AHU Installation Qualification (IQ) Protocol: Complete Guide with Format & Checklist

AHU Installation Qualification (IQ) Protocol Objective: The objective of this protocol is to verify that the AHU is installed as per approved design specifications, drawings, and manufacturer recommendations. This AHU Installation Qualification (IQ) Protocol covers the following:

SERIAL NO.	ITEM DESCRIPTION
1.0	Identification and inspection of the contact surfaces and non-contact surfaces
2.0	OVERVIEW:
2.1	Objective
2.2	Purpose
2.3	Scope
2.4	Responsibility
2.5	Execution Team
3.0	ACCEPTANCE CRITERIA
4.0	REVALIDATION
5.0	INSTALLATION QUALIFICATION PROCEDURE
5.1	System Description
5.2	Instructions for Filling the Checklist
5.3	Installation Check-List
5.4	Identification Of Major Components
5.5	Identification, classification, and verification of process control instruments
5.6	Identification and inspection of utilities
5.7	Identification and inspection of the contact surfaces and non-contact surfaces
5.8	Identification of Safety Feature(s)
5.9	Verification of Drawing and Documents
5.10	Abbreviations
5.11	Deficiency And Corrective Action(s) Report(s)
5.12	Annexure(s)
6.0	INSTALLATION QUALIFICATION FINAL REPORT
6.1	Summary
6.2	Conclusion
6.3	Final report approval

1.0	PROTOCOL APPROVAL:

Signing of this approval page of Protocol indicates agreement with the qualification approach described in this document. If modifications to the qualification approach become necessary, an addendum shall be prepared and approved. The protocol cannot be used for execution unless approved by the following authorities.

This Installation Qualification protocol of Air handling unit has been reviewed and approved by the following persons:

XYZ Pharmaceutical:

FUNCTION	NAME	DEPARTMENT	SIGNATURE	DATE
PREPARED BY		QUALITY ASSURANCE
REVIEWED BY		PROJECTS / ENGINEERING
REVIEWED BY		PRODUCTION
APPROVED BY		QUALITY ASSURANCE

Service Company name:

Name	Designation	Signature	Date

2.0

OVERVIEW:

2.1	OBJECTIVE:
	The objective of developing and executing this protocol is to collect sufficient data pertaining to the Air handling system and define the qualification requirements and acceptance criteria for the unit. Successful completion of these qualification requirements will provide assurance that the Air handling system was installed as required in the service area. Installed components should comply with the engineering design, and specification of the equipment and Vendor recommendations. To ensure that appropriate interconnections are made for utilities /equipment before starting installation qualification. Ensure that the system meets the cGMP and Regulatory requirements.
2.2	PURPOSE:
	The purpose of this protocol is to establish documentary evidence to ensure that the Air handling system received matches the Design specification and also to ensure that it is properly and safely installed.

2.3	SCOPE:
	The installation qualification protocol shall be followed for AHU of manufacturing facility at XYZ Pharmaceuticals (Location). This protocol defines the methods and documentation that shall be used to evaluate the system installation in accordance with the specifications and intended use. Successful implementation of this protocol shall verify that the systems installed meet the requirements specified. Installation checks shall be performed to document that all the components of the systems are installed with proper supporting services and utilities. All documentation, including manufacturer’s manuals for the components described in this protocol shall be verified for availability. Any exceptional conditions encountered during the qualification studies shall be identified for review. Exceptional conditions shall be investigated and the appropriate course of action determined. All data shall be documented.
2.4	RESPONSIBILITY:
	The following shall be responsible; Quality Assurance Officer/Executive – For preparation of protocol Projects / Engineering Head – For execution  Production Head – For execution support Quality Assurance Head – For adequacy and final approval

2.5	EXECUTION TEAM:
	The satisfactory installation of the Air handling system shall be verified by executing the qualification studies described in this protocol. The successfully executed protocol documents that the Air handling system is installed and is satisfactorily integrated. Execution team is responsible for the execution of installation of Air handling system. Execution team comprises of:

DEPARTMENT	DESIGNATION	NAME	SIGNATURE	DATE
PROJECTS / ENGINEERING
PRODUCTION
QUALITY ASSURANCE

3.0	ACCEPTANCE CRITERIA:
1	The AHU shall meet the system description given in design qualification.
2	The AHU shall meet with the acceptance criteria mentioned under the topic “Identification of major components”.

4.0	REVALIDATION CRITERIA:
	The machine has to be revalidated if:
	If there are any major changes in system components which affect the performance of the system, after a major breakdown, maintenance activity. As per revalidation date and schedule.

5.0	INSTALLATION QUALIFICATION PROCEDURE:
5.1	HVAC SYSTEM DESCRIPTION

Air handling unit is a closed system which re-circulates air free from particulate matter to different areas. Following parts are installed in the system.

