design qualification

CLIENT : TEVA API INDIA LIMITED DOC. NO:

ACV/TEVA/DQ-01

PROJECT : HVAC WORK FOR MPP BUILDING March 8, 2010

CONTRACTOR : ACV SYSTEMS PRIVATE LIMITED of 15

DESIGN QUALIFICATION FOR AHU, AW & EXHAUST FAN

TABLE OF CONTENTS:

SR. NO. DESCRIPTION PAGE NO.

0 Table of Contents 1

1.0 Design Qualification Protocol Approval 2

2.0 Objective 3

3.0 Scope 3

4.0 Responsibilities 3

5.0 Pre-Requisites 3

6.0 References 4

7.0 Equipment / System Description 4 - 10

8.0 Basis of Equipment / System Design 11

9.0 Design Data (Detailed Specifications for Major Components) 11-12

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 Room Data Sheet

18

Enclosure - 4 Technical Specifications 19


ACV/TEVA/DQ-01




1.0 DESIGN QUALIFICATION PROTOCOL APPROVAL

PREPARED BY:

NAME DESIGNATION ORGANISATION SIGNATURE DATE

MR. Rahul. AGGARWAL

TECHNICAL DIRECTOR

ACV SYSTEMS PVT. LTD.

APPROVED BY:


TEVA API INDIA

LIMITED

CHECKED BY:


TEVA API INDIA

LIMITED


ACV/TEVA/DQ-01




2.0 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.

3.0 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


ACV/TEVA/DQ-01




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:


ACV/TEVA/DQ-01




SYSTEM NUMBER

CATERED AREAS HYGIENE CLASS/

LEVEL

AHU – 1

Ground Floor for Change Room, Air Lock, Centrifugal Material/PAL, Blender Room Sifter Mill, Clean Corridor, RVD Room, Wash Room,

Storage, Packing & Quarantine Room

10,0000

AHU – 1

Ground Floor for Change Room, Air Lock, Centrifugal Material/PAL, Blender Room Sifter Mill, Clean Corridor, RVD Room, Wash Room,

Storage, Packing & Quarantine Room

10,0000

AHU – 4

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

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)


ACV/TEVA/DQ-01




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. Pre-Filters of (EU-4) 10μ in Size – 610 x 610 x 50 mm = 6 Nos. 610 x 305 x 50 mm = 2 Nos.

2. 8 Row Deep Cooling Coil. 3. 2 Row Deep Hot water Coil. 4. Blower Section with DIDW backward curved blower. 5. Supply Air Blower with Motor 18.5 KW / 4 Pole 6. Fine-Filters of (EU-7) 1μ in Size – 610 x 610 x 305 mm = 6 Nos.

610 x 305 x 305 mm = 2 Nos. 7. Semi-HEPA Filters (EU-9) of 1μ in Size – 610 x 610 x 305 mm = 6 Nos.

610 x 305 x 305 mm = 2 Nos. 8. Exhaust Air Blower with motor 15.0 KW / 4 Pole

9. Bag filter of (EU-5) 5μ Size – 610 x 610 x 360 mm = 6 Nos. 7.2.2 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.


ACV/TEVA/DQ-01




AHU System consists of following components:

7.3.1 AHU-4( 5500 CFM)

1. Pre-Filters of (EU-4) 10μ in Size – 610 x 610 x 50 mm = 2 Nos. 305 x 610 x 50 mm = 2 Nos.

2. 8 Row Deep Cooling Coil. 3. 2 Row Deep Hot Water Coil. 4. Blower Section with DIDW backward curved blower. 5. Supply Air Blower with Motor 5.5 KW / 4 Pole

6. Fine-Filters of (EU-7) 1μ in Size – 610 x 610 x 305 mm = 2 Nos. 305 x 610 x 305 mm = 2 Nos.

7.3.2 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. Pre-Filters of (EU-4) 10μ in Size – 610 x 610 x 50 mm = 1 No. 2. 8 Row Deep Cooling Coil. 3. 2 Row Deep Hot Water Coil. 4. Blower Section with DIDW backward curved blower. 5. Supply Air Blower with Motor 2.2 KW / 2 Pole 6. Fine-Filters of (EU-7) 1μ in Size – 610 x 610 x 305 mm = 1 No.

