Abstract: The disclosed sterilization monitoring device comprises a perfusion channel with a chemical indicating composition disposed in fluid communication with the perfusion channel. Exposure to a sterilant creates a laterally moving front across the chemical indicating composition in the perfusion channel.

Abstract: The present disclosure relates generally to chemical indicators. In particular, the chemical indicators are useful for monitoring sterilization processes. The chemical indicator includes a fluid pathway and a chamber comprises a chemical-indicating composition.

Abstract: A self-contained biological sterilization indicator is provided. The self-contained biological sterilization indicator includes an outer container having at least one liquid-impermeable wall and an interior volume; a sealed, openable, liquid-impermeable inner container enclosing a predetermined volume of an aqueous medium; a dry coating that comprises i) a plurality of viable test microorganisms useful to detect exposure to an oxidative sterilant and ii) an effective amount of a sterilant-resistance modulator; and a pathway that permits vapor communication between the interior volume and an atmosphere outside the outer container. The inner container and the dry coating are disposed in the interior volume. The modulator comprises an amino acid. The effective amount causes an increase in sensitivity of the test microorganisms to the oxidative sterilant relative to an otherwise-identical dry coating that lacks the effective amount.

Abstract: Spore carriers suitable for use in biological indicators are described. The spore carriers include a substrate such as polymeric film or non-woven web with a hydrophilic nanostructured layer bonded to it. Spores are bonded to the nanostructured layer. Nanostructured layers including nanoparticles, such as acid-sintered silica nanoparticles are described. Biological indicators including such spore carriers are also described.

Abstract: A self-contained biological sterilization indicator is provided. The self-contained biological sterilization indicator includes an outer container having at least one liquid-impermeable wall and an interior volume; a sealed, openable, liquid-impermeable inner container enclosing a predetermined volume of an aqueous medium; a dry coating that comprises i) a plurality of viable test microorganisms useful to detect exposure to an oxidative sterilant and ii) an effective amount of a sterilant-resistance modulator; and a pathway that permits vapor communication between the interior volume and an atmosphere outside the outer container. The inner container and the dry coating are disposed in the interior volume. The modulator comprises an amino acid. The effective amount causes an increase in sensitivity of the test microorganisms to the oxidative sterilant relative to an otherwise-identical dry coating that lacks the effective amount.

Abstract: An article and method are provided for assessing the efficacy of a sterilization process. The article comprises an outer container having an interior volume; a dry source of measurable biological activity disposed in the interior volume; and an effective amount of a dry agent for neutralizing a sterilant compound; wherein both the source of measurable biological activity and the agent are in vapor communication with an environment outside the outer container. The method comprises exposing the article to a first sterilant and, optionally, a second sterilant for a period of time and detecting the measurable biological activity.

Abstract: Spore carriers suitable for use in biological indicators are described. The spore carriers include a substrate such as polymeric film or non-woven web with a hydrophilic nanostructured layer bonded to it. Spores are bonded to the nanostructured layer. Nanostructured layers including nanoparticles, such as acid-sintered silica nanoparticles are described. Biological indicators including such spore carriers are also described.

Abstract: An article and method are provided for assessing the efficacy of a sterilization process. The article comprises an outer container having an interior volume; a dry source of measurable biological activity disposed in the interior volume; and an effective amount of a dry agent for neutralizing a sterilant compound; wherein both the source of measurable biological activity and the agent are in vapor communication with an environment outside the outer container. The method comprises exposing the article to a first sterilant and, optionally, a second sterilant for a period of time and detecting the measurable biological activity.

Abstract: Spore carriers suitable for use in biological indicators are described. The spore carriers include a substrate such as polymeric film or non-woven web with a hydrophilic nanostructured layer bonded to it. Spores are bonded to the nanostructured layer. Nanostructured layers including nanoparticles, such as acid-sintered silica nanoparticles are described. Biological indicators including such spore carriers are also described.

Abstract: A process challenge device comprising process challenge device comprising a container defining a space within the container, wherein the space can fully contain a process indicator; and at least one pressure-actuating valve associated with the container, wherein the at least one pressure-actuating valve regulates entrance of a sterilant into and exiting of a gas and/or liquid out of the space within the container, methods of using the device and a kit including the device are disclosed.

Abstract: A process challenge device comprising process challenge device comprising a container defining a space within the container, wherein the space can fully contain a process indicator; and at least one pressure-actuating valve associated with the container, wherein the at least one pressure-actuating valve regulates entrance of a sterilant into and exiting of a gas and/or liquid out of the space within the container, methods of using the device and a kit including the device are disclosed.

Abstract: Spore carriers suitable for use in biological indicators are described. The spore carriers include a substrate such as polymeric film or non-woven web with a hydrophilic nanostructured layer bonded to it. Spores are bonded to the nanostructured layer. Nanostructured layers including nanoparticles, such as acid-sintered silica nanoparticles are described. Biological indicators including such spore carriers are also described.

Abstract: An article and method are provided for assessing the efficacy of a sterilization process. The article comprises an outer container having an interior volume; a dry source of measurable biological activity disposed in the interior volume; and an effective amount of a dry agent for neutralizing a sterilant compound; wherein both the source of measurable biological activity and the agent are in vapor communication with an environment outside the outer container. The method comprises exposing the article to a first sterilant and, optionally, a second sterilant for a period of time and detecting the measurable biological activity.

Abstract: A sterilization process challenge device comprising a solid body comprised of walls which define a space, wherein the space can fully contain a sterilization indicator and a volume of gas of at least 5 cubic centimeters and not more than 1000 cubic centimeters; a flow restrictor associated with the solid body such that any flow of the gas out of the space and any flow of a sterilant into the space is restricted; wherein the sterilization indicator indicates whether or not it has been contacted by the sterilant for a time and at a temperature sufficient to sterilize an article; and wherein the walls of the solid body are impervious to the sterilant and have a thickness of at least 0.3 centimeter, methods of using the device and a kit including the device are disclosed.

Abstract: Sterilization indicators that include a neutralizer, such indicators useful for testing the effectiveness of a sterilization procedure by measuring the activity of an active enzyme whose activity is correlated with the survival of microorganisms.

Abstract: Sterilization indicators that include a neutralizer, such indicators useful for testing the effectiveness of a sterilization procedure by measuring the activity of an active enzyme whose activity is correlated with the survival of microorganisms.

Abstract: Sterilization indicators that include a neutralizer, such indicators useful for testing the effectiveness of a sterilization procedure by measuring the activity of an active enzyme whose activity is correlated with the survival of microorganisms.

Abstract: The disclosure provides processes and systems for sterilizing an object using a sterilant gas. In some embodiments, the sterilant gas is produced by the thermal decomposition of a salt. Compositions to generate sterilant gasses are also disclosed.

Abstract: A process challenge device comprising process challenge device comprising a container defining a space within the container, wherein the space can fully contain a process indicator; and at least one pressure-actuating valve associated with the container, wherein the at least one pressure-actuating valve regulates entrance of a sterilant into and exiting of a gas and/or liquid out of the space within the container, methods of using the device and a kit including the device are disclosed.

Abstract: A sterilization process challenge device comprising a first container comprising walls which define a first space within the first container; a process indicator within the first space; at least one sterilant access for a sterilant to enter the first space within the first container; wherein at least one of the walls which defines the first space is a flexible wall; and wherein the walls are impervious to the sterilant; a method of using the device; and a kit including the device are disclosed.