Abtox, Inc.

Other

Depuy Orthopaedics, Inc.

Pharmaceutical Systems, Inc.

Ross A Caputo

Kern A Moulton

Bryant A Campbell

Bryant A Campbell, Deceased

Phillip A Martens

Thomas J Amsler

Kangyan Du

Jeffrey Jones

Jeffery Jones

Robert J Thrash

Davoud Khorzad

Thomas F Cullen

Jimmy Fisher

Robert R Reich, Jr

By Louise Campbell, Legal Representative

Afaf Wensky

Apparatus and method for testing one or more sterilization indicators (e.g., biological indicators or chemical indicators) or other articles by contacting them under controlled sterilization conditions with a flowing antimicrobial gas containing hydrogen peroxide vapor are disclosed. This invention also provides apparatus and method for testing sterilization processes that use a flowing antimicrobial gas containing hydrogen peroxide vapor under controlled sterilization conditions, or for testing materials for such processes under controlled sterilization conditions, or for testing both such processes and such materials under controlled sterilization conditions. There can be an essentially square-wave contact of the sterilization indicators or other articles with the antimicrobial gas (i.e., short rise time to reach full concentration of the antimicrobial gas in contact with the sterilization indicators or other articles and short fall time to remove all of the antimicrobial gas from contact with the sterilization indicators or other articles). A preferred way of generating a substantially constant flow of antimicrobial gas of substantially constant hydrogen peroxide concentration may be used to generate the antimicrobial gas. A preferred way of determining the hydrogen peroxide concentration in the antimicrobial gas may be used.

Apparatus for testing sterilization methods and materials

A process and equipment for plasma sterilization in which articles in a sterilizing chamber are taken through at least one combination sterilizing cycle. The articles to be sterilized may include the interior of a vessel or chamber. In that case, the vessel or chamber itself may serve as a sterilizing chamber and connects to the plasma generating chamber. Each combination sterilizing cycle includes a pulsed treatment with gaseous antimicrobial agent, removal of the gaseous antimicrobial agent, and a plasma treatment. The pulsed treatment includes one or more pulse-vacuum cycles, each pulse-vacuum cycle includes the steps of evacuating the sterilizing chamber and exposing the article to the gaseous antimicrobial agent with a predetermined pressure profile during a predetermined time. The gaseous antimicrobial agent is preferably carried in a gas mixture with a nonreactive carrier gas. In one embodiment, the predetermined pressure is pulsed. In another embodiment, it is ramped. After the pulsed treatment, the antimicrobial agent is removed by evacuating the sterilizing chamber. The plasma treatment includes exposure of the article to a plasma having essentially uncharged, highly reactive free radicals, molecules and atoms.

Process and apparatus for plasma sterilizing with pulsed antimicrobial agent treatment

A process for plasma sterilization in which articles in a sterilizing chamber are taken through at least one combination sterilizing cycle. The articles to be sterilized may include the interior of a vessel or chamber. In that case, the vessel or chamber itself may serve as a sterilizing chamber and connects to the plasma generating chamber. Each combination sterilizing cycle includes a pulsed treatment with gaseous antimicrobial agent, removal of the gaseous antimicrobial agent, and a plasma treatment. The pulsed treatment includes one or more pulse-vacuum cycles, each pulse-vacuum cycle includes the steps of evacuating the sterilizing chamber and exposing the article to the gaseous antimicrobial agent with a predetermined pressure profile during a predetermined time. The gaseous antimicrobial agent is preferably carried in a gas mixture with a nonreactive carrier gas. In one embodiment, the predetermined pressure is pulsed. In another embodiment, it is ramped. After the pulsed treatment, the antimicrobial agent is removed by evacuating the sterilizing chamber. The plasma treatment includes exposure of the article to a plasma having essentially uncharged, highly reactive free radicals, molecules and atoms.

Process for plasma sterilizing with pulsed antimicrobial agent treatment

Devices useful to monitor whether or not an article has been exposed to sterilizing conditions are provided and comprise a package and an indicator associated with the package. The package is sufficiently permeable to admit sterilizing gas or vapor into the package. The indicator associated with the package changes color from a first color (indicating ambient conditions) to a second color (indicating exposure to acidic gas or vapor). Both the first and second colors of the indicator are stable and preferably substantially maintain their colors under ambient conditions. Particularly, preferred embodiments are adapted for use with peracetic acid sterilization processes.

Packaging systems for peracid sterilization processes

Biological indicators are provided for use in validating and routinely monitoring oxidizing gas sterilizations. The biological indicators are based on Bacillus circulans spores that are enclosed in packages with sufficient permeability to admit a sterilizing amount of vapor while being substantially bacteria impermeable.

Bacillus circulans based biological indicator for gaseous sterilants

A system for testing sterilization processes is provided by a vessel having a chamber, a plasma generator adapted to generate a plasma upstream of the chamber, a monitor associated with the chamber, and a biological or chemical indicator disposable within the chamber. The plasma generator generates upstream plasma that contains a plurality of atomic and/or molecular species, and the monitor is capable of determining a concentration of selected species in the plasma when flowing through the chamber.

