Abstract: The disclosed technology relates to a genetically engineered biological indicator, comprising: at least one test organism and at least one reporter gene suitable for producing an indicator enzyme, the reporter gene being taken up by the test organism; and at least one repressor gene that inhibits expression of the reporter gene until the reporter gene is exposed to at least one inducer. A process and an apparatus for using the biological indicator are disclosed.

Abstract: An impact and crush resistant shipping container for a vial and cap assembly, e.g., a FABI, the container having sides and a bottom defining a cavity and an opening, and a closeable cover; a partitioning divider defining at least one vertical receptacle for receiving a portion of the vial and cap assembly; an insert having at least one opening therethrough for receiving the vial and cap assembly, each opening sized such that the vial and cap assembly can be suspended in the opening, and the partitioning divider is positionable with respect to the insert such that the vial and cap assembly can be suspended at least partially within the receptacle, and the partitioning divider and the insert with the at least one vial and cap assembly suspended therein are positionable within the cavity such that the cover can be closed without contacting the at least one vial and cap assembly.

Abstract: An oxidative dye indicator composition comprising an indicator dye that has been pre-reacted with a reducing agent prior to use in an oxidizing or disinfectant sterilizing system. The pre-reacted dye, when subjected to an oxidizing disinfection or sterilization agent, such as peracetic acid or hydrogen peroxide, under goes a visible color change and thus can serve as a chemical, process, or chemical integrator, indicator. The dyes include various azines, thiazines, and oxazines compounds and the reducing agents include alkali metal alkoxides and alkaline earth metal alkoxide compounds.

Abstract: A sterilization test pack, including a base comprising a pair of recessed compartments, wherein the recessed compartments are arranged in a non-concentric relationship and are in fluid communication with each other; a cover attached to the base and forming a sealed enclosure for the recessed compartments; an external channel providing the only fluid communication between the sealed enclosure and an external environment; a selected sterilization indicator in a first of the recessed compartments; and a chemical integrator and/or a chemical indicator in a second of the recessed compartments, in which the external channel is configured to allow only restricted flow of a gaseous sterilization medium into the recessed compartments and the base and cover are otherwise impenetrable by the gaseous sterilization medium.

Abstract: The disclosed technology relates to a genetically engineered biological indicator, comprising: at least one test organism and at least one reporter gene suitable for producing an indicator enzyme, the reporter gene being taken up by the test organism; and at least one repressor gene that inhibits expression of the reporter gene until the reporter gene is exposed to at least one inducer. A process and an apparatus for using the biological indicator are disclosed.

Abstract: The disclosed technology relates to a sterilization indicator, including a carrier, the carrier having a first surface and a second surface; a support, the support having a first section and a second section, the carrier overlying the first section of the support, the second surface of the carrier being adhered to the first section of the support; and a biological indicator supported by the carrier; the sterilization indicator being formed by applying the biological indicator to the carrier and then adhering the carrier to the support, the carrier being adhered to the support using sonic welding, in which the sonic welding, when applied to the carrier with the biological indicator applied, exhibits no significant difference in viability of the biological indicator following the sonic welding as compared to prior to the sonic welding.

Abstract: The disclosed technology relates to a genetically engineered biological indicator, comprising: at least one test organism and at least one reporter gene suitable for producing an indicator enzyme, the reporter gene being taken up by the test organism; and at least one repressor gene that inhibits expression of the reporter gene until the reporter gene is exposed to at least one inducer. A process and an apparatus for using the biological indicator are disclosed.

Abstract: The disclosed technology relates to a sterilization indicator, including a carrier, the carrier having a first surface and a second surface; a support, the support having a first section and a second section, the carrier overlying the first section of the support, the second surface of the carrier being adhered to the first section of the support; and a biological indicator supported by the carrier; the sterilization indicator being formed by applying the biological indicator to the carrier and then adhering the carrier to the support, the carrier being adhered to the support using sonic welding, in which the sonic welding, when applied to the carrier with the biological indicator applied, exhibits no significant difference in viability of the biological indicator following the sonic welding as compared to prior to the sonic welding.

