PROCESS CHALLENGE DEVICE AND METHOD
    2.
    发明申请

    公开(公告)号:WO2022254275A1

    公开(公告)日:2022-12-08

    申请号:PCT/IB2022/054634

    申请日:2022-05-18

    Abstract: The disclosed process challenge device is a casing and a self-contained biological indicator operatively connected to the casing. The biological indicator has a housing with an open end and an interior space, a plurality of viable test microorganisms or an active enzyme in the housing, a sterilant pathway extending through the housing to the test microorganisms or the active enzyme, a detection reagent in the interior space, and an aqueous liquid in an openable container,. The aqueous liquid is in selective communication with the viable test microorganisms or active enzyme. A first portion of the biological indicator has an open end and is disposed in the casing and a second portion of the self-contained biological indicator is disposed outside the casing. The second portion of the biological indicator comprises a part of the housing through which the aqueous liquid and detection reagent can be observed.

    INSTANT READ-OUT BIOLOGICAL INDICATOR
    3.
    发明申请

    公开(公告)号:WO2020136608A1

    公开(公告)日:2020-07-02

    申请号:PCT/IB2019/061382

    申请日:2019-12-26

    Abstract: A self-contained sterilization process biological indicator is provided. The indicator includes a cuvette having at least one liquid-impermeable wall that forms an opening into a compartment, a predetermined number of sterilization process-resistant spores disposed in the compartment, a liquid medium disposed in the compartment, and a nucleic acid-interacting dye disposed in the compartment, with the proviso that the self-contained sterilization process biological indicator does not include an effective amount of germination medium and/or microbial growth medium. The opening is part of a pathway that permits passage of a sterilant gas into the compartment. The nucleic acid-interacting dye is fluorescent when bound to DNA or RNA. A method of using the self-contained sterilization process biological indicator to determine the effectiveness of a sterilization process is also provided.

    INSTANT READ-OUT BIOLOGICAL INDICATOR WITH GROWTH CONFIRMATION

    公开(公告)号:WO2020136613A1

    公开(公告)日:2020-07-02

    申请号:PCT/IB2019/061398

    申请日:2019-12-27

    Abstract: A self-contained sterilization process biological indicator is provided. The indicator includes a cuvette having at least one liquid-impermeable wall that forms an opening into a compartment, a nucleic acid-interacting dye disposed in the compartment, a predetermined number of sterilization process-resistant spores disposed in the compartment, a first liquid medium disposed in the compartment, and a nutrient composition that facilitates germination and/or outgrowth of a viable spore. The spores in the self-contained sterilization process biological indicator are contacting the dye. The nutrient composition is disposed in the compartment and isolated from the spores. The opening is part of a pathway that permits passage of a sterilant gas into the compartment. The nucleic acid-interacting dye is fluorescent when it interacts with DNA or RNA. A method of using the self-contained sterilization process biological indicator to determine the effectiveness of a sterilization process is also provided.

    PLASMA STERILIZATION AND DRYING SYSTEM AND METHODS

    公开(公告)号:WO2019130223A1

    公开(公告)日:2019-07-04

    申请号:PCT/IB2018/060626

    申请日:2018-12-26

    Abstract: A system and methods for sterilizing and drying contaminated articles, particularly medical articles, and more particularly the hollow internal areas of medical instruments or lumens of medical endoscopes. The system includes a plasma generator having an electrode, a shield, and a dielectric gap between the electrode and the shield. A source of electrical power connected to the plasma generator applies an electrode energy density between the electrode and the shield. A source of a sterilizing gas precursor provides a flow of the sterilizing gas precursor through the plasma generator to generate a plasma, thereby forming a sterilizing gas including acidic and/or oxidizing species. The contaminated article is exposed to the sterilizing gas for a time sufficient to achieve a desired degree of sterilization. A turbulent flow of a drying gas is used to dry the contaminated article alternately with the exposure of the contaminated article to the sterilizing gas.

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