The present invention, inter alia, relates to a closed sterilized container comprising at least one carrier which is a stabilizer; and at least one biomolecule reversibly attached to the carrier, wherein said carrier partially or completely covers the attached biomolecules and wherein said at least one carrier is selected from the group consisting of (poly)peptides such as dipeptides or tripeptides, amino acids, polyalcohols, polyethyleneglycols, ionic liquids, compatible solutes, saponins and a mixture thereof. The invention also relates to methods for producing sterilized containers according to the invention and uses thereof.

The present invention, inter alia, relates to a closed sterilized container comprising at least one carrier which is a stabilizer; and at least one biomolecule reversibly attached to the carrier, wherein said carrier partially or completely covers the attached biomolecules and wherein said at least one carrier is selected from the group consisting of (poly)peptides such as dipeptides or tripeptides, amino acids, polyalcohols, polyethyleneglycols, ionic liquids, compatible solutes, saponins and a mixture thereof. The invention also relates to methods for producing sterilized containers according to the invention and uses thereof.

A biological indicator for determining the efficacy of an oxidative sterilization process, and its methods of use. The biological indicator comprises a set of microbial spores, at least one fluorescent sensor protein, and a culture medium, the fluorescent sensor protein being capable of yielding an optically detectable signal when the fluorescent sensor protein is not in a denatured state due to the oxidative sterilization process, and a different optically detectable signal when the fluorescent sensor protein is in a denatured state after the oxidative sterilization process.

A biological indicator for determining the efficacy of an oxidative sterilization process, and its methods of use. The biological indicator comprises a set of microbial spores, at least one fluorescent sensor protein, and a culture medium, the fluorescent sensor protein being capable of yielding an optically detectable signal when the fluorescent sensor protein is not in a denatured state due to the oxidative sterilization process, and a different optically detectable signal when the fluorescent sensor protein is in a denatured state after the oxidative sterilization process.

Devices for detecting microorganism strains or target cellular analytes are provided. The device includes a filter holder, the filter holder comprising a tip portion; a nonwoven article disposed on the tip portion of the filter holder; and an adaptor attacked to the filter holder, the adaptor defining an aperture. Methods of detecting microorganisms and/or cellular analytes in a fluid sample using the devices are also provided. The method includes obtaining the device; placing a lumened or cannulated device in fluid communication with the device; and passing a fluid sample suspected of containing at least one microorganism strain or target cellular analyte from the lumened or cannulated device through the device and contacting the nonwoven article. The method further includes contacting the nonwoven article with at least one detection reagent and detecting the presence of the at least one microorganism strain or target cellular analyte concentrated by the nonwoven article. Kits and systems including the devices are also provided.

Devices for detecting microorganism strains or target cellular analytes are provided. The device includes a filter holder, the filter holder comprising a tip portion; a nonwoven article disposed on the tip portion of the filter holder; and an adaptor attacked to the filter holder, the adaptor defining an aperture. Methods of detecting microorganisms and/or cellular analytes in a fluid sample using the devices are also provided. The method includes obtaining the device; placing a lumened or cannulated device in fluid communication with the device; and passing a fluid sample suspected of containing at least one microorganism strain or target cellular analyte from the lumened or cannulated device through the device and contacting the nonwoven article. The method further includes contacting the nonwoven article with at least one detection reagent and detecting the presence of the at least one microorganism strain or target cellular analyte concentrated by the nonwoven article. Kits and systems including the devices are also provided.

A method for automated microbial monitoring in an isolator having a transfer lock, the method comprising the steps: first providing at least one nutrient medium carrier holder at, in each case, a first position within the isolator; second providing at least one nutrient medium carrier within the transfer lock; first robot-assisted transferring of an individual nutrient medium carrier from the transfer lock to a free nutrient medium carrier holder; and first robot-assisted placing of the transferred nutrient medium carrier in the free nutrient medium carrier holder. Further, a system for automated microbial monitoring in an isolator and a computer program are also disclosed.

A method for validating a method for sterilizing an item, making it possible to validate the sterility assurance level achieved with this sterilization method. The method includes carrying out a first step of contaminating a container receiving the item with more than 10.sup.5 living microorganism cells, then carrying out a first sterilization cycle with the chosen method, then opening the container in order to contaminate it again with more than 10.sup.5 living microorganism cells, then carrying out a second sterilization cycle with the same method, and finally checking the sterility of the container after the first sterilization cycle and after the second sterilization cycle. The method is applicable in particular for products and devices intended for health use.

A method for validating a method for sterilizing an item, making it possible to validate the sterility assurance level achieved with this sterilization method. The method includes carrying out a first step of contaminating a container receiving the item with more than 10.sup.5 living microorganism cells, then carrying out a first sterilization cycle with the chosen method, then opening the container in order to contaminate it again with more than 10.sup.5 living microorganism cells, then carrying out a second sterilization cycle with the same method, and finally checking the sterility of the container after the first sterilization cycle and after the second sterilization cycle. The method is applicable in particular for products and devices intended for health use.

A biological indicator (100) for use in a liquid-chemical decontamination system is disclosed. The biological indicator may include a housing (102) and a cap (106) coupled to the housing. The cap may comprise a liquid chamber and at least two ports. One of the ports may connect to a liquid passage in the cap such that liquids such as liquid-chemical decontaminants may be introduced and removed from the biological indicator via this port.