Abstract:
A self-contained biological sterilization indicator is provided. The self-contained biological sterilization indicator includes an outer container having at least one liquid-impermeable wall and an interior volume; a sealed, openable, liquid-impermeable inner container enclosing a predetermined volume of an aqueous medium; a dry coating that comprises i) a plurality of viable test microorganisms useful to detect exposure to an oxidative sterilant and ii) an effective amount of a sterilant-resistance modulator; and a pathway that permits vapor communication between the interior volume and an atmosphere outside the outer container. The inner container and the dry coating are disposed in the interior volume. The modulator comprises an amino acid. The effective amount causes an increase in sensitivity of the test microorganisms to the oxidative sterilant relative to an otherwise-identical dry coating that lacks the effective amount.
Abstract:
A biological sterilization indicator device is provided. The device comprises a body, a plurality of test microorganisms, and an oxygen-modulated first fluorescent sensor. The body comprises a first layer attached to a second layer, forming at least one isolatable microchamber and at least one primary passageway that provides fluidic communication between ambience and the at least one microchamber. The microchamber has an isolated volume of about 0.5 microliters to about 9.5 microliters. The plurality of test microorganisms and the oxygen-modulated first fluorescent sensor are disposed in the microchamber. A method of using the device to determine the effectiveness of a sterilization process is also provided.