1. AHU Body
2. Pre-Filter
3. Heating coil
4. Cooling Coil
5. Blower
6. Motor
7. Secondary Filter
8. Supply Air Housing Box and Perforated Sheet
9. Return Air Riser
10. HEPA Filter
11. GI Ducting
12. Insulation

This is a closed box-type construction having a chamber for mixing the fresh and the return air.  The fresh air is made to pass through the 10m  & 5m filter. The Cooling and Heating coils are fixed in the system to maintain Relative Humidity % and temperature at the place of intended use. 

The system is provided with damper in fresh air duct and return air duct so that the system can supply the desired quantity and quality of air at the designated areas.

 Instrumentation Details:

1. Differential pressure transmitter
2. VFD
3. Filter condition monitoring sensor
4. Chilled & Hot water control valves 
5. Chilled air sensor after cooling coil
6. Temperature and RH sensor

Filters:

•  The pre-filter is made of synthetic washable material having 10m  + 5m rating, and has filtration efficiency of 90% down to 10m and 90% down to 5m filter.
• The Fine Filter has a 3 m rating and has a filtration efficiency of 99%.
• The HEPA Filter is having 0.3m rating, with an efficiency of 99.97%.

The total volume of air is supplied to the different areas by supply duct, which is made up of G.I. sheet of 24-gauge thickness. The returned air is suck back through the return air duct network.

Auto Control Valve

The auto control valve operates so as to maintain the desired temperature and Relative Humidity % in the area of intended use in the designated place. The valve automatically controls the flow of chilled and hot water in the cooling and heating coils.

Air Handling Units:

The double-skinned AHU consists of double-skinned panels with anodized extruded aluminium sections. Framework bolted together with a sandwich panel having 24 gauge G.I. pre-coated for outer and 20 gauge G.I. plain for inner skin .50 mm thick PUF to be injected between the two panels. Drain tray is of 18 gauge S.S 304.

Air distribution:

Air distribution is enabled by GSS supply and return air ducts. The supply air duct joints are sealed with Silicon sealant. Flange joints are provided with 3 mm thick Neoprene gasket. Air supplied into the rooms through supply air terminal filters to achieve good air distribution and is returned through low-level GSS return air risers with down to 10 m return air filters. The slab-mounted supply terminals are of the bottom-loading type.

Supply air terminal HEPA Filters:

For all the critical areas, conditioned and filtered air is supplied to the room through terminal HEPA filters (0.3 micron 99.97% efficiency).

Return air Riser:

For all the critical areas, return air risers are provided to collect the air from just above the floor level for better dust removal.

Duct leakage test:

The smoke testing to be conducted for detecting the duct leakage.

Piping system:

Mild steel  ‘C’ class pipes are used for entire chilled water. Drain pipes are GI ‘B’ class. Butterfly / Gate valves are provided at all AHU coils required to facilitate shut-off for servicing. Controls valves are provided with all coils for the chilled water & hot water flow. ‘Y’ Strainers are also provided in chilled & hot water supply lines.

Purge air system:

The purge air is to be collected by global exhaust unit, which is provided separately for XYZ block. This purge air unit system has heat recovery system to gain energy from the purge air.

Insulation:

The supply air ducts and return air ducts are insulated respectively with 16 mm and 9 mm PUF. The chilled supply /return water pipes are insulated with 25 / 19 mm thick nitrile rubber. All insulated hot water pipes are clad with 24-gauge aluminium cladding.

Reviewed By:

Date:

5.2	INSTRUCTION FOR FILLING THE CHECKLIST
1	In case of the compliance of the test, use the word ‘Complies’; otherwise, use ‘Does not comply‘ to indicate non-compliance.
2	For identification of the components of the equipment and utilities, use the word ‘’yes’’ to show its presence and use ‘No’ to indicate the absence of the identity.
3	Give the detailed information in the summary and conclusion part of the Installation Qualification report.
4	Whichever column is blank or not used, ‘NA’ shall be used.
5	Put (tick mark) wherever applicable.

