STERILITY INDICATING BIOLOGICAL COMPOSITIONS, ARTICLES AND METHODS
    2.
    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:US20140370535A1

    公开(公告)日:2014-12-18

    申请号:US14471867

    申请日:2014-08-28

    IPC分类号: C12Q1/37

    CPC分类号: C12Q1/37 A61L2/28 C12Q1/22

    摘要: 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.

    摘要翻译: 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用于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。