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This manuscript examines the history and regulatory framework surrounding terminal sterilization practices.

May 2, 2026

Redecorating theÂ Decision Tree.

Key Points

This manuscript examines the history and regulatory framework surrounding terminal sterilization practices.
Reviewed documentation including EMA/PIC/S Decision Trees and USP <1229> guidelines.
Analyzed the differences between proposed sterilization processes and validation methods.
Identified contradictions between EMA/PIC/S guidelines and USP <1229> recommendations.
Supported a more flexible approach for sterilization cycle development as per USP guidelines.

Abstract

This manuscript reviews the history of terminal sterilization regulation and process expectations. Practices for this culminated in the EMA / PIC/S Decision Trees (EMA/CHMP/CVMP/QWP/850374/2015, March 2019) which outlines recommended process choices for steam and other sterilization methods. That guidance document is contrary to the recommendations included in USP Sterilization of Compendial Materials. This manuscript supports a preference for the more flexible approach to sterilization cycle development and validation provided in the USP general chapter.

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Redecorating theÂ Decision Tree.

Key Points

Abstract

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