Document Control
Document Number: PQ-BC-001
Version: 1.0
Effective Date: YYYY-MM-DD
Reviewed By: [Name]
Approved By: [Name]
Performance Qualification Protocol for Class II/III Biosafety Cabinet
Objective
The objective of this Performance Qualification (PQ) Protocol is to ensure that the Class II/III Biosafety Cabinet operates within specified parameters to maintain aseptic conditions for cell line and culture handling.
Scope
This protocol applies to the Performance Qualification of the Class II/III Biosafety Cabinet used in the Production/Cell Culture area for biologics upstream processing.
Responsibilities
The Validation Team is responsible for the execution of this protocol, while the Quality Assurance (QA) team will oversee compliance with regulatory requirements and acceptance criteria.
Prerequisites
- Completion of Installation Qualification (IQ) for the Biosafety Cabinet.
- Training of personnel on the operation of the Biosafety Cabinet.
- Availability of all necessary materials and equipment for testing.
Equipment Description
The Class II/III Biosafety Cabinet provides a sterile environment for the safe handling of biological materials. It utilizes HEPA filters to ensure the integrity of the airflow and containment of hazardous materials.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Verify airflow velocity at work surface. | Airflow velocity: 100±20 ft/min. | Calibration report. |
| PQ-02 | HEPA filter integrity test. | No leaks detected; pass DOP test. | Test report. |
| PQ-03 | Containment test using smoke. | No smoke escape from the cabinet. | Video evidence. |
Detailed Test Cases
Test Case PQ-01: Airflow Velocity
Measure the airflow velocity at the work surface using an anemometer. Ensure the measurement is taken at multiple points across the work surface. Document results.
Test Case PQ-02: HEPA Filter Integrity
Perform a DOP test to verify the integrity of the HEPA filter. Ensure that no leaks are present. Document findings in the test report.
Test Case PQ-03: Containment Test
Introduce smoke into the cabinet and observe for any escape. Record the observations and provide video evidence for review.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on the PQ results. Investigate and implement corrective actions as necessary.
Approvals
All results and documentation must be reviewed and approved by the Quality Assurance team before final acceptance of the Performance Qualification.