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Installation qualification protocol for air handling unit & air distribution system

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OBJECTIVE The objective of this protocol is to provide an outline for the inspection of static attributes, written procedure and guidelines and respective acceptance criteria for the Installation and Operational Qualification of Air handling unit . The Air-Handling unit caters to:-

AREA DETAILS

Sr. No

Name of the area

Area (SQFT)

Height (FT)

Installation Qualification                  

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Each installed components and sub component complies with the engineering design and manufacture recommendations. To ensure that appropriate interconnections are made for utilities / equipment that all the features are defined before the start up of operational qualification. The system meets the current good manufacturing practice requirements. To prepare tentative standard operating procedures. Calibration of instruments Functional keys. Design parameters Alarms & interlock systems Verification of standard operating procedures. Sequential operation Effect of power failure on the equipment SYSTEM / EQUIPMENT DESCRIPTION The Air Handling unit is designed to provide and maintain the following conditions in the area where it caters AHU Capacity of air filtration – __________ CFM. Temperature — NMT 25 ºC RH — NMT 60 % Description: Air handling unit is a recirculation system, in double skin modular construction. AHU will have extruded aluminium frame with sandwiched panel of G.I. sheet duly pre coated from outside & 43 mm thick PUF filled in between. Fresh air enters through 10µ fresh air filter. Air then passes through mixing section with (10 +5) µ pre-filter, 6 rows deep chilled water coil (CH W) coil & 2 rows deep Hot water (H W) coil is placed on condensate tray, Sandwiched type in SS-304 construction with proper drain point. The air will then pass through 3µ fine filter installed in AHU supply plenum. FA damper are provide with 10µ G-4 pre- filter, EA damper are provide with (0.3µ)H-13 HEPA filter.

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Filtered air after 3µ filter will be supplied to the room via leak proof GSS Ducting through ceiling mounted Supply air Hepa (0.3 µ) H-13 and air will return through return air Riser via return duct to mixing chamber. Both ends of the GI ducts will have flanges & flanges will have neoprene gasket. GI ducts will be thermally insulated by Polyethylene foam insulation. Air volume control dampers shall be installed at (fresh, return) air inlet, (supply, bleed) air outlet of AHU and Supply air Hepa & Risers. Fire damper should be installed on supply & return air duct near to AHU. RESPONSIBILITY Engineering and Maintenance Department Preparation of the IQ protocol in conjunction with user . Checking the protocol for adequacy and accuracy prior to the approval. Providing guidance, wherever required to the related departments. Quality Assurance Department Providing guidance and check the protocol document. Head Operations Checking the protocol for adequacy and accuracy. Providing required details to the Engineering / Maintenance. Collection of data and preparation of final design. Execution of the protocol and preparation of IQ summary report. User department Approval of protocol. ABBREVIATIONS:

Sr. No.

Term

Explanation

1

AHU

Air Handling Unit

2

DQ

Design Qualification.

3

IQ

Installation Qualification

4

OQ

Operational Qualification

5

GI

Galvanized Iron

6

SS

Stainless Steel.

7

Temp

Temperature

8

RH

Relative Humidity

9

ACPH

Air Changes per Hour.

10

CFM

Cubic Feet per minute

11

MOC

Material of construction

12

Cont.

Continued

13

WC

Water column

14

SOP

Standard Operating Procedures

15

0

Degree centigrade

16

m

Micron

17

cGMP

Current Good manufacturing practices

18

Min

Minimum

19

Max

Maximum

20

NMT

Not more than

21

NLT

Not less than

22

NA

Not Applicable

23

EPS

Expanded polystyrene

C

24

DX

Direct Expansion

25

HEPA

High efficiency particulate air

Sr. No.

Term

Explanation

26

FPI

Fins per Inch.

27

ADP

Apparatus dew point

28

ISO

International Organization for Standardization.

29

URS

User requirement specification

30

Q. A. Head

Quality Assurance Head

31

VCD

Volume Control Damper.

32

GSS

Galvanized sheet steel

33

AL.

