Performance Qualification Protocol for Terminal HEPA Filters in Sterile Environments
Document Control:
Document Number: PQ-THF-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed by: [Insert Reviewer Name]
Approval Date: [Insert Approval Date]
Objective
The objective of this Performance Qualification (PQ) protocol is to validate the performance of Terminal HEPA Filters used in sterile environments, ensuring their effectiveness in maintaining Grade A/B conditions as per ISO14644 Annex 1 standards.
Scope
This protocol applies to the Terminal HEPA Filters utilized in the Engineering area for the filtration of air in sterile injectables and aseptic processing environments.
Responsibilities
The following roles are responsible for the execution and oversight of this PQ protocol:
- Validation Lead: Overall coordination and execution of the PQ.
- Quality Assurance: Review and approval of the protocol and results.
- Engineering Team: Execution of the test procedures and documentation of results.
Prerequisites
Prior to executing the PQ, the following prerequisites must be met:
- Installation Qualification (IQ) must be completed and approved.
- Operational Qualification (OQ) must be completed and approved.
- All necessary equipment and materials must be available and calibrated.
Equipment Description
The Terminal HEPA Filters are designed to provide high-efficiency particulate air filtration for maintaining sterile environments in pharmaceutical manufacturing. These filters are critical for ensuring that air quality meets the required standards for Grade A/B areas.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| TP-01 | Integrity Leak Test | No leaks detected | Test report |
| TP-02 | Airflow Face Velocity Measurement | Within specified range per ISO14644 | Measurement log |
Detailed Test Cases
Test Case 1: Integrity Leak Test
Procedure: Conduct an integrity leak test using a suitable method (e.g., DOP test) to ensure no leaks in the HEPA filter.
Acceptance Criteria: No leaks detected.
Evidence: Documented test results including any deviations observed.
Test Case 2: Airflow Face Velocity Measurement
Procedure: Measure the airflow face velocity at various points across the HEPA filter using calibrated anemometers.
Acceptance Criteria: Airflow face velocity must fall within the specified range as defined in ISO14644 Annex 1.
Evidence: Measurement logs and calibration certificates for the anemometer used.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on the qualification. A deviation report must be generated and reviewed by the Quality Assurance team.
Approvals
This protocol must be approved by the following individuals:
- Validation Lead: ____________________ Date: __________
- Quality Assurance: ____________________ Date: __________
- Engineering Manager: ____________________ Date: __________