Biological indicator with integral package
Inventors
Assignees
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Publication Number
US-8765398-B2
Publication Date
2014-07-01
Expiration Date
Abstract
A biological indicator for determining the effectiveness of a sterilization process is disclosed having a package and carrier integral therewith. The package includes a first sheet and a second sheet having a bottom portion, side portions and a top portion. The first and second sheets are joined together generally along a periphery of the first and second sheets by a peelable adhesive. A carrier having a plurality of spores thereon for determining the effectiveness of a sterilization process is attached to the package between the first and second sheets and at least a portion of the resealable adhesive. The package may be opened and subsequently partially or fully closed to enclose the carrier.
Core Innovation
The invention relates to a biological indicator for determining the effectiveness of a sterilization process. The biological indicator includes a package having a first sheet and a second sheet including a bottom portion, side portions and a top portion, and the first and second sheets are joined together along a periphery by a peelable adhesive.
A carrier having a plurality of spores for determining the effectiveness of the sterilization process is attached to the package between the first and second sheets and to at least a portion of the peelable adhesive. The package may be opened and subsequently partially or fully closed to enclose the carrier, and opening exposes the carrier while keeping it attached during the sterilization cycle.
After sterilization, the package is partially or fully reclosed to enclose the carrier, reducing microbial contamination and false positives during subsequent culturing. The disclosure further includes an alternative package dome adjacent the spore well and an embodiment with a disk carrier having a sealed spoon-handle end for cutting the inoculated test portion.
Claims Coverage
The document provides two independent claims, one directed to the biological indicator and one directed to a method of using the biological indicator. Across the independent claims, the core inventive features are centered on an openable and partially or fully recloseable package with peelable adhesive, and a spore carrier attached between sheets and to the adhesive to support exposure during the sterilization process and reclosure afterward.
Openable and recloseable peelable-adhesive package enclosing a spore carrier
A package having a first sheet and a second sheet joined along a periphery by a peelable adhesive, wherein the package may be opened and subsequently partially or fully closed to enclose a carrier having a plurality of spores.
Spore carrier attached between sheets and to the peelable adhesive for sterilization effectiveness determination
A carrier having a plurality of spores for determining the effectiveness of a sterilization process, attached to the package between the first and second sheets and to at least a portion of the peelable adhesive.
Top opening of the package by pulling sheets to expose the carrier
Opening the package from the top portion by pulling the first and second sheets to release the first or second sheet from each other by the peelable adhesive and exposing the carrier.
Placement in a sterilization chamber and enclosure by partial or full closing after sterilization
Placing the biological indicator in a sterilization chamber and subjecting the biological indicator to the sterilization process, followed by partially or fully closing the package to enclose the carrier.
Overall, the independent claims cover a packaged biological indicator where a peelable adhesive joins first and second sheets along a periphery, enabling opening from a top portion to expose a spore carrier while the carrier remains attached, and enabling partial or full reclosure after the sterilization process to enclose the carrier.
Stated Advantages
Reduces microbial contamination and false positives during subsequent culturing.
Documented Applications
Determining the effectiveness of a sterilization process using the biological indicator.
Reducing microbial contamination and false positives during subsequent culturing after the sterilization process.
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