Vapor sterilization using a non-aqueous source of hydrogen peroxide

• US 5,674,450 A
• Filed: 01/06/1995
• Issued: 10/07/1997
• Est. Priority Date: 04/28/1994
• Status: Expired due to Term

• Current Assignee: Johnson & Johnson Medical Incorporated (Johnson & Johnson)
• Original Assignee: Johnson & Johnson Medical Incorporated (Johnson & Johnson)
• Inventors: Lin, Szu-Min, Jacobs, Paul Taylor, Swanzy, James Archie
• Primary Examiner(s): Warden, Robert J.
• Assistant Examiner(s): Thornton, Krisanne M.
• Application Number:
  US08/369,786
• Time in Patent Office: 1,005 Days
• Field of Search: 422/1, 422/22, 422/23, 422/28, 422/29, 422/33, 422/295, 422/305, 423/587
• US Class Current: 422/29
• CPC Class Codes: A01N 2300/00 Combinations or mixtures of active ingredients covered by classes A01N27/00 - A01N65/48 with other active or formulation relevant ingredients, e.g. specific carrier materials or surfactants, covered by classes A01N25/00 - A01N65/48
• CPC Class Codes: A01N 25/08 containing solids as carriers or diluents
• CPC Class Codes: A01N 25/18 Vapour or smoke emitting compositions with delayed or sustained release
• CPC Class Codes: A01N 59/00 Biocides, pest repellants or attractants, or plant growth regulators containing elements or inorganic compounds
• CPC Class Codes: A61L 2/14 Plasma, i.e. ionised gases
• 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 2202/122 Chambers for sterilisation
• CPC Class Codes: A61L 2202/14 Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps
• CPC Class Codes: C01B 15/01 Hydrogen peroxide
• CPC Class Codes: C01B 15/037 Stabilisation by additives
• CPC Class Codes: C01B 15/06 containing sulfur
• CPC Class Codes: C01B 15/08 Peroxysulfates
• CPC Class Codes: C01B 15/103 containing only alkali metals as metals
• CPC Class Codes: C01B 15/14 containing silicon
• CPC Class Codes: C01B 15/16 containing phosphorus
• CPC Class Codes: Y10S 525/92 Polyurethane having terminal ethylenic unsaturation

Abstract

An apparatus and process for hydrogen peroxide vapor sterilization of medical instruments and similar devices make use of hydrogen peroxide vapor released from a substantially non-aqueous organic hydrogen peroxide complex, such as a urea-peroxide complex. Optionally, a plasma can be used in conjunction with the vapor. A method for preparing substantially non-aqueous hydrogen peroxide complexes is also provided. These complexes are useful as a source of peroxide vapor in hydrogen peroxide vapor sterilizers and as a component of self-sterilizing packaging materials.

Claims

1. An apparatus for hydrogen peroxide sterilization of an article, comprising:

a container for holding the article to be sterilized; and

a source of hydrogen peroxide vapor located within said container, said source comprising a substantially non-aqueous organic hydrogen peroxide complex which does not decompose to release a hydrohalic acid, said source configured so that said vapor can contact said article to effect sterilization.

2. The apparatus of claim 1, wherein said container comprises a breathable barrier.

3. The apparatus of claim 1, wherein said complex is a urea-peroxide complex.

4. The apparatus of claim 1, wherein said complex is a polyvinylpyrrolidone-peroxide complex.

5. The apparatus of claim 1, wherein said complex is a nylon 6-peroxide complex.

6. The apparatus of claim 1, wherein said complex is a 1,3 dimethylurea-peroxide complex.

7. The apparatus of claim 1, wherein said complex is unstable under vacuum.

8. The apparatus of claim 7, wherein said complex is a glycine anhydride-peroxide complex.

9. The apparatus of claim 1, further comprising a heater located within said container, whereby said complex is placed on said heater and heated to facilitate the release of said vapor from said complex.

10. The apparatus of claim 1, further comprising an enclosure disposed outside of said container in which said complex is located, and an inlet providing fluid communication between said container and said enclosure, such that vapor released from said complex travels along said inlet and into said container to effect sterilization.

11. The apparatus of claim 10, further comprising a heater configured to heat said complex.

12. The apparatus of claim 10, further comprising a closeable valve disposed in said inlet such that when said valve is closed, said enclosure is isolated from said container.

13. The apparatus of claim 1, further comprising a vacuum pump in fluid communication with said container for evacuating the container.

