Installation qualification protocol for air handling unit & air distribution system

 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

 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.
  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

0
15 C 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

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

 EXECUTION TEAM
Signature /
Department Responsibility Name Designation
Date

Quality Monitoring and reviewing

Assurance the validation activities

Execute the validation

activity and provide
Engineering necessary support for the
proper installation of the
equipment

Participate and provide

Production necessary support for the
validation activity

 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,
 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
Title Acceptance criteria
YES / NO

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

 Remarks___________________________________________________________________
 Component: Fresh air Pre Filter
Acceptance
Specification =
Feature
Acceptance Criteria criteria fulfilled How verified
YES / NO

Manufacturer Air Tech.

Physical
Location AHU
Inspection along
with Unit Drawing
Filter Class /
10 µ
Efficiency
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

 Remarks____________________________________________________________________
 Component: Pre Filter (Combo)
Acceptance
Feature Specification criteria fulfilled How verified
YES / NO

Manufacturer Air tech.

Coil protection in mixing

Location
chamber

Filter Class /
10 µ +5 µ
Separation Efficiency

Physical
Model / Type Flange type Filter
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

Installed in Return Plenum at

Installation
clean condition

 Remarks_________________________________________________________________
 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

Physical
Model / Type Flange type Filter
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

Installed in Supply Plenum at

Installation
clean condition

 Remarks__________________________________________________________________
 Component: Bleed air Filter
Acceptance
Feature Specification criteria fulfilled How verified
YES / NO

Manufacturer Air Tech.

Location AHU

Physical
Filter Class / Inspection
0.3 µ
Efficiency along with Unit
Drawing

Model / Type Flange type

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

Number of Filters 1 Nos

Installation Installed in Exhaust air Module

 Remarks__________________________________________________________________
 Component: HEPA Filter
Acceptance
Feature Specification criteria fulfilled How verified
YES / NO

Manufacturer NA

Location NA

Filter Class /
NA
Separation Efficiency

Model / Type NA Physical

Inspection
along with Unit
Drawing
Dimensions (mm) NA

Number of Filters NA

Pressure difference measuring NA

Installation NA

 Remarks__________________________________________________________________
 Component: Fan – Motor
Acceptance
Feature Specification criteria fulfilled How verified
YES / NO

Make Punker
Type PLUG Type (non spark proof)

Capacity 2718 cfm

Total Static Pressure 115 mm of wc

Fan/ Blower speed(RPM) 2754

Motor

CG / BBL / ABB / Siemens or

Make
equivalent make

Type TEFC 3Ph / 4Pole

Rating 3.7 kw,2 Pole EFF-2

 Remarks_________________________________________________________________
 Component: Damper
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

 Remarks__________________________________________________________________
 Component: Ductwork
Specification = Acceptance
How
Feature Acceptance criteria fulfilled
verified
criteria YES / NO
Material GI sheets

Manufacturer of Sheets Jindal / Tata

Zinc Coating Thickness Coating of 120g/Sqmtr

Ducting
Layout
All joints are with angle iron flanges
Duct joints &
and neoprene rubber gaskets.
Visual
Inspecti
on
Silicon sealant at all the longitudinal
Type of sealing at joints
& transverse joints.

Sheet thickness 20/22/24 SWG

Installation Completed under clean condition

 Remarks__________________________________________________________________
 Component: Outlet Terminal Box
Specification = Acceptance
Feature Acceptance criteria fulfilled How verified
criteria YES / NO

Manufacturer MKP

Ducting Layout
Type Swirl Diffuser & Visual
Inspection

Installation Completed

 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

  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).
 Deviation No.: ______________________
Deviation

Observed by: Date:

Assessment and Action

Conducted by: Date:

Action taken

Executed by: Date:

Verified by: Date:

IQ SUMMARY AND CONCLUSION:

 SUMMARY
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
CONCLUSION
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 Forms and Records (Annexures)

 Not Applicable
 Distribution
 Master copy – Quality Assurance
 Controlled copies- Quality Assurance, User Departments
 History
Date Revision Number Reason for Revision

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