Document ID: PQ-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Performance Qualification Protocol for Sterilizing Autoclave in Ophthalmics Production
Objective: To validate the performance of the sterilizing autoclave used for sterilizing stoppers, caps, and parts in the production of sterile eye drops and eye ointments.
Scope: This protocol applies to the sterilizing autoclave utilized in the production area for ophthalmic products, ensuring compliance with URS Annex 15 and Annex 11.
Responsibilities:
- Validation Team: Execute the PQ protocol and document results.
- Quality Assurance: Review and approve the PQ protocol and results.
- Production Team: Ensure proper operation of the autoclave during testing.
Prerequisites:
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- All personnel trained on the use of the sterilizing autoclave.
- Availability of necessary documentation and equipment.
Equipment Description:
The sterilizing autoclave is designed to sterilize components such as stoppers, caps, and parts used in the production of ophthalmic products. The critical parameters include F0 mapping, vacuum pulses, and cycle logs.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| F0-01 | Perform F0 mapping for the sterilization cycle. | F0 value must meet or exceed specified limits. | F0 mapping report. |
| VP-01 | Verify vacuum pulses during the sterilization cycle. | Vacuum levels must be within defined range. | Vacuum pulse logs. |
| CL-01 | Review cycle logs for completeness and accuracy. | All cycles must be logged and reviewed. | Cycle log documentation. |
Detailed Test Cases:
- Test Case F0-01: Execute F0 mapping by placing thermocouples at critical locations within the autoclave. Record temperatures to ensure the F0 value is achieved.
- Test Case VP-01: Monitor vacuum levels throughout the cycle. Ensure that the vacuum is achieved and maintained as per specifications.
- Test Case CL-01: Review cycle logs post-test to confirm that all data is recorded and adheres to the required standards.
Deviations: Any deviations from the defined acceptance criteria must be documented and assessed for impact on product quality.
Approvals:
- Validation Team Lead: ______________________ Date: ___________
- Quality Assurance Manager: ______________________ Date: ___________
Data Integrity Checks:
- Ensure all data entries in logs are timestamped and signed by the operator.
- Conduct periodic audits of the cycle logs for completeness.
- Implement electronic data capture systems with secure access controls.