Abstract: The disclosed invention provides a self-contained sterilization indicator for evaluating the effectiveness of a sterilization process. The sterilization indicator includes a cap configured for housing a growth medium, the cap being mountable on a container that contains a concentration of microorganisms. The cap comprises an inner chamber for housing the growth media. The inner chamber has an opening and a breakable barrier overlying the opening for encapsulating the growth media within the inner chamber of the cap. The biological indicator is adapted for breaking the breakable barrier at a selected time to introduce the growth medium into the container such that the growth medium contacts the microorganisms.

Abstract: The disclosed technology relates to a sterilization indicator and a process to concentrate signal generated by constraining it to a minimal surface, in a minimal volume and minimal pH and growth buffering or mediating influences. The sterilization indicator may comprise a carrier 12, the carrier having a first surface 14 and a second surface 16; a support 20, the support having a first section 22 and a second section 24, the carrier 12 overlying the first section 12 of the support 20, the second surface 16 of the carrier being adhered to the first section 22 of the support 20; and a biological indicator 30 supported by the carrier 12. The second section 24 of the support 20 may be of sufficient dimension to permit handling the sterilization indicator 10 without contacting the biological indicator 30. A process for making the sterilization indicator is disclosed. Processes for using the sterilization indicator are disclosed.

Abstract: The disclosed invention relates to a method for monitoring a sterilization process. The method comprises: (A) exposing an article to be sterilized and a biological indicator to a sterilization medium during a sterilization process, the biological indicator comprising a cell with a plasma membrane; and (B) measuring the membrane potential of the cell to detect the viability of the cell.

Abstract: A biological indicator for monitoring the effectiveness of a sterilizing or disinfecting treatment or process. A compound or condition is disclosed which comprises a substrate having a surface layer containing functional groups thereon desirably free of silicon linking groups. The functional groups are desirably in the form of a monolayer of a uniformed distribution and of a selected quantity. Various types of microorganism indicators, such as spores, and/or etiological agent indicators are covalently bonded to the surface layer functional groups through a crosslinking reagent and thus form a uniform number and distribution of the microorganism and/or etiological agent indicators. After being subjected to sterilization or other similar disinfecting treatments or processes, along with various articles such as instruments, the indicator can be cultivated to determine the effectiveness of the sterilization, disinfection, etc. treatment or process.

Abstract: The disclosed technology relates to a sterilization indicator and a process to concentrate signal generated by constraining it to a minimal surface, in a minimal volume and minimal pH and growth buffering or mediating influences. The sterilization indicator may comprise a carrier 12, the carrier having a first surface 14 and a second surface 16; a support 20, the support having a first section 22 and a second section 24, the carrier 12 overlying the first section 12 of the support 20, the second surface 16 of the carrier being adhered to the first section 22 of the support 20; and a biological indicator 30 supported by the carrier 12. The second section 24 of the support 20 may be of sufficient dimension to permit handling the sterilization indicator 10 without contacting the biological indicator 30. A process for making the sterilization indicator is disclosed. Processes for using the sterilization indicator are disclosed.

Abstract: The disclosed technology relates to a sterilization indicator and a process to concentrate signal generated by constraining it to a minimal surface, in a minimal volume and minimal pH and growth buffering or mediating influences. The sterilization indicator may comprise a carrier 12, the carrier having a first surface 14 and a second surface 16; a support 20, the support having a first section 22 and a second section 24, the carrier 12 overlying the first section 12 of the support 20, the second surface 16 of the carrier being adhered to the first section 22 of the support 20; and a biological indicator 30 supported by the carrier 12. The second section 24 of the support 20 may be of sufficient dimension to permit handling the sterilization indicator 10 without contacting the biological indicator 30. A process for making the sterilization indicator is disclosed. Processes for using the sterilization indicator are disclosed.

