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    • 1. 发明授权
    • Biological culture growth and observation device
    • 生物培养生长观察装置
    • US5661029A
    • 1997-08-26
    • US242014
    • 1994-05-12
    • Jim SelfRobert D. HallR. Daniel Webster
    • Jim SelfRobert D. HallR. Daniel Webster
    • C12M1/16G02B21/34C12M3/00
    • C12M23/46C12M23/04C12M23/12C12M23/22C12M23/34C12M23/38G02B21/34
    • A biological culture growth and observation system provides for the growth of a biological sample in a growth medium, and the observation of the grown sample (organism) through a microscope objective once growth is sufficient as to permit discrimination of the biological sample. Observation and growth is achieved in a single device. The system includes a tray with a top, and a sealable section on the top. Included within the tray is a depression, or well, that receives the growth medium to grow the biological organism in the well. A lid is sealable and resealable around the sealable section on the top of the tray. An interior side of the lid, that faces the growth medium, does not fog up in the presence of the growth medium. Optionally included is a barrier layer that is positioned over the well. The barrier layer minimizes evaporation from the growth medium and permits the biological culture growth and observation system to have a long shelf life.
    • 生物培养生长和观察系统提供了生长培养基中生物样品的生长,并且一旦生长足以允许鉴别生物样品,则通过显微镜物镜观察生长的样品(生物体)。 在单个设备中实现观察和增长。 该系统包括具有顶部的托盘和顶部的可密封部分。 包括在托盘内的是凹陷或井,其接收生长培养基以在井中生长生物体。 盖可以在托盘顶部的可密封部分周围可密封和重新密封。 面向生长介质的盖的内侧在生长培养基的存在下不会起雾。 可选地包括位于井上的阻挡层。 阻隔层使生长培养基的蒸发最小化,并允许生物培养生长和观察系统具有长的保质期。
    • 4. 发明授权
    • Process challenge device and method
    • 过程挑战设备和方法
    • US06653096B1
    • 2003-11-25
    • US09379682
    • 1999-08-24
    • Dennis ChristensenR. Daniel WebsterHarvey A. Markinson
    • Dennis ChristensenR. Daniel WebsterHarvey A. Markinson
    • C12Q122
    • C12Q1/22Y10S435/808
    • A process challenge device tailored to mimic the resistance of a particular product-package combination to a particular biological inactivation, disinfection, or sterilization process. The device is used to challenge the process, thus providing a means to validate the efficacy of the process. In one embodiment, the process indicator includes a biological indicator organism stored on a carrier 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 or enzyme substrate that is separated from the chamber containing the process 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 or enzyme substrate to contact the process indicator.
    • 定制的过程挑战装置,以模拟特定产品包装组合对特定生物灭活,消毒或灭菌过程的抵抗力。 该装置用于挑战该过程,从而提供了验证该过程的功效的手段。 在一个实施例中,过程指示器包括存储在封装在由阻挡膜材料形成的腔室内的载体上的生物指示器生物体。 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合适的培养基或酶底物的单独的第二室,其通过分离装置(例如阀,夹子或易碎分离)与包含过程指示器的室分离。 两个室之间的分离装置能够在完成该过程之后根据要求去除,从而允许培养基或酶底物与过程指示剂接触。
    • 5. 发明授权
    • Process challenge device and method
    • 过程挑战设备和方法
    • US5942408A
    • 1999-08-24
    • US887753
    • 1997-07-03
    • Dennis E. ChristensenR. Daniel WebsterHarvey A. Markinson
    • Dennis E. ChristensenR. Daniel WebsterHarvey A. Markinson
    • C12Q1/22
    • C12Q1/22Y10S435/805
    • 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.
    • 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。
    • 7. 发明申请
    • Apparatus and Method for Process Challenge Devices
    • 过程挑战设备的装置和方法
    • US20130230910A1
    • 2013-09-05
    • US13783844
    • 2013-03-04
    • Dennis E. ChristensenR. Daniel Webster
    • Dennis E. ChristensenR. Daniel Webster
    • C12Q1/22
    • C12Q1/22A61L2/28C12M37/06Y10T29/49Y10T29/49817
    • 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 uses a self-containing biological indicator (SCBI) with a biological indicator and media ampule located within a plastic vial. By altering the materials and/or configuration of the SCBI a wide range of resistances to sterilant gas processes may be achieved.
    • 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。 该装置使用具有生物指示剂的自体生物指示剂(SCBI)和位于塑料小瓶内的培养基安瓿。 通过改变SCBI的材料和/或构型,可以实现对杀菌剂气体方法的广泛的阻力。