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    BIOLOGICAL STERILIZATION INDICATOR DEVICES AND METHODS OF USE
    1.
    发明申请
    BIOLOGICAL STERILIZATION INDICATOR DEVICES AND METHODS OF USE 审中-公开
    生物灭菌指示剂装置及其使用方法

    公开(公告)号：WO2013122852A1

    公开(公告)日：2013-08-22

    申请号：PCT/US2013/025500

    申请日：2013-02-11

    Applicant: 3M INNOVATIVE PROPERTIES COMPANY ,  AHIMOU, Francois ,  CHANDRAPATI, Sailaja ,  HALVERSON, Kurt J. ,  WEBB, Heather M. ,  WILLIAMS, Michael G.

    Inventor： AHIMOU, Francois ,  CHANDRAPATI, Sailaja ,  HALVERSON, Kurt J. ,  WEBB, Heather M. ,  WILLIAMS, Michael G.

    IPC: C12Q1/22

    CPC classification number: C12Q1/22 ,  G01N21/6428 ,  G01N2201/061

    Abstract: A biological sterilization indicator device is provided. The device comprises a body, a plurality of test microorganisms, and an oxygen-modulated first fluorescent sensor. The body comprises a first layer attached to a second layer, forming at least one isolatable microchamber and at least one primary passageway that provides fluidic communication between ambience and the at least one microchamber. The microchamber has an isolated volume of about 0.5 microliters to about 9.5 microliters. The plurality of test microorganisms and the oxygen-modulated first fluorescent sensor are disposed in the microchamber. A method of using the device to determine the effectiveness of a sterilization process is also provided.

    Abstract translation: 提供生物灭菌指示装置。 该装置包括主体，多个测试微生物和氧调制的第一荧光传感器。 主体包括附接到第二层的第一层，形成至少一个可隔离的微室和至少一个主要通道，其提供环境与至少一个微室之间的流体连通。 微室具有约0.5微升至约9.5微升的隔离体积。 多个测试微生物和氧调制的第一荧光传感器设置在微室中。 还提供了使用该装置来确定灭菌过程的有效性的方法。

    BIOLOGICAL STERILIZATION INDICATOR, SYSTEM, AND METHODS OF USING SAME
    2.
    发明申请
    BIOLOGICAL STERILIZATION INDICATOR, SYSTEM, AND METHODS OF USING SAME 审中-公开
    生物灭菌指示剂，系统及其使用方法

    公开(公告)号：WO2010045138A3

    公开(公告)日：2011-03-31

    申请号：PCT/US2009060332

    申请日：2009-10-12

    Applicant: 3M INNOVATIVE PROPERTIES CO ,  CHANDRAPATI SAILAJA ,  PEDERSON JEFFREY C ,  WEBB HEATHER M ,  SMITH JEFFREY D ,  HALVERSON KURT J ,  BEHUN BRYAN S ,  LUDOWISE PETER D

    Inventor： CHANDRAPATI SAILAJA ,  PEDERSON JEFFREY C ,  WEBB HEATHER M ,  SMITH JEFFREY D ,  HALVERSON KURT J ,  BEHUN BRYAN S ,  LUDOWISE PETER D

    IPC: A61L2/28 ,  C12Q1/22

    CPC classification number: A61L2/28 ,  C12Q1/22

    Abstract: A biological sterilization indicator, system, and methods of determining the effectiveness of a sterilization process. The biological sterilization indicator can include a locus of spores, a reservoir containing a liquid, and a sterilant path positioned to provide fluid communication between ambience and the locus of spores. The reservoir can have a closed state in which the reservoir is not in fluid communication with the locus of spores and an open state in which the reservoir is in fluid communication with the locus of spores. The biological sterilization indicator system can include the biological sterilization indicator and a detection device adapted to be coupled to the biological sterilization indicator. In some embodiments, the method can include assaying the spores for a detectable change in a characteristic, and detecting substantially all of the detectable change.

