Document Control:
Document Number: OQ-BC-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approval Date: [Date]
Operational Qualification Protocol for Biosafety Cabinet (Class II/III)
Objective: To validate the operational performance of the Biosafety Cabinet (Class II/III) to ensure it meets the required specifications for aseptic handling of cell lines and cultures.
Scope: This protocol applies to the Biosafety Cabinet (Class II/III) utilized in the Production/Cell Culture area for handling biologics in compliance with ISO 14644 Annex 1 standards.
Responsibilities:
- Validation Team: Responsible for conducting and documenting the OQ tests.
- Quality Assurance: Responsible for reviewing and approving the OQ protocol and results.
- Production Personnel: Responsible for operating the equipment as per the established protocols.
Prerequisites:
- Installation Qualification (IQ) must be completed and approved.
- Personnel must be trained on the operation of the Biosafety Cabinet.
- All necessary materials and equipment for testing must be available.
Equipment Description:
The Biosafety Cabinet (Class II/III) is designed for aseptic handling of biological materials, providing personnel, product, and environmental protection. It utilizes HEPA filters for air filtration and maintains a controlled airflow to ensure containment.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify airflow velocity at the front and work zone. | Airflow velocity within specified limits (e.g., 100-120 ft/min). | Calibration report, airflow measurements. |
| OQ-02 | Perform HEPA filter integrity test. | HEPA filter integrity meets specified standards (e.g., no leaks detected). | Test results, filter integrity report. |
| OQ-03 | Conduct containment testing. | Containment levels meet regulatory requirements. | Containment test report. |
Detailed Test Cases:
- Test ID: OQ-01
- Procedure: Measure airflow at the front and work zone using an anemometer.
- Acceptance Criteria: Airflow velocity must be within 100-120 ft/min.
- Evidence: Documented measurements and calibration report.
- Test ID: OQ-02
- Procedure: Use a DOP test to assess HEPA filter integrity.
- Acceptance Criteria: No leaks detected; filter efficiency must be ≥ 99.97%.
- Evidence: DOP test results and filter integrity report.
- Test ID: OQ-03
- Procedure: Conduct a containment test using a tracer gas.
- Acceptance Criteria: Containment levels must meet regulatory requirements.
- Evidence: Containment test report.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed and implemented as necessary.
Approvals:
- Validation Team Lead: ____________________ Date: ____________
- Quality Assurance: ______________________ Date: ____________