A self-contained sterilization process biological indicator is provided. The indicator includes a housing. Test microorganisms disposed in the housing are enveloped by a wax composition. The wax composition comprises a long-chain (greater than C22) linear or branched alkyl or alkenyl alcohol, wherein the alkyl or alkenyl alcohol is not linked through an ester bond or an ether bond to a short chain alkyl or aryl (C1-C6) group, wherein the alkyl or alkenyl alcohol is not linked through an ester bond or an ether bond to a long chain (C8-C36) alkyl or alkenyl group, wherein the alkyl or alkenyl alcohol is not linked through an amide bond to a linear or branched long chain (C8-C36) alkyl or alkenyl amine or acid. The wax composition has a melting point between 78° C. and 120° C. Also contained in the housing are a nutrient composition and an openable container containing a liquid medium.

A microbial indicator device for liquid disinfection comprises a first cavity, a source of biological activity fluidically coupled to the first cavity via a portion of a first fluidic path, a filter membrane positioned in a second fluidic path for a disinfectant, and a first coupling portion fluidically coupled to the source of biologically activity via the second fluidic path. The filter membrane has a first side and a second side, wherein the first side is in fluid communication with the first fluidic path. The filter membrane has a pore size sufficient to retain at least a portion of the source of biological activity on the first side. The device further comprises a frangible container contained in the first cavity, wherein a liquid in the container is in fluid communication with the first cavity when the container is fractured.

A microbial indicator device for liquid disinfection comprises a first cavity, a source of biological activity fluidically coupled to the first cavity via a portion of a first fluidic path, a filter membrane positioned in a second fluidic path for a disinfectant, and a first coupling portion fluidically coupled to the source of biologically activity via the second fluidic path. The filter membrane has a first side and a second side, wherein the first side is in fluid communication with the first fluidic path. The filter membrane has a pore size sufficient to retain at least a portion of the source of biological activity on the first side. The device further comprises a frangible container contained in the first cavity, wherein a liquid in the container is in fluid communication with the first cavity when the container is fractured.

The disclosed multilayer test pack comprises a channel lamina to form a recessed channel, and then a seal layer covers the recessed channel to form an embedded channel By providing the recessed channel in a thin-film channel lamina, the recessed channel tolerances are better controlled. Further, using thin films for the channel lamina, which can be formed into a roll, allows for a continuous unrolling and continuous bonding to a seal layer.

A SCBI useful in ambient air pressure systems is disclosed. The SCBI includes a body which serves as the culture tube, a glass media ampoule, an inoculated stainless steel disc positioned on the top of the glass media ampoule so that the spores are close to the top/opening of the SCBI, filter paper on the top of the body and overlying the disc, and a cap.

A SCBI useful in ambient air pressure systems is disclosed. The SCBI includes a body which serves as the culture tube, a glass media ampoule, an inoculated stainless steel disc positioned on the top of the glass media ampoule so that the spores are close to the top/opening of the SCBI, filter paper on the top of the body and overlying the disc, and a cap.

The biological functionality of living microbial spores is modified using phenotypic engineering to endow the resulting modified spores with novel functionality that extends the usefulness of the spores for a variety of practical applications including, for example, sterility testing, the release of active compounds, and cell-based biosensing systems. An embodiment entails engineering Bacillus spores to acquire synthetic new functions that enable the modified spores to sense and rapidly transduce specific germination signals in their surroundings. The newly acquired functions allow the spores to perform, for example, as self-reporters of cellular viability, self-indicating components of cell-based biosensors, and in other analytical systems. Also disclosed are methods for testing adequate sterility of a system by using engineered spores.

The biological functionality of living microbial spores is modified using phenotypic engineering to endow the resulting modified spores with novel functionality that extends the usefulness of the spores for a variety of practical applications including, for example, sterility testing, the release of active compounds, and cell-based biosensing systems. An embodiment entails engineering Bacillus spores to acquire synthetic new functions that enable the modified spores to sense and rapidly transduce specific germination signals in their surroundings. The newly acquired functions allow the spores to perform, for example, as self-reporters of cellular viability, self-indicating components of cell-based biosensors, and in other analytical systems. Also disclosed are methods for testing adequate sterility of a system by using engineered spores.

A method of verifying the efficacy of a disinfection process is provided. The method includes flowing a liquid disinfectant into an indicator device that has a plurality of indicator microorganisms disposed therein, the indicator microorganisms comprising or capable of producing a detectable enzyme activity; contacting the indicator microorganisms with the liquid disinfectant for a predetermined minimum first period of time at a first temperature; after contacting the indicator microorganisms with the liquid disinfectant for the first period of time at the first temperature, contacting the indicator microorganisms for a second period of time with a detection medium comprising a detection reagent; and during or after the second period of time, detecting a quantity of the detectable enzyme activity that was not inactivated by the contact with the disinfectant. The indicator device is also provided.

A method of verifying the efficacy of a disinfection process is provided. The method includes flowing a liquid disinfectant into an indicator device that has a plurality of indicator microorganisms disposed therein, the indicator microorganisms comprising or capable of producing a detectable enzyme activity; contacting the indicator microorganisms with the liquid disinfectant for a predetermined minimum first period of time at a first temperature; after contacting the indicator microorganisms with the liquid disinfectant for the first period of time at the first temperature, contacting the indicator microorganisms for a second period of time with a detection medium comprising a detection reagent; and during or after the second period of time, detecting a quantity of the detectable enzyme activity that was not inactivated by the contact with the disinfectant. The indicator device is also provided.