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1. 发明申请

WO2021173438A1 SYSTEMS AND METHODS FOR STERILIZING IODOPHOR COMPOSITIONS 审中-公开
公开(公告)号：WO2021173438A1
公开(公告)日：2021-09-02
申请号：PCT/US2021/018715
申请日：2021-02-19
申请人： CAREFUSION CORPORATION
发明人： SIERACKI, Nathan , MCGINLEY, Christopher , ORTIZ, Moises
IPC分类号： A61L2/00 , A61L2/04 , A01N59/12 , A61K33/18
摘要： Systems and methods for sterilizing iodophor compositions are described. In some cases, the iodophor composition comprises a complex comprising iodine and a polymer (i.e., an iodine-polymer complex). The iodine-polymer complex may be polyvinylpyrrolidone iodine (also referred to as "povidone-iodine" or "PVP-I") or iodine povacrylex. Methods are described for heating an initial iodophor composition to produce a sterilized iodophor composition. The resulting sterilized iodophor composition may have a relatively high assurance of sterility (e.g., a sterility assurance level of 10-3 or less, 10-6 or less). In some cases, heating the initial iodophor composition comprises exposing at least a portion of a container containing the initial iodophor composition to a heated liquid. In certain cases, the heated liquid is part of a moving liquid stream (e.g., a cascading waterfall stream produced by a cascading waterfall sterilizer). According to some embodiments, it was surprisingly determined that heating an initial iodophor composition even to a relatively low maximum temperature (i.e., a "sterilization temperature") while maintaining the sterilization temperature for a relatively short amount of time (i.e., a "sterilization time") can still lead to a relatively high assurance of sterility using certain methods described herein. As a result, sterilization systems and methods described herein may advantageously preserve certain positive attributes of an initial iodophor composition (e.g., potency, pH, viscosity).

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