Abstract: Compositions include a compound preparable by reaction of components comprising an optionally crosslinked polyethylenimine and at least one an amine-reactive hydrolyzable organosilane represented by the formula R—Z—SiY3. R represents an amine-reactive group containing 1 to 18 carbon atoms; Z represents a divalent organic group containing 1 to 8 carbon atoms; and each Y independently represents a hydrolyzable group. Methods of using the compositions to make articles, and articles produces thereby are also disclosed. A composition comprising an intimate mixture of a crosslinked polyethylenimine and a polymeric binder material, and a method of making it is also disclosed.

Abstract: The present disclosure relates to sterilization monitoring devices, as well as and methods and kits for evaluating sterilization processes using sterilization monitoring devices.

Abstract: An example sterilization indicator (102) includes a cover (122), an indicator (102), and a seal (142). The cover (122) defines at least a portion of a cavity (138). The indicator (102) is disposed within the cavity (138). The indicator (102) is configured to fluidly couple with an internal cavity (110) of a sterilization package (package) and indicate an exposure to a sterilant. The seal (142) is configured to form a microorganism barrier between an exterior of the cover (122) and an internal cavity (110) of a sterilization package (100).

Abstract: The present disclosure relates to an article for detecting a disinfectant via visual feedback. The article have a first substrate with a first major surface and opposite ends. The article also comprises a process indicator disposed on at least a portion of the first major surface. The process indicator reacts with at least one liquid disinfectant selected from the group consisting of glutaraldehyde, ortho-phthalaldehyde, hydrogen peroxide, peroxyacetic acid, and combinations thereof. The process indicator can be formed from a synthetic amine-containing polymer derived from polyethylenimine (PEI). The article can have a flow channel that is formed by a portion of the process indicator and that extends between the opposite ends. The disclosure also relates to a kit containing the article as well as a method of using the article in a disinfection process. The article is used to diagnose issues in an automated endoscope reprocessors (AERs).

Abstract: The disclosed film backing has a multilayer extensible substrate with a securing adhesive that can secure to a surface and a tab to stretch the extensible substrate to remove the securing adhesive from the underlying surface. Stretching the extensible substrate will easily release the adhesive from the underlying surface. Therefore, a strong adhesive can be used. The multilayer extensible substrate includes an elastic layer forming the core adjacent to a plastically-deforming layers forming the skin to minimize the elasticity of the overall construction.

Abstract: 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.

Abstract: A sterilization test pack may include a shell defining an indicator compartment having a volume; a channel extending between a compartment opening and an exterior opening, the channel being in fluid communication with the indicator compartment through the compartment opening and surrounding atmosphere being in fluid communication with the channel through the exterior opening such that the indicator compartment is in fluid communication with the surrounding atmosphere through the channel, the channel having a length measured between the compartment opening and the exterior opening and a hydraulic radius along the length; and an indicator disposed in the indicator compartment, where a ratio of the compartment volume to the channel hydraulic radius may range from 1000 cm2 to 8000 cm2.

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: 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.

Abstract: 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.

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 system for assessing efficacy of a sterilization process is disclosed. The system includes a biological indicator, a receptacle configured to receive the biological indicator, an actuator mechanism, and a sensing system operatively coupled to the actuator mechanism. A method of using the system for assessing efficacy of a sterilization process is also disclosed.

Abstract: Post-steam sterilization wet pack indicators are described. The indicators generally comprise a moisture-impermeable layer having a first surface and a moisture-indicating layer comprising a reversible colorimetric steam-sterilization-compatible moisture-indicating medium. The moisture-indicating layer is disposed on or near the first surface of the moisture-impermeable layer. The area of the moisture-indicating layer is dimensionally smaller than the moisture-impermeable layer such that the edges of the moisture-impermeable layer extend beyond the edges of the moisture-indicating layer. Articles and packages comprising wet pack indicators are also described.

Abstract: Compositions include a compound preparable by reaction of components comprising an optionally crosslinked polyethylenimine and at least one an amine-reactive hydrolyzable organosilane represented by the formula R—Z—SiY3. R represents an amine-reactive group containing 1 to 18 carbon atoms; Z represents a divalent organic group containing 1 to 8 carbon atoms; and each Y independently represents a hydrolyzable group. Methods of using the compositions to make articles, and articles produces thereby are also disclosed. A composition comprising an intimate mixture of a crosslinked polyethylenimine and a polymeric binder material, and a method of making it is also disclosed.

Abstract: Compositions include a compound preparable by reaction of components comprising an optionally crosslinked polyethylenimine and at least one an amine-reactive hydrolyzable organosilane represented by the formula R—Z—SiY3. R represents an amine-reactive group containing 1 to 18 carbon atoms; Z represents a divalent organic group containing 1 to 8 carbon atoms; and each Y independently represents a hydrolyzable group. Methods of using the compositions to make articles, and articles produces thereby are also disclosed. A composition comprising an intimate mixture of a crosslinked polyethylenimine and a polymeric binder material, and a method of making it is also disclosed.

Abstract: A method of disinfecting a medical device comprises three steps. First, a disinfectant is contacted with a process indicator and the medical device. The disinfectant comprises at least one aldehyde. The process indicator contains a synthetic amine-containing compound disposed on a substrate. The synthetic amine-containing compound comprises at least one of primary amino groups or secondary amino groups, and is reactive with the disinfectant to form at least one adduct. The synthetic amine-containing compound and the medical device are in fluid communication through the disinfectant. A predetermined disinfectant exposure criterion exists for contacting the disinfectant with the medical device. Second, the process indicator is spectrally observed and at least one parameter is obtained therefrom that is predictive of the predetermined disinfectant exposure criterion. The third step is determining that the predetermined disinfectant exposure criterion has been achieved.

Abstract: 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.

Abstract: 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.

Abstract: The present disclosure relates to an article for detecting a disinfectant via visual feedback. The article have a first substrate with a first major surface and opposite ends. The article also comprises a process indicator disposed on at least a portion of the first major surface. The process indicator reacts with at least one liquid disinfectant selected from the group consisting of glutaraldehyde, ortho-phthalaldehyde, hydrogen peroxide, peroxyacetic acid, and combinations thereof. The process indicator can be formed from a synthetic amine-containing polymer derived from polyethylenimine (PEI). The article can have a flow channel that is formed by a portion of the process indicator and that extends between the opposite ends. The disclosure also relates to a kit containing the article as well as a method of using the article in a disinfection process. The article is used to diagnose issues in an automated endoscope reprocessors (AERs).

Abstract: 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.