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Points to Consider for Implementation of Pre-Use Post-Sterilization Integrity Testing (PUPSIT) (single user digital version)

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  • Description
  • Table of Contents

This Points to Consider document was developed as part of the PDA/BioPhorum Sterilizing Filtration Quality Risk Management Consortium. It provides the reader with points to consider on how to best implement and execute a pre-use/post-sterilization integrity test (PUPSIT) of the final sterilizing grade liquid filters for products that are not terminally sterilized.

Variations in the filtration design, set-up, operation, process stream attributes, and manufacturing operational philosophies all have a significant impact on how PUPSIT is incorporated into a manufacturing process. Therefore, there is not a "one size fits all" solution for PUPSIT implementations. Instead, there are several attributes related to the integrity test operation that one must consider in determining how best to design, implement and run PUPSIT for a specific application.

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Table of Contents:

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  1. Introduction
  2. Glossary
  3. Background
  4. Understanding Risk Drivers for PUPSIT Implementation
  5. Integration of PUPSIT into the Manufacturing Operation
  6. Conclusion
  7. References
  8. Appendix: Two Examples of PUPSIT Implementation

Figures and Tables Index

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