Document Number: OQ-001
Version: 1.0
Effective Date: YYYY-MM-DD
Prepared By: [Name]
Reviewed By: [Name]
Approved By: [Name]
Operational Qualification Protocol for Sanitary Transfer Pump in IV Infusions
Objective: To validate the operational performance of the Sanitary Transfer Pump used for transferring bulk solutions in IV Infusions, ensuring compliance with defined acceptance criteria.
Scope: This protocol applies to the Sanitary Transfer Pump (Mag Drive/Centrifugal) used in the Production area for the transfer of low-volume parenteral (LVP) and small-volume parenteral (SVP) solutions.
Responsibilities:
- Validation Team: Execute the OQ protocol and document results.
- Quality Assurance: Review and approve the protocol and results.
- Production Team: Provide necessary support and access to the equipment.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Availability of all necessary documentation and equipment.
- Training of personnel on equipment operation.
Equipment Description:
The Sanitary Transfer Pump (Mag Drive/Centrifugal) is designed to transfer bulk solutions in a sterile manner, ensuring product integrity and compliance with regulatory standards.
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| OQ-001 | Verify flow rate at specified settings. | Flow rate within specified limits as per URS. | Flow rate measurement logs. |
| OQ-002 | Check shear seal integrity during operation. | No leaks observed during testing. | Visual inspection report. |
Detailed Test Cases:
- Test Case OQ-001: Measure and document the flow rate of the pump at various settings (e.g., low, medium, high). Compare results against the acceptance criteria defined in the URS.
- Test Case OQ-002: Operate the pump under normal conditions and inspect for any leaks from the shear seal. Document findings and confirm that no leaks are present.
Deviations:
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan will be implemented as needed.
Approvals:
Prepared By: ____________________ Date: __________
Reviewed By: ____________________ Date: __________
Approved By: ____________________ Date: __________