Document Control:
Document ID: PQ-EDS-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Performance Qualification Protocol for Stent Coating Machine
Objective: To validate the performance of the Stent Coating Machine to ensure it meets specified requirements for drug-polymer coating application on drug-eluting stents.
Scope: This protocol applies to the Stent Coating Machine used in the R&D and Production areas for the application of drug-polymer coatings on coated devices.
Responsibilities:
- Validation Team: Responsible for executing and documenting the qualification process.
- Quality Assurance: Responsible for reviewing and approving the protocol and reports.
- Operations: Responsible for ensuring the equipment is set up and maintained as per SOPs.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Completion of Operational Qualification (OQ).
- Availability of all necessary materials and equipment for testing.
Equipment Description:
The Stent Coating Machine is designed to apply a uniform drug-polymer coating on stents through spray or dip methods. The critical parameters include coating thickness uniformity, spray parameters, and drying time records.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Measure coating thickness using a micrometer at various points on the stent. | Coating thickness uniformity within ±10% of target. | Thickness measurement records. |
| PQ-02 | Record spray parameters during operation (pressure, distance, and angle). | Parameters within specified limits as per URS. | Spray parameter logs. |
| PQ-03 | Document drying times for coated stents. | Drying time within specified limits. | Drying time records. |
Detailed Test Cases:
- Test Case PQ-01: Ensure that the coating thickness is uniform across the stent surface by taking measurements at multiple points. Document any variations and assess against acceptance criteria.
- Test Case PQ-02: During the coating process, monitor and record the spray parameters. Verify that they remain within the defined operational limits.
- Test Case PQ-03: After coating, measure the drying time and ensure it meets the acceptance criteria. Document any discrepancies.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis should be performed, and corrective actions should be implemented as necessary.
Approvals:
- Validation Team Lead: ______________________ Date: ___________
- Quality Assurance Manager: ______________________ Date: ___________
Data Integrity Checks: Ensure all data captured during the qualification process is stored securely and is easily retrievable. Implement checks for data accuracy and completeness at each stage of the testing.