A process for determining the viability of a biological indicator includes exposing the biological indicator to a viability detection medium, the biological indicator including test microorganisms, the exposing the biological indicator to the viability detection medium producing a gaseous reaction product when one or more of the test microorganisms are viable. The presence or absence of the gaseous reaction product produced by the biological indicator combined with the viability detection medium is detected with a sensing device, the sensing device comprising a resistive sensor, wherein the presence of the gaseous reaction product indicates the presence of viable test microorganisms and the absence of the gaseous reaction product indicates the absence of viable test microorganisms. A sterilization detection device includes a container configured to contain the biological indicator, a viability detection medium, and the sensing device.

A process for determining the viability of a biological indicator includes exposing the biological indicator to a viability detection medium, the biological indicator including test microorganisms, the exposing the biological indicator to the viability detection medium producing a gaseous reaction product when one or more of the test microorganisms are viable. The presence or absence of the gaseous reaction product produced by the biological indicator combined with the viability detection medium is detected with a sensing device, the sensing device comprising a capacitive sensor, wherein the presence of the gaseous reaction product indicates the presence of viable test microorganisms and the absence of the gaseous reaction product indicates the absence of viable test microorganisms. A sterilization detection device includes a container configured to contain the biological indicator, a viability detection medium, and the sensing device.

A plate cleaning device (1) for cleaning a clamp plate of a fermenter, wherein the clamp plate has a plurality of receptacles each configured to hold a bioreactor vessel, and at least one conduit with a conduit opening per receptacle. The device comprises a plate seat member (3), a cover member (2), a plurality of valve units (4), a first fluid terminal (71), a second fluid terminal (74) and a control unit (9). The plate seat member (3) is configured to hold the clamp plate (6) in a predefined position and orientation. The cover member (2) is configured to close the plate seat member (3) such that the clamp plate (6) is tightly enclosed by the plate seat member (3) and the cover member (2). The plurality of valve units (4) is configured to be coupled to the cover member (2) such that at least one valve unit (4) is associated to each of the conduit openings (62) of the clamp plate (6). The first fluid terminal (71) is configured to receive a first fluid container and the second fluid terminal (74) to receive a second fluid container. The cover member (2) is equipped with channels each having a first open end and a second open end. Each of the first open ends of the channels of the cover member (2) is positioned to be connected to one of the conduit openings (62) of the clamp plate (6). The valve units (4) are configured to be coupled to the second open ends of the channels of the plate such that all of the at least one conduit openings (62) per receptacle are associated to one valve (4). The first fluid terminal (71) and the second fluid terminal (74) are coupled to each of the valve units (4). The control unit (9) is configured to selectively connect the first fluid terminal (71) and the second fluid terminal (74) to the second open ends of the channels of the cover member (2).

Provided herein are isolation processes and the associated hardware to allow fluid streams to be isolated from a sterilized system (e.g., a sterile process vessel) that contains a sterile process. The isolation processes described herein allow for continuous removal of fluid streams (e.g., waste streams, liquid containing recombinant therapeutic proteins) from a sterilized system (e.g., a biological manufacturing system), which provides for less manual manipulation of the sterilized system and a decreased risk of contaminating the sterilized system.

A process for determining the viability of a biological indicator includes exposing the biological indicator to a viability detection medium, the biological indicator including test microorganisms, the exposing the biological indicator to the viability detection medium producing a gaseous reaction product when one or more of the test microorganisms are viable. The presence or absence of the gaseous reaction product produced by the biological indicator combined with the viability detection medium is detected with a sensing device, the sensing device comprising an electro-mechanical sensor, wherein the presence of the gaseous reaction product indicates the presence of viable test microorganisms and the absence of the gaseous reaction product indicates the absence of viable test microorganisms. A sterilization detection device includes a container configured to contain the biological indicator, a viability detection medium, and the sensing device.

A method is provided for vaporized hydrogen peroxide cleaning of a chamber. The method includes altering a temperature of air in the chamber from an initial temperature to a sterilization temperature over a first time period. The method also includes injecting vaporized hydrogen peroxide into air in the chamber to alter a relative humidity of hydrogen peroxide vapor in the chamber to a sterilization level over the first time period. The method also includes maintaining the temperature at the sterilization temperature and the relative humidity at the sterilization level over a second time period. The method also includes reducing the relative humidity from the sterilization level to a safe level over a third time period. In one embodiment, the method is provided for vaporized hydrogen peroxide cleaning of an interior chamber of an incubation container. In other embodiments, the incubation chamber featured in the method is provided.

A method is provided for vaporized hydrogen peroxide cleaning of a chamber. The method includes altering a temperature of air in the chamber from an initial temperature to a sterilization temperature over a first time period. The method also includes injecting vaporized hydrogen peroxide into air in the chamber to alter a relative humidity of hydrogen peroxide vapor in the chamber to a sterilization level over the first time period. The method also includes maintaining the temperature at the sterilization temperature and the relative humidity at the sterilization level over a second time period. The method also includes reducing the relative humidity from the sterilization level to a safe level over a third time period. In one embodiment, the method is provided for vaporized hydrogen peroxide cleaning of an interior chamber of an incubation container. In other embodiments, the incubation chamber featured in the method is provided.

The invention relates to a bioindicator and a method for using the bioindicator for microbiological testing of washing machines. The device according to the invention allows a safe, reliable, cost-effective and easy-to-use microbiological test of the disinfection performance of washing machines. The invention further relates to a use of the bioindicator and a kit comprising 10 bioindicators. In particular, the invention relates to a closed bioindicator for a verification of disinfecting washing processes.

A sterilization system includes a vial, a carrier of microorganisms disposed in the vial, and a fluid management system having an output connectable to the vial for delivering a liquid chemical sterilant and a neutralizer thereto. Additionally, a growth medium may be delivered to the vial such that the vial and growth medium may assessed for a change to a visual characteristic indicative of sterilization inefficacy.

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.