Operation Qualification Protocol For Air Handling Unit & Air Distribution System - Pharmaceutical Guidance

27/11/2022, 08:30 Operation qualification protocol for air handling unit & air distribution system - Pharmaceutical Guidance
Operation qualification protocol for air handling unit & air

distribution system
 Pharma Editor  December 1, 2016  Validation & Qualification  5,768 Views
Operation qualification protocol for air handling unit & air distribution system
Purpose:
The purpose of this protocol is:
To verify the operational attributes of the Heating Ventilation and Air Conditioning system, critical to serve
the intended purpose.
To establish the suitability of the draft SOP prepared for the operation of System.
To document the observations for future reference.
Requalification:
Operational Qualification to be repeated in case of:
Replacement of any major component / instrument.
Major modification in the existing equipment.
During monitoring if equipment is found to be malfunctioning (Broken or not working properly).
Shifting of the equipment from one location to another location.
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.
https://pharmaguidances.com/operation-qualification-protocol-for-air-handling-unit-air-distribution-system/ 1/13
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.
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
System Description
The Air Handling Unit GF-02 consists of:
Air Circulation System
Air Cooling System
Air Distribution Network
Air Filtration System
Control System
Safety System
FUNCTION: The AHU is designed to circulate the air in the area after passing it over cooling coils to
maintain the required environmental conditions and passing it through the series of filters to maintain
desired cleanliness level in the area. The air in-take and out-take of the system is designed to maintain
certain degree of pressure gradient, temperature and Relative Humidity in the area as per the
requirement.
The major components of the air-handling unit are briefly described as below:
Air Circulation System
Blower: – Blower is provided in the unit to supply air in the working area. This blower is direct driven by a
motor. The blower takes the air from the atmosphere and / or from the rooms as return air and delivers it

to the working areas through air distribution network
Air Cooling and Heating System
Cooling Coil: –The air Temperature and RH should be controlled by cooling coil. It has Coated Al.fins and
Chilled water circulated through coil by copper tubes. The Dry air passing through coil before entering in
room via ducting system.
Hot water Coil: –The air Temperature and RH should be controlled by HW coils. It has Coated Al.fins and
Chilled water circulated through coil by copper tubes. The Dry air passing through coil before entering in
room via ducting system.
Air Distribution System
Air Distribution Network. An air distribution network is provided to supply the air, delivered by the
blowers, into the working areas. By using the same network, return air flows back to the air handling unit
to maintain certain pressure gradient and other parameters like Temperature & RH.
AIR FILTRATION SYSTEM
10 micron Pre Filters: – Fresh air filters having filtration efficiency upto 90% down to 10m are provided in
the Fresh air intake of the AHU to filter out dust particles from the service area air.
0.3 micron HEPA Filters: – HEPA filters having filtration efficiency up to 99.99% down to 0.3m are
provided in the Air Handling Unit for bleed air.
10+5 micron combo Pre Filters: –Combo pre filters having filtration efficiency up to (90% down to 10 m
+ 95% down to 5m) are provided before cooling coil in the return air of the Air Handling Unit to filter out the
dust particles.
3 micron Fine Filters: – Fine filters having filtration efficiency up to 99% down to 3m are provided after
the cooling coil and blower to remove fine particles from the treated air.
CONTROL SYSTEM
Instrumentation and Control System: – For the purpose of controlling of various parameters,
Proportional thermostat have been provided.
The Air-Handling unit caters to:-
AREA DETAILS
Sr. No Name of the area Area (SQFT) Height (FT)
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
R H – NMT 60 %
Operational Qualification Procedure
Pre Requisite of OQ Test
Equipment should be installed properly as defined in Installation Qualification Protocol of the equipment.
Utilities should be provided to the equipment.
Required identification tags should be available at site in appropriate place.
Test Equipment
Following test equipments are required for Operational Qualification Test.
Calibration Calibration
Test Equipment Purpose Done on Due on
Required Confirmed By
For checking the
Magnehelic Pressure Drop

