Method of sterilization using pretreatment with hydrogen peroxide

• US 6,030,579 A
• Filed: 04/04/1996
• Issued: 02/29/2000
• Est. Priority Date: 04/04/1996
• 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, Addy, Tralance O., Jacobs, Jon Morrell
• Primary Examiner(s): Kemmerer, Elizabeth
• Assistant Examiner(s): Romeo, David S.
• Application Number:
  US08/628,965
• Time in Patent Office: 1,426 Days
• Field of Search: 422/7, 422/22, 422/23, 422/28, 422/29, 422/33, 422/40, 422/292, 422/906, 220/87.1, 220/9.3, 210/436
• US Class Current: 422/28
• CPC Class Codes: A61L 2/14 Plasma, i.e. ionised gases
• CPC Class Codes: A61L 2/16 using chemical substances
• CPC Class Codes: A61L 2/186 Peroxide solutions
• CPC Class Codes: A61L 2/208 Hydrogen peroxide
• CPC Class Codes: A61L 2202/122 Chambers for sterilisation
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps
• CPC Class Codes: Y10S 220/913 Ventilated container
• CPC Class Codes: Y10S 422/906 Plasma or ion generation means

Abstract

A method for hydrogen peroxide vapor sterilization of medical devices and similar instruments having long narrow lumens or diffusion restricted areas includes the step of pretreating the article to be sterilized with a dilute solution of hydrogen peroxide prior to exposure to a vacuum or a vacuum followed by plasma. The method is such that, upon vaporization of the solution caused by the vacuum, the hydrogen peroxide remains in contact with the article for a time sufficient to achieve sterilization.

Claims

1. A method for sterilizing an interior of a device having a lumen, comprising:

contacting the interior of said lumen with a liquid solution comprising hydrogen peroxide; and

exposing said device to a selected negative pressure and a selected temperature to vaporize said hydrogen peroxide,

wherein said lumen has a length and diameter which provide the same or more diffusion restriction than provided by a reference lumen 27 cm in length and having an internal diameter of 3 mm, at said selected pressure and said selected temperature,

and wherein said hydrogen peroxide vapor diffuses from inside to outside of said lumen, for a time period sufficient to effect sterilization of said lumen by hydrogen peroxide vapor.

2. The method of claim 1, wherein said liquid solution is an aerosol.

3. The method of claim 1, wherein said solution is peracetic acid.

4. The method of claim 1, wherein said contacting step comprises delivery of said liquid solution via one or more methods selected from the group consisting of injection, static soak, liquid flow-through and aerosol spray.

5. The method of claim 1, wherein the lumen of said device is at least 27 cm in length and has an internal diameter of no more than 1 mm.

6. The method of claim 1, further comprising exposing said device to a plasma while exposing the device to negative pressure.

7. The method of claim 6, wherein said method is performed within a first chamber and wherein said plasma is generated in a second, separate chamber and said method further comprises the step of flowing said plasma into said first chamber.

8. The method of claim 6, wherein said method is performed within a sealed chamber and said plasma is generated within said chamber.

9. The method of claim 1, wherein if the exposing step is conducted at 40°

C. and 10 torr for one hour and if in the contacting step 1 mg of hydrogen peroxide per liter of lumen volume is introduced into said lumen, said lumen is sufficiently diffusion restricted to retain a concentration of 0.17 mg or more hydrogen peroxide per liter of lumen volume, wherein 0.17 mg/L is the total concentration of hydrogen peroxide liquid at 1 atmosphere pressure, remaining after the exposing step.

10. The method of claim 1, wherein if the exposing step is conducted at 40°

C. and 10 torr for one hour and if in the contacting step 1 mg of hydrogen peroxide per liter of lumen volume is introduced into said lumen, said lumen is sufficiently diffusion restricted to retain 17% or more of the total hydrogen peroxide introduced therein after the exposing step, wherein the 17% is the hydrogen peroxide liquid at 1 atmosphere pressure, remaining after the exposing step.

