An article for assessing efficacy of a sterilization process is provided. The article includes a housing, a plurality of genetically-modified spore-forming test microorganisms disposed in the housing, a liquid medium disposed in an openable container that is disposed in or attached to the housing, and an enzyme substrate disposed in the housing or in the openable container. The genetically-modified test microorganism comprises a functional fusion gene that encodes a non-naturally occurring chimeric protein, the chimeric protein comprising a first segment and a second segment that is contiguous with the first segment. The first segment comprises at least a portion of a first polypeptide that is normally found in spores and the second segment comprises a second polypeptide having a detectable enzymatic activity. The enzyme substrate is capable of reacting with the detectable enzyme activity to form a detectable product. A method of using the test microorganisms is also provided.

The disclosure is directed at a system and method for rapid detection of low level bacteria in a growth medium. The method is directed at a two-stage process whereby a growth medium is incubated along with a first test formulation component for a predetermined period of time. After the incubation period, a second test formulation component is added to the growth medium to determine if there is a bacteria in the growth medium.

The disclosure is directed at a system and method for rapid detection of low level bacteria in a growth medium. The method is directed at a two-stage process whereby a growth medium is incubated along with a first test formulation component for a predetermined period of time. After the incubation period, a second test formulation component is added to the growth medium to determine if there is a bacteria in the growth medium.

Inoculating systems/devices, methods for inoculating a target, and coating methods are disclosed. An example inoculating system may include an inoculating member having a transfer region and a handle region. A pre-determined quantity of viable microorganisms may be disposed on the transfer region. The inoculating member may be configured to transfer the pre-determined quantity of viable microorganisms to a target during an inoculation operation without having to rehydrate the pre-determined quantity of viable microorganisms prior to the inoculating operation.

The present disclosure provides a monitoring device comprising a test composition, a test element comprising a test portion to which the test composition is releasably adhered, a detection reagent, and a container comprising a first end with an opening and a second end opposite the first end. The test composition comprises a predetermined quantity of tracer analyte. The container is configured to receive the test portion and configured to be operationally coupled to an analytical instrument. The tracer analyte and the detection reagent each are capable of participating in one or more chemical reaction that results in the formation of a detectable product. A method of using the monitoring device to assess the efficacy of a washing process is also provided.

The present disclosure provides a monitoring device comprising a test composition, a test element comprising a test portion to which the test composition is releasably adhered, a detection reagent, and a container comprising a first end with an opening and a second end opposite the first end. The test composition comprises a predetermined quantity of tracer analyte. The container is configured to receive the test portion and configured to be operationally coupled to an analytical instrument. The tracer analyte and the detection reagent each are capable of participating in one or more chemical reaction that results in the formation of a detectable product. A method of using the monitoring device to assess the efficacy of a washing process is also provided.

A process is presented for determining the effectiveness of sterilizing processes for medical devices with the following steps: providing a data structure, wherein the data structure represents a grid formed of a plurality of three-dimensional cells; recreating the medical device arranged in the sterilizer in the data structure in such a way that a first multiplicity of cells of the grid represent a body of the medical device and that a second multiplicity of cells represent an interior of the sterilizer which is not occupied by the body of the medical device; recreating an initial state in the data structure in such a way that each cell of the second multiplicity of cells is assigned data relating to the temperature prevailing at the location of the cell, the quantity of a first medium located in the area of the cell, and the quantity of a second medium located in the area of the cell; recreating, step by step, changes in the temperature, in the quantity of the first medium and in the quantity of the second medium occurring in each cell of the second multiplicity of cells during the sterilization process; and calculating a reduction in a germ loading achieved in each cell of the second multiplicity of cells during the sterilization process taking into consideration the prevailing temperature, quantity of the first medium and quantity of the second medium in the respective cell in each step. Furthermore, a data processing system and a computer program product for carrying out the process are presented.

A process is presented for determining the effectiveness of sterilizing processes for medical devices with the following steps: providing a data structure, wherein the data structure represents a grid formed of a plurality of three-dimensional cells; recreating the medical device arranged in the sterilizer in the data structure in such a way that a first multiplicity of cells of the grid represent a body of the medical device and that a second multiplicity of cells represent an interior of the sterilizer which is not occupied by the body of the medical device; recreating an initial state in the data structure in such a way that each cell of the second multiplicity of cells is assigned data relating to the temperature prevailing at the location of the cell, the quantity of a first medium located in the area of the cell, and the quantity of a second medium located in the area of the cell; recreating, step by step, changes in the temperature, in the quantity of the first medium and in the quantity of the second medium occurring in each cell of the second multiplicity of cells during the sterilization process; and calculating a reduction in a germ loading achieved in each cell of the second multiplicity of cells during the sterilization process taking into consideration the prevailing temperature, quantity of the first medium and quantity of the second medium in the respective cell in each step. Furthermore, a data processing system and a computer program product for carrying out the process are presented.

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.

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.