A biological indicator reader is provided for reading a plurality of biological indicators to determine the effectiveness of at least a sterilization process. Each biological indicator is configured to exhibit fluorescence when the sterilization process has failed. Each reader comprises a housing having a plurality of biological indicator holders, a heater coupled to the housing and configured to heat the plurality of biological indicator holders to a preselected temperature to incubate the biological indicators, a UV light emitter configured to emit UV light through a first aperture on the side of each holder and an optical detector positioned under a second aperture on the bottom of the biological indicator holder, the optical detector configured to detect fluorescence intensity indicating the effectiveness of the sterilization process. A method of using the biological indicator reader is provided. A biological indicator system and display are also provided.

A barrier system of a production plant, in particular a pharmaceutical production plant, with a closed or separate area in which a sterile environment is provided, wherein a handling device for automated sampling with a contact sample is arranged in the closed or separate area, as well as methods for automated sampling.

Methods, systems, and devices for non-invasive measurement of cell cultures are described that provide for remote monitoring of cell status. The system includes a cell culture vessel, at least one monitoring layer, at least one measurement device, and a communication component. The cell culture vessel may include at least one cell culture chamber configured for cell growth and for closed-system operation. The monitoring layer is external to the at least one cell culture chamber. In some cases, the communication component is configured to transmit data from the monitoring layer to a remote location.

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.

A biological sterilization indicator is disclosed that in some embodiments comprises a housing having a first enclosure and a second enclosure, an ampule containing a liquid growth medium, and an insert disposed at least partially in the first enclosure. The insert may have a platform including a top surface, an abutment surface, and a side surface, as well as a first void disposed in the platform and configured to allow passage of a first volume of the liquid growth medium into the second enclosure and a second void disposed through at least a portion of the side surface and configured to allow passage of a second volume of the liquid growth medium into the second enclosure. Methods of using the indicator are also disclosed.

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 present invention provides a microorganism inspection system that is capable of instantly inspecting individual containers for microorganism contamination of the containers that are filled with or accommodate medicine and the like. The present invention has a supply means for supplying a predetermined amount of clean air to the inside or the outer surface of a container, a collecting means for collecting the air supplied to the container by the supply means, and a detecting means for detecting microorganisms included in the air collected by the collecting means.

A self-contained biological indicator (SCBI) is disclosed. The SCBI may include a first ampule and a second ampule. The first ampule may contain a first volume of a first growth medium, and the second ampule may contain a second volume of a second growth medium. The SCBI is configured such that the first ampule may be broken before the second ampule. The SCBI may be analyzed for changes in fluorescence of the first growth medium. Then, the SCBI may be analyzed for changes in a color of the second growth medium.

The invention relates to a method and a module for sterility testing based on optically analyzing at least one test liquid (3), which test liquid (3) is contained in a liquid container (4), wherein depending on the contamination state of the test liquid (3), non liquid contaminants (5) are distributed in the test liquid. It is proposed, that in an analyzing routine (9) performed by a control arrangement (6), image-related data (10) representing at least one optical image (I) of the test liquid (3), generated by a sensor arrangement (11), are being transmitted from the sensor arrangement (11) to the control arrangement (6) and the contamination state of the test liquid (3) is derived from the image-related data (10) based on the interrelation between the distribution characteristics of the contaminants (5) and the respective contamination state.

A biological indicator for testing the efficacy of sterilization or disinfection processes of closed environments or confined spaces, the biological indicator comprising a carrier; biological material supported on or embedded in the carrier; and a carrier container comprising a body and a cap. The carrier is fixed within an inner space of the cap, the cap being able to be placed in an open position completely exposing the carrier and the biological material to the closed environment or confined space to be disinfected. A method for determine the efficacy of a process of sterilization or disinfection of closed environments or confined spaces, preferably by means of an enzyme and a fluorescence compound, using said biological indicator.