Document Number: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Operational Qualification Protocol for Filter Integrity Tester
Objective: To verify the filter integrity of prefilled syringes and cartridges using the Filter Integrity Tester, ensuring compliance with URS Annex 11.
Scope: This protocol applies to the qualification of the Filter Integrity Tester used in the Production/QC area for verifying filter integrity of products that have a direct impact on product quality.
Responsibilities:
- Validation Team: Develop and execute the OQ protocol.
- Quality Assurance: Review and approve the protocol and results.
- Production/QC Personnel: Ensure the equipment is maintained and calibrated.
Prerequisites:
- Equipment must be installed and operational.
- Personnel must be trained on the operation of the Filter Integrity Tester.
- Calibration records must be available and up-to-date.
Equipment Description:
The Filter Integrity Tester is an instrument designed to verify the integrity of filters used in prefilled syringes and cartridges, ensuring no leakage occurs that could compromise product safety and efficacy.
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| OQ-FT-01 | Perform bubble point diffusion test. | Pass if no bubbles are detected. | Test log report. |
| OQ-FT-02 | Review audit trail logs for accuracy. | All logs must be complete and without discrepancies. | Audit trail report. |
Detailed Test Cases:
Test Case 1: Bubble Point Diffusion Test
- Setup the Filter Integrity Tester according to the manufacturer’s instructions.
- Insert the prefilled syringe/cartridge into the tester.
- Initiate the bubble point diffusion test.
- Record observations and results.
Test Case 2: Audit Trail Review
- Access the Filter Integrity Tester’s software.
- Generate the audit trail log report.
- Review for any missing entries or anomalies.
- Document findings.
Deviations:
Any deviations from the protocol must be documented and justified. If acceptance criteria are not met, the testing must be repeated, and corrective actions taken.
Approvals:
This protocol must be approved by the Quality Assurance department before execution.