Authors
Michael Sadowski, Kenneth Paddock, Arnan Ben-David, Tiffany Bullock, Declan Fogarty, Matt Hofacre
Published in
PDA journal of pharmaceutical science and technology. Aug 14, 2026. Epub Aug 14, 2026.
Abstract
This paper reviews USP's proposed consolidation of sterilization informational chapters, particularly revised USP <1229> and <1229.1>, concluding that it creates significant technical gaps and perpetuates redundancies and areas of misalignment with established global standards and guidances for moist heat sterilization. While USP's general goal of streamlining is supported, the revised chapters provide far less depth than ISO 17665:2024 and PDA Technical Reports No. 1 and No. 48, omitting or insufficiently addressing key lifecycle elements such as installation qualification, operational qualification, cycle development, performance qualification, and ongoing control, and other critical topics such as steam quality, biological indicator use, and process lethality. The paper recommends that USP maintain <1229> as an overarching sterilization chapter, delete modality-specific chapters, and instead cross-reference recognized global standards and guidance documents for detailed technical requirements, thereby improving scientific alignment, reducing duplication, supporting regulatory expectations, and making USP sterilization guidance more practical and useful for sterility assurance professionals.
PMID:
42601219
Bibliographic data and abstract were imported from PubMed on 15 Aug 2026.
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