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
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-10513678-B2
Publication Date
2019-12-24
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 disclosed invention relates to a self-contained biological indicator comprising a body adapted to serve as a culture tube and including a collar, a cap, and a rupturable glass ampoule. The body includes a substantially uniform cylindrical side wall with a substantially constant diameter and a bottom wall closing the body, and the collar extends outwardly from the cylindrical side wall at the other end and has an open end adapted to receive the cap, with the collar including a plurality of inwardly extending ribs.
A cap is adapted to engage the body in an open position and a closed position. The cap includes a top wall and a cylindrical side wall adapted to engage the collar, and the cylindrical side wall includes a plurality of apertures. A rupturable glass ampoule includes growth media located in the body, and a stainless steel disc inoculated with spores is positioned on top of the glass ampoule and adjacent the ribs, with filter paper covering the stainless steel disc.
The self-contained biological indicator is configured so that when the glass ampoule is ruptured, growth media is released to incubate and detect live spores. The spore disc is adapted to drop down into the body when the glass ampoule is ruptured, and the disc position relative to the collar ribs and the cap apertures supports exposure of the inoculated disc to sterilant airflow in ambient-pressure conditions, enabling detection via a color indicator turning yellow.
Claims Coverage
The document includes two independent claims. Across these independent claims, the core inventive features include a culture-tube body with a ribbed collar, a cap that engages open and closed positions with apertures, a rupturable glass ampoule containing growth media, and a spore-inoculated stainless steel disc covered by filter paper; one claim further specifies disc drop-down into the body upon ampoule rupture and quantitative constraints on cap apertures and rib/collar configuration.
Culture-tube body with outward collar and inward ribs
A body adapted to serve as a culture tube having a substantially uniform cylindrical side wall with a substantially constant diameter, a bottom wall closing the body, and a collar at the other end extending outwardly with an open end having an interior diameter greater than the cylindrical side wall, the collar including a plurality of inwardly extending ribs.
Cap engaging open and closed positions with apertured cylindrical side wall
A cap adapted to engage the body in an open position and a closed position, the cap including a top wall and a cylindrical side wall adapted to engage the collar, where the cylindrical side wall includes a plurality of apertures.
Rupturable glass ampoule containing growth media in the body
A rupturable glass ampoule including growth media in the body.
Spores on stainless steel disc positioned adjacent ribs and covered by filter paper
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.
Inward ribs extending collar length and even with inside wall
The plurality of inwardly extending ribs extend the horizontal length of the collar and are substantially even with the inside wall of the cylindrical side wall of the body.
Cap aperture count limited to six to eight
The plurality of apertures comprise six to eight apertures.
Formulated soybean casein digest culture medium growth media
Growth media in the rupturable glass ampoule wherein the growth media is a formulated soybean casein digest culture medium.
Spore disc drops down into body when ampoule is ruptured
The stainless steel disc is adapted to drop down into the body when the glass ampoule is ruptured.
Both independent claims cover a self-contained biological indicator built like a culture tube with a ribbed collar, an apertured cap for open and closed engagement, a rupturable glass ampoule containing growth media, and a filter-covered stainless steel spore disc adjacent to the ribs; one independent claim additionally specifies the disc drop-down behavior, the formulated soybean casein digest growth media, and the six-to-eight aperture range.
Stated Advantages
Enables incubation and detection of live spores using released growth media and exposure supported by ambient-pressure sterilant airflow.
Documented Applications
Used in ambient-air sterilization and decontamination systems including isolators and restricted access barrier systems (RABS).
A hydrogen peroxide gas, chlorine dioxide gas, or nitrogen dioxide gas ambient-air sterilization and decontamination context is described for reaching an inoculated disc for detection.
Interested in licensing this patent?