5.3 INSTALLATION CHECKLIST for AHU Installation Qualification (IQ) Protocol

Sr.No.	Statement	Yes/No	Checked By	Date
1	Verify that the “as-built drawings” are complete and represent the design concept.
2	Verify that major components are securely anchored and shock-proof.
3	Verify that there is no observable physical damage.
4	Verify that there is sufficient space for maintenance, as provided.
5	Verify that all electrical connections have been made.
6	All access parts are examined and cleared of any debris.
7	Required electric connections are tight, weather-proof, and earthed.
8	Verify that identification nameplate is visible.
9	Units installed on foundation and secured in place as per manufacturer’s recommendations.
10	Ensure AHU outer skin is made up of green colored GI material.
11	Dampers are installed as indicated in the air flow diagram and are easily operable.
12	Fresh air damper
13	Supply air damper
14	Return air damper
15	Verify supply and return air duct routing to each room is as per ducting layout diagram.
16	Check grills are installed in each room as per ducting layout diagram.
17	Service lines like chilled water and hot water are connected to AHU system as indicated in line diagram.
18	2-way proportioning control valve is installed in chilled water return line as shown in schematic piping diagram.
19	3-way proportioning control valve is installed on hot water return line as in schematic diagram.
20	Valves on chilled water service lines are installed correctly as per direction indicated in schematic diagram, are easily operable, and connected to BMS.
21	Valves on hot water service lines are installed correctly as per direction indicated in schematic diagram, are easily operable, and connected to BMS.
22	All joints of piping, ducting, AHU body, and blower are properly sealed.
23	Check the motor provided is flame proof / non-flame proof.
24	Variable Frequency Drive (VFD) is installed as per design specification.
25	Check DDC panel is installed and is connected to VFD.
26	Ensure following components are provided with earthing: a) Motor, b) VFD.
27	Verify that PO is available and copy of the same is attached.

Reviewed By:

Date:

5.4	IDENTIFICATION OF MAJOR COMPONENTS:
	Describe each critical component, check them, and fill in the inspection checklist.
System Components		Design Specification	Complies / Does Not Comply	Method of Verification	Checked By Sign / Date
A) Air handling unit: Construction details
Make		—
Type		Double skin floor-mounted
Frame structure		Extruded profile Aluminium, Anodised with thermal break.
Dimension (Lx W x H)		3470x 1540×3000 mm
Panel		43±0.5 mm thick sandwich type
Inner skin		20 gauge GI Plain
Outer skin		24 Gauge G.I. precoated
Insulation		Polyurethane
Panel lock		Low projection, hand-operated, Aluminium construction.
Handle		‘C’ type Aluminium
Hinges		Nylon die cast with S.S. pivot
Dampers		Oppose blade Aerofoil design, low leakage, aluminium anodized.
Drain pan		1.2mm thick S.S. 304
Vibrator isolator below AHU		Shall be provided with antivibration pad below AHU.

System Components	Design Specification		Complies / Does Not Comply	Method of Verification	Checked By Sign / Date
1. Fan
Type	Plug type
Make	—
Diameter	450 RD
Fan speed RPM	2910
2. Motor	15 HP -2 Pole, 3Ph., Sq.Cg in Non-FLP Construction, RPM 2895
Make	—
3. Filters
Make		—
Pre Filter		90% down to 10 micron+ 90% down to 5 micron combination
5 micron bag filter Size-Qty		592X592X500 –4No
10 micron filter Size-Qty		592X592X50 –4No
Secondary filter		99% – 3 micron
Size-Qty & Type		610 x 610 x 305-4No. Flange type
4. Coils
Chilled water coil size	12.5” H x 48” L -6RD
Hot water coil size	12.5” H x 48.0” L -2 RD
5. Ductings
Type	Rectangular / Square
MOC	GSS
Thickness	24 mm

System Components	Design Specification	Complies / Does Not Comply	Method of Verification	Checked By Sign / Date
Type of insulation	PUF, 16/9 mm
Pressure testing	To be carried out and report to be enclosed
Type of sealant	GE 2000
MOC dampers	Aluminium
No. of supply air dampers
No. of return air dampers
Type of duct supports	MS, 40 mm. angle supported to the ceiling
Type of flange to flange connections	Milled steel flange connection. Sealing to be done with rubber gasket, and the duct flanges shall be tightened with GI nuts and bolts.
6. Return air risers
Make	—
Type of mounting	Vertical
Size
MOC	MS powder coated
Thickness of the riser sheet	18 SWG
Quantity of riser
Clearance between floor and riser	8 inch
Riser filter size
Efficiency	90%
System Components	Design Specification	Complies / Does Not Comply	Method of Verification	Checked By Sign / Date
Quantity of diffusers
No. of grills
Size of grill
7. Hot water piping
Size of header	80 mm
Size of tapping
Type of inlet valve	BF/Ball valve
Type of outlet valve	BF/Ball valve
Type of insulation	Rock wool aluminium cladding
Thickness of insulation	50 mm
8. Chilled water piping
Size of header	125 mm
Size of tapping	As per enclosed piping drawing
Type of inlet valve	BF/Ball valve
Type of outlet valve	BF/Ball valve
Type of insulation	Nitrile rubber
Thickness of insulation	19 mm
9. Pressure testing of pipelines
Hot water	Report to be enclosed
Chilled water	Report to be enclosed
10. Electrical and control system
Location of control panel	Service floor

5.5 IDENTIFICATION, CLASSIFICATION & VERIFICATION OF PROCESS CONTROL INSTRUMENTS:

Process control instruments are Indicators, Sensors, Controllers, and Gauges. These are classified into two categories.

