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 process challenge device comprising process challenge device comprising a container defining a space within the container, wherein the space can fully contain a process indicator; and at least one pressure-actuating valve associated with the container, wherein the at least one pressure-actuating valve regulates entrance of a sterilant into and exiting of a gas and/or liquid out of the space within the container, methods of using the device and a kit including the device are disclosed.
Abstract:
A sterilization process challenge device comprising a first container comprising walls which define a first space within the first container; a process indicator within the first space; at least one sterilant access for a sterilant to enter the first space within the first container; wherein at least one of the walls which defines the first space is a flexible wall; and wherein the walls are impervious to the sterilant; a method of using the device; and a kit including the device are disclosed.
Abstract:
Sterilization indicator test packs for testing the effectiveness of a sterilization procedure are provided. Both non-challenge and challenge-type test packs are disclosed. The non-challenge test packs include generally comprise a tray for holding a sterilization indicator the tray containing an elevated rim surface defining the perimeter of the tray and a recessed trough for receiving a sterilization indicator. The rim surface includes a plurality of spaced-apart grooves along its length extending through the rim to the recessed trough; a sterilization indicator within the recessed trough of the tray; and a lid that forms a plurality of channels with the grooves in the tray such that sterilant can enter the tray through the channels and contact the sterilization indicator. The challenge-type test packs generally include a tray for holding a sterilization indicator, the tray comprising a substantially planar surface, a recessed trough for receiving a sterilization indicator, and a recessed groove of a defined length and cross-sectional area extending through the recessed trough and penetrating the edge of the tray; a sterilization indicator within the recessed trough of the tray; and a lid forming a substantially sterilant-impermeable seal with the planar surface of the tray and forming a lumen path with the recessed groove in the tray.