Document Control Number: PQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Performance Qualification Protocol for Sterility Test Isolator in NDDS Analytics
Objective: To validate the performance of the Sterility Test Isolator used for sterility testing in NDDS applications, ensuring compliance with defined acceptance criteria.
Scope: This protocol applies to the Sterility Test Isolator utilized in the microbiology area for critical NDDS analytics, focusing on sterility testing procedures.
Responsibilities:
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the PQ protocol and results.
- Microbiology Team: Responsible for conducting sterility tests as per the protocol.
Prerequisites:
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of necessary materials and personnel for testing.
- Training of personnel on the use of the Sterility Test Isolator.
Equipment Description:
The Sterility Test Isolator is designed for performing sterility tests in a controlled environment, ensuring that samples remain uncontaminated during testing. Key features include leak integrity, airflow control, and VHP cycle capabilities.
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| PQ-001-01 | Leak Integrity Test | No leaks detected | Test report |
| PQ-001-02 | Airflow Verification | Airflow within specified limits | Calibration report |
| PQ-001-03 | VHP Cycle Audit Trail Review | Complete and accurate audit trail | Audit trail report |
Detailed Test Cases:
- Test Case 1: Conduct Leak Integrity Test using pressure decay method. Document results and ensure no leaks are present.
- Test Case 2: Measure airflow rates at designated points. Ensure airflow is within acceptable limits as defined in the URS.
- Test Case 3: Review VHP cycle audit trail for completeness and accuracy. Confirm all cycles are logged and meet defined criteria.
Data Integrity Checks:
- Verification of data entry accuracy during testing.
- Cross-checking recorded values against calibrated instruments.
- Ensuring audit trails are intact and accessible for review.
Deviations: Any deviations from the established protocol must be documented and justified. A deviation report should be generated for review.
Approvals:
Prepared By: ______________________ Date: _______________
Reviewed By: ______________________ Date: _______________
Approved By: ______________________ Date: _______________