1. Critical (C): The instruments whose performance will directly affect the quality parameters of the product.
2. Non – critical (N): The instruments whose performance failure will not affect product quality and which are used for process control.

Instruments	Check	Observation	Class	Checked by	Date
Temperature & RH Indicator	Check for any physical damage
	Make
	Range details
Differential Pressure Transmitter  (Across Rooms)	Check for any physical damage
	Make
	Range details

5.5 IDENTIFICATION & INSPECTION OF UTILITIES:

The utilities required are identified on the basis of information available in Design qualification document, information brochure, and purchase order.

Utility	Requirement	Purpose	Verified by
Power
Chilled water
Hot water

5.6 IDENTIFICATION & INSPECTION OF THE CONTACT SURFACES & NON CONTACT SURFACES

In this section, all components of the equipment, which may come into direct/indirect contact with the product, are probably affecting the product’s safety, purity, and efficacy.

Contact surfaces are listed based on Physical inspection, Instruction manuals, drawings, and Design qualification documents.

CONTACT SURFACES

Component	Specified MOC	Observation	Method of verification	Checked by
AHU Housing	Double Skin Type PUF insulated, made out of GI inside and outside, powder coated.
Pre Filters	Non-Woven synthetic media, one side HDPE mesh with Aluminum casing
Secondary Filters	Non-woven synthetic media, one side HDPE mesh with Aluminium casing
Ducts	Galvanized Iron
HEPA Filters	Micro glass fiber paper, aluminum separator

Comments:

Reviewed By:

Date:

5.8	IDENTIFICATION OF SAFETY FEATURES:
	Identify and record the safety features (if any) and their function in following tables:

Safety Features Description	Function	Identified By (Sign)	Date
1. Earthing of motor	To avoid accidents due to the leakage current.
2. Insulation of hot surface	To avoid burn injury.
3. Door limit switch	To avoid accidents during operation

Reviewed By:

Date:

5.9	VERIFICATION OF DRAWING AND DOCUMENTS:
	Following documents are reviewed and attached as listed below:
Sr. No.	DRAWING AND DOCUMENT DETAIL	CHECKED BY (SIGN)	DATE
	Air flow diagram of  AHU
	Ducting layout
	Piping layout and Instrumentation layout
	Risers layout
	Pressure differential datasheet
	AHU hot water manifold drawing
	AHU chilled water manifold drawing
	Design datasheet
	AHU GA drawing
	Leak test for duct

Reviewed By:

Date:

5.10	ABBREVIATIONS
	Following Abbreviations are used in the installation qualification protocol of Air handling unit
	AHU: Air Handling Unit HEPA: High efficiency particulate air HVAC: Heating, ventilation, and air conditioning CFM: Cubic feet per minute MOC: Material of construction GI: Galvanized iron PVC: Polyvinyl chloride RPM: Rotation per minute BHP: Break Horse Power SA:  Supply air                            RA: Return air DOP: Dioctyl pthalate SWG: Standard wire gauge VFD: Variable frequency drive GSS: Galvanized stainless steel  PUF: Polyurethane Foam HDPE: High-density polyethylene DDC: Direct Digital controller

5.11	DEFICIENCY AND CORRECTIVE ACTION (S) REPORT (S)
Following deficiency was identified and corrective actions taken in consultation with the validation team.
Description of deficiency:
Corrective action(s) taken:

Reviewed By:

Date:

5.12   Annexure:

Sr.No.	Annexure No.	Annexure Details

6.0	INSTALLATION QUALIFICATION FINAL REPORT:
All the IQ data sheets and discrepancy reports shall be reviewed by validation team to prepare summary report. The summary of IQ shall be used to draw conclusion for approval of installation qualification report.

6.1	SUMMARY
6.2	CONCLUSION

Reviewed By:

Date:

6.3 FINAL REPORT APPROVAL

It has been verified that all tests required by this protocol are completed, reconciled, and attached to this protocol or included in the qualification summary report. Verified that all amendments and discrepancies are documented, approved, and attached to this protocol.

Signature in the block below indicates that all items in this qualification report of air handling unit have been reviewed and found to be acceptable and that all variations or discrepancies have been satisfactorily resolved.

NAME	DESIGNATION	DEPARTMENT	SIGNATURE	DATE
		PROJECTS / ENGINEERING
		PRODUCTION
		QUALITY ASSURANCE