Steris Inc.

Surigot, Inc.

Jerry Falkowski

Giridhar Shamsunder

Edna I Hu

Pamela M Lyons

Steven J Risner

Mizanu Kebede

A suspension of microorganisms includes a detectable indicator material, such as a food coloring, for ensuring that a biological indicator receives a preselected population of the microorganisms. A microorganism delivery system delivers the suspension with the indicator material from a tank (10) to a plurality of needles (18) where it is delivered to a carrier material (22), such as filter, chromatography, or blotter paper, or glass fiber passing beneath the needles or micropipetted onto non-absorptive or non-penetrable carriers, such as plastic polymers or stainless steel coupons. In the event of a malfunction in the system, such as a blockage in one of the needles or intermittent delivery of the microorganism suspension, the absence of color on the impregnated carrier material indicates the absence of microorganisms. The impregnated or otherwise treated carrier material may be evaluated visually or using an automated detector system (32) which signals an alarm in the event that absences in the color or other indicator material are detected.

System for ensuring distribution of spores on a spore carrier

A self-contained biological indicator for evaluating the efficacy of sterilization processes utilizing hydrogen peroxide and hydrogen peroxide/peracetic acid plasma and vapor as the sterilant is disclosed. The self-contained biological indicator includes a translucent, vapor-permeable, container including a source of dormant microorganisms, a sealed ampule containing a culture medium that is capable of promoting the growth of surviving microorganisms, a neutralizing tablet that is capable of decomposing hydrogen peroxide sterilant, and an actuating mechanism that permits mixture of the source of microorganisms, culture medium and the hydrogen peroxide neutralizing tablet to be brought into contact from the exterior of the indicator. In one embodiment the self-contained biological indicator is comprised of a plurality of generally cylindrical, telescoping vials being operable from an unsealed, sterilization test configuration to a sealed and activated configuration for incubation. In the sterilization test configuration the integrity of the enclosure is interrupted by a plurality of openings which permit the flow of sterilant vapor into the indicator during a sterilization cycle. After exposure to the sterilization cycle is complete the indicator is operable to a sealed configuration in which the gas permeable openings are blocked by the telescoping movement of the container vials. After the indicator has been exposed to a sterilization cycle and placed in the sealed condition the deformable container may be actuated by finger pressure to bring the microorganism source, culture medium, and the hydrogen peroxide decomposing tablet into contact.

Self-contained biological indicator for non traditional sterilization

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Cary, NC, United States of America

Jerry Falkowski