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 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.

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.