27/11/2022, 08:36 INSTALLATION QUALIFICATION PROTOCOL FOR AIR HANDLING UNIT - Pharmaceutical Guidance

INSTALLATION QUALIFICATION PROTOCOL FOR AIR HANDLING UNIT

 Pharmaceutical Guidanace  March 7, 2020  Validation & Qualification  3,069 Views

INSTALLATION QUALIFICATION PROTOCOL FOR AIR HANDLING UNIT & AIR DISTRIBUTION SYSTEM

TABLE OF CONTENTS

Sr. No Description Page No.

1 Objective

2 System / Equipment Description

3 Responsibility

4 Execution Team

5 Installation Verification

6 Installation Check

7 Documentation Requirement

8 Deviation Report

9 Installation Qualification Summary & Conclusion

10 Abbreviations

11 Certification for Installation Qualification

OBJECTIVE

The objective of this protocol is to provide an outline for the inspection of static attributes, written procedure
and / or guidelines and respective acceptance criteria for the Installation & Operational Qualification of Air

handling unit manufactured by Vendor and supplied by Client.

The Air-Handling unit caters to:-

AREA DETAILS

Sr. No Name of the area Area (SQFT) Height (FT)

1 Sampling 148 9.84

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2 Wash 41 9.84

3 Change Room 59 9.84 

4 Sampling 149 9.84

5 Air lock 77 9.84

6 Sifting 162 9.84

7 PM Sampling 81 9.84

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Installation Qualification

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

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The Air Handling unit is designed to provide and maintain the following conditions in the area where it caters

AHU Capacity of air filtration — 2718 CFM. 

Temperature — NMT 25 ºC

RH — NMT 60 %

Description:

Air handling unit (AHU-GF-02) 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 CHW coil & 2 rows deep HW 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.

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

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Engineering and Maintenance Department

Preparation of the IQ protocol in conjunction with user and R&D if required.

Checking the protocol for adequacy and accuracy prior to the approval.

Collection of data and preparation of final design.

Execution of the protocol and preparation of IQ summary report.

User / R & D department

Providing required details to the Engineering / Maintenance.

Checking the protocol for adequacy and accuracy.

Head Operations

Providing guidance and check the protocol document.

Quality Assurance Department

Providing guidance, wherever required to the related departments.

Approval of protocol.

INSTALLATION VERIFICATION

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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, rules of technique and
the defined requests of M/s. Client, 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 of M/s. Client.

The following drawings were compared on site to the existing installation:

Floor Plan Drawing

Room Data Sheet

Design Verification
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The following components were checked if they are according to the design specification:

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

Title Acceptance criteria
YES / NO

The drawing reflects “as built”

Layout
conditions

The drawing reflects “as built”

Room Data Sheet
conditions

The drawing reflects “as built”

Grills Location Drawing
conditions

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Component: Fresh air Pre Filter

Acceptance
Specification =
Feature criteria fulfilled How verified
AcceptanceCriteria
YES / NO

Manufacturer Air Tech.

Location AHU

Filter Class /
10 µ
Efficiency
Physical Inspection

along with Unit

Model / Type Flange type
Drawing
Dimensions of
305 x 305 x 50 mm
Filters(mm)

Number of Filters 1 Nos

Installation Installed in Fresh air Module

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Component: Pre Filter (Combo)

Acceptance
Feature Specification criteria fulfilled How verified

YES / NO

Manufacturer Air tech. Physical

Inspection along
Coil protection in mixing
Location with Unit Drawing
chamber

Filter Class /

10 µ +5 µ

Separation Efficiency

Model / Type Flange type Filter

610 x 610 x 380

Dimensions (mm)
305 x 610 x 380

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Number of Filters 1 Nos Each

Pressure difference 
4-5 mm
measuring

Installed in Return Plenum

Installation
at clean condition

Component: Fine Filter

Acceptance
Feature Specification criteria fulfilled How verified
YES / NO

Manufacturer Air tech.

Location Supply Chamber in AHU

Filter Class /
3µ
Separation Efficiency

Model / Type Flange type Filter

Physical
610 x 610 x 305
Inspection along
Dimensions (mm)
305 x 610 x 305 with Unit Drawing

Number of Filters 1 Nos Each

Pressure difference
7.5-8.5 mm
measuring

Installed in Supply Plenum

Installation
at clean condition

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Component: Bleed air Filter

Acceptance

Feature Specification criteria fulfilled How verified

YES / NO

Manufacturer Air Tech.

Location AHU

Filter Class /
Physical
0.3 µ
Efficiency Inspection along
with Unit Drawing
Model / Type Flange type

Dimensions of Filters(mm) 305 x 305 x 305 mm

Number of Filters 1 Nos

Installed in Exhaust air

Installation
Module

Component: HEPA Filter

Acceptance
Feature Specification criteria fulfilled How verified
YES / NO

Manufacturer Physical
Inspection along
Location
with Unit Drawing

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Filter Class /

Separation Efficiency 

Model / Type

Dimensions (mm)

Number of Filters

Pressure difference

measuring

Installation

Component: Fan – Motor

Acceptance
Feature Specification criteria fulfilled How verified

YES / NO

Make Punker

PLUG Type (non spark

Type
proof)

Capacity 2718 cfm

Total Static Pressure 115 mm of wc

Fan/ Blower speed(RPM) 2754

Motor

CG / BBL / ABB / Siemens

Make
or equivalent make

Type TEFC 3Ph / 4Pole

Rating 3.7 kw,2 Pole EFF-2

Component: Damper
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Acceptance
Specification =
Feature criteria fulfilled How verified
AcceptanceCriteria 
YES / NO

Supply, Return, Fresh & Bleed

Location
air damper
Visual Inspection
Opposed blade low leakage GI
Model / Type
damper

Component: Ductwork

Specification = Acceptance

Feature Acceptance criteria fulfilled How verified

criteria YES / NO

Material GI sheets

Manufacturer of Sheets Jindal / Tata

Zinc Coating Thickness Coating of 120g/Sqmtr

All joints are with angle iron

Duct joints flanges and neoprene rubber
gaskets.
Ducting Layout
Silicon sealant at all the & Visual
Type of sealing at joints longitudinal & transverse Inspection
joints.

Sheet thickness 20/22/24 SWG

Completed under clean

condition
Installation

Component: Outlet Terminal Box

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Feature Specification = Acceptance How verified

Acceptance criteria fulfilled

criteria YES / NO

Manufacturer MKP
Ducting Layout &
Type Swirl Diffuser
Visual Inspection
Installation Completed

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 and System specification

Instrumentation calibration : Calibration certificate for the 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.

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).

IQ SUMMARY AND CONCLUSION

ABBREVIATIONS:-

Sr. No. Term Explanation

1 AHU Air Handling Unit

2 DQ Design Qualification.

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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 0C 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

24 DX Direct Expansion

25 HEPA High efficiency particulate air.

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ABBREVIATIONS (CONTD.):-

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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Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of
rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco
remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC,
TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently
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