Operational Qualification Protocol for Sterile Grade Filter Housing in Ophthalmics Production
Document ID: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared by: [Your Name]
Approved by: [Approver’s Name]
Objective
The objective of this Operational Qualification (OQ) protocol is to verify the performance and integrity of the Sterile Grade Filter Housing used in the production of ophthalmic products, ensuring it meets specified requirements and operates within defined parameters.
Scope
This protocol applies to the Sterile Grade Filter Housing located in the production area for ophthalmic products, specifically sterile eye drops and eye ointments.
Responsibilities
The Validation Team is responsible for executing the OQ protocol, documenting results, and ensuring compliance with regulatory requirements. The Quality Assurance team will review and approve the protocol and results.
Prerequisites
- Completion of Installation Qualification (IQ) for the Filter Housing.
- Availability of necessary equipment and materials for testing.
- Training of personnel involved in the OQ execution.
Equipment Description
The Sterile Grade Filter Housing is designed to hold sterilizing-grade filters used in the production of ophthalmic products. It is critical for ensuring that the final product remains sterile and free from contaminants.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001 | Pressure hold seal integrity test | Must maintain specified pressure without leaks for 30 minutes. | Pressure log data and visual inspection report. |
Detailed Test Cases
Test Case OQ-001: Pressure Hold Seal Integrity Test
Objective: To ensure the pressure hold seal integrity of the Sterile Grade Filter Housing.
Procedure:
1. Connect the pressure gauge to the filter housing.
2. Increase pressure to the specified level.
3. Monitor the pressure for 30 minutes.
4. Record any pressure drop.
Acceptance Criteria: The pressure must remain stable without any drop for the entire duration of the test.
Evidence: Document the pressure readings and any observations during the test.
Deviations
Any deviations from the protocol must be documented and justified. If acceptance criteria are not met, a root cause analysis should be performed, and corrective actions must be implemented before re-testing.
Approvals
Prepared by: ______________________ Date: ____________
Approved by: ______________________ Date: ____________