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-11142741-B2
Publication Date
2021-10-12
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 relates to a self-contained biological indicator (SCBI) for monitoring the accuracy of a sterilization or decontamination process in an ambient air isolator. The SCBI is configured to receive sterilant gas in an open position and to contain the indicator structure during the sterilant exposure so that the process can be evaluated afterward. The SCBI includes a body adapted to serve as a culture tube and a collar with inwardly extending ribs that extend outward from a cylindrical side wall.
A cap is operable between an open position and a closed position and includes a top wall and a cylindrical side wall with apertures. A rupturable glass ampoule including growth media is positioned in the body, and a stainless steel disc inoculated with spores is positioned on top of the glass ampoule and adjacent the ribs. Filter paper covering the stainless steel disc is included, and the structural rib configuration with apertures supports sterilant access toward the spore-containing region during an open position exposure.
After exposure, the SCBI is removed from the isolator and closed, and the glass ampoule is ruptured within the closed SCBI to release the growth media. In the closed condition, the stainless steel disc is adapted to drop down into the cylindrical side wall to contact the inoculated spores with the released growth media. Determining the accuracy of the sterilization or decontamination process is then performed based on the indicator outcome following incubation and color change to detect live spores.
Claims Coverage
The document provides one independent claim describing a complete method for determining the accuracy of sterilization or decontamination in an ambient air isolator using a specific SCBI structure and operational sequence. Dependent claims refine the independent claim by specifying sterilant gas options and particular structural constraints for the SCBI components.
Ambient air isolator accuracy determination using a self-contained biological indicator
Determining the accuracy of a sterilization or decontamination process in an ambient air isolator by placing a self-contained biological indicator (SCBI) in an open position for sterilant gas entry, subjecting the isolator to sterilant gas, removing the SCBI and closing it, rupturing a glass ampoule in the closed SCBI to release growth media, adapting a spore-inoculated stainless steel disc to drop down into the cylindrical side wall to contact inoculated spores with the growth media, and determining the accuracy of the sterilization process or the decontamination process.
Culture-tube body with outward collar and inwardly extending ribs supporting sterilant access
Providing a body adapted to serve as a culture tube having a cylindrical side wall with no recessed areas, a bottom wall closing the body, and a collar at the other end with an open end having an interior diameter greater than the cylindrical side wall interior diameter and adapted to receive a cap, wherein the collar includes a plurality of inwardly extending ribs.
Open/closed cap with apertures over the collar and a sealed retention engagement
Using 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 of the body, and the cylindrical side wall includes a plurality of apertures.
Rupturable glass ampoule plus spore-inoculated stainless steel disc and filter paper covering
Including a rupturable glass ampoule including growth media in the body, a stainless steel disc inoculated with spores positioned on top of the glass ampoule and adjacent the plurality of ribs, and filter paper covering the stainless steel disc.
Disc drop-down upon rupture to contact inoculated spores with released growth media
Rupturing the glass ampoule in the closed SCBI to release the growth media to the body, wherein 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.
Sterilant gas selection from hydrogen peroxide, chlorine dioxide, or nitrogen dioxide
Subjecting the ambient air isolator to a sterilant gas chosen from hydrogen peroxide gas, chlorine dioxide gas, or nitrogen dioxide gas.
Specific rib configuration of twelve ribs
Defining the plurality of ribs as twelve ribs.
Ribs configured to permit sterilant airflow downward along the body side toward the bottom
Configuring the ribs to permit airflow of a sterilant down the side of the body toward its bottom.
Cap aperture count defined as six to eight apertures
Configuring the cylindrical side wall of the cap to include six to eight apertures.
Cap retention structure using an internal annular groove and body collar annular protrusions
Providing an internal annular groove in the cap and body collar annular protrusions, where upper and lower annular protrusions on the body collar engage the groove to retain the cap in open and closed positions.
Overall, the claim set covers an SCBI-based method in an ambient air isolator that combines a culture-tube body with a ribbed collar, an open/closed apertured cap, a rupturable ampoule containing growth media, a spore-inoculated stainless steel disc covered by filter paper, and a disc drop-down mechanism upon ampoule rupture, with dependent claims further specifying sterilant gas options and detailed structural constraints for ribs, apertures, and cap retention.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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