14. The apparatus of claim 10, further comprising a vacuum pump in fluid communication with said container or said enclosure, such that said enclosure and said container can be evacuated independently or simultaneously.

15. The apparatus of claim 14, wherein said pump is in fluid communication with both said container and said enclosure, further comprising a closeable valve disposed between said pump and said container, and between said pump and said enclosure, and between said enclosure and said container.

16. The apparatus of claim 14, wherein said pump is a first pump in fluid communication with said container, further comprising a second pump in fluid communication with said enclosure.

17. The apparatus of claim 1, further comprising an electrode inside said container for generating a plasma around said article.

18. The apparatus of claim 1, wherein said complex is in a solid phase.

19. A method for hydrogen peroxide vapor sterilization of an article, comprising:

placing said article into a container; and

contacting the article with a hydrogen peroxide vapor released from a substantially non-aqueous organic hydrogen peroxide complex which does not decompose to release a hydrohalic acid, so as to contact and sterilize the article.

20. The method of claim 19, wherein the complex has less than 10% water.

21. The method of claim 19, further comprising heating said complex to facilitate the release of said vapor from said complex.

22. The method of claim 19, further comprising evacuating the container before introducing said vapor into said container.

23. The method of claim 19, further comprising generating a plasma in the container after introducing said vapor into said container.

24. The method of claim 19, wherein the contacting step comprises pressure pulsing of said vapor.

25. A method for hydrogen peroxide sterilization of an article, comprising:

placing the article in a enclosure containing a substantially non-aqueous hydrogen peroxide complex;

sealing said enclosure; and

allowing said enclosure to stand at a temperature below about 70°

C. for a time sufficient to release hydrogen peroxide vapor from said complex to effect sterilization of the article.

26. The method of claim 25, wherein said enclosure is allowed to stand at a pressure less than atmospheric pressure.

27. The method of claim 25, wherein said enclosure is allowed to stand at a temperature below about 40°

C.

28. The method of claim 25, wherein said enclosure is heated to a temperature greater than 23°

C. to facilitate release of said vapor.

29. The method of claim 25, wherein said enclosure is a pouch.

30. The method of claim 25, wherein said enclosure is a container.

31. The method of claim 25, wherein said enclosure is a chamber.

32. The method of claim 25, wherein said enclosure is a room.

33. The method of claim 25, wherein said hydrogen peroxide complex is in the form of a powder.

34. The method of claim 25, wherein said hydrogen peroxide complex is in the form of a tablet.

35. The method of claim 25, wherein said sealing step comprises sealing said enclosure with a gas permeable material.

36. The method of claim 35, wherein said gas permeable material is selected from the group consisting of TYVEK™

, CSR wrap, and paper.

43. The method of claim 25 or 38, further comprising generating a plasma within said container to surround said article and maintaining the article in said plasma for a time sufficient to effect sterilization of the article.

44. The method of claim 25 or 38, further comprising generating a plasma within said container to surround said article and maintaining the article in said plasma for a time sufficient to remove residual hydrogen peroxide from said article.

37. A sealed enclosure containing a sterile product and a substantially, non-aqueous hydrogen peroxide complex capable of releasing hydrogen peroxide vapor.

38. A method for hydrogen peroxide sterilization of an article having an exterior and a narrow lumen therein, comprising:

connecting a vessel containing a substantially non-aqueous hydrogen peroxide complex to the lumen of the article;

placing the article within a container;

evacuating the container; and

contacting the lumen of the article with hydrogen peroxide vapor released from said substantially non-aqueous hydrogen peroxide complex at a temperature less than about 70°

C.

39. The method of claim 38, additionally comprising contacting the exterior of the article with a second source of sterilant.

40. The method of claim 39, wherein the second source of sterilant comprises chlorine dioxide.

41. The method of claim 40, wherein the second source of sterilant comprises a source that releases hydrogen peroxide.

42. The method of claim 41, wherein the second source of sterilant comprises a second substantially non-aqueous hydrogen peroxide complex, said second substantially non-aqueous hydrogen peroxide complex being the same or different complex as the hydrogen peroxide complex referred to in the connecting step.

45. A method for hydrogen peroxide vapor sterilization of an article, comprising:

placing said article into a container; and

contacting the article with a hydrogen peroxide vapor to contact and sterilize the article, said vapor being released from a substantially non-aqueous hydrogen peroxide complex which does not decompose to release a hydrohalic acid.