Yes
Gauge across the AHU
Filters
For checking the

Multi Meter / Electrical Supply
Yes
Clamp Meter. and Current rating
of the motors.
Remarks / Discrepancy (If any): __________________________________________
Reported by
(Engineering) (Name) (Sign.) (Date)
Verified by
Qualification of Execution Team
The execution team should be qualified for conducting Operational Qualification of the equipment

Date of Training:
Title:
S. No. Name of the Trainee Employee Number Signature
Training Given By (Name) (Designation) (Sign.) (Date)
Training Given By (Name) (Designation) (Sign.) (Date)
Inspection checklist
The SOP shall be drafted and verified for operation during Operational Qualification testing. If any
changes / modifications are found SOP shall be revised considering all changes.
Prior to the Qualification test, the Personnel shall be trained by the competent Engineer from the supplier /
user on the operational features of the equipment / system and method of qualification protocol.
The trained personnel shall carry out the Operational Qualification for key functionality and safety
features. Record the observations in the individual test data sheets. Checkpoints designed for the purpose
of OQ are also aimed at verification of existing and drafted SOPs.
Report the deficiency from the specified function, if any in the protocol.
Operational Qualification
Instrument Calibration
S. Name of the Calibration Calibration Due 

Location Calibrated By
No. Equipment Done on on
Magnehelic
gauges
Checked by
(Name) (Sign.) (Date)

(Engineering)
Verified by
(Quality Assurance)
Key Functionality
The critical components of the Air Handling System shall be checked to ensure that these are operating to
meet the desired design specification, as given by the supplier.
The following attributes are considered as critical
Primary Checks of Blower and Motor Assembly
Operation of Blower Motor Assembly
Operation of Cooling and Heating system
Flow of air through filters
Safety Function
Operational Checks
Specified
S. No. Test Particulars Observations Checked By
Function
1 Primary Checks
1.1 Check for the Supply Blower and Motor of Air Handling Unit
Specified
Function

Blower and Motor
Check the Supply
should be
Blower and Motor
properly fitted on
1.1.1 assembly for proper
base frame and
fitment on base
tightened with
frame.
bolts and nuts.
Motor shaft
Check the motor
should rotate
1.1.2 shaft rotation,
smoothly when
manually.
rotated manually.
Blower should
Check the Blower rotate smoothly
1.1.3
rotation, manually. when rotated
manually.
Motor should be
Check the motor
tightened with
1.1.4 shaft key and hub
shaft key and hub
screws.
screws.
Blower should be
Check the Blower
tightened with
1.1.5 shaft key and hub
shaft key and hub
screws.
screws.
1.2 Check for Air Handling Unit Dampers
Specified
Function

Open and close the
Fresh Air damper of
the Air Handling Unit
for its operation,
Damper should
manually.
1.2.1 open and close
Note: Adjust the smoothly.
damper in full open
condition after the
checking.
Open and close

the supply air
Volume control
Damper of the Air
Handling Unit for
Damper should
its operation,
1.2.2 open and close
manually.
smoothly.
Note: Adjust the
damper in full
open condition
after the checking.
S. No. Test Particulars Specified Function Observations Checked By
2 Operational Checks
2.1 Check for the Power supply
2.1.1 Switch on the main Power supply indicator

power supply to the should glow in the control
panel
control panel Located at

Ground Floor.

Switch on the control
Air Handling Unit blower
2.1.2 panel power supply to
motor should start.
the Air Handling Unit
2.2 Check for the Supply Air Blower
Check the supply air There should not be any

2.2.1 blower for any abnormal abnormal sound in the
sound supply air blower.
Check the direction of Blower should rotate as

2.2.2 the rotation of the per the arrow mark
blower. indicated on the blower.
2.3 Check for the AHU Filtration System
Check the differential Differential pressure of the

2.3.1 pressure of the 10+5 m filters should be between
filters 4-12mm of wc
Check the differential Differential pressure of the

