Critical review demonstrates technical gaps in revised USP sterilization chapters, highlighting the need to cross-reference established global standards for moist heat sterilization.
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.
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Sadowski et al. (2026) studied this question.
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