Document Number: OQ-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approved By: [Name]
Operational Qualification Protocol for Laminar Air Flow Equipment in Biologics Production
Objective: To validate the operational performance of the Laminar Air Flow (LAF) equipment used for aseptic protection in upstream processing of biologics.
Scope: This protocol applies to the Laminar Air Flow equipment utilized in the production and cell culture areas, ensuring compliance with acceptance criteria as per URS ISO14644 Annex 1.
Responsibilities:
- Validation Team: Execute the protocol and document results.
- Quality Assurance: Review and approve the protocol and results.
- Production Team: Provide access to the equipment and assist during testing.
Prerequisites:
- All personnel involved must be trained in aseptic techniques.
- Equipment must be properly installed and calibrated.
- Preliminary cleaning and maintenance must be performed.
Equipment Description:
The Laminar Air Flow (LAF) system is designed to provide a sterile environment by filtering air through HEPA filters, ensuring unidirectional airflow to protect products from contamination during the production and cell culture processes.
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| OQ-001-01 | Measure air velocity at various points within the LAF. | Air velocity must be within 0.45 – 0.65 m/s. | Velocity measurement report. |
| OQ-001-02 | Conduct HEPA integrity smoke study. | No leaks or contamination observed. | Smoke study observation report. |
Detailed Test Cases:
Test Case 1: Air Velocity Measurement
Objective: To ensure that the air velocity is within the specified range for effective aseptic protection.
Method: Use a calibrated anemometer to measure air velocity at multiple points in the LAF. Record the values.
Acceptance Criteria: Air velocity must be between 0.45 m/s and 0.65 m/s.
Test Case 2: HEPA Integrity Smoke Study
Objective: To confirm the integrity of the HEPA filters and the absence of contamination.
Method: Introduce smoke into the LAF and observe for any leaks or contamination.
Acceptance Criteria: No leaks or contamination must be observed during the smoke study.
Deviations:
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed to address any issues identified during testing.
Approvals:
__________________________
Validation Team Lead
__________________________
Quality Assurance Manager