Method for indicating exposure to an oxidative sterilant or disinfectant

• US 6,218,189 B1
• Filed: 04/13/1999
• Issued: 04/17/2001
• Est. Priority Date: 11/07/1997
• Status: Expired due to Term

• Current Assignee: Johnson & Johnson Medical Incorporated (Johnson & Johnson)
• Original Assignee: Johnson & Johnson Medical Incorporated (Johnson & Johnson)
• Inventors: Hui, Henry K., Feldman, Leslie A., Ebrahim, Alireza, Kohli, Nitu, Antonoplos, Patricia A.
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US09/290,592
• Time in Patent Office: 735 Days
• Field of Search: 422/56, 422/57, 422/61, 422/58, 422/28, 436/1, 436/2, 436/166
• US Class Current: 436/1
• 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: C12Q 1/22 Testing for sterility conditions
• CPC Class Codes: G01N 31/226 for investigating the degree of sterilisation

Abstract

A method and apparatus detect exposure to an oxidation-type sterilant using a non-PH-sensitive bleachable dye as a chemical indicator. A change in color indicates exposure to oxidation-type sterilant.

Claims

1. A method for indicating adequate exposure to an oxidative sterilant or disinfectant comprising:

exposing a surface having a non-pH-sensitive, bleachable dye thereon to an oxidative sterilant or disinfectant; and

viewing said bleachable dye for a change in color.

2. The method of claim 1, wherein said surface is a metallic surface.

3. The method of claim 2, wherein said bleachable dye is an azo dye.

4. The method of claim 2, wherein said surface comprises anodized aluminum.

5. The method of claim 2, wherein said surface comprises a chromate conversion coating.

6. The method of claim 1, wherein said exposing comprises providing oxidation-type sterilant in gaseous form to a chamber containing medical devices.

7. The method of claim 1, wherein the oxidative sterilant or disinfectant is selected from the group consisting of hydrogen peroxide, ozone, chlorine dioxide, and peracetic acid.

8. The method of claim 1, wherein the oxidative sterilant or disinfectant is in plasma form.

9. The method of claim 1, wherein said exposing comprises placing a self-contained biological indicator having a surface with bleachable dye thereon in an oxidative sterilization chamber.

10. The method of claim 9, wherein said surface having bleachable dye thereon comprises a generally flat disc on said self-contained biological indicator.

11. The method of claim 1, wherein said exposing comprises placing a test pack with an azo dye chemical indicator thereon in an oxidation-type sterilization chamber, said test pack configured to provide for gas flow into said test pack by diffusion.

12. The method of claim 1, wherein said exposing comprises placing a container in a sterilization chamber, said container having a cover, said cover secured to said container with a tamper-evident device, said tamper-evident device having said surface with said non-pH-sensitive bleachable dye thereon.

13. The method of claim 1, wherein said change in color is not apparent until a plurality of exposing steps are conducted.

14. The method of claim 1, wherein said exposing a surface comprises exposing a flexible medium having non-pH-sensitive bleachable dye and adhesive thereon.