Vessel useful for monitoring plasma sterilizing processes

Apparatus for plasma sterilizing with pulsed antimicrobial agent

A method for plasma sterilization within a controlled temperature range includes exposing the interior of a chamber and any articles therein to a gas plasma flowing from a plasma generating chamber until the temperature in the chamber rises to a preselected maximum temperature. The flow of the plasma gas to the chamber is terminated when the temperature in the chamber falls to a temperature below the preselected maximum temperature. These steps are repeated until sterilization of the interior of the chamber or any articles therein is effected. The temperature below the preselected maximum temperature when gas plasma flow is again initiated is preferably not more than 3.degree. C. below the preselected maximum temperature. The gas plasma can be generated from a gas mixture that includes oxidizing and/or reducing agents. Preferably the pressure in the sterilizing chamber rises to from 0.1 to 10 torr when the gas plasma is flowing into the chamber, and the pressure in the sterilizing chamber falls to a lower pressure when the gas plasma flow into the sterilizing chamber is terminated. The articles to be sterilized include the interior of a vessel or chamber. The vessel or chamber itself serves as a sterilizing chamber and connects to the plasma generating chamber.

Plasma cycling sterilizing process

A process for plasma sterilization including exposing an article in a sterilizing chamber to at least one combination sterilizing cycle. Each combination sterilizing cycle includes a pulsed treatment with gaseous antimicrobial agent, removal of the gaseous antimicrobial agent, and a plasma treatment. The pulsed treatment includes one or more pulse-vacuum cycles, each pulse-vacuum cycle includes the steps of evacuating the sterilizing chamber and exposing the article to the gaseous antimicrobial agent with a predetermined pressure profile during a predetermined time. The gaseous antimicrobial agent is preferably carried in a gas mixture with a nonreactive carrier gas. In one embodiment, the predetermined pressure is pulsed. In another embodiment, it is ramped. After the pulsed treatment, the antimicrobial agent is removed by evacuating the sterilizing chamber. The plasma treatment includes exposing the article to a plasma having essentially uncharged, highly reactive free radicals and atoms.

Plasma sterilizing process with pulsed antimicrobial agent pretreatment

A method for plasma sterilization within a controlled temperature range includes exposing an article in a sterilizing chamber to a gas plasma flowing from a plasma generating chamber until the temperature in the sterilizing chamber rises to a preselected maximum temperature. The flow of the plasma gas to the sterilizing chamber is terminated until the temperature in the sterilizing chamber falls to a temperature below the preselected maximum temperature. These steps are repeated until sterilization of the article is effected. The temperature below the preselected maximum temperature when gas plasma flow is again initiated is preferably not more than 3.degree. C. below the preselected maximum temperature. The gas plasma can be generated from a mixture of gases consisting essentially of argon, helium, nitrogen or mixtures thereof; from 1 to 21 (v/v) % oxygen; and from 1 to 20 (v/v) % hydrogen; or a mixture containing from 1 to 10 (v/v) % oxygen and from 3 to 7 (v/v) % hydrogen; or a mixture containing 1 to 10 (v/v) % hydrogen and from 90 to 99 (v/v) % of argon, helium, nitrogen or mixtures thereof. Preferably the pressure in the sterilizing chamber rises to from 0.1 to 10 torr when the gas plasma is flowing into the chamber, and the pressure in the sterilizing chamber falls to a lower pressure when the gas plasma flow into the sterilizing chamber is terminated.

A method for flash sterilization with a plasma gas includes exposing an unpackaged article in a sterilizing chamber to a gas plasma flowing from a plasma generating chamber until the temperature in the sterilizing chamber rises to a preselected maximum temperature of at least 100.degree. C. The flow of the plasma gas to the sterilizing chamber is terminated until the temperature in the sterilizing chamber falls to a temperature below the preselected maximum temperature. These steps are repeated until sterilization of the article is effected. The temperature below the preselected maximum temperature when gas plasma flow is again initiated is preferably not more than 3.degree. C. below the preselected maximum temperature. The gas plasma can be generated from a mixture of gases consisting essentially of argon, helium, nitrogen or mixtures thereof; from 1 to 21 (v/v) % oxygen; and from 1 to 20 (v/v) % hydrogen; or a mixture containing from 1 to 10 (v/v) % oxygen and from 3 to 7 (v/v) % hydrogen; or a mixture containing 1 to 10 (v/v) % hydrogen and from 90 to 99 (v/v) % of argon, helium, nitrogen or mixtures thereof. Preferably the pressure in the sterilizing chamber rises to from 0.1 to 10 torr when the gas plasma is flowing into the chamber, and the pressure in the sterilizing chamber falls to a lower pressure when the gas plasma flow into the sterilizing chamber is terminated.

Flash sterilization with plasma

A process for plasma sterilization comprising exposing an article in a sterilizing chamber to at least one cycle comprising a pulsed treatment with gaseous antimicrobial agent and a plasma treatment. The pulsed treatment comprises at least two pulse-vacuum cycles, each pulse-vacuum cycle comprising the steps of exposing the article to the gaseous antimicrobial agent at a pressure of from 4 to 18 torr and reducing the pressure in the sterilizing chamber to from 0.1 to 4 torr. The plasma treatment comprising exposing the article to a plasma generated from gases selected from the group consisting essentially of argon, helium, nitrogen, oxygen, hydrogen and mixtures thereof, the exposure to the plasma being carried out at a pressure of from 0.1 to 10 torr and a temperature of less than 80.degree. C. The antimicrobial agent is selected from the group consisting of hydrogen peroxide, a peracid antimicrobial agent, and mixtures thereof, the peracid antimicrobial agent being selected from the group consisting of saturated and unsaturated peralkanoic acids having from 1 to 8 carbon atoms and halogenated derivatives thereof.

Growing community of inventors

Long Grove, IL, United States of America

Ross A Caputo