Design Qualification Protocol for HEPA Integrity Test System
Document Number: DQ-HEPA-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Objective
The objective of this Design Qualification (DQ) protocol is to ensure that the HEPA Integrity Test System (Photometer + Aerosol Generator) is designed and installed in compliance with the necessary requirements for testing HEPA filter integrity in sterile environments.
Scope
This protocol applies to the HEPA Integrity Test System used in the Engineering area for testing the integrity of HEPA filters in sterile (injectables/aseptic) applications.
Responsibilities
The validation team is responsible for executing this protocol, documenting results, and ensuring compliance with acceptance criteria. The Engineering team will provide support and maintenance of the equipment.
Prerequisites
All personnel involved in the testing must be trained on the operation of the HEPA Integrity Test System and the relevant standard operating procedures (SOPs).
Equipment Description
The HEPA Integrity Test System consists of a photometer and an aerosol generator designed to assess the integrity of HEPA filters. It operates by generating a known concentration of aerosol and measuring the concentration downstream of the filter.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| DQ-HEPA-001-01 | Perform aerosol concentration scan. | Aerosol concentration meets pass/fail criteria based on ISO14644. | Test report and data logs. |
Detailed Test Cases
Test Case 1: Verify aerosol generation capability.
Expected Result: Aerosol generator produces specified concentration.
Test Case 2: Measure downstream aerosol concentration.
Expected Result: Concentration is within acceptable limits as per ISO14644.
Deviations
Any deviations from the acceptance criteria must be documented and investigated, and corrective actions must be implemented as necessary.
Approvals
This protocol must be reviewed and approved by the Quality Assurance and Engineering departments prior to execution.