Document ID: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Operational Qualification Protocol for Sanitary Transfer Pump
Objective: To validate the operational performance of the Sanitary Transfer Pump used for transferring sterile and non-sterile solutions in the production area.
Scope: This protocol applies to the Sanitary Transfer Pump utilized in the production of nasal and otic products, impacting product quality directly.
Responsibilities:
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the OQ protocol and results.
- Production Staff: Ensure the equipment is operated according to the protocol during the qualification process.
Prerequisites:
- Equipment installation must be complete and verified.
- All staff involved in the qualification must be trained on the equipment and procedures.
- All necessary materials and documentation must be available prior to testing.
Equipment Description:
The Sanitary Transfer Pump is designed for the transfer of sterile and non-sterile solutions. It features a shear seal mechanism to maintain integrity during operation, ensuring no contamination occurs during the transfer process.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001-01 | Verify flow rate at specified settings. | Flow rate within URS specifications. | Flow rate measurement log. |
| OQ-001-02 | Check shear seal integrity. | No leaks or breaches observed. | Visual inspection report. |
Detailed Test Cases:
Test Case OQ-001-01: Flow Rate Verification
Objective: To confirm that the flow rate of the pump meets the specifications outlined in the URS.
Procedure: Operate the pump at various settings and measure the flow rate using calibrated flow meters.
Acceptance Criteria: The flow rate must fall within the parameters defined in the URS.
Expected Results: Documented flow rate measurements should match acceptance criteria.
Test Case OQ-001-02: Shear Seal Integrity Check
Objective: To ensure the shear seal mechanism is functioning properly and maintains integrity during operation.
Procedure: Operate the pump under normal conditions and inspect for any signs of leakage or seal failure.
Acceptance Criteria: No leaks or breaches should be observed during the inspection.
Expected Results: Visual inspection report confirming integrity of the shear seal.
Deviations:
Any deviations from the protocol must be documented and assessed. A corrective action plan should be developed for any critical failures impacting product quality.
Approvals:
_______________________
Validation Team Lead
_______________________
Quality Assurance Manager