Fluorinated 4′-alkylumbelliferyl a-D-glucopyranosides, biological sterilization indicators including the same and methods of using the same

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 the structural formula
• wherein:
• one of R1 and R2 is F and the other is H, and
• R3 is an alkyl group having from 1 to 12 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 the range from 6.0 to 9.0.

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 the structural formula
• wherein:
• one of R1 and R2 is F and the other is H, and
• R3 is an alkyl group having from 1 to 12 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 the range from 6.0 to 9.0.

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 the structural formula
• wherein:
• one of R1 and R2 is F and the other is H, and
• R3 is an alkyl group having from 1 to 12 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 the 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.