Document Control
Document Number: OQ-AHU-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Operational Qualification Protocol for AHU in Aseptic Areas
Objective: To validate the performance of the Air Handling Unit (AHU) in the aseptic area, ensuring compliance with specified acceptance criteria and operational requirements.
Scope: This protocol applies to the Operational Qualification of the AHU utilized in the HVAC system serving classified rooms for sterile injectable products. It encompasses the critical parameters impacting product quality.
Responsibilities:
- Validation Team: Execute the protocol and document results.
- Quality Assurance: Review and approve the protocol and results.
- Engineering: Ensure equipment is installed and maintained per specifications.
Prerequisites:
- Installation Qualification (IQ) completed and approved.
- All necessary equipment and instruments calibrated and in place.
- Staff trained on validation procedures and equipment operation.
Equipment Description:
The AHU is designed to provide controlled airflow, temperature, relative humidity (RH), and differential pressure (DP) to maintain the required environmental conditions in the aseptic area. It includes alarms, trend monitoring, and an audit trail for data integrity.
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| OQ-AHU-01 | Measure ACH | ≥ 20 ACH | Calibration Certificates, Raw Data |
| OQ-AHU-02 | Measure Airflow Temperature | 18°C to 24°C | Temperature Logs |
| OQ-AHU-03 | Measure Relative Humidity | 30% to 60% | Humidity Logs |
| OQ-AHU-04 | Measure Differential Pressure | ≥ 0.5 in. WC | DP Logs |
| OQ-AHU-05 | Verify Alarm Functions | All alarms functional | Alarm Test Logs |
| OQ-AHU-06 | Review Trends | No significant deviations | Trend Analysis Reports |
| OQ-AHU-07 | Audit Trail Verification | Complete and accurate | Audit Trail Reports |
Detailed Test Cases:
Test Case OQ-AHU-01: Measure ACH
Procedure: Use calibrated airflow meter to measure the air changes per hour (ACH) in the classified room.
Acceptance Criteria: ACH must be equal to or greater than 20.
Evidence: Record readings in the validation log and attach calibration certificates.
Test Case OQ-AHU-02: Measure Airflow Temperature
Procedure: Measure temperature at various points using calibrated thermometers.
Acceptance Criteria: Temperature must be maintained between 18°C and 24°C.
Evidence: Temperature logs to be documented and reviewed.
Test Case OQ-AHU-03: Measure Relative Humidity
Procedure: Measure RH using calibrated hygrometers.
Acceptance Criteria: RH must be maintained between 30% and 60%.
Evidence: Humidity logs to be documented and reviewed.
Test Case OQ-AHU-04: Measure Differential Pressure
Procedure: Measure DP using calibrated manometers.
Acceptance Criteria: DP must be equal to or greater than 0.5 in. WC.
Evidence: DP logs to be documented and reviewed.
Test Case OQ-AHU-05: Verify Alarm Functions
Procedure: Test all alarm functions for proper operation.
Acceptance Criteria: All alarms must function correctly.
Evidence: Alarm test logs to be documented.
Test Case OQ-AHU-06: Review Trends
Procedure: Analyze trends from the monitoring system.
Acceptance Criteria: No significant deviations should be noted.
Evidence: Trend analysis reports to be documented.
Test Case OQ-AHU-07: Audit Trail Verification
Procedure: Review audit trails for completeness and accuracy.
Acceptance Criteria: Audit trails must be complete and accurate.
Evidence: Audit trail reports to be documented.
Deviations:
Any deviations from the acceptance criteria must be documented and evaluated for impact on product quality.
Approvals:
Validated by: [Insert Name] on [Insert Date]
Approved by: [Insert Name] on [Insert Date]