vendor & manufacturers to design and fabricate the system
(equipment & component) to meet design intent.
SCOPE
Applicable to the HVAC System for TEVA API INDIA LIMITED at Gwalior, Malanpur.
Data sheet for the subjected equipment and its major components is defined by the
engineering department in consultation with the User department, which is finalized
and mutually discussed with the system supplier, ACV Systems Pvt. Ltd.
The design qualification is a basic document for the subsequent Validation activity.
4.0
RESPONSIBILITIES
4.1
ACV SYSTEMS PVT. LTD.:

Preparation of the DQ Protocol in consultation with the User.
Collection of Data & preparation of final design.
Execution of the protocol and preparation of DQ Summary Report.
4.2
TEVA API INDIA LIMITED

Checking the protocol for accuracy and adequacy prior to the approval.
Review and approval of the protocol.
Review and approval of the design qualification report.
5.0
PRE-REQUISITES
Prior to the preparation of the Design Qualification Protocol following conditions is
fulfilled:
Approval of user Requirement Specification to the HVAC System URS
CLIENT
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DOC. NO:
ACV/TEVA/DQ-01
March 8, 2010
Page 4 of 15
6.0
REFERENCE
Following documents have been referred in preparation of this protocol:
Validation Master Plan Document # VMP/MF/06001
ASHRAE Standards
7.0
EQUIPMENT / SYSTEM DESCRIPTION

The subjected HVAC System is designed for MPP BUILDING.
The HVAC System is designed in such a way to:
Minimize or eliminate the potential sources of airborne contamination.
Provide desired environment conditions w.r.t. Temperature, Relative Humidity,
Pressure Differentials etc.
The entire Plant has been divided into different Hygiene Class / Level as per WHO
cGMP Regulatory requirements & ISPE Baseline Pharmaceutical Guidelines for MPP
Building. The HVAC System consists of 3 Set Air Handling Unit (AHU-1, AHU-4 &
AHU-5), 2 Set Air Washer (AW-1 & AW-3) 6 Set Exhaust Fan - (EX FAN 1, EX FAN
2 & EX FAN 3)
The major division of AHU Systems is as tabulated below:
7.1
TABLE:
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March 8, 2010
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SYSTEM
NUMBER
AHU 1
AHU 1
AHU 4
CATERED AREAS
Ground Floor for Change Room, Air Lock,
Centrifugal Material/PAL, Blender Room Sifter
Mill, Clean Corridor, RVD Room, Wash Room,
Storage, Packing & Quarantine Room
Ground Floor for Change Room, Air Lock,
Centrifugal Material/PAL, Blender Room Sifter
Mill, Clean Corridor, RVD Room, Wash Room,
Storage, Packing & Quarantine Room
Ground Floor, First Floor & Second Floor for
Reception, Workers C/R, Visitor C/R, Tea Room,
Lobby, Dispensing Room, MAL, Air Lock, Material
entry, Lobby, Material Store, IPQC, Office, Lobby,
Storage & Material Store
HYGIENE CLASS/
LEVEL
10,0000
10,0000
Unclassified
AHU 5
Ground Floor For RVD
Unclassified
AW 1
Ground Floor For Hall (Reactors Area),

Centrifuge, Centrifuge, Wash & AFND
Unclassified
AW 3
Second Floor For Reactors Area
Unclassified
Exhaust Fan 1
First Floor For Reactors Area
Exhaust Fan 2
Second Floor For Reactors Area
Exhaust Fan 3
Third Floor For Reactors Area
The Air Handling Unit (AHU) is a closed type box construction, which filters, cools/
heats & supplies the air to the conditioned space.
Air Handling Systems is described below;
7.2
Air Handling System (AHU-1)
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March 8, 2010
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This Air Handling System is a once thru system, which supplies the conditioned air.
AHU System consists of following components:
7.2.1 AHU-1(Supply 12500 CFM)

1.
2.
3.
4.
5.
6.
7.
8.
9.
7.2.2
Pre-Filters of (EU-4) 10 in Size 610 x 610 x 50 mm = 6 Nos.