Aluminium

34

NR

Not Required

35

DIDW

Double Inlet Double Width

36

DB

Dry Bulb

37

FLP

Flame Proof

38

KW

Kilo Watt

39

HP

Horse Power

40

Ph

Phase

41

Sq. Cg.

Squirrel Cage

42

Pa

Pascal

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EXECUTION TEAM

Department

Responsibility

Quality Assurance

Monitoring and reviewing the validation activities

Engineering

Execute the validation activity and provide necessary support for the proper installation of the equipment

Production

Participate and provide necessary support for the validation activity

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Name

Designation

Signature / Date

The following components were checked if they are according to the design specification: Design Verification Room Data Sheet Floor Plan Drawing INSTALLATION VERIFICATION It was checked and proved that the Air Handling unit and the documentation correspond to the order. In addition, changes and supplements were identified and documented. This review is the basis for further functional reviews, maintenance and modification control. The IQ protocol defines test procedures, acceptance criteria and the documents that are necessary to prove that the Air Handling unit was installed correctly and corresponds to the specifications of the manufacturers as well as client and that it is suitable for the planned application. The completely executed and finally approved protocol confirms that the Air Handling system is corresponds to all acceptance criteria. The Installation-Qualification is valid as documented evidence, that the Air Handling Unit corresponds with all checkpoints of design plans, all components of manufacturer’s documentation,

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rules of technique and the defined requests, The basis for the installation qualification was the detailed design, room tables and the technical Manufacturers documentation. The following appendices, in the qualification protocol attached, were used for execution of the installation qualification to prove the Air Handling Unit corresponds with the defined requests. The following drawings were compared on site to the existing installation: Fresh air filter (G-4) Pre Filter (G-4 +F-5 ) Combo Fine Filter (F-7) Bleed Air Filter (H-13) Supply Blower – Motor Cooling coil Heating Coil Supply/Return Air dampers Fire Dampers Duct work INSTALLATION CHECK The listed drawings shall be compared on site to the existing installed and any discrepancy shall be marked by redlining in the drawing. After the completion of the walk down, the checked drawings have to be signed with date and signature and have to be attached to these protocols. General Verification:Acceptance criteria fulfilled YES / NO

Title

Acceptance criteria

Layout

The drawing reflects “as built” conditions

Room Data Sheet

The drawing reflects “as built” conditions

Grills Location Drawing

The drawing reflects “as built” conditions

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Remarks___________________________________________________________________ Component: Fresh air Pre Filter Acceptance

Feature

Specification = Acceptance Criteria

Manufacturer

Air Tech.

Location

AHU

Filter Class / Efficiency

10 µ

criteria fulfilled YES / NO

How verified

Physical Inspection along with Unit Drawing

Model / Type

Flange type

Dimensions of Filters(mm)

305 x 305 x 50 mm

Number of Filters

1 Nos

Installation

Installed in Fresh air Module

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Remarks____________________________________________________________________ Component: Pre Filter (Combo)

Feature

Specification

Manufacturer

Air tech.

Location

Coil protection in mixing chamber

Filter Class / Separation Efficiency

10 µ +5 µ

Model / Type

Flange type Filter

Acceptance criteria fulfilled YES / NO

How verified

Physical Inspection along with Unit Drawing

610 x 610 x 380 Dimensions (mm) 305 x 610 x 380

Number of Filters

1 Nos Each

Pressure difference measuring

4-5 mm

Installation

Installed in Return Plenum at clean condition

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Remarks_________________________________________________________________ Component: Fine Filter

Feature

Specification

Acceptance criteria fulfilled YES / NO

How verified

Manufacturer

Air tech.

Location

Supply Chamber in AHU

Filter Class / Separation Efficiency

3µ

Model / Type

Flange type Filter

Physical Inspection along with Unit Drawing

610 x 610 x 305 Dimensions (mm) 305 x 610 x 305

Number of Filters

1 Nos Each

Pressure difference measuring

7.5-8.5 mm

Installation

Installed in Supply Plenum at clean condition

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Remarks__________________________________________________________________ Component: Bleed air Filter

Feature

Specification

Manufacturer

Air Tech.

