Document Control Number: IQ-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Prepared by: [Your Name]
Approved by: [Approver’s Name]
Installation Qualification for RABS/Isolator in Ophthalmic Production
Objective: To verify that the RABS/Isolator system is installed correctly and operates according to the specified requirements for aseptic filling of sterile ophthalmic products.
Scope: This protocol applies to the RABS/Isolator utilized in the production area for filling sterile eye drops and eye ointments, impacting product quality directly.
Responsibilities:
- Validation Team: Preparation and execution of the IQ protocol.
- Quality Assurance: Review and approval of the protocol and results.
- Production Team: Provide access and support during the qualification process.
Prerequisites:
- Completion of Design Qualification (DQ).
- Installation of RABS/Isolator system.
- Training of personnel on equipment operation.
Equipment Description:
The RABS/Isolator system is designed to provide an aseptic barrier during the filling of sterile ophthalmic products. It includes glove ports for operator access, integrated monitoring systems, and VHP (Vaporized Hydrogen Peroxide) decontamination capabilities.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify glove integrity using leak testing. | No leaks detected. | Leak test report. |
| IQ-02 | Check VHP cycle logs for proper decontamination. | All cycles completed as per protocol. | VHP log records. |
| IQ-03 | Inspect overall system for installation compliance. | All components installed as per specifications. | Installation checklist. |
Detailed Test Cases:
- Test ID: IQ-01
- Procedure: Conduct a glove integrity test using a leak detection method.
- Acceptance Criteria: No leaks detected.
- Evidence: Documented leak test report.
- Test ID: IQ-02
- Procedure: Review VHP cycle logs to ensure all decontamination cycles were executed correctly.
- Acceptance Criteria: All cycles completed as per protocol.
- Evidence: VHP log records.
- Test ID: IQ-03
- Procedure: Perform a visual inspection of the RABS/Isolator to ensure compliance with installation requirements.
- Acceptance Criteria: All components installed as per specifications.
- Evidence: Completed installation checklist.
Deviations: Any deviations from the acceptance criteria must be documented and addressed in accordance with the deviation management procedure.
Approvals:
_____________________
Prepared by: [Your Name]
_____________________
Approved by: [Approver’s Name]