OPERATION QUALIFICATION PROTOCOL FOR AIR HANDLING UNIT (AHU) IN PHARMA
The AHU is designed to circulate the air in the area after passing it over cooling coils to maintain the required environmental conditions and pass it through the filters to maintain the desired cleanliness level. The air intake and out-take of the system is designed to support a 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 below:
Air Circulation System
Blower: A blower is provided in the unit to supply air in the working area. This blower is directly 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 an air distribution network
Air Cooling and Heating System
Cooling Coil: –The air Temperature and RH should be controlled by the cooling coil. It has Coated Al.fins and Chilled water circulated through the coil by copper tubes. The Dry air passes through the coil before entering in room via the 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 the coil by copper tubes. The Dry air passes through the coil before entering in room via a 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 gradients and other parameters like Temperature & RH.
AIR FILTRATION SYSTEM
10 micron Pre Filters: – Fresh air filters having filtration efficiency up to 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 the 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.
OPERATION QUALIFICATION PROTOCOL CONTENTS
- Pre-Approval
- Overview
- Purpose
- Requalification
- System Distribution
- System Description
- Operational Qualification Procedure
- Pre Requisite for OQ Test
- Test Equipment
- Qualification of Execution Team
- Inspection Checklist
- Operational Qualification
- Instrument Calibration
- Key Functionality
- Operational Checks
- SOP verification
- Deficiency, if any, and Corrective Action Report
- Acceptance Criteria
- Summary and Conclusion
- Certification for Operational Qualification
Pre-Approval: The signing of this Approval page of Operational Qualification for AHU indicates agreement with the Operational Qualification approach described in this document. If any Modifications become necessary, an addendum will be attached.
Purpose: The purpose of this protocol is:
- Verifying the operational attributes of the Heating Ventilation and Air Conditioning system is critical to serving the intended purpose.
- To establish the suitability of the draft SOP prepared for the operation of the System.
- To document the observations for future reference.
Re-qualification: 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.
System Description: The Air Handling Unit consists of:
- Air Circulation System
- Air Cooling System
Air Distribution Network
- Air Filtration System
- Control System
- Safety System
Instrumentation and Control System: – To control various parameters, a Proportional thermostat has been provided. The Air-Handling unit caters to:-
AREA DETAILS
| 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 |
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
- R H – NMT 60 %
Operational Qualification Procedure
Pre Requisite of OQ Test
Equipment should be installed properly as defined in the Installation Qualification Protocol of the equipment.
Utilities should be provided for the equipment.
Required identification tags should be available at the site in the appropriate place.
Test Equipment
The following test equipment is required for the Operational Qualification Test.
Magnehelic Gauge – For checking the Pressure Drop across the AHU Filters – Calibration Required-yes
Multi Meter / Clamp Meter. – For checking the Electrical Supply and Current rating of the motors – Calibration is required
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.
Before 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 the method of qualification protocol. This training shall be recorded.
The trained personnel shall carry out the Operational Qualification following the Procedures mentioned for key functionality and safety features. Record the observations in the individual test data sheets. Checkpoints designed for OQ are also aimed at the verification of existing and drafted SOPs.
Report the deficiency from the specified function, if any in the protocol.
Operational Qualification
Instrument Calibration
Magnehelic gauges: Calibration Done on /Calibration Due on /Calibrated By
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
Check for the Supply Blower and Motor of the Air Handling Unit
Check the Supply Blower and Motor assembly for proper fitment on the base frame and Motor should be properly fitted on the base frame and tightened with bolts and nuts.
Check the motor shaft rotation, manually.- Motor shaft should rotate smoothly when rotated manually.
Check the Blower rotation, manually. – The blower should rotate smoothly when rotated manually.
Check the motor shaft key and hub screws – The blower should rotate smoothly when rotated manually.
Check the motor shaft key and hub screws – The motor should be tightened with the shaft key and hub screws
Check the Blower shaft key and hub screws – The blower should be tightened with the shaft key and hub screws.
Check for Air Handling Unit Dampers
Open and close the Fresh Air damper of the Air Handling Unit for its operation, manually. -The damper should open and close smoothly.
Note: Adjust the damper in full open condition after the checking.
Open and close the supply air Volume control Damper of the Air Handling Unit for its operation, manually. – The damper should open and close smoothly.
Note: Adjust the damper in full open condition after the checking.
Operational Checks
Check for the Power supply
Switch on the main power supply to the control panel Located on the Ground Floor. – The power supply indicator should glow in the control panel
Switch on the control panel power supply to the Air Handling Unit – The Air Handling Unit blower motor should start.
Check for the Supply Air Blower
Check the supply air blower for any abnormal sound – There should not be any abnormal sound in the supply air blower.
Check the direction of the rotation of the blower – The blower should rotate as per the arrow mark indicated on the blower.
Check for the AHU Filtration System
Check the differential pressure of the 10+5 m filters – The differential pressure of the filters should be between 4-12mm of WC
Check the differential pressure of the 3 m filters – The differential pressure of the filters should be between 12-15mm of wc
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
Acceptance Criteria
Operational Qualification shall be considered acceptable when all the conditions specified in various above test data sheets have been met.
Any deviation from the acceptance criteria of the specific checkpoint shall be reported and the decision should be taken for the rejection, replacement, or rectification of the equipment/component.
Whether the acceptance criteria of the protocol and specific checkpoints are met.
SUMMARY AND CONCLUSION
The system is now ready FOR PERFORMANCE QUALIFICATION