Standard Operating Procedure for Equipment Validation of HEPA Integrity Test System
Purpose: To ensure the HEPA Integrity Test System (Photometer + Aerosol Generator) is validated for its intended use in testing HEPA filter integrity in sterile environments.
Scope: This SOP applies to the validation of the HEPA Integrity Test System used in the Engineering area for sterile (injectables/aseptic) processes.
Definitions:
- HEPA: High-Efficiency Particulate Air filter.
- DQ: Design Qualification.
- IQ: Installation Qualification.
- OQ: Operational Qualification.
- PQ: Performance Qualification.
Roles:
- Validation Team: Responsible for executing the validation process.
- Quality Assurance: Ensures compliance with regulatory requirements.
- Engineering: Maintains the equipment and oversees its use.
Lifecycle Procedure:
- Design Qualification (DQ): Review design specifications and intended use.
- Installation Qualification (IQ): Verify installation per manufacturer’s specifications.
- Operational Qualification (OQ): Conduct tests to ensure equipment operates within specified limits.
- Performance Qualification (PQ): Not applicable for this equipment.
GDP Controls: Ensure Good Documentation Practices (GDP) are followed throughout the validation process, including proper record-keeping and version control.
Acceptance Criteria Governance: Acceptance criteria shall adhere to ISO 14644 standards for cleanroom environments, ensuring HEPA filter integrity is maintained.
Calibration/PM Governance: The HEPA Integrity Test System shall undergo calibration and preventive maintenance according to the manufacturer’s recommendations and internal procedures.
Change Control Triggers: Any changes in equipment, process, or environment that may affect the HEPA Integrity Test System must initiate a change control process.
Revalidation Triggers and Periodic Review: Revalidation is required every 12 months or whenever significant changes occur that may impact the system’s performance.
Records/Attachments List:
- Validation Protocols
- Validation Reports
- Calibration Certificates
- Change Control Documents
- Maintenance Logs