Self-contained biological indicator
AssigneeEthicon, Inc.
InventorsBen Fryer, Yan Fang
Life of this patent
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Abstract
A self-contained biological indicator (“SCBI”) is disclosed. The SCBI may include a first ampule and a second ampule. The first ampule may contain a first volume of a first growth medium, and the second ampule may contain a second volume of a second growth medium. The SCBI is configured such that the first ampule may be broken before the second ampule. The SCBI may be analyzed for changes in fluorescence of the first growth medium. Then, the SCBI may be analyzed for changes in a color of the second growth medium.
Claims21
A self-contained biological indicator, comprising:
- a first ampule having a first top and a first bottom, the first ampule containing a first volume of a first growth medium;
- a second ampule having a second top and a second bottom, the second ampule containing a second volume of a second growth medium;
- and
- a cap,
- wherein the cap is disposed above the first ampule and the second ampule, the first ampule is disposed adjacent to the second ampule, and the first top is disposed closer to the cap than the second top.
A method of determining whether a sterilization cycle is efficacious, comprising:
- providing an self-contained biological indicator, the self-contained biological indicator including
- a vial;
- a cap disposed atop a vial in a first position, and
- a first ampule disposed beneath the cap and at least partially disposed within the vial, the first ampule having a first top and containing between approximately 50 μl and 150 μl of a first growth medium;
- subjecting the self-contained biological indicator to the sterilization cycle;
- breaking the first ampule;
- and
- analyzing the self-contained biological indicator for changes in fluorescence of the first growth medium.
Dependencies are inferred from the claim text.