Sterilization monitors and method of use

• US 6,706,537 B2
• Filed: 08/02/2001
• Issued: 03/16/2004
• 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:
  US09/921,065
• Publication Number:
  US 20030207453A1
• Time in Patent Office: 957 Days
• Field of Search: 422/86, 422/5, 422/6, 422/28, 422/87, 422/56, 422/58, 422/61, 436/164, 436/169, 436/167, 116/206
• US Class Current: 436/167
• 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 liquid peracid sterilant, comprising

exposing a monitor composition including a colorant susceptible to halogenation and a halogen source to a liquid peracid during a sterilization process, wherein the liquid peracid contacts the halogen source to produce halogen which halogenates the colorant to cause a color change in the composition, wherein said sterilization process is monitored by detecting the distinct color change in the composition.

2. The method of claim 1, wherein said halogenated colorant is susceptible to additional reactions which cause the monitor composition te undergoes a distinct color change dependent upon the concentration of acid present during the sterilization process, exposure time, and exposure temperature.

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

4. The method of claim 1, wherein said monitor composition is carried on a substrate.

5. The method of claim 1, wherein the sterilization process includes the use of a sterilization solution including a peracid, wherein the concentration of peracid in the sterilization solution is at least 1000 ppm.

6. The method of claim 1, wherein said colorant comprises phenol red or a salt of phenol red.

7. The method of claim 1, wherein said colorant is selected from the group consisting of cresol red, fluorescein, chlorophenol red, m-cresol purple, pyrogallol red, crystal violet lactone, 3,4,5,6-tetrabromophenol, 3′

,3″

,5′

,5″

-tetraiodophenol phthalein, 4,5,6,7-tetrachlorofluorescein, basic fuchsin, phenolphthalein, xylene cyanole FF, resorufin, indigo carmine, thionin, variamine blue, indophenol, neutral red, pararosaniline acetate, erioglaucine, malachite green oxalate, indigo, bromocresol green.

8. The method of claim 1, wherein said colorant comprises phenol red and said halogen source comprises potassium bromide.

9. The method of claim 1, wherein the exposure occurs during a sterilization process.

10. The method of claim 9, wherein said monitor composition is exposed to the peracid for at least 1 minute.

11. The method of claim 1, wherein the monitor composition is exposed to the peracid for at least 1 second.

12. The method of claim 11, wherein the sterilization process includes the use of a sterilization solution including a peracid, and wherein the concentration of the peracid in the sterilization solution is at least 1000 ppm and the monitor composition is contacted with the sterilization solution.

13. The method of claim 1, wherein said halogen source comprises an alkali halide salt.

14. The method of claim 13, wherein said salt comprises potassium bromide.

15. The method of claim 1, wherein said monitor composition further comprises a buffer.

16. The method of claim 15, wherein said buffer comprises sodium acetate.

17. A method of monitoring a sterilization process that uses a liquid peracid sterilant, comprising

contacting a sterilization monitoring device with a liquid peracid from a sterilization solution during the sterilization process, and sterilization monitoring device including a vapor barrier wherein peracid vapor from the liquid sterilant penetrates the vapor barrier and contacts a monitor composition in the sterilization monitoring device,

wherein the monitor composition includes a colorant susceptible to halogenation and a halogen source, and the peracid contacts the halogen source to produce halogen which halogenates the colorant to cause a distinct color change in the composition, and wherein the sterilization process is monitored by detecting the distinct color change in the composition.

18. The method of claim 17, wherein said halogenated colorant is susceptible to additional reactions which cause the monitoring composition to undergo a distinct color change that provides an indication if the sterilization process meets pre-determined sterilization parameters.

19. The method of claim 17, wherein said peracid is peracetic acid.

20. The method of claim 17, wherein said colorant is phenol red and said halogen source is potassium bromide.

21. The method of claim 17, wherein said monitor composition further comprises a buffer.

22. A sterilization monitoring device comprising a housing including a vapor permeable barrier and a monitor composition enclosed within the housing, the monitor composition including a halogen source and a colorant susceptible to halogenation in the presence of a peracid, wherein the peracid contacts the halogen source to produce halogen which halogenates the colorant to cause a color change in the composition.

23. The sterilization monitoring device of claim 22, wherein said colorant comprises phenol red or its alkali salt.

24. The sterilization monitoring device of claim 22, wherein said colorant is selected from the group consisting of cresol red, fluorescein, chlorophenol red, m-cresol purple, pyrogallol red, crystal violet lactone, 3,4,5,6-tetrabromophenol, 3′

,3″

,5′

,5″

-tetraiodophenol phthalein, 4,5,6,7-tetrachlorofluorescein, basic fuchsin, phenolphthalein, xylene cyanole FF, resorufin, indigo carmine, thionin, variamine blue, indophenol, neutral red, pararosaniline acetate, erioglaucine, malachite green oxalate, indigo, bromocresol green.

25. The sterilization monitoring device of claim 22, wherein said colorant comprises phenol red and said halogen source comprises potassium bromide.

26. The sterilization monitoring device of claim 22, wherein said halogen source comprises an alkali halide salt.

27. The sterilization monitoring device of claim 26, wherein said salt comprises potassium bromide.

28. The sterilization monitoring device of claim 22, wherein said monitor composition further comprises a buffer.

29. The sterilization monitoring device of claim 28, wherein said buffer comprises sodium acetate.