Document Control:
Document Number: OQ-EDS-001
Version: 1.0
Effective Date: 2023-10-01
Prepared By: [Your Name]
Reviewed By: [Reviewer Name]
Approved By: [Approver Name]
Operational Qualification Protocol for Sterilization System Used in Coated Device Production
Objective: To validate the sterilization process of coated devices using the Sterilization System (EO/Gamma/E-beam) ensuring compliance with established acceptance criteria.
Scope: This protocol applies to the Sterilization System utilized in the production area for the sterilization of drug-eluting stents and coated devices.
Responsibilities:
- Validation Team: Execute the OQ protocol and document results.
- Quality Assurance: Review and approve the protocol and results.
- Production Team: Provide necessary support and access to the equipment.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Availability of all necessary documentation and records.
- Training of personnel on equipment operation and validation protocols.
Equipment Description:
The Sterilization System is designed to sterilize coated devices using various methods including Ethylene Oxide (EO), Gamma radiation, and Electron Beam (E-beam) sterilization. The system is critical for ensuring the safety and efficacy of drug-eluting stents.
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| OQ-001 | Perform cycle/dose mapping | Mapping records demonstrate compliance with URS Annex11 Annex15 | Cycle mapping report |
| OQ-002 | Audit trail verification | Audit trail is complete and accurate | Audit trail report |
Detailed Test Cases:
- Test Case OQ-001: Validate cycle/dose mapping records.
- Ensure all parameters are logged during the sterilization cycle.
- Confirm that the mapping records are compliant with URS Annex11 Annex15.
- Test Case OQ-002: Verify the audit trail.
- Check that all actions performed on the Sterilization System are recorded.
- Ensure that the audit trail is tamper-proof and accurate.
Deviations:
Any deviations from the established protocols must be documented and approved by the Quality Assurance team prior to proceeding with the validation process.
Approvals:
All results and documentation must be reviewed and approved by designated personnel to ensure compliance with regulatory requirements and internal standards.
Data Integrity Checks:
- Regular backups of cycle mapping records.
- Access controls to ensure only authorized personnel can modify records.
- Periodic audits of the audit trail to verify compliance.