Abstract: A biological sterilization indicator (BI) system and method. The system can include a BI and a reading apparatus comprising a well. The BI can include a housing, which can include a first portion, and a second portion movable between a first “unactivated” position and a second “activated” position. The reading apparatus can detect at least one of (i) when the well is empty; (ii) when the biological sterilization indicator is positioned in the well with the second portion of the housing in the first position, and (iii) when the biological sterilization indicator is positioned in the well with the second portion of the housing in the second position. The method can include detecting at least one of the above conditions, which can be used to detect an activation status of the biological sterilization indicator.

Abstract: A biological sterilization indicator (BI). The BI can include a housing, and a container positioned in the housing. The container can contain a liquid and at least a portion of the container can be frangible. The BI can further include a first chamber and a second chamber. The second chamber can include at least one source of biological activity. The BI can further include a substrate positioned in the housing between the first chamber and the second chamber. The substrate can be positioned in fluid communication with the first chamber and the second chamber, and the substrate can be further positioned such that the substrate is not in direct contact with the source of biological activity.

Abstract: A method for detecting a xerophilic microorganism is provided. The method comprises providing a sample to be tested, an aqueous diluent comprising about 1.0 to about 10.2 weight percent glycerol, and a thin film culture device comprising a cold water-reconstitutable medium to facilitate the growth of a microorganism. The method further comprises mixing the sample with the aqueous diluent to form an inoculum, contacting a predefined amount of the inoculum with the reconstitutable medium to form an inoculated thin film culture device, incubating the inoculated thin film culture device for a period of time, and detecting a presence or an absence of colony of a microorganism. Kits for detecting a xerophilic microorganism according to the method are also provided.

Abstract: A biological sterilization indicator (BI). The BI can include a housing, and a container positioned in the housing. The container can contain a liquid and at least a portion of the container can be frangible. The BI can further include a first chamber and a second chamber. The second chamber can include at least one source of biological activity. The BI can further include a substrate positioned in the housing between the first chamber and the second chamber. The substrate can be positioned in fluid communication with the first chamber and the second chamber, and the substrate can be further positioned such that the substrate is not in direct contact with the source of biological activity.

Abstract: The present invention provides method of detecting a predetermined biological activity. The method includes using an aqueous mixture comprising a first indicator reagent with a first absorption spectrum and a second indicator reagent. The second indicator reagent is converted by the predetermined biological activity to a second biological derivative with a second emission spectrum. The first absorbance spectrum includes detectable absorbance in at least a portion of wavelengths present in the second emission spectrum. The first indicator reagent is received and concentrated from an aqueous liquid by a substrate, facilitating the detection of the second biological derivative.

Abstract: A thin film culture device for detecting yeast and mold microorganisms in a sample is provided. The culture device comprises a body comprising a self-supporting substrate having a first major surface and a second major surface; a first adhesive composition disposed on a portion of the first major surface of the substrate; a substantially dry, cold-water-soluble first hydrogel-forming composition adhered to the first adhesive composition; and a plurality of indicator agents. The plurality of indicator agents comprises three indicator agents for detecting distinct glycosidase enzyme activities, an indicator agent for detecting an alkyl esterase enzyme activity, and an indicator agent for detecting a phosphatase enzyme activity, wherein each of the plurality of indicator agents comprises a detectable reporter group. A method of using the culture device is also provided.

Abstract: A biological sterilization indicator (BI) system and method. The system can include a BI and a reading apparatus comprising a well. The BI can include a housing, which can include a first portion, and a second portion movable between a first “unactivated” position and a second “activated” position. The BI can further include a frangible container containing a liquid and dimensioned to be positioned in the housing. The reading apparatus can be configured to detect activation of the biological sterilization indicator, for example, by detecting that the second portion is in the second position, and/or by detecting that the liquid from the frangible container is present in a specific chamber of the biological sterilization indicator. The method can include positioning the BI in the well of the reading apparatus and detecting activation, for example, by detecting one or more of the above conditions.

Abstract: A biological sterilization indicator device is provided. The device comprises a body, a plurality of test microorganisms, and an oxygen-modulated first fluorescent sensor. The body comprises a first layer attached to a second layer, forming at least one isolatable microchamber and at least one primary passageway that provides fluidic communication between ambience and the at least one microchamber. The microchamber has an isolated volume of about 0.5 microliters to about 9.5 microliters. The plurality of test microorganisms and the oxygen-modulated first fluorescent sensor are disposed in the microchamber. A method of using the device to determine the effectiveness of a sterilization process is also provided.

Abstract: A biological sterilization indicator (BI) system and method. The system can include a BI and a reading apparatus comprising a well. The BI can include a housing, which can include a first portion, and a second portion movable between a first “unactivated” position and a second “activated” position. The BI can further include a frangible container containing a liquid and dimensioned to be positioned in the housing. The reading apparatus can be configured to detect activation of the biological sterilization indicator, for example, by detecting that the second portion is in the second position, and/or by detecting that the liquid from the frangible container is present in a specific chamber of the biological sterilization indicator. The method can include positioning the BI in the well of the reading apparatus and detecting activation, for example, by detecting one or more of the above conditions.

Abstract: A biological sterilization indicator (BI) and a method of using same for assaying the lethality of a sterilization process. The BI can include a housing, which can include a first portion, and a second portion, which can be movable with respect to the first portion between a first and second position. The BI can further include a frangible container comprising a liquid. The BI can further include a spore reservoir and a projection positioned in the housing. The projection can be configured to fracture the container when the second portion of the housing is moved from the first position to the second position. The method can include maintaining a minimal cross-sectional area of space around the container when the second portion of the housing is in the first position, and fracturing the container in response to moving the second portion between the first and second positions.

