Unitary biological indicator for gaseous sterilants and process

Coating processes – Medical or dental purpose product; parts; subcombinations;... – Analysis – diagnosis – measuring – or testing product

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435 31, 435 38, 435810, 4352874, 4352876, 422 55, 422 56, 422 58, 422 86, G01N 2100

Patent

active

057501840

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.

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