Document Control Number: OQ-HEPA-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Operational Qualification Protocol for HEPA Integrity Test System
Objective: To establish the operational qualification of the HEPA Integrity Test System to ensure it meets the required standards for testing HEPA filter integrity in sterile environments.
Scope: This protocol applies to the HEPA Integrity Test System (Photometer + Aerosol Generator) used in the Engineering area for testing the integrity of HEPA filters in aseptic processing environments.
Responsibilities:
- Validation Team: Prepare and execute the OQ protocol.
- Quality Assurance: Review and approve the protocol and results.
- Engineering: Provide support and access to the test equipment.
Prerequisites:
- Training on the operation of the HEPA Integrity Test System.
- Calibration of the HEPA Integrity Test System within the last 12 months.
- Availability of all necessary materials and equipment.
Equipment Description: The HEPA Integrity Test System consists of a photometer and aerosol generator designed to test the integrity of HEPA filters. The system evaluates the aerosol concentration through a scan method, providing critical data for filter performance.
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| OQ-TEST-001 | Perform aerosol concentration scan and record results. | Pass/Fail criteria must meet ISO14644 standards. | Test results log and calibration certificates. |
Detailed Test Cases:
Test Case OQ-TEST-001:
- Ensure the HEPA Integrity Test System is powered on and calibrated.
- Set the aerosol generator to the specified concentration levels.
- Conduct the aerosol concentration scan.
- Document the aerosol concentration levels detected by the photometer.
- Compare results against the acceptance criteria defined by ISO14644.
Deviations: Any deviations from the protocol must be documented and justified. If acceptance criteria are not met, a root cause analysis must be performed.
Approvals:
- Prepared By: ______________________ Date: ___________
- Reviewed By: ______________________ Date: ___________
- Approved By: ______________________ Date: ___________