Document Control Number: OQ-IS-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared by: [Insert Name]
Approved by: [Insert Name]
Operational Qualification Protocol for Isolator / RABS System
Objective: To validate the Isolator / RABS System for the production of prefilled syringes and cartridges, ensuring it provides a compliant aseptic processing environment.
Scope: This protocol applies to the operational qualification of the Isolator / RABS System in the production area, focusing on critical parameters that impact product quality.
Responsibilities:
- Validation Team: Execute the qualification protocol and document results.
- Quality Assurance: Review and approve the qualification documentation.
- Production Team: Ensure the equipment is maintained and operated according to SOPs.
Prerequisites:
- Installation Qualification (IQ) completed and approved.
- Standard Operating Procedures (SOPs) in place for operation and maintenance.
- Personnel trained on equipment usage and safety protocols.
Equipment Description: The Isolator / RABS System is designed to provide an aseptic processing environment for the filling of prefilled syringes and cartridges. It includes features for pressure integrity monitoring and VHP (Vaporized Hydrogen Peroxide) decontamination cycles.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001 | Pressure Integrity Test | Pressure maintained within specifications for 30 minutes | Pressure log report |
| OQ-002 | VHP Cycle Audit Trail Review | Audit trail logs show complete cycle without deviations | Audit trail log report |
Detailed Test Cases:
- Test Case OQ-001: Conduct a pressure integrity test by sealing the system and monitoring pressure levels over a 30-minute period. Document any fluctuations and ensure they remain within acceptable limits.
- Test Case OQ-002: Review the VHP cycle audit trail logs to confirm that each cycle was completed without any interruptions or errors. Ensure all cycles adhere to the defined parameters.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed and implemented as necessary.
Approvals:
- Validation Team Lead: _______________________ Date: ___________
- Quality Assurance Manager: __________________ Date: ___________
Data Integrity Checks:
- Ensure all data entries in the audit trails are timestamped and linked to user identification.
- Perform periodic reviews of data logs to confirm accuracy and completeness.