Self-contained biological indicator
Inventors
Sullivan, John • Krushefski, Garrett • McCauley, Kurtis • Gillitzer, Eric • Spain, Nicholas • Campbell, Connor • Coleman, Ren • Morrell, Edward • Wedding, Jimmy • Schwend, John
Assignees
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Publication Number
US-11667878-B2
Publication Date
2023-06-06
Expiration Date
Abstract
A SCBI useful in ambient air pressure systems is disclosed. The SCBI includes a body which serves as the culture tube, a glass media ampoule, an inoculated stainless steel disc positioned on the top of the glass media ampoule so that the spores are close to the top/opening of the SCBI, filter paper on the top of the body and overlying the disc, and a cap.
Core Innovation
The invention provides a self-contained biological indicator (SCBI) configured to function in a sterilization chamber in an open position to allow sterilant gas to enter the SCBI. The SCBI includes a body adapted to serve as a culture tube with a cylindrical side wall without recessed areas, a bottom wall, and a collar at the opposite end that extends outwardly to receive a cap. The collar includes a plurality of inwardly extending ribs, and the cap is adapted to engage the body in an open position and a closed position.
The SCBI further includes a cap with a top wall and a cylindrical side wall adapted to engage the collar, where the cylindrical side wall includes a plurality of apertures. Inside the body, the SCBI includes a rupturable glass ampoule containing growth media, and it includes a stainless steel disc inoculated with spores positioned on top of the glass ampoule and adjacent the plurality of ribs.
In use, the SCBI is placed in the sterilization chamber in an open position, the sterilization chamber is subjected to sterilant gas, and the SCBI is removed. The glass ampoule is ruptured in the SCBI to release the growth media to the body so the stainless steel disc is adapted to drop down into the cylindrical side wall of the body to contact the inoculated spores with the growth media. The SCBI is then closed and the accuracy of the sterilization process or decontamination process is determined.
Claims Coverage
The document provides two independent claims: one directed to a method of determining the accuracy of sterilization or decontamination, and one directed to a self-contained biological indicator having a specific culture-tube-like structure with a rupturable glass ampoule and a spore-inoculated stainless-steel disc. Across the independent claims, the inventive features center on exposing the SCBI to sterilant gas while open, rupturing internal growth media to contact spores, and the non-recessed cylindrical body and collar/cap structure with ribs and apertures.
Sterilant exposure with open-position SCBI having a non-recessed culture-tube body and inward ribs
Placing a self-contained biological indicator in a sterilization chamber in an open position wherein a sterilant gas will enter the SCBI, the SCBI comprising a body adapted to serve as a culture tube with a cylindrical side wall which does not contain any recessed areas, a bottom wall closing the body, and a collar with a plurality of inwardly extending ribs, wherein the collar extends outwardly to receive a cap.
Cap with apertures for sterilant gas entry and engagement in open and closed positions
Providing a cap adapted to engage the body in an open position and a closed position, where the cap includes a top wall and a cylindrical side wall adapted to engage the collar, and where the cylindrical side wall includes a plurality of apertures.
Rupturable glass ampoule containing growth media with a spore-inoculated stainless steel disc
Including a rupturable glass ampoule including growth media in the body and a stainless steel disc inoculated with spores on top of the glass ampoule and adjacent the plurality of ribs, then rupturing the glass ampoule after removal to release the growth media so the stainless steel disc is adapted to drop down into the cylindrical side wall of the body to contact the inoculated spores with the growth media.
Method steps closing the SCBI and determining sterilization or decontamination accuracy
Subjecting the sterilization chamber to the sterilant gas, removing the SCBI, rupturing the glass ampoule to release the growth media, closing the SCBI, and determining the accuracy of the sterilization process or the decontamination process.
The independent claims collectively define a method and an SCBI structure in which sterilant gas enters an open SCBI, internal growth media is released by rupturing a glass ampoule, and a spore-inoculated stainless steel disc contacts the spores after dropping within the non-recessed cylindrical body, followed by closing the SCBI and determining sterilization or decontamination accuracy.
Stated Advantages
Enables determining the accuracy of a sterilization process or a decontamination process.
Documented Applications
Monitoring or determining accuracy of sterilization or decontamination in a sterilization chamber, including use in ambient-air isolator/RABS systems as described in the disclosure.
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