An ultraviolet (UV) light test device is suitable for ascertaining the efficacy of a germicidal UV light source. The UV light test device includes a population of viable microbial material having a residual water content of less than five percent. The population of viable microbial material is encapsulated in a container. At least a portion of the container is formed of a UV light transmissible material such that UV light from the germicidal UV light source is able to contact the population of viable microbial material.

A configurable device for the flexible provision of connections and/or functions in a biopharmaceutical process includes a body in which predefined pipe sections and plug-in locations are formed by recesses in the material of the body. The configurable device further includes a plurality of functional elements which are adapted to be inserted into the plug-in locations.

This invention relates to a biological indicator derived from a composition comprising: a host organism comprising a spore forming bacteria; a reporter gene for producing an indicator enzyme; a regulatory gene; and a vehicle for inserting the reporter gene and the regulatory gene in the host organism; the host organism bearing a transposable genetic element in its genome for inserting an insertion sequence in the regulatory gene; the insertion sequence comprising a transposase, a pair of terminal inverted repeat sequences, and at least one open reading frame for expressing the transposase. The vehicle may be taken up by the host organism. The insertion sequence may be inserted in the regulatory gene. The host organism may undergo sporulation to form the biological indicator. A process and an apparatus for using the biological indicator are disclosed.

This invention relates to a biological indicator derived from a composition comprising: a host organism comprising a spore forming bacteria; a reporter gene for producing an indicator enzyme; a regulatory gene; and a vehicle for inserting the reporter gene and the regulatory gene in the host organism; the host organism bearing a transposable genetic element in its genome for inserting an insertion sequence in the regulatory gene; the insertion sequence comprising a transposase, a pair of terminal inverted repeat sequences, and at least one open reading frame for expressing the transposase. The vehicle may be taken up by the host organism. The insertion sequence may be inserted in the regulatory gene. The host organism may undergo sporulation to form the biological indicator. A process and an apparatus for using the biological indicator are disclosed.

The invention relates to the validation of decontamination processes and in particular to new surrogate organisms and mixtures of said microorganisms used for validating the decontamination processes.

This invention relates to a biological indicator, comprising: a carrier; and a spore deposit on the carrier, wherein at least about 95% of the area of the spore deposit comprises spores residing in a single spore layer.

This invention relates to a biological indicator, comprising: a carrier; and a spore deposit on the carrier, wherein from about 70% to about 95% of the area of the spore deposit comprises spores residing in a single spore layer, and the remainder of the area of the spore deposit comprises spores residing in a stacked configuration.

Disclosed herein are biological indicators suitable for use in a liquid-chemical sterilization process that may be conducted by an automated endoscope reprocessor. The biological indicator may include one or more ports for introducing and removing a liquid chemical sterilant therefrom. The biological indicators may include features, such as a declivity leading to a port opening or a pipette, that may assist in transferring the liquid chemical sterilant. The system may additionally include a holder having features that facilitate use of the system and biological indicators.

In an embodiment, the present disclosure pertains to a method for evaluation of sterility in a solution using impedance sensing. In another embodiment, the present disclosure pertains to a method for evaluation of bioburden in a solution. In a further embodiment, the present disclosure pertains to various devices for evaluation of sterility or bioburden.