Operational Qualification Protocol for Terminal HEPA Filters
Document Number: OQ-THF-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Terminal HEPA Filters used in the engineering area meet the defined acceptance criteria for HEPA filtration in Grade A/B environments as per ISO 14644 Annex 1.
Scope
This protocol applies to the Terminal HEPA Filters utilized in the sterile manufacturing area for injectables/aseptic processes. It encompasses the qualification activities necessary to ensure compliance with regulatory requirements.
Responsibilities
The following personnel are responsible for the execution and oversight of this protocol:
- Validation Team: Execution of the OQ protocol
- Quality Assurance: Review and approval of the protocol
- Engineering: Maintenance and operation of the equipment
Prerequisites
- Completion of Installation Qualification (IQ) for Terminal HEPA Filters.
- Availability of all necessary equipment and materials for testing.
- Training of personnel on OQ procedures.
Equipment Description
The Terminal HEPA Filters are designed to provide high-efficiency particulate air filtration for Grade A/B environments, ensuring the removal of airborne contaminants to maintain sterility during the manufacturing of injectable products.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-THF-01 | Integrity Leak Test | No leaks detected | Test report |
| OQ-THF-02 | Airflow Face Velocity Measurement | Within specified limits as per ISO 14644 Annex 1 | Measurement logs |
Detailed Test Cases
Test ID: OQ-THF-01
Procedure: Perform an integrity leak test using a suitable method (e.g., DOP test) to ensure no leaks are present.
Acceptance Criteria: No leaks detected.
Evidence: Documented test report indicating results.
Test ID: OQ-THF-02
Procedure: Measure the airflow face velocity across the HEPA filter using a calibrated anemometer.
Acceptance Criteria: Airflow face velocity must be within specified limits as per ISO 14644 Annex 1.
Evidence: Measurement logs and calibration certificates of the anemometer.
Deviations
Any deviations from the established procedures or acceptance criteria must be documented and justified. A deviation report should be submitted for review and approval.
Approvals
By signing below, the undersigned acknowledge the review and approval of this Operational Qualification Protocol.
_________________________
Validation Team Lead
_________________________
Quality Assurance Representative
_________________________
Engineering Representative