7.4.2 The Other Components of the System are as follows: -


ACV/TEVA/DQ-01




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. Pre-Filter of (EU-4) 10 μ 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.

2. Supply Air Blower with Motor (2 Nos.) - 15.0 KW / 4 Pole 3. Fine Filter of (EU-) 7μ 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.

4. Fan Pulley, Motor Pulley, Cell deck Pad, Belt & Pump 7.5.2 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:


ACV/TEVA/DQ-01




7.6.1 AW – 3 (36000 CFM) 1. Pre-Filter of (EU-4) 10 μ of Size – 610 x 610 x 50 mm = 18 Nos.

305 x 610 x 50 mm = 6 Nos. 2. Supply Air Blower with Motor (2 Nos.) - 11.0 KW / 4 Pole 3. Fine Filter of (EU-) 7μ of Size – 610 x 610 x 305 mm = 18 Nos.

305 x 610 x 305 mm = 6 nos. 4. Fan Pulley, Motor Pulley, Cell deck Pad, Belt & Pump

7.6.2 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. Pre-Filter of (EU-4) 10 μ of Size – 610 x 610 x 50 mm = 8 Nos. 610 x 305 x 50 mm = 4 Nos.

2. Supply Air Blower with Motor (2 Nos.) – 3.7 KW / 4 Pole 3. Centrifugal DIDW forward curved Blower 4. 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:


ACV/TEVA/DQ-01




7.7.1 Exhaust Fan – 2 ( 9000 CFM)

1. Pre-Filter of (EU-4) 10 μ of Size – 610 x 610 x 50 mm = 4 Nos. 610 x 305 x 50 mm = 2 Nos.

2. Supply Air Blower with Motor (2 Nos.) – 3.7 KW / 4 Pole 3. 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. Pre-Filter of (EU-4) 10 μ of Size – 610 x 610 x 50 mm = 4 Nos. 2. Supply Air Blower with Motor (2 Nos.) – 2.2 KW / 4 Pole 3. Centrifugal DIDW forward curved Blower 4. Fan Pulley, Motor Pulley, & Belt

7.6.2 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


ACV/TEVA/DQ-01




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



9. Ground Floor Plan HVAC Ducting Layout ACV/DL/TEVA/GF/001

(Rev. 03)

10. First Floor Plan HVAC Ducting Layout ACV/DL/TEVA/FF/002

(Rev. 03)

11. Second Floor Plan HVAC Ducting Layout ACV/DL/TEVA/SF/003

(Rev. 02)

9.0 DESIGN DATA (Detailed Specification for Major Components)

Bill of Quantities (BOQ) for all components of the system enclosed as Enclosure 1.


ACV/TEVA/DQ-01




Technical specifications for all major components that have been identified in the HVAC System is described enclosed as Enclosure 4.

SR. NO.

COMPONENT PURPOSE SPECIFICATION

1. Pre Filter

Pre-filtration of air up to 10µ

Enclosed as Technical

Specification sheet

2. Fine-Filter Fine File of air up to 1 µ

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 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.


ACV/TEVA/DQ-01




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 manufacturer’s 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.


ACV/TEVA/DQ-01




13.0 DESIGN QUALIFICATION APPROVAL 13.1 ACV SYSTEMS PVT. LTD.

SR. NO. NAME DESIGNATION SIGNATURE DATE

1. RAHUL.AGGARWAL TECHNICAL DIRECTOR

13.2 TEVA API INDIA LIMITED

SR. NO. NAME DESIGNATION SIGNATURE DATE

1.

2.


ACV/TEVA/DQ-01




14.0 ABBREVIATIONS

SR. NO. ABBREVIATIONS

1. AHU Air Handling Unit

2. ASHRAE American Society of Heating, Refrigeration & Air Conditioning Engineering

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


ACV/TEVA/DQ-01




16. QA Quality Assurance

17. URS User Requirement Specification

18. VMP Validation Master Plan

19. MPP Multi Product Plant

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