Process for decontaminating or sterilizing an article

• US 10,463,754 B2
• Filed: 11/11/2014
• Issued: 11/05/2019
• Est. Priority Date: 04/28/2014
• Status: Active Grant

• Current Assignee: American Sterilizer Company (Steris Corporation)
• Original Assignee: American Sterilizer Company (Steris Corporation)
• Inventors: Burke, Peter A., Leggett, Mark James, Centanni, Michael A.
• Primary Examiner(s): Yoo, Regina M
• Application Number:
  US14/537,958
• Publication Number:
  US 20150306266A1
• Time in Patent Office: 1,820 Days
• CPC Class Codes: A01N 2300/00 Combinations or mixtures of active ingredients covered by classes A01N27/00 - A01N65/48 with other active or formulation relevant ingredients, e.g. specific carrier materials or surfactants, covered by classes A01N25/00 - A01N65/48
• CPC Class Codes: A01N 37/16 containing the group; Thio analogues thereof
• CPC Class Codes: A01N 59/00 Biocides, pest repellants or attractants, or plant growth regulators containing elements or inorganic compounds
• CPC Class Codes: A61L 2/183 Ozone dissolved in a liquid
• CPC Class Codes: A61L 2/186 Peroxide solutions
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps

Abstract

This invention relates to a a process for decontaminating or sterilizing an article contaminated with spores. The process comprises contacting the spores with a liquid sterilant for a sufficient period of time to effect a desired reduction (e.g., at least a 4 log reduction) in the number of spores capable of returning to vegetative growth. The liquid sterilant may comprise water, an antimicrobial agent (e.g., peracetic acid) and a peroxide (e.g., hydrogen peroxide).

Claims

1. A process for sterilizing an article contaminated with bacterial spores using a liquid sterilant, the liquid sterilant consisting essentially of water, peracetic acid, acetic acid, sulfuric acid and hydrogen peroxide, the article comprising a medical, dental, pharmaceutical, veterinary or mortuary instrument, the liquid sterilant having a concentration of the hydrogen peroxide in the range from 0.1 to 0.8% by weight, the concentration of the peracetic acid being in the range from about 0.005 to 0.08% by weight, the weight ratio of the peracetic acid to the hydrogen peroxide being in the range from 0.001 to about 0.1, the concentration of acetic acid being in the range from 0.001 to 0.3% by weight, the concentration of sulfuric acid being in the range from 0.001 to 0.3% by weight;

wherein the process is conducted using a sterilizing apparatus which comprises a sterilization chamber and a sterilant introduction system, the process comprising;

placing the contaminated article in the sterilization chamber;

flowing the liquid sterilant from the sterilant introduction system into the sterilization chamber in contact with the contaminated article, maintaining the liquid sterilant at a temperature in the range from about 20°

C. to about 80°

C. in contact with the contaminated article for a period of time in the range from about 0.5 to about 240 minutes to sterilize the article and effect at least a 4 log reduction in the number of bacterial spores that are capable of returning to vegetative growth;

draining the liquid sterilant from the sterilization chamber;

flowing rinse water in the sterilization chamber in contact with the article; and

removing the article from the sterilization chamber.

2. The process of claim 1 wherein the article is made of a material comprising brass, copper, aluminum, stainless steel, carbon steel, plastic, glass, adhesive or a combination of two or more thereof.

3. The process of claim 1 wherein the article comprises an endoscope.

4. The process of claim 1 wherein the temperature of the liquid sterilant is in the range from about 40°

C. to about 60°

C.

5. The process of claim 1 wherein the contact time of the article with the liquid sterilant is in the range from about 2 to about 60 minutes.

6. The process of claim 1 wherein the water comprises tap water, deionized water, distilled water, water purified by osmosis, or a mixture of two or more thereof.

7. The process of claim 1 wherein the bacterial spores comprise bacteria of the Bacillus or Clostridia genera.

8. The process of claim 1 wherein the bacterial spores comprise Geobacillus stearothermophilus spores Bacillus atrophaeus spores, Bacillus subtilis spores, Bacillus pumilus spores, Bacillus coagulans spores, Clostridium sporogenes spores, Bacillus subtilis globigii spores, Bacillus cereus spores, Bacillus circulans spores, Bacillus anthracis spores, or a mixture of two or more thereof.

9. The process of claim 1 wherein the bacterial spores comprise one or more Bacillus subtilis strains.