Standard Operating Procedure for Equipment Validation of Dynamic HEPA Pass Box
Purpose: This SOP outlines the validation process for the Dynamic HEPA Pass Box used for material transfer within the facility, ensuring compliance with regulatory requirements and operational efficiency.
Scope: This procedure applies to the validation of the Dynamic HEPA Pass Box utilized in the Solid Dosage Form (OSD) manufacturing area.
Definitions:
- Pass Box: A device used to transfer materials between controlled environments while minimizing contamination.
- HEPA: High-Efficiency Particulate Air filter, used to maintain air quality.
- Validation: The process of establishing documented evidence that a system meets its intended use.
Roles:
- Validation Team: Responsible for executing the validation process.
- Quality Assurance: Ensures compliance with regulatory standards and reviews validation documentation.
- Maintenance Personnel: Conducts calibration and preventive maintenance as per schedule.
Lifecycle Procedure:
- Design Qualification (DQ): Assess user requirements and ensure equipment specifications meet operational needs.
- Installation Qualification (IQ): Verify the installation of the Pass Box according to manufacturer specifications.
- Operational Qualification (OQ): Test the Pass Box’s operational parameters to ensure it functions as intended.
- Performance Qualification (PQ): Confirm the Pass Box performs effectively under actual operating conditions.
GDP Controls: Good Documentation Practices (GDP) must be followed throughout the validation process, ensuring all records are accurate, complete, and traceable.
Acceptance Criteria Governance: Acceptance criteria for the validation of the Pass Box will adhere to URS ISO 14644 Annex 11 guidelines, focusing on air cleanliness and particulate matter control.
Calibration/PM Governance: Calibration and preventive maintenance must be performed annually, with records maintained in accordance with standard operating procedures.
Change Control Triggers: Any modifications to the Pass Box or its operating procedures must initiate a change control process to assess potential impacts on validation status.
Revalidation Triggers and Periodic Review: Revalidation will occur every 12 months, or sooner if changes are made to the equipment or processes that could affect its performance.
Records/Attachments List:
- Validation Protocols
- Validation Reports
- Calibration Certificates
- Maintenance Logs
- Change Control Documentation