    Abstract translation: 一种生物灭菌指标，系统和确定灭菌过程有效性的方法。 生物灭菌指示剂可以包括孢子的位点，含有液体的储存器和定位成在气氛和孢子的位置之间提供流体连通的消毒剂通道。 储存器可以具有闭合状态，其中储存器不与孢子的轨迹流体连通，并且储存器与孢子的轨迹流体连通的打开状态。 生物灭菌指示器系统可以包括生物灭菌指示器和适于联接到生物灭菌指示器的检测装置。 在一些实施方案中，该方法可以包括测定孢子以获得特征的可检测变化，并且检测基本上所有可检测的变化。

    METHOD OF DETECTING A BIOLOGICAL ACTIVITY
    6.
    发明申请
    METHOD OF DETECTING A BIOLOGICAL ACTIVITY 审中-公开
    检测生物活性的方法

    公开(公告)号：WO2012061212A1

    公开(公告)日：2012-05-10

    申请号：PCT/US2011/058210

    申请日：2011-10-28

    Applicant: 3M INNOVATIVE PROPERTIES COMPANY ,  CHANDRAPATI, Sailaja ,  WEBB, Heather M. ,  PEDERSON, Jeffrey C. ,  ENGEL, Brian J.

    Inventor： CHANDRAPATI, Sailaja ,  WEBB, Heather M. ,  PEDERSON, Jeffrey C. ,  ENGEL, Brian J.

    IPC: C12Q1/22

    CPC classification number: C12Q1/22 ,  C12Q1/04

    Abstract: A method of detecting a biological activity is provided. The method includes contacting; in a liquid medium selected to facilitate a predetermined biological activity; a sample, an indicator reagent, and a substrate that receives and concentrates a biological derivative of the indicator reagent. The method further includes observing a portion of the substrate to detect the biological derivative. The method can be used to detect the presence or absence of a target cell.

    Abstract translation: 提供了检测生物活性的方法。 该方法包括接触; 在选择用于促进预定生物活性的液体介质中; 样品，指示剂试剂和接收并浓缩指示剂试剂的生物衍生物的底物。 该方法还包括观察基底的一部分以检测生物衍生物。 该方法可用于检测靶细胞的存在或不存在。

    BIOLOGICAL COMPOSITIONS, ARTICLES AND METHODS FOR MONITORING STERILIZATION PROCESSES
    7.
    发明申请
    BIOLOGICAL COMPOSITIONS, ARTICLES AND METHODS FOR MONITORING STERILIZATION PROCESSES 审中-公开
    生物组合物，用于监测灭菌过程的文章和方法

    公开(公告)号：WO2010045517A1

    公开(公告)日：2010-04-22

    申请号：PCT/US2009/060936

    申请日：2009-10-16

    Applicant: 3M INNOVATIVE PROPERTIES COMPANY ,  CHANDRAPATI, Sailaja ,  WEBB, Heather M. ,  HALVERSON, Kurt J.

    Inventor： CHANDRAPATI, Sailaja ,  WEBB, Heather M. ,  HALVERSON, Kurt J.

    IPC: C12Q1/22

    CPC classification number: C12Q1/22

    Abstract: A sterility indicating composition comprising a plurality of sterilization process resistant spores; a germination medium comprising a sub-lethal amount of at least one cell-permeant nucleic acid-interacting fluorescent dye and at least one nutrient for germination of the spores; wherein the at least one cell-permeant fluorescent dye can interact with nucleic acids present in and produced by the plurality of spores during germination or during germination and outgrowth of the spores to produce an increase in fluorescence intensity, indicating that viable spores are present, and wherein the cell-permeant fluorescent dye is sufficiently stable at least at a temperature for incubating the spores to produce the increase in fluorescence intensity, a sterilization process indicator comprising the composition, and a method of determining the effectiveness of a sterilization process using the composition and indicator are disclosed.

    Abstract translation: 一种无菌指示组合物，其包含多个耐灭菌过程的孢子; 包含亚致死量的至少一种细胞渗透性核酸相互作用荧光染料和至少一种用于孢子发芽的营养物的发芽培养基; 其中所述至少一种细胞透过性荧光染料可以在发芽过程中或在芽孢的发芽和生长期间与存在于和由多个孢子产生的核酸相互作用以产生荧光强度的增加，从而表明存在可行的孢子，以及 其中所述细胞透过性荧光染料至少在用于培养孢子以产生荧光强度增加的温度下是足够稳定的，包含该组合物的灭菌过程指示剂以及使用该组合物确定灭菌过程的有效性的方法，以及 指标。

    BIOLOGICAL STERILIZATION INDICATOR
    9.
    发明申请
    BIOLOGICAL STERILIZATION INDICATOR 审中-公开
    生物灭菌指示剂

    公开(公告)号：WO2012061227A3

    公开(公告)日：2012-08-23

    申请号：PCT/US2011058257

    申请日：2011-10-28

    Applicant: 3M INNOVATIVE PROPERTIES CO ,  CHANDRAPATI SAILAJA ,  WEBB HEATHER M ,  PEDERSON JEFFREY C ,  SMITH JEFFREY D ,  DUDA RUTHANN R ,  ENGEL BRIAN J