610 x 305 x 50 mm = 2 Nos.
8 Row Deep Cooling Coil.
2 Row Deep Hot water Coil.
Blower Section with DIDW backward curved blower.
Supply Air Blower with Motor 18.5 KW / 4 Pole
Fine-Filters of (EU-7) 1 in Size 610 x 610 x 305 mm = 6 Nos.
610 x 305 x 305 mm = 2 Nos.
Semi-HEPA Filters (EU-9) of 1 in Size 610 x 610 x 305 mm = 6 Nos.
610 x 305 x 305 mm = 2 Nos.
Exhaust Air Blower with motor 15.0 KW / 4 Pole
Bag filter of (EU-5) 5 Size 610 x 610 x 360 mm = 6 Nos.
The Other Components of the System are as follows: 1. Temperature and relative humidity sensor with DDC Controller for
controlling temperature and RH.
2. Velocity sensor with DDC Controller for controlling a supply air speed of
blower.
3. DP sensor for controlling pressure.
7.2.3 False ceiling mounted HEPA filter box with perforated SS Sheet
7.2.4 G.I. Return Grill with perforated Aluminum Grill.
For above refer AHU Drawing No. FL-9076-1B enclosed
7.3

This Air Handling System is a re-circulation system, which supplies the conditioned
air.
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March 8, 2010
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7.3.1 AHU-4( 5500 CFM)
1.
2.
3.
4.
5.
6.
7.3.2
Pre-Filters of (EU-4) 10 in Size 610 x 610 x 50 mm = 2 Nos.

305 x 610 x 50 mm = 2 Nos.
2 Row Deep Hot Water Coil.
Fine-Filters of (EU-7) 1 in Size 610 x 610 x 305 mm = 2 Nos.
305 x 610 x 305 mm = 2 Nos.
The Other Components of the System are as follows: 1. Humidistat and Thermostat for controlling the temperature & humidity.
7.3.3 Supply Air Diffuser mounted with false ceiling

7.3.4 Return Air Diffuser mounted with false ceiling.
For above refer AHU Drawing No. FL-9076-3C enclosed
7.4.1

This Air Handling System is a once thru system, which supplies the conditioned air.
7.4.1 AHU-5 (1850 CFM)

1.
2.
3.
4.
5.
6.
Pre-Filters of (EU-4) 10 in Size 610 x 610 x 50 mm = 1 No.

2 Row Deep Hot Water Coil.
Fine-Filters of (EU-7) 1 in Size 610 x 610 x 305 mm = 1 No.
7.4.2 The Other Components of the System are as follows: -
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March 8, 2010
Page 8 of 15

1. Humidistat and Thermostat for controlling the temperature & humidity.
7.4.3 Supply Air Diffuser mounted with false ceiling.
7.4.4 Return Air Diffuser mounted with false ceiling.
For above refer AHU Drawing No. FL-9076-2C
7.5
Air Washer (AW 1)

This Air washer system having a capacity of 40000 CFM, which supplies the Cooled
Filtered air.
AW 1 System consists of following components:
7.5.1 AW 1 (40000 CFM)

1.
2.
3.
4.
7.5.2
Pre-Filter of (EU-4) 10 of Size 610 x 610 x 50 mm = 18 Nos.

305 x 610 x 50 mm = 6 Nos.
610 x 305 x 50 mm = 3 Nos.
305 x 305 x 50 mm = 1 No.
Supply Air Blower with Motor (2 Nos.) - 15.0 KW / 4 Pole
Fine Filter of (EU-) 7 of Size 610 x 610 x 305 mm = 18 Nos.
305 x 610 x 305 mm = 6 nos.
610 x 305 x 305 mm = 3 Nos.
305 x 305 x 305 mm = 1 No.
Fan Pulley, Motor Pulley, Cell deck Pad, Belt & Pump
Aluminum Powder Coated Supply Air Grille.
7.5.3 Return Air Grill

For above refer Drawing No. FL-9076-7B enclosed
7.6
Air Washer (AW 3)

This Air washer system having a capacity of 36000 CFM, which supplies the Cooled
Filtered air.
AW 3 System consists of following components:
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March 8, 2010
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7.6.1 AW 3 (36000 CFM)
1.
2.
3.
4.
7.6.2

