Abtox, Inc.

Other

Depuy Orthopaedics, Inc.

Kern A Moulton

Ross A Caputo

Bryant A Campbell, Deceased

Bryant A Campbell

Jim Fisher

Thomas J Amsler

Kangyan Du

Jeffrey Jones

Jeffery Jones

By Louise Campbell, Legal Representative

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

An apparatus for plasma sterilization of articles is provided that comprises a plasma generator and a sterilizing chamber. The plasma generator has an inlet for receiving a premixed gas mixture from a pressurized source. The pressurized gas mixture source is a single container (or multiple containers with the same contents), having a noble gas and further having a non-flammable mixture of hydrogen and oxygen.

Plasma sterilizer apparatus using a non-flammable mixture of hydrogen

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

A canister is provided that is adapted for use in a plasma induced sterilization process. The canister contains a gas mixture that is pressurized to between about 2200 psig to about 2500 psig. The gas mixture has about 2.0 to 2.4 (v/v) percent hydrogen and about 2.6 to 3.0 (v/v) percent oxygen, and the rest of the gas mixture is noble gas or a mixture of noble gases.

Canister with plasma gas mixture for sterilizer

A method for plasma sterilization comprises exposing an article to be sterilized to a neutral active species of a plasma generated from a premixed gas mixture comprising oxygen, hydrogen, and a noble gas. The exposure of the article to the plasma is carried out at reduced pressures and a chamber temperature of less than 63.degree. C. for a time period sufficient to effect sterilization. The apparatus for plasma sterilization of articles comprises a plasma generator, a sterilizing chamber, and a source of pressurized gas mixture in fluid communication with the plasma generator. The source of pressurized gas mixture has a noble gas and a substantially nonflammable mixture of hydrogen and oxygen, which is preferably between about 2.0 to 2.4 (v/v) percent hydrogen and between 2.6 to 3.0 (v/v) percent oxygen.

Plasma gas mixture for sterilizer and method

Apparatus for plasma sterilizing with pulsed antimicrobial agent

A method for plasma sterilization includes exposing an article to be sterilized to a plasma generated from a gas mixture. The gas mixture being either (a) argon, helium, nitrogen, or mixtures thereof, and oxygen and hydrogen; (b) argon, helium, nitrogen or mixtures thereof, and hydrogen; or (c) argon, helium, nitrogen or mixtures thereof, and oxygen. The exposure of the article to the plasma is carried out at a pressure of from 0.1 to 10 torr and a chamber temperature of less than 63.degree. C. for a time period sufficient to effect sterilization. Contaminated articles can be pretreated in a plasma generated from oxygen and optionally argon, helium and/or nitrogen at the same conditions for up to 5 minutes to remove protein. The apparatus for plasma sterilization of articles includes a plasma generator and a sterilizing chamber. The plasma generator includes a plurality of generator tubes positioned in one or more electromagnetic field zones defined by one or more waveguides. The outlet of the generator tube preferably has a restriction for maintaining the gas pressure in the plasma generating chamber at from 0.3 to 10 torr.

Plasma sterilizer and method

A plasma sterilizer and method employ essentially uncharged, highly reactive free radicals, atoms and excited molecules of a gas mixture to sterilize articles. The gas mixture includes oxidizing and/or reducing agents and is ionized into a plasma having ionization products that include highly destructive components in the form of charged particles and ultra-violet radiation. A plasma distribution device blocks the ultra-violet radiation and facilitates the recombination of the charged particles such that essentially uncharged, highly reactive free radicals, atoms and excited molecules of the gas mixture are delivered to the articles.

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 method for plasma sterilization includes exposing an article to be sterilized to a plasma generated from a gas mixture. The gas mixture is either (a) argon, helium, nitrogen, or mixtures thereof, and oxygen and hydrogen; (b) argon, helium, nitrogen or mixtures thereof, and hydrogen; or (c) argon, helium, nitrogen or mixtures thereof, and oxygen. The exposure of the article to the plasma is carried out at a pressure of from 0.1 to 10 torr and a chamber temperature of less than 63.degree. C. for a time period sufficient to effect sterilization. Contaminated articles cna be pretreated in a plasma generated from oxygen and optionally argon, helium and/or nitrogen at the same conditions for up to 5 minutes to remove protein. The apparatus for plasma sterilization of articles includes a plasma generator and a sterilizing chamber. The plasma generator includes a plurality of generator tubes positioned in one or more electromagnetic field zones defined by one or more waveguides. The outlet of the generator tube preferably has a restriction for maintaining the gas pressure in the plasma generating chamber at from 0.3 to 10 torr.

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

Livermore, CA, United States of America

Kern A Moulton