    Inventor： CHANDRAPATI SAILAJA ,  WEBB HEATHER M ,  PEDERSON JEFFREY C ,  SMITH JEFFREY D ,  DUDA RUTHANN R ,  ENGEL BRIAN J

    IPC: C12Q1/22

    CPC classification number: C12M37/06 ,  C12M23/32 ,  C12M25/06 ,  C12Q1/04 ,  C12Q1/22 ,  G01N21/6486

    Abstract: A biological sterilization indicator (BI). The BI can include a housing, and a container positioned in the housing. The container can contain a liquid and at least a portion of the container can be frangible. The BI can further include a first chamber and a second chamber. The second chamber can include at least one source of biological activity. The BI can further include a substrate positioned in the housing between the first chamber and the second chamber. The substrate can be positioned in fluid communication with the first chamber and the second chamber, and the substrate can be further positioned such that the substrate is not in direct contact with the source of biological activity.

    Abstract translation: 生物灭菌指示剂（BI）。 BI可以包括壳体和位于壳体中的容器。 容器可以容纳液体，容器的至少一部分可以是易碎的。 BI还可以包括第一室和第二室。 第二室可包括至少一种生物活性来源。 BI还可以包括位于第一室和第二室之间的壳体中的基板。 衬底可以定位成与第一腔室和第二腔室流体连通，并且衬底可以进一步定位成使得衬底不与生物活性源直接接触。

    STERILITY INDICATING BIOLOGICAL COMPOSITIONS, ARTICLES AND METHODS
    10.
    发明申请
    STERILITY INDICATING BIOLOGICAL COMPOSITIONS, ARTICLES AND METHODS 审中-公开
    表明生物组成的无效性，文章和方法

    公开(公告)号：WO2010045433A1

    公开(公告)日：2010-04-22

    申请号：PCT/US2009/060805

    申请日：2009-10-15

    Applicant: 3M INNOVATIVE PROPERTIES COMPANY ,  CHANDRAPATI, Sailaja ,  WEBB, Heather, M. ,  WEI, Ai-Ping

    Inventor： CHANDRAPATI, Sailaja ,  WEBB, Heather, M. ,  WEI, Ai-Ping

    IPC: A61L2/28 ,  C12Q1/18 ,  C12M1/40

    CPC classification number: C12Q1/37 ,  A61L2/28 ,  C12Q1/22

    Abstract: A sterility indicating composition comprising a plurality of sterilization process resistant spores which contain an active protease during germination and initial outgrowth of the spores; and a germination medium comprising at least one labeled protease substrate and at least one nutrient for germination of the spores; wherein the medium is essentially free of a) any active protease other than the active protease contained by the plurality of spores and b) any protease substrate other than the at least one labeled protease substrate, other than any protease substrate originating from the plurality of spores, and other than any protease substrate which does not compete with the labeled protease substrate for the active protease; and wherein the at least one labeled protease substrate comprises a peptide which can be cleaved by the active protease and which is labeled with one or more dye groups, at least one of which undergoes a detectable change when the peptide is cleaved by the active protease, and wherein the labeled protease substrate is stable at least at a temperature for incubating the spores, a sterilization process indicator comprising the composition, and a method of determining the effectiveness of a sterilization process using the composition and indicator are disclosed.

    Abstract translation: 一种不育指示组合物，其包含多个灭菌过程抗性孢子，其在萌发期间含有活性蛋白酶和孢子的初始产生; 以及包含至少一种标记的蛋白酶底物和至少一种用于孢子发芽的营养物的发芽培养基; 其中所述培养基基本上不含a）除所述多个孢子所含的活性蛋白酶以外的任何活性蛋白酶，和b）除所述至少一个标记的蛋白酶底物之外的任何蛋白酶底物，而不是源于所述多个孢子的任何蛋白酶底物 ，而不是与活性蛋白酶的标记的蛋白酶底物竞争的任何蛋白酶底物以外的其它蛋白酶底物; 并且其中所述至少一个标记的蛋白酶底物包含可被活性蛋白酶切割并且被一个或多个染料基团标记的肽，当肽被活性蛋白酶切割时，其中的至少一种经历可检测的变化， 并且其中标记的蛋白酶底物至少在培养孢子的温度下是稳定的，包括该组合物的灭菌过程指示剂以及使用该组合物和指示剂确定灭菌过程的有效性的方法。

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