Document Control Number: PQ-2023-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Performance Qualification Protocol for Cleanrooms in Aseptic Processing
Objective: To validate the performance of Grade A/B/C/D cleanrooms to ensure compliance with established standards for aseptic processing.
Scope: This protocol covers the performance qualification of cleanroom facilities used for the aseptic processing of sterile injectables.
Responsibilities:
- Validation Team: Execute the protocol and document results.
- Quality Assurance: Review and approve the protocol and results.
- Engineering: Ensure all equipment and systems are maintained and calibrated.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Calibration of all monitoring equipment.
- Availability of cleanroom environment for testing.
Equipment Description: The facility consists of Grade A, B, C, and D cleanrooms designed for aseptic processing, equipped with HEPA filtration systems, temperature and humidity controls, and airflow visualization systems.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| TP-001 | ISO Class Recovery Test | ISO Class 5 or better | Test report |
| TP-002 | Air Change Rate (ACH) Measurement | Minimum 20 ACH | Measurement log |
| TP-003 | Differential Pressure (DP) Test | Positive pressure maintained | DP gauge readings |
| TP-004 | Temperature and Humidity Check | Temp: 20-24°C; RH: 30-60% | Monitoring logs |
| TP-005 | Airflow Visualization with Smoke | No dead spots observed | Visualization video |
Detailed Test Cases:
- Test Case TP-001: Conduct ISO Class recovery test using a calibrated particle counter post-operation. Document recovery rates and compare against ISO Class 5 standards.
- Test Case TP-002: Measure air change rates using an anemometer at various locations. Ensure minimum 20 air changes per hour are achieved.
- Test Case TP-003: Monitor differential pressure using calibrated gauges. Ensure positive pressure is maintained at all times.
- Test Case TP-004: Log temperature and humidity using calibrated sensors. Ensure parameters fall within specified limits.
- Test Case TP-005: Utilize smoke tubes to visualize airflow patterns. Document any dead spots or anomalies.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A formal deviation report should be generated for each incident.
Approvals:
- Validation Team Lead: ____________________ Date: __________
- Quality Assurance Manager: ____________________ Date: __________
- Engineering Manager: ____________________ Date: __________