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    • 4. 发明申请
    • STERILITY INDICATING BIOLOGICAL COMPOSITIONS, ARTICLES AND METHODS
    • 表明生物组成的无效性,文章和方法
    • WO2010045433A1
    • 2010-04-22
    • PCT/US2009/060805
    • 2009-10-15
    • 3M INNOVATIVE PROPERTIES COMPANYCHANDRAPATI, SailajaWEBB, Heather, M.WEI, Ai-Ping
    • CHANDRAPATI, SailajaWEBB, Heather, M.WEI, Ai-Ping
    • A61L2/28C12Q1/18C12M1/40
    • C12Q1/37A61L2/28C12Q1/22
    • 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.
    • 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。
    • 5. 发明申请
    • BIOLOGICAL STERILIZATION INDICATOR AND METHOD OF USING SAME
    • 生物灭菌指示剂及其使用方法
    • WO2011011189A1
    • 2011-01-27
    • PCT/US2010/041010
    • 2010-07-06
    • 3M INNOVATIVE PROPERTIES COMPANYSMITH, Jeffrey D.PEDERSON, Jeffrey C.CHANDRAPATI, Sailaja
    • SMITH, Jeffrey D.PEDERSON, Jeffrey C.CHANDRAPATI, Sailaja
    • C12Q1/22A61L2/28
    • C12Q1/22A61L2/28
    • A biological sterilization indicator (BI) and a method of using same for assaying the lethality of a sterilization process. The BI can include a housing, which can include a first portion (104), and a second portion (106), which can be movable with respect to the first portion between a first and second position. The BI can further include a frangible container (120) comprising a liquid. The BI can further include a spore reservoir (114) and a projection (158) positioned in the housing. The projection can be configured to fracture the container when the second portion of the housing is moved from the first position to the second position. The method can include maintaining a minimal cross-sectional area of space around the container when the second portion of the housing is in the first position, and fracturing the container in response to moving the second portion between the first and second positions.
    • 生物灭菌指示剂(BI)及其用于测定灭菌过程的致死性的方法。 BI可以包括壳体,其可以包括第一部分(104)和第二部分(106),第二部分可以在第一和第二位置之间相对于第一部分移动。 BI还可以包括包含液体的易碎容器(120)。 BI还可包括孢子储存器(114)和定位在壳体中的突起(158)。 突起可以被构造成当壳体的第二部分从第一位置移动到第二位置时破裂容器。 该方法可以包括当壳体的第二部分处于第一位置时保持容器周围的空间的最小横截面面积,并且响应于在第一和第二位置之间移动第二部分而破裂容器。
    • 8. 发明申请
    • BIOLOGICAL COMPOSITIONS, ARTICLES AND METHODS FOR MONITORING STERILIZATION PROCESSES
    • 生物组合物,用于监测灭菌过程的文章和方法
    • WO2010045517A1
    • 2010-04-22
    • PCT/US2009/060936
    • 2009-10-16
    • 3M INNOVATIVE PROPERTIES COMPANYCHANDRAPATI, SailajaWEBB, Heather M.HALVERSON, Kurt J.
    • CHANDRAPATI, SailajaWEBB, Heather M.HALVERSON, Kurt J.
    • C12Q1/22
    • C12Q1/22
    • 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.
    • 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。