Abstract: A biological sterilization indicator, system, and methods of determining the effectiveness of a sterilization process. The biological sterilization indicator can include a locus of spores, a reservoir containing a liquid, and a sterilant path positioned to provide fluid communication between ambience and the locus of spores. The reservoir can have a closed state in which the reservoir is not in fluid communication with the locus of spores and an open state in which the reservoir is in fluid communication with the locus of spores. The biological sterilization indicator system can include the biological sterilization indicator and a detection device adapted to be coupled to the biological sterilization indicator. In some embodiments, the method can include assaying the spores for a detectable change in a characteristic, and detecting substantially all of the detectable change.

Abstract: A method for detecting a xerophilic microorganism is provided. The method comprises providing a sample to be tested, an aqueous diluent comprising about 1.0 to about 10.2 weight percent glycerol, and a thin film culture device comprising a cold water-reconstitutable medium to facilitate the growth of a microorganism. The method further comprises mixing the sample with the aqueous diluent to form an inoculum, contacting a predefined amount of the inoculum with the reconstitutable medium to form an inoculated thin film culture device, incubating the inoculated thin film culture device for a period of time, and detecting a presence or an absence of colony of a microorganism. Kits for detecting a xerophilic microorganism according to the method are also provided.

Abstract: A biological sterilization indicator (BI) and a method of using same for assaying the lethality of a sterilization process. The BI can include a housing, which can include a first portion, and a second portion, which can be movable with respect to the first portion between a first and second position. The BI can further include a frangible container comprising a liquid. The BI can further include a spore reservoir and a projection positioned in the housing. The projection can be configured to fracture the container when the second portion of the housing is moved from the first position to the second position. The method can include maintaining a minimal cross-sectional area of space around the container when the second portion of the housing is in the first position, and fracturing the container in response to moving the second portion between the first and second positions.

Abstract: A biological sterilization indicator, system, and methods of determining the effectiveness of a sterilization process. The biological sterilization indicator can include a locus of spores, a reservoir containing a liquid, and a sterilant path positioned to provide fluid communication between ambience and the locus of spores. The reservoir can have a closed state in which the reservoir is not in fluid communication with the locus of spores and an open state in which the reservoir is in fluid communication with the locus of spores. The biological sterilization indicator system can include the biological sterilization indicator and a detection device adapted to be coupled to the biological sterilization indicator. In some embodiments, the method can include assaying the spores for a detectable change in a characteristic, and detecting substantially all of the detectable change.

Abstract: A biological sterilization indicator (BI) and method of using same. The BI can include a housing, and a container positioned in the housing. The container can contain a liquid and at least a portion of the container can be frangible. The BI can further include a first chamber and a second chamber. The second chamber can include at least one source of biological activity. The BI can further include a first fluid path positioned to fluidly couple the first chamber and the second chamber, and a second fluid path positioned to allow displaced gas to move out of the second chamber. The method can include moving displaced gas out of the second chamber via the second fluid path as a sterilant is moved into the second chamber via the first fluid path and/or as the liquid is moved into the second chamber via the first fluid path.

Abstract: A thin film culture device for detecting yeast and mold microorganisms in a sample is provided. The culture device comprises a body comprising a self-supporting substrate having a first major surface and a second major surface; a first adhesive composition disposed on a portion of the first major surface of the substrate; a substantially dry, cold-water-soluble first hydrogel-forming composition adhered to the first adhesive composition; and a plurality of indicator agents. The plurality of indicator agents comprises three indicator agents for detecting distinct glycosidase enzyme activities, an indicator agent for detecting an alkyl esterase enzyme activity, and an indicator agent for detecting a phosphatase enzyme activity, wherein each of the plurality of indicator agents comprises a detectable reporter group. A method of using the culture device is also provided.

Abstract: 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

Abstract: The present invention provides method of detecting a predetermined biological activity. The method includes using an aqueous mixture comprising a first indicator reagent with a first absorption spectrum and a second indicator reagent. The second indicator reagent is converted by the predetermined biological activity to a second biological derivative with a second emission spectrum. The first absorbance spectrum includes detectable absorbance in at least a portion of wavelengths present in the second emission spectrum. The first indicator reagent is received and concentrated from an aqueous liquid by a substrate, facilitating the detection of the second biological derivative.

Abstract: A biological sterilization indicator (BI) and method of using same. The BI can include a housing, and a container positioned in the housing. The container can contain a liquid and at least a portion of the container can be frangible. The BI can further include a first chamber and a second chamber. The second chamber can include at least one source of biological activity. The BI can further include a first fluid path positioned to fluidly couple the first chamber and the second chamber, and a second fluid path positioned to allow displaced gas to move out of the second chamber. The method can include moving displaced gas out of the second chamber via the second fluid path as a sterilant is moved into the second chamber via the first fluid path and/or as the liquid is moved into the second chamber via the first fluid path.

Abstract: The present invention provides method of detecting a predetermined biological activity. The method includes using an aqueous mixture comprising a first indicator reagent with a first absorption spectrum and a second indicator reagent. The second indicator reagent is converted by the predetermined biological activity to a second biological derivative with a second emission spectrum. The first absorbance spectrum includes detectable absorbance in at least a portion of wavelengths present in the second emission spectrum. The first indicator reagent is received and concentrated from an aqueous liquid by a substrate, facilitating the detection of the second biological derivative.