Standard Operating Procedure for the Validation of Terminal Sterilization Autoclaves (LVP)
Purpose: This SOP outlines the validation process for Terminal Sterilization Autoclaves used in the production of IV infusions, ensuring compliance with regulatory requirements and maintaining product quality.
Scope: This procedure applies to all Terminal Sterilization Autoclaves utilized for the terminal sterilization of filled units within the production area. It is applicable to all personnel involved in the validation process.
Definitions:
- Terminal Sterilization: The process of rendering a filled unit sterile through the application of heat and pressure.
- Autoclave: A device used to sterilize equipment and supplies by subjecting them to high-pressure steam at a specified temperature.
- CSV: Computerized System Validation, ensuring that computerized systems operate as intended.
Roles:
- Validation Team: Responsible for the execution and documentation of validation activities.
- Quality Assurance: Ensures compliance with regulatory requirements and reviews validation documentation.
- Production Personnel: Operate the autoclave and follow established procedures.
Lifecycle Procedure:
- Design Qualification (DQ): Verify that the autoclave design meets user requirements.
- Installation Qualification (IQ): Confirm that the equipment is installed correctly and functions as intended.
- Operational Qualification (OQ): Ensure that the autoclave operates within specified limits and performs effectively.
- Performance Qualification (PQ): Validate the autoclave’s performance under actual operating conditions.
GDP Controls: Good Documentation Practices must be adhered to throughout the validation process, ensuring that all records are complete, accurate, and traceable.
Acceptance Criteria Governance: Acceptance criteria will be established based on User Requirement Specifications (URS) and aligned with Annex 15 and Annex 11 of the relevant regulations.
Calibration/PM Governance: The autoclave must undergo regular calibration and preventive maintenance as per the manufacturer’s recommendations and internal SOPs to ensure continued performance.
Change Control Triggers: Any modifications to the autoclave, its operating procedures, or related processes must initiate a change control process to assess potential impacts on validation status.
Revalidation Triggers and Periodic Review: Revalidation is required annually or whenever significant changes occur that may affect the validated state of the equipment.
Records/Attachments List:
- Validation Protocols
- Validation Reports
- Calibration Certificates
- Change Control Documentation
- Maintenance Logs