Location

AHU

Filter Class / Efficiency

0.3 µ

Model / Type

Flange type

Dimensions of Filters(mm)

305 x 305 x 305 mm

Acceptance criteria fulfilled YES / NO

How verified

Physical Inspection along with Unit Drawing

Number of Filters

1 Nos

Installation

Installed in Exhaust air Module

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Remarks__________________________________________________________________ Component: HEPA Filter

Feature

Specification

Manufacturer

NA

Location

NA

Filter Class / Separation Efficiency

NA

Model / Type

NA

Dimensions (mm)

NA

Number of Filters

NA

Pressure difference measuring

NA

Installation

NA

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Acceptance criteria fulfilled YES / NO

How verified

Physical Inspection along with Unit Drawing

Remarks__________________________________________________________________ Component: Fan – Motor

Feature

Specification

Make

Punker

Acceptance criteria fulfilled YES / NO

How verified

Type

PLUG Type (non spark proof)

Capacity

2718 cfm

Total Static Pressure

115 mm of wc

Fan/ Blower speed(RPM)

2754

Motor

Make

CG / BBL / ABB / Siemens or equivalent make

Type

TEFC 3Ph / 4Pole

Rating

3.7 kw,2 Pole EFF-2

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Remarks_________________________________________________________________ Component: Damper

Feature

Specification = AcceptanceCriteria

Location

Supply, Return, Fresh & Bleed air damper

Model / Type

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Opposed blade low leakage GI damper

Acceptance criteria fulfilled YES / NO

How verified

Visual Inspection

Remarks__________________________________________________________________ Component: Ductwork

Feature

Specification = Acceptance criteria

Acceptance criteria fulfilled YES / NO

How verified

Material

GI sheets

Manufacturer of Sheets

Jindal / Tata

Zinc Coating Thickness

Coating of 120g/Sqmtr

Duct joints

All joints are with angle iron flanges and neoprene rubber gaskets.

Type of sealing at joints

Silicon sealant at all the longitudinal & transverse joints.

Sheet thickness

20/22/24 SWG

Installation

Completed under clean condition

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Ducting Layout & Visual Inspecti on

Remarks__________________________________________________________________ Component: Outlet Terminal Box

Feature

Specification = Acceptance criteria

Manufacturer

MKP

Type

Swirl Diffuser

Installation

Completed

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Acceptance criteria fulfilled YES / NO

How verified

Ducting Layout & Visual Inspection

Remarks________________________________________________________________________  DOCUMENTATION REQUIREMENT  The purpose of documentation is to provide basis for further validation (OQ) and generated documented evidence that the equipment / system was manufactured as per the desired design criteria.  General : Purchase order : System specification 

Instrumentation calibration : Calibration certificate for the

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Magnehelic Gauge  Other certificates : Certification Manifold valves, Ducting, & Insulation  Lists : Equipment and instrument list with Component descriptions. : Electrical component parts list with descriptions. Spare parts list.  

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DEVIATION REPORT All discrepancies between specification and Acceptance criteria fulfilled yes / no on site concerning the installation equipment, piping, supply and supervision facilities which are discovered during the Acceptance criteria fulfilled yes / no of this protocol have to be documented in this divergence report. This page may be copied (as often as you need it in case of more than one discovered divergence). Deviation No.: ______________________

Deviation

Observed by:

Date:

Assessment and Action

Conducted by:

Date:

Action taken

Executed by:

Verified by:

Date:

Date:

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IQ SUMMARY AND CONCLUSION:  SUMMARY ——————————————————————————————————————————— ———– 

CONCLUSION ——————————————————————————————————————————— ———–   

Forms and Records (Annexures) Not Applicable Distribution

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Master copy – Quality Assurance Controlled copies- Quality Assurance, User Departments History Date

Revision Number

Reason for Revision

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New