Apparatus with a chemical indicator for indicating exposure to an oxidative sterilant or disinfectant

• US 6,551,555 B2
• Filed: 12/19/2000
• Issued: 04/22/2003
• Est. Priority Date: 11/07/1997
• Status: Expired due to Term

• Current Assignee: Johnson & Johnson
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Feldman, Leslie A., Ebrahim, Alireza, Kohli, Nitu, Antonoplos, Patricia A., Hui, Henry K.
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US09/741,633
• Publication Number:
  US 20020051733A1
• Time in Patent Office: 854 Days
• Field of Search: 422/57, 422/58, 422/61, 422/28, 422/34, 422/37, 436/1, 436/2, 436/166
• US Class Current: 422/416
• 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

An apparatus for determining exposure to an oxidative sterilant is described. The apparatus includes a chemical indicator for indicating exposure to the oxidative sterilant and a biological indicator for determining the effectiveness of the exposure to the oxidative sterilant. The chemical indicator has a metallic surface with a non-pH sensitive permanent indicator on the surface for indicating exposure to the oxidative sterilant. The chemical indicator may be on a self-contained biological indicator. The biological indicator and chemical indicator may be inside a test pack, where the test pack restricts sterilant flow to the indicators.

Claims

1. An apparatus for determining exposure to an oxidation-type sterilant or disinfectant, said apparatus comprising:

a biological indicator for determining the effectiveness of exposure to the oxidation-type sterilant; and

a chemical indicator for indicating exposure to the oxidation-type sterilant, wherein said chemical indicator comprises;

a metallic surface; and

non-pH sensitive indicator means on said surface for indicating exposure to the oxidation-type sterilant.

2. The apparatus of claim 1, wherein said indicator means is an azo dye.

3. The apparatus of claim 1, wherein said indicator means is a permanent indicator means.

4. The apparatus of claim 1, wherein said surface comprises anodized aluminum.

5. The apparatus of claim 1, wherein said surface comprises a chromate conversion coating.

6. The apparatus of claim 1, wherein said biological indicator is a self-contained biological indicator.

7. The apparatus of claim 6, wherein said chemical indicator comprises a generally flat disk on said self-contained biological indicator.

8. The apparatus of claim 1, further comprising a test pack, wherein said test pack is configured to provide for gas flow into said test pack by diffusion and wherein said chemical indicator and said biological indicator are inside said test pack.

9. The apparatus of claim 1, wherein said apparatus comprises a container having a cover, wherein said cover is secured to said container with a tamper-evident device and wherein said tamper-evident device has said surface with said non-pH sensitive bleachable dye thereon.

10. The apparatus of claim 1, wherein said metallic surface comprises a flexible medium having said indicator means on at least a first surface of said flexible medium.

11. The apparatus of claim 10, further comprising adhesive on a second surface of said flexible medium.

12. The apparatus of claim 1, further comprising a warranty indicator which provides notice when a warranty of said apparatus is still in effect.

13. The apparatus of claim 1, wherein said oxidation-type sterilant comprises hydrogen peroxide.

14. The apparatus of claim 13, wherein said oxidation-type sterilant comprises aqueous hydrogen peroxide.

15. The apparatus of claim 13, wherein said oxidation-type sterilant comprises hydrogen peroxide vapor or gas.

16. An apparatus for determining exposure to an oxidation-type sterilant or disinfectant, said apparatus comprising:

a biological indicator for determining the effectiveness of exposure to the oxidation-type sterilant; and

a chemical indicator for indicating exposure to the oxidation-type sterilant, wherein said chemical indicator comprises;

a metallic surface; and

non-pH sensitive indicator means permanently bound on said surface for indicating exposure to the oxidation-type sterilant.

17. An apparatus for determining exposure to an oxidation-type sterilant or disinfectant, said apparatus comprising:

a biological indicator for determining the effectiveness of exposure to the oxidation-type sterilant; and

a chemical indicator for indicating exposure to the oxidation-type sterilant, wherein said chemical indicator comprises;

a metallic surface; and

non-pH sensitive indicator means on said metallic surface for indicating exposure to the oxidation-type sterilant,

wherein at least a portion of said metallic surface is on the outside of a container within which said biological indicator is housed.