The air handling unit (AHU-GF-02) is a recirculation system, in double-skin modular construction. AHU will have an extruded aluminum frame with a sandwiched panel of G.I. sheet duly pre-coated from the outside & 43 mm thick PUF filled in between.

Fresh air enters through a 10µ fresh air filter. Air then passes through the mixing section with (10 +5) µ pre-filter, 6 rows deep CHW coil & 2 rows deep HW coil is placed on a condensate tray, Sandwiched type in SS-304 construction with proper drain point. The air will then pass through a 3µ fine filter installed in the AHU supply plenum.

FA dampers are provided with a 10µ G-4 pre-filter, and EA dampers are provided with a (0.3µ)H-13 HEPA filter.

Filtered air after the 3µ filter will be supplied to the room via leakproof GSS Ducting through ceiling-mounted Supply air Hepa (0.3 µ) H-13  and air will return through a return air Riser via return duct to the mixing chamber.

Both ends of the GI ducts will have flanges & flanges will have neoprene gaskets. 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. A fire damper should be installed on the supply & return air duct near AHU.


System / Equipment Description
Execution Team
Installation Verification
Installation Check
Documentation Requirement
Deviation Report
Installation Qualification Summary & Conclusion
Certification for Installation Qualification


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 the Vendor and supplied by the Client.

The Air-Handling unit caters to:-

Name of the area Area (SQFT) Height (FT)
Sampling 148 9.84
Wash 41 9.84
Change Room 59 9.84
Sampling 149 9.84
Air lock 77 9.84
Sifting 162 9.84
PM Sampling 81 9.84

Installation Qualification

Each installed component and sub-component complies with the engineering design and manufacture recommendations.

Ensure that appropriate interconnections are made for utilities/equipment and 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


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 %

RESPONSIBILITY: 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 before 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 checking the protocol document. 

Quality Assurance Department

  • Providing guidance, wherever required to the related departments.
  • Approval of protocol.


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 necessary documents to prove that the Air Handling unit was installed correctly and corresponds to the specifications of the manufacturers as well as the client and that it is suitable for the planned application. The completely executed and finally approved protocol confirms that the Air Handling system 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 the 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 manufacturer’s documentation.

The following appendices, in the qualification protocol attached, were used for the 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 : 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


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:-

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

Component: Fresh air Pre Filter

Feature Specification = acceptance criteria
Manufacturer Air Tech.
Location AHU
Filter Class / Efficiency 10 µ
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

Component:  Pre Filter (Combo) 

Feature Specification
Manufacturer Air tech.
Location Coil protection in the mixing chamber
Filter Class / Separation Efficiency 10 µ +5 µ
Model / Type Flange type Filter
Dimensions (mm) 610 x 610 x 380 & 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

Component:  Fine Filter

Feature Specification
Manufacturer Air tech.
Location Supply Chamber in AHU
Filter Class / Separation Efficiency 3 µ
Model / Type Flange type Filter
Dimensions (mm) 610 x 610 x 305 & 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

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
Number of Filters 1 Nos
Installation Installed in Exhaust air Module

Component:  HEPA Filter

Feature Specification
Filter Class / Separation Efficiency
Model / Type
Dimensions (mm)
Number of Filters
Pressure difference measuring

Component: Fan – Motor

Feature Specification
Make Punker
Type PLUG Type (non-spark proof)
Capacity 2718 cfm
Total Static Pressure 115 mm of wc
Fan/ Blower speed(RPM) 2754
Make CG / BBL / ABB / Siemens or equivalent make
Type TEFC 3Ph / 4Pole
Rating 3.7 kW,2 Pole EFF-2

Component:  Damper

Feature Specification = Acceptance Criteria
Location Supply, Return, Fresh & Bleed air damper
Model / Type Opposed blade low leakage GI damper

Component: Ductwork 

Feature Specification = Acceptance criteria
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

 Component: Outlet Terminal Box 

Feature Specification =Acceptance criteria
Manufacturer MKP
Type Swirl Diffuser
Installation Completed


The purpose of documentation is to provide the basis for further validation (OQ) and generate 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 parts list with descriptions. Spare parts list.


All discrepancies between specification and Acceptance criteria fulfilled yes/no on-site concerning the installation equipment, piping, supply, and supervision facilities 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).


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About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 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 leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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