A sterilization challenge device for verifying the efficacy of a gas sterilization process includes an outer container, an inner container, a chemical indicator, and a cap. The outer container includes an open end, a closed end, a chamber configured to contain the inner container containing the chemical indicator, and at least one hole arranged proximate the open end. The cap is configured to engage with the outer container to close the open end, and the at least one hole is configured to provide a flow path for the gaseous sterilant into the chamber.

A system that enables automatic biological indicator crushing and determination of biological indicator type and model in incubator devices with biological indicator readers.

Water-based formulations comprising an indicating composition dispersed in water are described. The water-based indicating compositions include an organic Bi(III) compound, a sulfur source, a carbonate salt, and strontium hydroxide. Formulations further including a resin and/or an acidic additive are also described.

Disclosed are methods for quantifying the cleanability of a surface of an article, for instance an aircraft interior component. In embodiments, a solution containing an artificial “dirt” is introduced to a surface under test to simulate a sullied condition. The sullied surface is subjected to at least one cleaning process. Obtained reference and post-cleaning light measurements are compared to determine a measurement difference corresponding to a cleanability of the surface and/or effectiveness of the at least one cleaning process. In embodiments, the measurement difference is assigned a cleanability score for at least one of determining a passing or failing cleanability, modifying the cleaning process, indicating the need for a second or subsequent cleaning, modifying the barrier coating formulation, redesigning the article, etc. The disclosed methods provide solutions for objective verification measures of surface cleanability used to facilitate new article designs, materials, barrier coatings, cleaning processes, cleaners, etc.

An indicator and method of use thereof, and indicator system and method of use thereof are provided to determine the degree of an oxidative treatment. An indicator is incorporated into the oxidative treatment. The object and the indicator are subjected to the oxidative treatment. A discoloration of the indicator occurs based on an oxidation of the polymer by a process condition of the oxidative treatment oxidizing the polymer. The discoloration of the indicator is measured against a threshold color value to determine the degree of the oxidative treatment.

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).

The present invention relates to a kit for checking the quality of cleaning of medical devices in situ comprising a staining solution by soaking comprising a colorant in a dilution phase compatible with the requirements of the medical environment, and a developing solution by soaking comprising said dilution phase.

Sterilization indicators include a first substrate and a second substrate. The first substrate has a compartment containing a fusible indicator material, and a channel in contact with the compartment for the molten indicator material to flow, and a wicking material in contact with the channel. The second substrate has a transparent segment aligned to overlay the wicking material. A high temperature sealing pressure sensitive adhesive layer adheres the first substrate to the second substrate. The adhesive layer includes a (meth)acrylate-based pressure sensitive adhesive matrix and a high temperature sealing agent. The high temperature sealing agent is essentially unreactive at ambient temperature but upon exposure to elevated temperatures forms a heat-sealed adhesive bond.

The disclosure provides compositions and methods for making a colorized solution of an aqueous disinfectant that is both stable in bulk solution and will fade to clear within a predetermined period of time after being applied to a surface, for example as a spray or film. The compositions and methods described here allow an end user to visualize both the extent of coverage and the duration of contact of the disinfectant with the surface, thereby providing more efficient disinfection of the surface.

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).