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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

: TEVA API INDIA LIMITED

PROJECT

: HVAC WORK FOR MPP BUILDING

March 8, 2010

CONTRACTOR : ACV SYSTEMS PRIVATE LIMITED

Page 2 of 15

DESIGN QUALIFICATION FOR AHU, AW & EXHAUST FAN

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

: TEVA API INDIA LIMITED

PROJECT

: HVAC WORK FOR MPP BUILDING

DOC. NO:
ACV/TEVA/DQ-01
March 8, 2010

CONTRACTOR : ACV SYSTEMS PRIVATE LIMITED

Page 3 of 15

DESIGN QUALIFICATION FOR AHU, AW & EXHAUST FAN

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

: TEVA API INDIA LIMITED

PROJECT

: HVAC WORK FOR MPP BUILDING

DOC. NO:
ACV/TEVA/DQ-01
March 8, 2010

CONTRACTOR : ACV SYSTEMS PRIVATE LIMITED

Page 4 of 15

DESIGN QUALIFICATION FOR AHU, AW & EXHAUST FAN

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:

CLIENT

: TEVA API INDIA LIMITED

PROJECT

: HVAC WORK FOR MPP BUILDING

CONTRACTOR : ACV SYSTEMS PRIVATE LIMITED

DOC. NO:
ACV/TEVA/DQ-01
March 8, 2010
Page 5 of 15

DESIGN QUALIFICATION FOR AHU, AW & EXHAUST FAN


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)

CLIENT

: TEVA API INDIA LIMITED

PROJECT

: HVAC WORK FOR MPP BUILDING

DOC. NO:
ACV/TEVA/DQ-01

CONTRACTOR : ACV SYSTEMS PRIVATE LIMITED

March 8, 2010
Page 6 of 15

DESIGN QUALIFICATION FOR AHU, AW & EXHAUST FAN

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

Air Handling System (AHU-4)


This Air Handling System is a re-circulation system, which supplies the conditioned
air.

CLIENT

: TEVA API INDIA LIMITED

PROJECT

: HVAC WORK FOR MPP BUILDING

CONTRACTOR : ACV SYSTEMS PRIVATE LIMITED

DOC. NO:
ACV/TEVA/DQ-01
March 8, 2010
Page 7 of 15

DESIGN QUALIFICATION FOR AHU, AW & EXHAUST FAN


AHU System consists of following components:
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.
8 Row Deep Cooling Coil.
2 Row Deep Hot Water Coil.
Blower Section with DIDW backward curved blower.
Supply Air Blower with Motor 5.5 KW / 4 Pole
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

Air Handling System (AHU-5)


This Air Handling System is a once thru system, which supplies the conditioned air.
AHU System consists of following components:

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.


8 Row Deep Cooling Coil.
2 Row Deep Hot Water Coil.
Blower Section with DIDW backward curved blower.
Supply Air Blower with Motor 2.2 KW / 2 Pole
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: -

CLIENT

: TEVA API INDIA LIMITED

PROJECT

: HVAC WORK FOR MPP BUILDING

DOC. NO:
ACV/TEVA/DQ-01
March 8, 2010

CONTRACTOR : ACV SYSTEMS PRIVATE LIMITED

Page 8 of 15

DESIGN QUALIFICATION FOR AHU, AW & EXHAUST FAN


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:

CLIENT

: TEVA API INDIA LIMITED

PROJECT

: HVAC WORK FOR MPP BUILDING

DOC. NO:
ACV/TEVA/DQ-01
March 8, 2010

CONTRACTOR : ACV SYSTEMS PRIVATE LIMITED

Page 9 of 15

DESIGN QUALIFICATION FOR AHU, AW & EXHAUST FAN


7.6.1 AW 3 (36000 CFM)
1.
2.
3.
4.
7.6.2

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


305 x 610 x 50 mm = 6 Nos.
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.

Pre-Filter of (EU-4) 10 of Size 610 x 610 x 50 mm = 8 Nos.


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.
Exhaust Fan 2 System consists of following components:

CLIENT

: TEVA API INDIA LIMITED

PROJECT

: HVAC WORK FOR MPP BUILDING

DOC. NO:
ACV/TEVA/DQ-01

CONTRACTOR : ACV SYSTEMS PRIVATE LIMITED

March 8, 2010
Page 10 of 15

DESIGN QUALIFICATION FOR AHU, AW & EXHAUST FAN


7.7.1 Exhaust Fan 2 ( 9000 CFM)

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.
Supply Air Blower with Motor (2 Nos.) 3.7 KW / 4 Pole
Centrifugal DIDW forward curved Blower
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.
Exhaust Fan 3 System consists of following components:

7.7.1 Exhaust Fan 3 ( 7500 CFM)


1.
2.
3.
4.
7.6.2

Pre-Filter of (EU-4) 10 of Size 610 x 610 x 50 mm = 4 Nos.


Supply Air Blower with Motor (2 Nos.) 2.2 KW / 4 Pole
Centrifugal DIDW forward curved Blower
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

CLIENT

: TEVA API INDIA LIMITED

PROJECT

: HVAC WORK FOR MPP BUILDING

DOC. NO:
ACV/TEVA/DQ-01
March 8, 2010

CONTRACTOR : ACV SYSTEMS PRIVATE LIMITED

Page 11 of 15

DESIGN QUALIFICATION FOR AHU, AW & EXHAUST FAN


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.

GA Drawing for AHU 4

FL-9076-3C

3.

GA Drawing for AHU 5

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.

GA Drawing for Exhaust Fan 2

FL-9076-15

8.

GA Drawing for Exhaust Fan 3

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

: TEVA API INDIA LIMITED

PROJECT

: HVAC WORK FOR MPP BUILDING

CONTRACTOR : ACV SYSTEMS PRIVATE LIMITED

March 8, 2010
Page 12 of 15

DESIGN QUALIFICATION FOR AHU, AW & EXHAUST FAN


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.

CLIENT

: TEVA API INDIA LIMITED

PROJECT

: HVAC WORK FOR MPP BUILDING

CONTRACTOR : ACV SYSTEMS PRIVATE LIMITED

DOC. NO:
ACV/TEVA/DQ-01
March 8, 2010
Page 13 of 15

DESIGN QUALIFICATION FOR AHU, AW & EXHAUST FAN


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.

CLIENT

: TEVA API INDIA LIMITED

PROJECT

: HVAC WORK FOR MPP BUILDING

DOC. NO:
ACV/TEVA/DQ-01
March 8, 2010

CONTRACTOR : ACV SYSTEMS PRIVATE LIMITED

Page 14 of 15

DESIGN QUALIFICATION FOR AHU, AW & EXHAUST FAN

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

: TEVA API INDIA LIMITED

PROJECT

: HVAC WORK FOR MPP BUILDING

CONTRACTOR : ACV SYSTEMS PRIVATE LIMITED

March 8, 2010
Page 15 of 15

DESIGN QUALIFICATION FOR AHU, AW & EXHAUST FAN

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

CLIENT

: TEVA API INDIA LIMITED

PROJECT

: HVAC WORK FOR MPP BUILDING

CONTRACTOR : ACV SYSTEMS PRIVATE LIMITED

DOC. NO:
ACV/TEVA/DQ-01
March 8, 2010
Page 16 of 15

DESIGN QUALIFICATION FOR AHU, AW & EXHAUST FAN


16.

QA

Quality Assurance

17.

URS

User Requirement Specification

18.

VMP

Validation Master Plan

19.

MPP

Multi Product Plant