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). 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 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 sterility indicating composition comprising a plurality of sterilization process resistant spores; a germination medium comprising a sub-lethal amount of at least one cell-permeant nucleic acid-interacting fluorescent dye and at least one nutrient for germination of the spores; wherein the at least one cell-permeant fluorescent dye can interact with nucleic acids present in and produced by the plurality of spores during germination or during germination and outgrowth of the spores to produce an increase in fluorescence intensity, indicating that viable spores are present, and wherein the cell-permeant fluorescent dye is sufficiently stable at least at a temperature for incubating the spores to produce the increase in fluorescence intensity, a sterilization process indicator comprising the composition, and a method of determining the effectiveness of a sterilization process using the composition and indicator are disclosed.

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 of sterilizing an article is provided. The method includes providing sterilization wrap system with which to wrap the article to be sterilized. The sterilization wrap system comprises a plurality of wrap units configured in a stack, at least one wrap unit in the stack being detachably attached to at least one other wrap unit in the stack.

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 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, 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, 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 of sterilizing an article is provided. The method includes providing sterilization wrap system with which to wrap the article to be sterilized. The sterilization wrap system comprises a plurality of wrap units configured in a stack, at least one wrap unit in the stack being detachably attached to at least one other wrap unit in the stack.

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 method of sterilizing an article is provided. The method includes providing sterilization wrap system with which to wrap the article to be sterilized. The sterilization wrap system comprises a plurality of wrap units configured in a stack, at least one wrap unit in the stack being detachably attached to at least one other wrap unit in the stack.

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). 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 method of detecting a biological activity is provided. The method includes contacting; in a liquid medium selected to facilitate a predetermined biological activity; a sample, an indicator reagent, and a substrate that receives and concentrates a biological derivative of the indicator reagent. The method further includes observing a portion of the substrate to detect the biological derivative. The method can be used to detect the presence or absence of a target cell.

Abstract: A method of sterilizing an article is provided. The method includes providing sterilization wrap system with which to wrap the article to be sterilized. The sterilization wrap system comprises a plurality of wrap units configured in a stack, at least one wrap unit in the stack being detachably attached to at least one other wrap unit in the stack.