305 x 610 x 50 mm = 6 Nos.
Supply Air Blower with Motor (2 Nos.) - 11.0 KW / 4 Pole
Fine Filter of (EU-) 7 of Size 610 x 610 x 305 mm = 18 Nos.
305 x 610 x 305 mm = 6 nos.
Fan Pulley, Motor Pulley, Cell deck Pad, Belt & Pump
Aluminum Powder Coated Supply Air Grille.
7.6.3 Return Air Grill

For above refer Drawing No. FL-9076-8B enclosed
7.6
Exhaust Fan 1
This Exhaust Fan system having a capacity of 10000 CFM (2 Nos.), which Exhuast the
Return air.
Exhaust Fan 1 System consists of following components:
7.6.1 Exhaust Fan 1 ( 10000 CFM)

1.
2.
3.
4.

610 x 305 x 50 mm = 4 Nos.
Supply Air Blower with Motor (2 Nos.) 3.7 KW / 4 Pole
Centrifugal DIDW forward curved Blower
Fan Pulley, Motor Pulley, & Belt
7.6.2 Return Air Grill with Exhaust Air Blower

For above refer Drawing No. FL-9076-8B enclosed as Enclosure
7.7
Exhaust Fan 2
This Exhaust Fan system having a capacity of 9000 CFM (2 Nos.), which Exhaust the
return air.
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March 8, 2010
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2.
3.
1. Pre-Filter of (EU-4) 10 of Size 610 x 610 x 50 mm = 4 Nos.

610 x 305 x 50 mm = 2 Nos.
4. Fan Pulley, Motor Pulley, & Belt
7.7.2 Return Air Grill with Exhaust Air Blower

For above refer Drawing No. FL-9076-15 enclosed
7.8
Exhaust Fan 3
This Exhaust Fan system having a capacity of 7500 CFM (2 Nos.), which Exhaust the
Return Air.

1.
2.
3.
4.
7.6.2

Fan Pulley, Motor Pulley, & Belt
Return Air Grill with Exhaust Air Blower

For above refer Drawing No. FL-9076-17 enclosed as Enclosure
7.7 Support Systems / Utilities

All Air Handling Systems & Air Washers are provided with following support utilities
that are important for the correct functioning of the system. However, the
performance of these support systems does not have any influence on the air
filtration capabilities of the system, it may be considered as Non-Critical Support
Systems.
Main Panel for AHUs.
Power, earthing & control cabling by TEVA API INDIA LIMITED
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ACV/TEVA/DQ-01
March 8, 2010
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Following Equipment / System of these support utilities are planned as per BOQ
(Refer enclosure 1)
8.0
BASIS OF EQUIPMENT / SYSTEM DESIGN

To achieve the desired level of Cleanliness Class as defined in as Room Data
Sheet enclosed as Enclosure - 3.
Following approved drawings for fabrication/execution, Enclosed as Enclosure 2.
SR. NO.
TITLE OF APPROVED DRAWINGS
DRAWING NUMBER
1.
GA Drawing for AHU 1
FL-9076-1B
2.
FL-9076-3C
3.
FL-9076-2C
4.
GA Drawing for AW 1
FL-9076-7B
5.
GA Drawing for AW 3
FL-9076-8B
6.
GA Drawing for Exhaust Fan 1
FL-9076-14
7.
FL-9076-15
8.
FL-9076-17
9.
Ground Floor Plan HVAC Ducting Layout
10.
First Floor Plan HVAC Ducting Layout
11.
Second Floor Plan HVAC Ducting Layout
9.0
ACV/DL/TEVA/GF/001
(Rev. 03)
ACV/DL/TEVA/FF/002
(Rev. 03)
ACV/DL/TEVA/SF/003
(Rev. 02)
DESIGN DATA (Detailed Specification for Major Components)

Bill of Quantities (BOQ) for all components of the system enclosed as Enclosure
1.
DOC. NO:
ACV/TEVA/DQ-01
CLIENT
PROJECT
March 8, 2010
Page 12 of 15

