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公开(公告)号:US20240194301A1
公开(公告)日:2024-06-13
申请号:US18286242
申请日:2022-05-18
Applicant: AMGEN INC.
Inventor: Nicholas DeSantis , Shaun Devitt
Abstract: Systems and methods are provided for evaluate inactivation kinetics of a biological indicator using a resistometer that is intended for a gaseous sterilization process. The gaseous sterilization process may include multiple sterilant gas injection phases. Systems and methods are provided for evaluating correlation of D values, obtained by both enumeration and fraction negative methods for determining viable spore counts, and to determine whether there are any serious deviations from a linear survivor curve that is based on the enumeration and fraction negative methods.