Document Number: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approved By: [Insert Name]
Operational Qualification Protocol for Dynamic Pass Box with HEPA
Objective: To establish and document the operational qualification (OQ) of the Dynamic Pass Box with HEPA for material transfer with air purge in the facility.
Scope: This protocol applies to the operational qualification of the Dynamic Pass Box utilized in the Solid Dosage Form (OSD) area for indirect product impact.
Responsibilities:
- Validation Team: Execute and document the OQ activities.
- Quality Assurance: Review and approve the OQ protocol and results.
- Maintenance Team: Ensure the equipment is operational prior to OQ execution.
Prerequisites:
- Equipment installed and operational.
- Training completed for personnel involved.
- All necessary documentation available (URS, specifications, etc.).
Equipment Description:
The Dynamic Pass Box with HEPA is a system designed for material transfer with an air purge mechanism to maintain cleanliness and prevent contamination in the facility. It features HEPA filtration, interlocks, and alarms to ensure operational integrity.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001-01 | Verify airflow rates | Airflow meets specifications as per URS | Calibration report |
| OQ-001-02 | Check HEPA integrity | HEPA filter integrity test results are acceptable | Test report |
| OQ-001-03 | Test interlocks and alarms | All interlocks and alarms function correctly | Functional test report |
Detailed Test Cases:
- Test ID: OQ-001-01
- Procedure: Measure airflow rates using an anemometer at designated points.
- Acceptance Criteria: Airflow should be within specified limits as defined in the URS.
- Evidence: Calibration report documenting airflow measurements.
- Test ID: OQ-001-02
- Procedure: Conduct a HEPA integrity test using appropriate methods (e.g., DOP test).
- Acceptance Criteria: Results must indicate no leaks in the HEPA filter.
- Evidence: Test report confirming HEPA integrity.
- Test ID: OQ-001-03
- Procedure: Simulate conditions to test interlocks and alarms.
- Acceptance Criteria: All alarms activate and interlocks function as intended.
- Evidence: Functional test report with results.
Deviations: Any deviations from the acceptance criteria must be documented and reviewed by the validation team and quality assurance.
Approvals:
- Validation Team Lead: ____________________
- Quality Assurance: ____________________
Data Integrity Checks:
- Ensure all test results are recorded in a validated system.
- Maintain electronic records with audit trails for all OQ activities.
- Verify backup procedures for data storage and retrieval.