8-fluoro-4-alkylumbelliferyl α-D-glucopyranoside, biological sterilization indicator including the same and its use in a method of determining efficacy of a sterilization process
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.
1 . A self-contained biological sterilization indicator comprising:
a housing,
bacterial spores comprising, and/or capable of producing, an enzyme capable of catalyzing cleavage of an enzyme substrate represented by a structural formula
wherein R is an alkyl group having 1 to 4 carbon atoms; 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 a range from 6.0 to 9.0.
2 . The self-contained biological sterilization indicator of claim 1 , wherein the self-contained biological sterilization indicator is disposed inside a process-challenge device.
3 . The self-contained biological sterilization indicator of claim 1 , wherein R is an alkyl group having 1 carbon atom.
4 . The self-contained biological sterilization indicator of claim 1 , wherein the self-contained biological sterilization indicator is capable of determining efficacy of two or more cycles chosen from a powerset of 121 gravity, 121 pre-vac, 121 SFPP, 132 gravity, 132 pre-vac, 132 SFPP, 134 pre-vac, 134 SFPP, 135 gravity, 135 pre-vac, and 135 SFPP.
5 . The self-contained biological sterilization indicator of claim 1 , wherein the mixture has an initial pH in the range from 6.0 to 7.0.
6 . 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 an enzyme substrate represented by a structural formula
wherein R is an alkyl group having 1 to 4 carbon atoms; and
(ii) a composition, wherein the composition comprises the enzyme substrate, wherein if the composition is brought into contact with the bacterial spores to form a mixture, the mixture will have an initial pH in a range from 6.0 to 9.0.
7 . The biological sterilization indicator of claim 6 , wherein at least one of components (i) or (ii) is disposed inside a process-challenge device.
8 . The biological sterilization indicator of claim 6 , wherein R is an alkyl group having 1 carbon atom.
9 . The biological sterilization indicator of claim 6 , wherein the composition is a liquid composition.
10 . The biological sterilization indicator of claim 6 , wherein the mixture has an initial pH in the range from 6.0 to 7.0.
11 . A method of assessing efficacy of a sterilization process, the method comprising sequentially:
a) providing a biological sterilization indicator comprising:
bacterial spores comprising, and/or capable of producing, an enzyme capable of catalyzing cleavage of an enzyme substrate represented by a structural formula
wherein R is an alkyl group having 1 to 4 carbon atoms; and
a composition, wherein the composition comprises the enzyme substrate, wherein if the composition is brought into contact with the bacterial spores to form a mixture, the mixture will have an initial pH in a range from 6.0 to 9.0;
b) subjecting at least the bacterial spores to the sterilization process;
c) contacting the composition with the bacterial spores; and
d) evaluating efficacy of the sterilization process.
12 . The method of claim 11 , wherein step d) comprises fluorescence spectroscopy.
13 . The method of claim 11 , wherein R is an alkyl group having 1 carbon atom.
14 . The method of claim 11 , wherein the composition and the bacterial spores are both contained within a housing.