Operational Qualification for Leak Test Machine in Prefilled Syringes & Cartridges
Document Number: OQ-CCIT-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared by: [Name]
Approved by: [Name]
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Leak Test Machine (CCIT) operates within specified parameters and meets the acceptance criteria outlined in the User Requirement Specification (URS) Annex 11.
Scope
This protocol applies to the Leak Test Machine utilized in the Production/QC area for the verification of container closure integrity of prefilled syringes and cartridges. The protocol encompasses all necessary tests to ensure compliance with regulatory requirements.
Responsibilities
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Production Personnel: Responsible for providing access to the equipment and assisting in the execution of the protocol.
Prerequisites
- Completion of Installation Qualification (IQ) for the Leak Test Machine.
- Availability of the required test materials and equipment.
- Training of personnel on the operation of the Leak Test Machine.
Equipment Description
The Leak Test Machine (CCIT) is an instrument designed to perform container closure integrity testing for prefilled syringes and cartridges. It utilizes advanced leak detection technology to ensure that the containers are sealed properly and maintain sterility.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001 | Perform leak sensitivity audit trail log review. | Audit trail logs must demonstrate leak sensitivity within specified limits. | Printed audit trail log report. |
| OQ-002 | Conduct leak tests using standard test samples. | All test samples must pass integrity testing. | Test results report. |
| OQ-003 | Verify calibration of the Leak Test Machine. | Calibration records must be current and within specified limits. | Calibration certificate. |
Detailed Test Cases
Test Case OQ-001: Leak Sensitivity Audit Trail Log Review
Review the audit trail logs for the Leak Test Machine to confirm that the leak sensitivity is within acceptable limits as defined in URS Annex 11. Document any anomalies and ensure corrective actions are taken.
Test Case OQ-002: Conduct Leak Tests
Utilize standard test samples to perform leak tests. Record results and ensure that all samples meet the acceptance criteria. Any failures must be investigated and documented.
Test Case OQ-003: Calibration Verification
Verify that the Leak Test Machine is calibrated according to the manufacturer’s specifications. Ensure that all calibration records are up to date and available for review.
Deviations
Any deviations from the protocol must be documented and justified. A deviation report must be submitted for review and approval by the Quality Assurance team.
Approvals
Prepared by: [Name] – [Title] – [Date]
Approved by: [Name] – [Title] – [Date]
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