Operational Qualification Protocol for Stent Coating Machine
Document Control:
- Document Number: OQ-001
- Version: 1.0
- Effective Date: [Insert Date]
- Reviewed By: [Insert Name]
- Approval Date: [Insert Date]
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Stent Coating Machine operates according to the defined specifications and meets the acceptance criteria for applying drug-polymer coatings to drug-eluting stents and coated devices.
Scope
This protocol applies to the Stent Coating Machine used in the R&D and Production areas for the application of drug-polymer coatings. It covers the operational parameters and performance qualifications necessary for compliance with regulatory requirements.
Responsibilities
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the OQ protocol and results.
- Engineering: Responsible for maintaining the equipment and ensuring it is calibrated.
Prerequisites
- Completion of Installation Qualification (IQ).
- Equipment calibration must be up to date.
- Training of personnel on the operation of the Stent Coating Machine.
Equipment Description
The Stent Coating Machine is designed to apply a uniform drug-polymer coating to stents and coated devices using either spray or dip methods. The machine is equipped with adjustable parameters for coating thickness, spray parameters, and drying times.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001 | Verify coating thickness uniformity | Coating thickness within specified limits | Thickness measurement records |
| OQ-002 | Document spray parameters | Parameters match specifications | Spray parameter logs |
| OQ-003 | Record drying time | Drying time within specified limits | Drying time logs |
Detailed Test Cases
Test Case OQ-001: Coating Thickness Uniformity
Procedure: Measure the coating thickness at multiple points on the stent surface using a calibrated thickness gauge.
Acceptance Criteria: Coating thickness must be uniform and within the limits specified in the URS Annex 11 Annex 15.
Evidence: Record measurements in the thickness measurement log.
Test Case OQ-002: Spray Parameters
Procedure: Document the spray parameters during operation, including pressure, distance, and angle of application.
Acceptance Criteria: Parameters must match those specified in the equipment operational manual.
Evidence: Review and sign-off on spray parameter logs.
Test Case OQ-003: Drying Time
Procedure: Record the time taken for the coating to dry under specified conditions.
Acceptance Criteria: Drying time must be within the limits defined in the URS Annex 11 Annex 15.
Evidence: Document drying times in the drying time log.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis will be performed, and corrective actions will be implemented as necessary.
Approvals
This protocol must be reviewed and approved by the Validation Team and Quality Assurance prior to execution.