The invention relates to a self-contained biological indicator comprising a vial, an ampule arranged inside said vial, a growth medium for growing microorganisms, the growth medium being arranged inside the ampule and the growth medium having a first color, a biological indicator, a carrier for holding the biological indicator, wherein the biological indicator is arranged on the carrier, and at least one color change indicator having a second color, wherein the at least one color change indicator is arranged inside the vial but outside the ampoule, the growth medium does not contain any of the at least one color change indicator and the first color of the growth medium is changed by the second color of the at least one color change indicator when mixed with the at least one color change indicator.

This invention relates to a capacitor comprising two electrical conductors separated by a dielectric, the dielectric comprising microorganisms. The dielectric may comprise a biological indicator. This invention relates to a process for determining whether the microorganisms are alive or dead. The number of microorganisms can be determined. This invention relates to a process for testing the efficacy of a sterilization process using the capacitor.

This invention relates to a capacitor comprising two electrical conductors separated by a dielectric, the dielectric comprising microorganisms. The dielectric may comprise a biological indicator. This invention relates to a process for determining whether the microorganisms are alive or dead. The number of microorganisms can be determined. This invention relates to a process for testing the efficacy of a sterilization process using the capacitor.

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.

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.

A method and apparatus of aseptic processing and production of cells in a non-sterile enclosure apparatus without chemical biocides is disclosed, by controlling the level of humidity throughout the enclosure to 25% relative humidity (RH) or less, and preferably 20% or 15% or less RH. In addition, the temperature is controlled to 37° C., and consistent gas flow is maintained the enclosure. Colony forming units from microbial contamination detected by environmental monitoring within the enclosure are significantly reduced in this method.

A method and apparatus of aseptic processing and production of cells in a non-sterile enclosure apparatus without chemical biocides is disclosed, by controlling the level of humidity throughout the enclosure to 25% relative humidity (RH) or less, and preferably 20% or 15% or less RH. In addition, the temperature is controlled to 37° C., and consistent gas flow is maintained the enclosure. Colony forming units from microbial contamination detected by environmental monitoring within the enclosure are significantly reduced in this method.

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. A portion of the ampule may be disposed inside 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. The second void of the insert may be an angled cut through the abutment surface and the side surface, which may be disposed entirely beneath the top surface. In some embodiments, stress concentrators and other features are included to reduce the force required to activate the biological sterilization indicator.

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. A portion of the ampule may be disposed inside 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. The second void of the insert may be an angled cut through the abutment surface and the side surface, which may be disposed entirely beneath the top surface. In some embodiments, stress concentrators and other features are included to reduce the force required to activate the biological sterilization indicator.

Various embodiments of a light detection device and a method of using the device are disclosed. In one or more embodiments, the light detection device can include a housing that extends along a housing axis between top and bottom surfaces. The device can also include a port that is adapted to receive a sample, and a door connected to the housing. The door can include an actuator portion adapted to selectively move the door between a closed position and an open position, and a cover portion connected to the actuator portion and adapted to close the port when the door is in the closed position and open the port when the door is in the open position to allow external access to the port.