Document Control
Document Number: DQ-HEPA-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Design Qualification Protocol for Terminal HEPA Filters in Sterile Environments
Meta Description: This document outlines the Design Qualification Protocol for Terminal HEPA Filters used in Grade A/B sterile environments, ensuring compliance with ISO14644 standards.
Tags: Equipment Validation, Sterile, HEPA Filters, Design Qualification, ISO14644
Objective
The objective of this Design Qualification (DQ) protocol is to establish and document the qualification of Terminal HEPA Filters used for HEPA filtration in Grade A/B sterile environments, ensuring compliance with regulatory standards and operational requirements.
Scope
This protocol applies to the validation of Terminal HEPA Filters utilized in the engineering area for sterile (injectables/aseptic) applications, directly impacting product safety and efficacy.
Responsibilities
- Validation Team: Responsible for the execution of the DQ protocol and documentation of results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
- Engineering: Responsible for the maintenance and operational readiness of the HEPA filters.
Prerequisites
- Completion of equipment installation and operational qualification (OQ).
- Availability of relevant standard operating procedures (SOPs).
- Training of personnel on the DQ protocol and equipment operation.
Equipment Description
The Terminal HEPA Filters are designed to provide high-efficiency particulate air (HEPA) filtration for Grade A/B environments, ensuring the removal of airborne contaminants in sterile manufacturing processes. The filters are critical for maintaining the required air quality standards as per ISO14644 Annex 1.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-HEPA-01 | Integrity leak test | No leaks detected | Test report |
| DQ-HEPA-02 | Airflow face velocity measurement | Within specified limits as per ISO14644 | Calibration report |
Detailed Test Cases
Test ID: DQ-HEPA-01
Procedure: Perform an integrity leak test using a suitable method (e.g., aerosol challenge). Document any leaks and ensure that the filter integrity is maintained.
Acceptance Criteria: No leaks detected in the filter.
Evidence: Test report documenting the integrity test results.
Test ID: DQ-HEPA-02
Procedure: Measure the airflow face velocity at various points across the filter face using a calibrated anemometer.
Acceptance Criteria: Measurements must fall within specified limits as per ISO14644 Annex 1.
Evidence: Calibration report and measurement logs.
Deviations
Any deviations from the acceptance criteria must be documented and investigated to determine the impact on the qualification process. A corrective action plan must be developed and implemented as necessary.
Approvals
Prepared By: ______________________
Date: ______________________
Approved By: ______________________
Date: ______________________