Unitary biological indicator for gaseous sterilants and process
First Claim
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1. A biological indicator, comprising:
- opposed first and second members, the first member including at least one deformable portion, the first and second members being held together and forming a pathway extending between an open end and a closed end, the pathway being configured as a tortuous path adjacent to the open end wherein the first and second members are constructed and positioned so as to be foldable into an overlaying position in which the tortuous path is disposed, the fold retarding fluid communication from the exterior at the open end of the pathway;
a selected microorganism being disposed along the pathway a spaced distance from the open end and downstream of the tortuous path; and
a frangible ampule being sandwiched between the opposed members beneath the deformable portion, the ampule containing an aqueous medium, whereby sufficient externally applied pressure against the deformable portion will rupture the ampule, and the ampule and the selected microorganism will be placed in fluid communication when the ampule is ruptured.
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Abstract
A biological indicator is formed from two members (or a sheet with one portion folded onto another portion) which are sealed together and form a pathway having three sections. One section opens to the exterior and is preferably configured as a tortuous path. A middle pathway portion downstream of the tortuous path houses a frangible ampule. The frangible ampule contains growth medium for microorganisms. An interior pathway portion (most downstream from the exterior) houses a carrier inoculated with spores of a microorganism. The biological indicator preferably is prepared by a process in which a thermoplastic sheet has the pathway formed by thermoforming and the sealing is by heat sealing.
88 Citations
14 Claims
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1. A biological indicator, comprising:
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opposed first and second members, the first member including at least one deformable portion, the first and second members being held together and forming a pathway extending between an open end and a closed end, the pathway being configured as a tortuous path adjacent to the open end wherein the first and second members are constructed and positioned so as to be foldable into an overlaying position in which the tortuous path is disposed, the fold retarding fluid communication from the exterior at the open end of the pathway; a selected microorganism being disposed along the pathway a spaced distance from the open end and downstream of the tortuous path; and a frangible ampule being sandwiched between the opposed members beneath the deformable portion, the ampule containing an aqueous medium, whereby sufficient externally applied pressure against the deformable portion will rupture the ampule, and the ampule and the selected microorganism will be placed in fluid communication when the ampule is ruptured. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A process of making a biological indicator, comprising:
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providing a cavity member sheet of deformable material having an initial surface with an axis there along and an edge intersecting the axis; deforming the cavity member sheet to form a pathway protruding from the initial surface and generally extending in the direction of the axis from adjacent to the end, the pathway defining a first pathway portion adjacent to the edge, an interior pathway portion, and a middle pathway portion therebetween, the first pathway portion having at least one 90°
angle with respect to the axis;disposing a frangible ampule in the middle pathway portion and a carrier in the interior pathway portion, the frangible ampule having microorganism growth medium therein, the carrier having microorganism spores thereon; sealing a backing member sheet to the initial surface; and
,creating a fold line between the first pathway portion and the middle pathway portion, the fold line adapted to facilitate selectively crimping the pathway between the edge and the ampule and thereby retarding fluid communication into the pathway. - View Dependent Claims (12, 13, 14)
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Specification