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. |
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.
Test Equipment | Purpose | Calibration Required | Done on | Due on | Calibration Confirmed By |
Magnehelic Gauge | For checking the Pressure Drop across the AHU Filters | Yes | |||
Multi Meter / Clamp Meter. | For checking the Electrical Supply and Current rating of the motors. | Yes |
- Remarks / Discrepancy (If any): __________________________________________
Reported by
(Engineering) |
(Name) |
(Sign.) |
(Date) |
Verified by
(Engineering) |
(Name) |
(Sign.) |
(Date) |
- 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 |
1 | |||
2 | |||
3 | |||
4 | |||
5 |
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. No. | Name of the Equipment | Location | Calibration Done on | Calibration Due on | Calibrated By |
Magnehelic gauges | |||||
Checked by
(Engineering) |
(Name) | (Sign.) | (Date) |
Verified by
(Quality Assurance) |
(Name) | (Sign.) | (Date) |
- 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
S. No. | Test Particulars | Specified Function | Observations | Checked By | |||||
1 | Primary Checks | ||||||||
1.1 | Check for the Supply Blower and Motor of Air Handling Unit | ||||||||
1.1.1 | Check the Supply Blower and Motor assembly for proper fitment on base frame. | Blower and Motor should be properly fitted on base frame and tightened with bolts and nuts. | |||||||
1.1.2 | Check the motor shaft rotation, manually. | Motor shaft should rotate smoothly when rotated manually. | |||||||
1.1.3 | Check the Blower rotation, manually. | Blower should rotate smoothly when rotated manually. | |||||||
1.1.4 | Check the motor shaft key and hub screws. | Motor should be tightened with shaft key and hub screws. | |||||||
1.1.5 | Check the Blower shaft key and hub screws. | Blower should be tightened with shaft key and hub screws. | |||||||
1.2 Check for Air Handling Unit Dampers | |||||||||
1.2.1 | Open and close the Fresh Air damper of the Air Handling Unit for its operation, manually.
Note: Adjust the damper in full open condition after the checking. |
Damper should open and close smoothly. | |||||||
1.2.2 | Open and close the supply air Volume control Damper of the Air Handling Unit for its operation, manually.
Note: Adjust the damper in full open condition after the checking. |
Damper should open and close smoothly. | |||||||
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 to the control panel Located at Ground Floor. | Power supply indicator should glow in the control panel | ||||||||
2.1.2 | Switch on the control panel power supply to the Air Handling Unit | Air Handling Unit blower motor should start. | ||||||||
2.2 Check for the Supply Air Blower | ||||||||||
2.2.1 | Check the supply air blower for any abnormal sound | There should not be any abnormal sound in the supply air blower. | ||||||||
2.2.2 | Check the direction of the rotation of the blower. | Blower should rotate as per the arrow mark indicated on the blower. | ||||||||
2.3 Check for the AHU Filtration System | ||||||||||
2.3.1 | Check the differential pressure of the 10+5 m filters | Differential pressure of the filters should be between 4-12mm of wc | ||||||||
2.3.2 | Check the differential pressure of the 3 m filters | Differential pressure of the filters should be between 12-15mm of wc | ||||||||
Checked by
(Engineering) |
(Name) |
(Sign.) |
(Date) |
|||||||
Verified by
(Engineering) |
(Name) | (Sign.) | (Date) | |||||||
- 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
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- CONCLUSION
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- 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
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