Abstract: A biological indicator for monitoring the effectiveness of a sterilization or disinfection treatment or process. The biological indicator comprises a substrate having a surface layer containing functional groups thereon desirably free of silicon linking groups. The functional groups are added to the surface through the use of a functionalized silane coupling agent, wherein two different functional groups are generally utilized and the functionalized silane is applied in a uniform and consistent manner thereby assuring that the microorganism or etiological agent indicators are attached to the substrate in a uniform and consistent manner through non-covalent bonding to the functional groups. After being subjected to sterilization or other similar disinfecting treatments or processes along with various articles such as instruments, the indicator can be cultivated or cultured to determine the effectiveness of the sterilization or disinfection treatment or process.

Abstract: A biological indicator for monitoring the effectiveness of a sterilizing, disinfecting treatment or process. A compound or condition is disclosed which comprises a substrate containing functional groups residing on a surface thereof, said functional end groups being desirably free of silicon linking groups. The functional end groups are desirably in the form of a monolayer of a uniform distribution and of a selected quantity. Various types of microorganisms, such as spores, fungi, mycobacteria, vegetative bacteria, protozoa, and/or etiological agents are covalently bonded to the functional end groups through a zero-length crosslinking agent and thus form a uniform number and distribution of microorganisms and/or etiological agent indicators on a surface of the substrate.

Abstract: The disclosed technology relates to a genetically engineered biological indicator, comprising: at least one test organism and at least one reporter gene suitable for producing an indicator enzyme, the reporter gene being taken up by the test organism; and at least one repressor gene that inhibits expression of the reporter gene until the reporter gene is exposed to at least one inducer. A process and an apparatus for using the biological indicator are disclosed.

Abstract: The disclosed technology relates to a sterilization indicator and a process to concentrate signal generated by constraining it to a minimal surface, in a minimal volume and minimal pH and growth buffering or mediating influences. The sterilization indicator may comprise a carrier 12, the carrier having a first surface 14 and a second surface 16; a support 20, the support having a first section 22 and a second section 24, the carrier 12 overlying the first section 12 of the support 20, the second surface 16 of the carrier being adhered to the first section 22 of the support 20; and a biological indicator 30 supported by the carrier 12. The second section 24 of the support 20 may be of sufficient dimension to permit handling the sterilization indicator 10 without contacting the biological indicator 30. A process for making the sterilization indicator is disclosed. Processes for using the sterilization indicator are disclosed.

Abstract: A biological indicator for monitoring the effectiveness of a sterilizing, disinfecting treatment or process. A compound or condition is disclosed which comprises a substrate having a surface layer containing functional groups thereon desirably free of silicon linking groups. The functional groups are desirably in the form of a monolayer of a uniformed distribution and of a selected quantity. Various types of microorganism indicators, such as spores and/or etiological agent indicators are covalently bonded to the surface layer functional groups through a crosslinking reagent and thus form a uniform number and distribution of the microorganism and/or etiological agent indicators. After being subjected to sterilization or other similar disinfecting treatments or processes, along with various articles such as instruments, the indicator can be cultivated to determine the effectiveness of the sterilization, disinfection, etc. treatment or process.

Abstract: A biological indicator for monitoring the effectiveness of a sterilizing or disinfecting treatment or process. A compound or condition is disclosed which comprises a substrate having a surface layer containing functional groups thereon desirably free of silicon linking groups. The functional groups are desirably in the form of a monolayer of a uniformed distribution and of a selected quantity. Various types of microorganism indicators, such as spores, and/or etiological agent indicators are covalently bonded to the surface layer functional groups through a crosslinking reagent and thus form a uniform number and distribution of the microorganism and/or etiological agent indicators. After being subjected to sterilization or other similar disinfecting treatments or processes, along with various articles such as instruments, the indicator can be cultivated to determine the effectiveness of the sterilization, disinfection, etc. treatment or process.