HVAC Operational Qualification, Purpose
HVAC Operational Qualification, To authenticate and document that the HVAC system of Sterile Production area of Cephalosporin Block of XX Pharmaceuticals Limited operates as per requirements and all the parameters of HVAC system meet the acceptance criteria of XX and manufacturer specifications.
HVAC Operational Qualification, Scope
This Operational Qualification (OQ) is to be performed against agreed acceptance criteria on the HVAC systems, comprising of Air Handling Units, Distribution / Return Ductworks, Chiller, Chilled Water Piping, Pumps, Control System etc. installed in the Cephalosporin Block of XX to serve the Sterile Production area of Cephalosporin Block.
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Responsibilities
[][]Protocol Preparation
[][]Validation (Engineering) Department of XX
[][]Protocol Execution
[][]Validation Team of XPL or other suitably qualified third party.
[][]Providing documentation on the equipment
[][]Related departments i.e. Engineering, Production, Validation, Microbiology department of PPL or other third party.
[][]Data documentation and preparation of the report
[][]Validation (Engineering) Department of PPL.
Project Description & Related issues
[][]The rooms of Sterile Production area have been classified as EU Class C and Class B. The air is supplied to the rooms of Class C area by AHU 2C.CE through three stages filtration by pre filter (G4), intermediate filter (F7 and F9) and finally HEPA (H14) filters.
[][]Furthermore, AHU 3B.CE supplies air to the class B area through 3 stages filtration such as pre filter (G4), intermediate filter (F7) and terminal filter (U15).
Operational Testing
Air flow verification
Test Method:
[][]Measure the supply air flow rate by using a flow hood. Assemble the flow-hood by firmly covering the whole supply diffusers. Open the flap of flow hood and switch on to get the readings of air flow.
[][]Set the flow-hood firmly to prevent air leakage over each individual supply air diffusers, HEPA filter and record the reading of the air flow volume in the result sheet.
Record the result in Appendix 1.
Acceptance Criteria:
[][]The air flow should be balanced throughout the area in such a way that it will produce an air volume not less than 10.00% of the design specification at each terminal.
[][]In some cases, exact air volume may be accepted at values lower or higher than 10.00% of design in order to meet room pressure requirements. Where the value is lower than the design, the value must be explained and justified.
Room Differential Pressure
Test Method:
[][]Prior to performing the test, verify that the design airflow volume tests have been carried out. HVAC system of the entire facility must be in continuous operation while performing this test.
[][]To avoid unexpected changes in pressure and to establish a baseline, all doors in the facility must be closed and no traffic is to be allowed through the facility during the test.
[][]Record the differential pressure from the calibrated magnehelic pressure gauge in the result sheet twice a day at rest and in operation conditions for three consecutive working days at each condition.
[][]Record the result in Appendix – 2.
Acceptance Criteria:
The acceptance criteria of differential pressure for each room have been stated in Appendix – 2.
Air change rate
Test Method:
[][]Measure the internal dimensions of each room and calculate the room volume.
[][]Calculate the total air supply to each room by summing the air supply from the individually measured HEPA filters or diffusers in above.
[][]Then calculate the number of air changes per hour for each room using the following formula:
=>Air change rate = Total measured room supply (m3/h)/ Measured room volume (m3)
Record the results in the result sheet in Appendix 3.
Acceptance Criteria:
[][]With reference to the previous section of ISPE Baseline Guide: Sterile Manufacturing Facilities the Air Change rate in all Classified area must be minimum 20.
Temperature and relative humidity
Test Method:
[][]Verify completion of HVAC system testing, adjusting and balancing work prior to performing these tests.
[][]Place calibrated thermometer/sensor and humidity device/sensor at the Return Air Grill.
[][]Allow time for the sensors to stabilize sufficiently for accurate readings.
[][]Measure the temperature and relative humidity at each processing room, twice a day under ‘at rest and in operation’ conditions for three consecutive working days each. Record the results in Appendix 4 and 5.
Acceptance Criteria:
[][]Temperature: 22deg.C±2deg.C for SPR058, SPR058, SPR066, SPR079 and NMT 25deg.C for other rooms in B area.
[][]NMT 25deg.C for C area.
[][]Relative Humidity (RH): NMT 30% for SPR058, SPR058, SPR066, SPR079 and NMT 55% for other rooms in B area.
[][]There is no limit of RH (%) in Grade C area as there will be no handling of Raw materials.
Particle count test
Test Method:
[][]Measure the particle count according to the procedure described in SOP and the printed data are attached with the report.
[][]Using the particle analyzer, count particles greater than or equal to 0.5 micron and also 5 micron in diameter at 1 m height at predefined number of positions in each room.
[][]The test will be performed for both at rest and at operation conditions and for three consecutive working days at each condition.
[][]The report is given from the Microbiology department which will be attached with the report.
Microbial count test:
Test method:
[][]Air borne microbial test is to be done according to the procedure described in SOP and the data are attached with the report.
[][]The test will be performed at rest and in operation conditions for three consecutive working days at each condition.
[][]All the results must be recorded on the appropriate forms of monitoring methodology.
[][]The limits of sterile and non sterile applications are recorded below.
[][]The report will be provided from the Microbiology department which will be attached with the report.
Clean up time or Recovery Test
Test Method:
[][]The recovery test is performed by………………according to the SOP No. …………. The results are recorded in Appendix – 6. The test will be performed only for the rooms where HEPA filter is installed in the supply terminal.
Acceptance Criteria:
[][]Clean up time will NMT 20 minutes. The “clean up” or “recovery” test should demonstrate a change in particle concentration by a factor of 100 within the specified time (according to ISO 14644-3 clause B.12).
Filter Integrity Test
Test Method:
[][]The test will be performed by……………………………..according to the SOP No. …………………………………..The copy of the test report is attached with the report.
Acceptance Criteria:
[][]Any leakage greater than 0.01% for H14 respectively of the upstream challenge aerosol concentration is considered unacceptable. HEPA Filter test report to be recorded in the Attachment.
Smoke test
Test Method:
=>The test will be performed by _______________________ according to the SOP No. ________________.
Acceptance Criteria:
[][]All the processing rooms are at positive pressure with respect to the adjacent corridor.
[][]Furthermore, in case of any two adjacent rooms of different classified areas, the higher classified area will be at positive pressure.
[][]So, the smoke will flow from positive to negative areas.
Instrument Calibration
=>The necessary instruments to complete the OQ of HVAC system of Sterile Production area of Cephalosporin Block is listed below:
| Sl. No. | Instrument Type | ID No. | Calibration Date | Calibration Due Date | Certificate No. | Initial & Date |
|---|---|---|---|---|---|---|
| 01 | Thermo hygrometer | CC-000-000-TMH-001 | ||||
| 02 | Differential Pressure Probe | CC-000-000-PID-001 with B1 | ||||
| 03 | Aerosol Photometer |
Deviation And Failure Investigation Summary
=>Record in the column below any deviations or failures that occurred during the OQ exercise.
Report Summary
=>The report summary of Operational Qualification of HVAC system of Sterile Production area of Cephalosporin Block Is as found.
Conclusion
[][]All / Some testing parameters of the Operational Qualification of HVAC system of Sterile Production area of Cephalosporin Block Comply / Do Not Comply with the acceptance criteria and the results obtained are attached with the protocol.
[][]The HVAC system of Sterile Production area of Cephalosporin Block is / is not qualifying the Operational Qualification test as per this protocol after proper justification of the deviation (if found). Hence, the system can be / cannot be used for production operation.
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HVAC Operational Qualification Protocol