Sterilization indicator

• US 6,063,631 A
• Filed: 05/21/1997
• Issued: 05/16/2000
• Est. Priority Date: 05/21/1997
• Status: Expired due to Fees

• Current Assignee: 3M Innovative Properties Company (3M Company)
• Original Assignee: 3M Innovative Properties Company (3M Company)
• Inventors: Ignacio, Ramon T.
• Primary Examiner(s): LUDLOW, JAN M
• Application Number:
  US08/859,759
• Time in Patent Office: 1,091 Days
• Field of Search: 436/1, 436/135, 422/86, 422/87, 422/28, 422/32
• US Class Current: 436/1
• CPC Class Codes: A61L 2/14 Plasma, i.e. ionised gases
• CPC Class Codes: A61L 2/186 Peroxide solutions
• CPC Class Codes: A61L 2/208 Hydrogen peroxide
• CPC Class Codes: A61L 2/26 Accessories or devices or components used for biocidal treatment
• CPC Class Codes: A61L 2/28 Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour apparatus involving enzymes or microorganisms C12M1/34; methods involving enzymes or microorganisms C12Q1/00
• CPC Class Codes: A61L 2202/21 Pharmaceuticals, e.g. medicaments, artificial body parts
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps
• CPC Class Codes: G01N 31/223 for investigating presence of specific gases or aerosols G01N31/221, G01N31/222 take precedence; actuation of fire alarm by presence of smoke or gases G08B17/10
• CPC Class Codes: G01N 31/226 for investigating the degree of sterilisation
• CPC Class Codes: G01N 31/228 for peroxides
• CPC Class Codes: Y10T 436/206664 Ozone or peroxide

Abstract

A sterilization indicator includes a substrate and indicator composition. The indicator composition contains a colorant, such as acid fuchsin, that undergoes a distinct color change if exposed to hydrogen peroxide vapor. The sterilization indicator can be used to monitor a sterilization process involving hydrogen peroxide vapor.

Claims

1. A method of monitoring a sterilization process including the use of hydrogen peroxide vapor, comprising:

exposing an item to be sterilized and an indicator composition containing acid fuchsin to hydrogen peroxide vapor,

wherein during said exposure to said hydrogen peroxide vapor, hydrogen peroxide chemically reacts with said acid fuchsin to cause a distinct color change in said indicator composition by said acid fuchsin becoming substantially colorless after chemically reacting with said hydrogen peroxide.

2. The method of claim 1, wherein said indicator composition is carried on a substrate.

3. The method of claim 2, wherein said substrate comprises a polyester strip.

4. The method of claim 1, wherein said item comprises a medical instrument.

5. The method of claim 1, wherein said item and said indicator composition are exposed to hydrogen peroxide vapor for at least 15 minutes.

6. The method of claim 5, wherein the concentration of hydrogen peroxide in said hydrogen peroxide vapor is at least 30%.

7. The method of claim 1, wherein the concentration of hydrogen peroxide in said hydrogen peroxide vapor is at least 30%.