Determining effectiveness of sterilization procedure from outside the sterilization package
AssigneeSolventum Intellectual Properties Company
InventorsKevin D. Landgrebe, G. Marco Bommarito, Timothy J. Nies
Life of this patent
Estimating the term…
Abstract
An example sterilization indicator (102) includes a cover (122), an indicator (102), and a seal (142). The cover (122) defines at least a portion of a cavity (138). The indicator (102) is disposed within the cavity (138). The indicator (102) is configured to fluidly couple with an internal cavity (110) of a sterilization package (package) and indicate an exposure to a sterilant. The seal (142) is configured to form a microorganism barrier between an exterior of the cover (122) and an internal cavity (110) of a sterilization package (100).
Claims20
A sterilization indicator, comprising:
- a cover defining at least a portion of a cavity;
- an indicator disposed within the cavity, wherein the indicator is configured to fluidly couple with an internal cavity of a sterilization package and indicate an exposure to a sterilant;
- and
- a seal configured to form a microorganism barrier between an exterior of the cover and the cavity of the sterilization package, wherein the sterilization indicator defines a laminate structure, wherein the cover comprises a cover layer, and wherein the indicator comprises an indicator layer disposed on the cover layer;
- a base, wherein the indicator layer is dimensionally smaller than the base, and edges of the base extend beyond the indicator, and wherein at least a portion of the edges of the base are coupled to at least a portion of the edges of the cover, wherein the base defines a second surface opposing the cover, and wherein at least a portion of the second surface of the base is configured to couple with an exterior of the sterilization package;
- and
- a release liner wherein the cover is peripherally bonded to the release liner such that the indicator is disposed between the release liner and the cover.
A sterilization indicator, comprising:
- a cover defining at least a portion of a cavity;
- an indicator disposed within the cavity, wherein the indicator is configured to fluidly couple with an internal cavity of a sterilization package and indicate an exposure to a sterilant;
- and
- a seal configured to form a microorganism barrier between an exterior of the cover and the cavity of the sterilization package, wherein the sterilization indicator defines a laminate structure, wherein the cover comprises a cover layer, and wherein the indicator comprises an indicator layer disposed on the cover layer;
- and
- a base, wherein the indicator layer is dimensionally smaller than the base, and edges of the base extend beyond the indicator, and wherein at least a portion of the edges of the base are coupled to at least a portion of the edges of the cover, wherein the base defines a second surface opposing the cover, and wherein at least a portion of the second surface of the base is configured to couple with an exterior of the sterilization package;
- wherein the base defines an aperture fluidly coupling the indicator with the internal cavity of the sterilization package.
A sterilization indicator, comprising:
- a cover defining at least a portion of a cavity;
- an indicator disposed within the cavity, wherein the indicator is configured to fluidly couple with an internal cavity of a sterilization package and indicate an exposure to a sterilant;
- and
- a seal configured to form a microorganism barrier between an exterior of the cover and the cavity of the sterilization package, wherein the sterilization indicator defines a laminate structure, wherein the cover comprises a cover layer, and wherein the indicator comprises an indicator layer disposed on the cover layer;
- a base, wherein the indicator layer is dimensionally smaller than the base, and edges of the base extend beyond the indicator, and wherein at least a portion of the edges of the base are coupled to at least a portion of the edges of the cover, wherein the base defines a second surface opposing the cover, and wherein at least a portion of the second surface of the base is configured to couple with an exterior of the sterilization package;
- and
- a process challenge device defining a channel fluidly coupling the indicator to the internal cavity of the sterilization package, wherein the process challenge device is configured to resist passage of the sterilant through the channel.
Dependencies are inferred from the claim text.