American Sterilizer Company

Steris Inc.

Tricia Cregger

Phillip P Franciskovich

William A Yirava

Mark J Duda

Peter A Burke

Robert E Bellow, Jr

Randal W Eveland

Antoinette Bower

Michael A Centanni

Mark Edward Pasmore

Alan M Solomon

Phillip F Franciskovich

Paul Vodkin

Nicole M Beahn

This invention relates to a chemical indicator for monitoring a vaporous hydrogen peroxide sterilization process. The chemical indicator comprises a reactive composition adhered to a substrate, the reactive composition comprising a transition metal reagent, an oxidizing agent, and a resin. A test pack containing the chemical indicator and a biological indicator is disclosed. Vaporous hydrogen peroxide sterilization processes using the chemical indicator and the test pack are disclosed.

Chemical indicator for monitoring hydrogen peroxide sterilization and disinfection processes

This invention relates to a biological indicator derived from a composition comprising: a host organism comprising a spore forming bacteria; a reporter gene for producing an indicator enzyme; a regulatory gene; and a vehicle for inserting the reporter gene and the regulatory gene in the host organism; the host organism bearing a transposable genetic element in its genome for inserting an insertion sequence in the regulatory gene; the insertion sequence comprising a transposase, a pair of terminal inverted repeat sequences, and at least one open reading frame for expressing the transposase. The vehicle may be taken up by the host organism. The insertion sequence may be inserted in the regulatory gene. The host organism may undergo sporulation to form the biological indicator. A process and an apparatus for using the biological indicator are disclosed.

Biological indicator

A combined sterilization indicator incubator and reader system, including a sterilization indicator vial containing one of a variety of selected biological indicators and a liquid, at least two incubator blocks, each incubator block independently operable to incubate the sterilization indicator vial at a plurality of independently selectable temperatures, each of the incubator blocks including at least one heating element operable to heat the incubator block to any one of the plurality of independently selectable temperatures; a light source, a photodetector and a control system configured to operate the combined system to determine the efficacy of a variety of sterilization processes. The system calculates and compares a slope to a predetermined threshold slope for the biological indicator, and provides output based only on the comparison of the calculated slope to the predetermined threshold slope without first determining either a baseline or a minimum value of the output from the photodetector.

Combined sterilization indicator incubator and reader system

A sterilization indicator system and method of using the system to determine efficacy of a sterilization process. The system may include a vial having an optional first compartment and a second compartment comprising a growth medium comprising one or more of a disaccharide, an oligosaccharide or a polysaccharide capable of conversion to a monosaccharide by germinating spores of the one or more species of microorganism, the vial being free of the monosaccharide prior to use; a strip including two or more electrodes to oxidize the monosaccharide and to carry a resulting electrical signal, and an apparatus to detect and measure the electrical signal resulting from the oxidation. Spores of a suitable biological indicator may be disposed in the first compartment and/or on the strip.

Non-enzyme based detection method for electronic monitoring of biological indicator

A sterilization test pack, including a base comprising a pair of recessed compartments, wherein the recessed compartments are arranged in a non-concentric relationship and are in fluid communication with each other; a cover attached to the base and forming a sealed enclosure for the recessed compartments; an external channel providing the only fluid communication between the sealed enclosure and an external environment; a selected sterilization indicator in a first of the recessed compartments; and a chemical integrator and/or a chemical indicator in a second of the recessed compartments, in which the external channel is configured to allow only restricted flow of a gaseous sterilization medium into the recessed compartments and the base and cover are otherwise impenetrable by the gaseous sterilization medium.

Test pack to monitor effectiveness of sterilization process

The disclosed invention relates to a method of making a sterilization indicator including depositing an electronically conductive material on a substrate using an ink jet printer and depositing a biological indicator on part or all of the electronically conductive material using the ink jet printer, and further relates to a method for monitoring a sterilization process including (A) exposing an article to be sterilized and a biological indicator to a sterilization medium during a sterilization process, the biological indicator comprising a cell with a plasma membrane in which the biological indicator is positioned on part or all of an electronically conductive material positioned on a substrate; and (B) measuring the membrane potential of the cell to detect the viability of the cell.

Methods for making a sterilization indicator and for monitoring a sterilization process using membrane potential

A sterilization indicator, including a first compartment containing a genetically engineered biological indicator, and a second compartment containing an enzyme substrate, the second compartment adapted to maintain the enzyme substrate separate from the biological indicator during sterilization, and to permit the enzyme substrate to contact the biological indicator after the biological indicator has been exposed to the sterilization medium; in which the genetically engineered biological indicator comprises at least one test organism and at least one reporter gene suitable for producing an indicator enzyme, the reporter gene being taken up by the test organism; and the test organism is free of any active or activatable repressor gene that would inhibit expression of the reporter gene if present in the test organism or sterilization indicator, and the indicator enzyme and the enzyme substrate are selected such that enzymatic action of the indicator enzyme upon the enzyme substrate yields a detectable signal.

Sterilization indicator including a simplified genetically engineered biological indicator

The disclosed technology relates to a genetically engineered biological indicator, comprising: at least one test organism and at least one reporter gene suitable for producing an indicator enzyme, the reporter gene being taken up by the test organism; and at least one repressor gene that inhibits expression of the reporter gene until the reporter gene is exposed to at least one inducer. A process and an apparatus for using the biological indicator are disclosed.

Growing community of inventors

Fairlawn, OH, United States of America

Tricia Cregger