Sterilization monitors

• US 6,287,518 B1
• Filed: 02/05/1998
• Issued: 09/11/2001
• Est. Priority Date: 06/25/1997
• 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., Piechowski, Allan P.
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US09/019,341
• Time in Patent Office: 1,314 Days
• Field of Search: 422/58, 422/61, 422/86, 422/28, 422/87, 436/1, 436/164, 436/169, 116/206, 206/439, 206/459.1
• US Class Current: 422/86
• 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

Abstract

A sterilization monitor includes a substrate and an monitor composition. The monitor composition contains a colorant and a halogen source and undergoes a distinct color change when exposed to a peracid. The sterilization monitor can be used to monitor a sterilization process involving a peracid. A sterilization monitoring device, including a sterilization monitor enclosed in a housing having a vapor permeable barrier, can also be used to monitor a sterilization process.

Claims

1. A method of monitoring a sterilization process including the use of a peracid vapor, comprising

exposing an item to be sterilized and an indicator composition comprising a fluorescein colorant susceptible to halogenation and a halogen source to a peracid vapor, wherein halogen from said halogen source halogenates said fluorescein colorant to cause a distinct color change in said indicator composition, wherein said sterilization process is monitored by detecting said distinct color change in said indicator composition.

2. The method of claim 1, wherein said colorant comprises a dye.

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

4. The method of claim 1, wherein said item and said indicator composition are exposed to peracid vapor for at least 10 minutes.

5. The method of claim 4, wherein the concentration of peracid in said peracid vapor is at least 4%.

6. The method of claim 1, wherein the concentration of peracid in said peracid vapor is at least 4%.

7. The method of claim 1, wherein said peracid comprises peracetic acid.

8. The method of claim 1, wherein said halogen source comprises potassium bromide.

9. The method of claim 1, wherein said halogen source comprises magnesium bromide.

10. The method of claim 1, wherein said indicator composition further comprises a resin binder.

11. The method of claim 1, wherein said peracid comprises peracetic acid, said colorant comprises fluorescein, and said halogen source comprises magnesium bromide.

12. The method of claim 11, wherein said indicator composition is carried on a substrate.

13. The method of claim 12, wherein said indicator composition further comprises a resin binder.