[EN] 8-FLUORO-4-ALKYLUMBELLIFERYL ALPHA-D-GLUCOPYRANOSIDE, BIOLOGICAL STERILIZATION INDICATOR INCLUDING THE SAME AND ITS USE IN A METHOD OF DETERMINING EFFICACY OF A STERILIZATION PROCESS<br/>[FR] 8-FLUORO-4-ALKYLUMBELLIFERYL ALPHA-D-GLUCOPYRANOSIDE, INDICATEUR DE STÉRILISATION BIOLOGIQUE LE COMPRENANT ET SON UTILISATION DANS UN PROCÉDÉ DE DÉTERMINATION DE L'EFFICACITÉ D'UN PROCÉDÉ DE STÉRILISATION
申请人:3M INNOVATIVE PROPERTIES CO
公开号:WO2021059058A1
公开(公告)日:2021-04-01
A self-contained biological sterilization indicator comprises: a housing; bacterial spores comprising, and/or capable of producing, an enzyme capable of catalyzing cleavage of an enzyme substrate; and a frangible container containing a composition, wherein the composition comprises the enzyme substrate, wherein if the frangible container is broken the composition will contact the bacterial spores to form a mixture having an initial pH in the range from 6.0 to 9.0. The enzyme substrate comprises a fluorinated 4'-alkylumbelliferyl α-D-glucopyranoside represented by the structural formula (I), wherein R is an alkyl group having from 1 to 12 carbon atoms. A biological sterilization indicator comprising a kit containing isolated components comprising (i) bacterial spores comprising, and/or capable of producing, an enzyme capable of catalyzing cleavage of the enzyme substrate and a method of assessing efficacy of a sterilization process are also disclosed.
一个独立的生物灭菌指示器包括:一个外壳;包含细菌孢子的、和/或能够产生能够催化酶底物裂解的酶的细菌孢子;以及一个易碎容器,其中容器内含有一种组合物,该组合物包括酶底物,如果易碎容器破裂,组合物将接触细菌孢子形成具有初始pH在6.0至9.0范围内的混合物。酶底物包括由结构式(I)表示的氟化的4'-烷基炔香豆蔻基α-D-葡萄糖苷,其中R是具有1至12个碳原子的烷基基团。还公开了一种包含孤立组分的套件的生物灭菌指示器,其中组分包括(i)包含细菌孢子的、和/或能够产生能够催化酶底物裂解的酶的细菌孢子,以及一种评估灭菌过程有效性的方法。