2.3.2 pressure of the 3 m filters should be between
filters 12-15mm of wc
Checked by
Verified by
(Engineering)
SOP VERIFICATION
SOP No. : _____________________
Title : _____________________
The System was operated as per the SOP and details are recorded as under:
Operated By: _____________________________________


Checked By: _____________________________________
Changes required in draft SOP (If any): _____________________________________
SOP to be corrected (Yes/No) : ____________________
Verified By : ____________________
Date : ____________________
Deficiency (if any) and Corrective Action Report
Description of deficiency and date observed: ______________________________________
Person, responsible for corrective action and date assigned: __________________________
Corrective actions taken and date conducted: ______________________________________
Conducted By : ___________________ Approved By : ___________________
Date : ___________________ Date : ___________________
Acceptance Criteria
Operational Qualification shall be considered acceptable when all the conditions specified in various test
data sheets.

Any deviation from the acceptance criteria of the specific checkpoint shall be reported and decision should
be taken for the rejection, replacement or rectification of the equipment / component.
Checks Observations Checked by
Whether the acceptance criteria of

the protocol and specific
checkpoints are met.
SUMMARY AND CONCLUSION:
SUMMARY
———————————————————————————————————————
CONCLUSION
———————————————————————————————————————
Forms and Records (Annexures)
Not Applicable
Distribution
Master copy – Quality Assurance
Controlled copies- Quality Assurance, Production, Quality Control.engineering
History
Date Revision Number Reason for Revision
– 00 New SOP
For More Updates Visit –https://pharmaguidances.com/jobs/
Pharma Editor

Operation Qualification Protocol For Air Handling Unit & Air Distribution System - Pharmaceutical Guidance

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Operation Qualification Protocol For Air Handling Unit & Air Distribution System - Pharmaceutical Guidance

Uploaded by

Copyright:

Available Formats

27/11/2022, 08:30 Operation qualification protocol for air handling unit & air distribution system - Pharmaceutical Guidance

Operation qualification protocol for air handling unit & air

The purpose of this protocol is:

the intended purpose.

To document the observations for future reference.

Operational Qualification to be repeated in case of:

Replacement of any major component / instrument.

Major modification in the existing equipment.

During monitoring if equipment is found to be malfunctioning (Broken or not working properly).

Shifting of the equipment from one location to another location.

Sr. No. Term Explanation

1 AHU Air Handling Unit

9 ACPH Air Changes per Hour.

10 CFM Cubic Feet per minute

11 MOC Material of construction 

14 SOP Standard Operating Procedures

17 cGMP Current Good manufacturing practices

20 NMT Not more than

21 NLT Not less than

23 EPS Expanded polystyrene

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

35 DIDW Double Inlet Double Width

37 FLP Flame Proof

41 Sq. Cg. Squirrel Cage

The Air Handling Unit GF-02 consists of:

Air Circulation System

Air Cooling System

Air Distribution Network

Air Filtration System

Air Circulation System

Air Cooling and Heating System

Air Distribution System

AIR FILTRATION SYSTEM

Proportional thermostat have been provided.

The Air-Handling unit caters to:-

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

Operational Qualification Procedure

Pre Requisite of OQ Test

Utilities should be provided to the equipment.

Required identification tags should be available at site in appropriate place.

Following test equipments are required for Operational Qualification Test.

For checking the

Magnehelic Pressure Drop

For checking the

Remarks / Discrepancy (If any): __________________________________________

(Engineering) (Name) (Sign.) (Date)

(Engineering) (Name) (Sign.) (Date)

Qualification of Execution Team

S. No. Name of the Trainee Employee Number Signature

Training Given By (Name) (Designation) (Sign.) (Date)

Training Given By (Name) (Designation) (Sign.) (Date)

S. Name of the Calibration Calibration Due 

(Name) (Sign.) (Date)

The following attributes are considered as critical

Primary Checks of Blower and Motor Assembly

Conducted By : _ Approved By : _

Date : _ Date : _