Technical specifications for all major components that have been identified in the
HVAC System is described enclosed as Enclosure 4.
SR.
NO.
1.
COMPONENT
Pre Filter
PURPOSE
Pre-filtration of air up to 10
2.
Fine-Filter
Fine File of air up to 1
3.
Cooling/Hot water
Maintain temp/Relative
Humidity
4.
Supply Air blower with

motor
Pump the conditioned air into

the conditioned space
5.
Heating/ Cooling Thermostat
To sense return air temperature

& give signal to the 3 way valve
6.
Magnehelic gauge
To Measure Pressure
Differential across room.
10.0
SPECIFICATION
Enclosed as
Technical
Specification sheet
DOCUMENTATION
For preparation and execution of subsequent qualification activities of the HVAC
System (IQ / OQ / PQ) and to generate documented evidence that the equipment/
system was manufactured as per the pre-defined design following
documents is provided in two copies.
SR.
NO.
DESCRIPTION OF REQUIRED DOCUMENT
1.
GENERAL:
a)
Purchase Orders
2.
MANUALS:
a)
Operation and maintenance manuals
b)
Operation and maintenance manuals for imported components and bought out
items.
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March 8, 2010
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3.
AS-BUILT DRAWINGS :
a)
Ground Floor Plan HVAC Ducting Layout (ACV/DL/TEVA/GF/001/03)
b)
First Floor Plan HVAC Ducting Layout (ACV/DL/TEVA/FF/002/03)
c)
Second Floor Plan HVAC Ducting Layout (ACV/DL/TEVA/SF/003/02)
4.
TEST CERTIFICATES :
a)
Material specifications and certificates for all contact surfaces
b)
Instrument Calibration Certificates
11.0 POST CONSTRUCTION REVIEW (For any kind of deviation, if any) & DISCUSSIONS
After the equipment was ready at manufacturers works. It was checked and no
deviation was found with respect to Design Qualification.
12.0 DESIGN QUALIFICATION SUMMARY AND CONCLUSION

On completion of DQ activity it is found that the manufactured system and its
component do not have any deviation with design specification. The system can be
taken for installation and further qualification.
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March 8, 2010
Page 14 of 15
13.0
DESIGN QUALIFICATION APPROVAL
13.1
ACV SYSTEMS PVT. LTD.
SR. NO.
NAME
DESIGNATION
1.
RAHUL.AGGARWAL
TECHNICAL DIRECTOR
SIGNATURE
DATE
SIGNATURE
DATE
13.2 TEVA API INDIA LIMITED
SR. NO.
1.
2.
NAME
DESIGNATION
DOC. NO:
ACV/TEVA/DQ-01
CLIENT
PROJECT
March 8, 2010
Page 15 of 15
14.0
ABBREVIATIONS
SR. NO.
ABBREVIATIONS
1.
AHU
Air Handling Unit
2.
ASHRAE
3.
BOQ
Bill Of Quantity
4.
CFM
Cubic Feet Per Minute
5.
cGMP
Current Good Manufacturing Practice
6.
DQ
Design Qualification
7.
GA
General Arrangement
8.
HEPA
High Efficiency Particulate Air
9.
HVAC
Heating Ventilation & Air Conditioning
10.
IQ
Installation Qualification
11.
ISO
International Standards Organization
12.
ISPE
International Society of Pharmaceutical Engineering
13.
MOC
Material Of Construction
14.
OQ
Operational Qualification
15.
PQ
Performance Qualification
American Society of Heating, Refrigeration & Air

Conditioning Engineering
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March 8, 2010
Page 16 of 15

16.
QA
Quality Assurance
17.
URS
User Requirement Specification
18.
VMP
Validation Master Plan
19.
MPP
Multi Product Plant

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What is the objective of the design qualification protocol?

What is the objective of the design qualification protocol?

What are the responsibilities of ACV Systems Pvt Ltd and Teva API India Limited in this protocol?

What are the responsibilities of ACV Systems Pvt Ltd and Teva API India Limited in this protocol?

DOC.

: TEVA API INDIA LIMITED

: HVAC WORK FOR MPP BUILDING

CONTRACTOR : ACV SYSTEMS PRIVATE LIMITED