Laminar Air Flow Performance Qualification, Purpose
Laminar Air Flow Performance Qualification, To authenticate and document that the performance of the Laminar Air Flow unit of Sterile Production area of Cephalosporin Block of XX Pharmaceuticals Limited (XPL) meets the user’s requirements of XPL Pharmaceutical Limited.
Laminar Air Flow Performance Qualification, Scope
This Performance Qualification (PQ) is to be performed against agreed acceptance criteria on the Laminar Air Flow Unit, which has been installed above the turn table after Depyrogenation Tunnel in Room of Sterile Production floor of Cephalosporin Block.
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Responsibilities
- Preparation of the protocol
-Engineering Department with the assistance of Validation team. - Executing the protocol
-Validation (Engineering) Department along with respective departmental person and engineers or other suitably qualified staff allocated from the site or contracted specialists as appropriate. - Microbiological Test
-Microbiology department - Data documentation and preparation of the report
-Validation (Engineering) department. - Verifying of the report
-Concerned departmental person. - Providing documentation on the equipment
-Related departments i.e. Engineering, Production, Microbiology, Validation or other appropriate departments and manufacturer.
Performance testing
- Air borne particle count test
=>Purpose: the purpose of this test is to ensure that the air borne particles are under the acceptance limit.
=>Test method: carry out the particle count test according to respective sop. Perform the test at rest and in operation conditions for 3 consecutive working days at each condition. Record the results in appendix – 1.
=>Test instrument id:
=>Acceptance criteria: the particle count specifications under the laminar air flow unit should meet the specification of room class a.
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Microbial Count test
- Purpose: To ensure that the microbial count meets the specification of clean room class A.
- Test Method: Perform the test at rest and in operation conditions for 3 consecutive working days at each condition. All results must be recorded on the appropriate forms of monitoring methodology and be compared with the alarm and specified action limits. The limits of sterile and non-sterile applications are specified below. Details are to be recorded in Appendix – 2.
- Test Instrument ID: N/A
- Acceptance Criteria: The microbial count must meet the clean room class – A specifications.
| Sl. No. | Room Class | Air Sample (cfu/m3) | Settle Plates (cfu/4 hours) | Contact Plate (cfu/plate) |
|---|---|---|---|---|
| 01 | A | <1 | <1 | <1 |
| 02 | B | 10 | 5 | 5 |
Deviation And Failure Investigation Summary
Record in the column below any deviations or failures that occurred during the PQ exercise.
| Deviation/ Failure | Deviation/ FailureDescription and assessment of impact on validation | Initial | Date |
|---|---|---|---|
| 1 | |||
| 2 | |||
| 3 |
Reference Documents
| Sl. No. | Title of the Document | Document No. |
|---|---|---|
| 01 | Clean rooms and associated controlled environments part 1: classification of air cleanliness | ISO 14644 – 1 |
| 02 | Clean rooms and associated controlled environments Part 3: Test methods | ISO 14644 – 2 |
| 03 | Standard Operating Procedure For Environmental Monitoring (Microbial & Particle Count) | In-house SOP |
Conclusion
- The performance qualification complies / does not comply with the acceptance criteria taken above and the obtained results are attached with the protocol.
- The laminar air flow unit of sterile production area of cephalosporin block is / is not qualifying the performance qualification test as per this protocol.
- Hence, the system can be / cannot be used for normal operation.
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Laminar Air Flow Performance Qualification Protocol