Validation Summary Report

Equipment: Terminal Sterilization Autoclave (LVP)

Subcategory: IV Infusions (LVP/SVP – Bags/Bottles)

Area: Production

1. Summary

This Validation Summary Report (VSR) provides an overview of the validation activities performed for the Terminal Sterilization Autoclave utilized in the production of IV Infusions. The report confirms that the equipment meets the required specifications and acceptance criteria as outlined in URS Annex 15 and Annex 11.

2. Scope/Boundaries

The scope of this validation includes the design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) of the Terminal Sterilization Autoclave. The boundaries are limited to the sterilization process of IV Infusions, specifically LVP/SVP bags and bottles.

3. Executed Protocol List

• DQ Protocol – Terminal Sterilization Autoclave
• IQ Protocol – Terminal Sterilization Autoclave
• OQ Protocol – Terminal Sterilization Autoclave
• PQ Protocol – Terminal Sterilization Autoclave

4. Deviations Summary

No significant deviations were recorded during the validation process. All protocols were executed as planned and met the acceptance criteria.

5. CPP Verification Summary

The key critical parameters (CPPs) verified during the validation include:

• F0 Mapping
• Load Patterns
• Venting Cycle Control
• Audit Trail

6. Conclusion

The validation of the Terminal Sterilization Autoclave has been successfully completed. The equipment has been qualified for use in the production of IV Infusions, with all critical parameters meeting the established acceptance criteria. Ongoing requalification will be performed every 12 months to ensure continued compliance.

7. Attachments Index

• Attachment 1: DQ Protocol Document
• Attachment 2: IQ Protocol Document
• Attachment 3: OQ Protocol Document
• Attachment 4: PQ Protocol Document
• Attachment 5: Validation Data and Results

8. Approvals

This report has been reviewed and approved by the following personnel:

• Quality Assurance Manager: ____________________
• Production Manager: ____________________
• Validation Specialist: ____________________