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1. 发明授权

US5942408A Process challenge device and method 失效
标题翻译：过程挑战设备和方法
公开(公告)号：US5942408A
公开(公告)日：1999-08-24
申请号：US887753
申请日：1997-07-03
申请人： Dennis E. Christensen , R. Daniel Webster , Harvey A. Markinson
发明人： Dennis E. Christensen , R. Daniel Webster , Harvey A. Markinson
IPC分类号： C12Q1/22
CPC分类号： C12Q1/22 , Y10S435/805
摘要： A process challenge device tailored to mimic the resistance of a particular product to a particular biological inactivation, disinfection, or sterilization process, and used to challenge the process, thus providing a means to validate the efficacy of the process. The process challenge device is used by subjecting the device containing indicator organisms to an inactivation or sterilization process, and culturing any surviving indicator organisms as a means to assess the efficacy of procedures for the inactivation of microorganisms. The device includes a biological indicator organism stored on a carrier substrate enclosed within a chamber formed by a barrier film material. The specific indicator organism and carrier substrate are chosen for their appropriateness for a given process. The materials comprising the barrier film material of the process challenge device are chosen for the materials' specific resistance to the given process. The process challenge device may also comprise a separate second chamber filled with an appropriate culture medium that is separated from the chamber containing the biological indicator by a separation means, such as a valve, a clip, or a frangible separation. The separation means between the two chambers is capable of being removed on demand after completion of the process thus allowing the culture medium to contact the biological indicator. This initiates the beginning of the culture phase which confirms non-survivability of the organism population and thus process efficacy. The incorporation of the culture medium into the device permits a level of convenience to the user not available in prior art inventions.
摘要翻译：定制的过程挑战装置，以模拟特定产品对特定生物灭活，消毒或灭菌过程的抵抗力，并用于挑战该过程，从而提供了验证过程效力的手段。通过使含有指示生物体的装置进行灭活或灭菌过程，并培养任何存活的指示生物体，以评估微生物灭活程序的功效的手段来使用过程挑战装置。该装置包括存储在封装在由阻挡膜材料形成的室内的载体基底上的生物指示生物体。选择具体的指示剂生物体和载体底物适合给定的过程。选择包含过程挑战装置的阻挡膜材料的材料用于材料对给定工艺的特异性抗性。过程攻击装置还可以包括填充有适当培养基的单独的第二室，其通过分离装置（例如阀，夹子或易碎分离）从包含生物指示器的室分离。两个室之间的分离装置能够在完成该过程之后根据需要去除，从而允许培养基接触生物指示剂。这启动了培养阶段的开始，这证实了生物群体的非生存性，从而确保了处理效力。将培养基并入装置允许在现有技术发明中不可用的用户的便利水平。

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