11. The method of claim 1, wherein the contacting step is repeated one or more times.

12. The method of claim 1, wherein the exposing step is repeated one or more times.

13. The method of claim 1, wherein both the contacting step and the exposing step are repeated one or more times.

14. The method of claim 1, wherein said solution is at a concentration of less than 25% by weight.

15. The method of claim 1, wherein said exposing step is performed for 60 minutes or less.

16. The method of claim 1, further comprising the step of heating said device during said exposing step.

17. The method of claim 1, wherein said exposing step occurs within a chamber, and wherein said method further comprises the step of heating said chamber during said exposing step.

18. The method of claim 17, wherein said chamber is heated to between about 40°

C. and about 45°

C.

19. The method of claim 1, additionally comprising heating said solution prior to said contacting step.

20. The method of claim 19, wherein said solution is heated to between about 40°

C. and about 45°

C.

21. The method of claim 1, wherein said exposing step comprises exposing said device to pressure less than the vapor pressure of hydrogen peroxide.

22. The method of claim 21, wherein said pressure is between 0 and 100 torr.

23. The method of claim 22, wherein said pressure is approximately 10 torr and the exposing step is conducted at a temperature of approximately 23°

C. to approximately 28°

C.

24. A method for sterilizing an interior and an exterior of an article having a lumen, comprising:

contacting the interior of said lumen with a liquid solution comprising hydrogen peroxide; and

placing said article in a diffusion-restricted environment, said contacting and placing steps being performed in either order;

followed by

exposing said diffusion-restricted environment to a selected negative pressure and a selected temperature to vaporize said hydrogen peroxide for a time period sufficient to effect sterilization of the interior and exterior of said article by hydrogen peroxide vapor, wherein said lumen has a length and diameter which provide the same or more diffusion restriction than provided by a reference lumen 27 cm in length and having an internal diameter of 3 mm, at said selected pressure and said selected temperature.

25. The method of claim 24, wherein the contacting step is performed before the placing step.

26. The method of claim 25, additionally comprising contacting the article with a liquid solution comprising hydrogen peroxide again after the placing step.

27. The method of claim 24, additionally comprising heating said solution prior to said contacting step.

28. The method of claim 24, wherein said exposing step occurs within a chamber, and wherein said method further comprises the step of heating said chamber during said exposing step.

29. The method of claim 24, wherein if the exposing step is conducted at 40°

C. and 10 torr for one hour and if in the contacting step 1 mg of hydrogen peroxide per liter of lumen volume is introduced into said lumen, said diffusion restricted environment is sufficiently diffusion restricted to retain 17% or more of the total hydrogen peroxide placed therein after the exposing step, wherein the 17% is the hydrogen peroxide liquid at one atmosphere pressure, remaining after the exposing step.

30. The method of claim 24, wherein if the exposing step is conducted at 40°

C. and 10 torr for one hour and if in the contacting step 1 mg of hydrogen peroxide per liter of lumen volume is introduced into said lumen, said diffusion restricted environment is sufficiently diffusion restricted to retain a concentration of 0.17 mg or more hydrogen peroxide after the exposing step per liter of lumen volume wherein said 0.17 mg/L or more hydrogen peroxide is the total concentration of hydrogen peroxide liquid at one atmosphere pressure, remaining after the exposing step.

31. The method of claim 24, wherein said solution is peracetic acid.

32. The method of claim 24, wherein said contacting step comprises delivery of said liquid solution via one or more methods selected from the group consisting of injection, static soak, liquid flow-through and aerosol spray.

33. The method of claim 24, further comprising exposing said article to a plasma while exposing the article to negative pressure.

34. The method of claim 33, wherein said method is performed within a first chamber and wherein said plasma is generated in a second, separate chamber and said method further comprises the step of flowing said plasma into said first chamber.

35. The method of claim 24, wherein said diffusion-restricted environment comprises a container with at least one exit tube.

36. The method of claim 35, wherein said exit tube is at least 1.0 cm in length.

37. The method of claim 35, wherein said exit tube has an internal diameter of 9 mm or less.

38. The method of claim 35, wherein said exit tube includes a filter.

39. The method of claim 38, wherein said filter is sufficient to prevent entry of bacteria from the environment into said container.

40. The method of claim 24, wherein said solution is at a concentration of less than 25% by weight.

41. The method of claim 24, wherein said exposing step is performed for 60 minutes or less.

42. The method of claim 24, further comprising the step of heating said article during said exposing step.

43. The method of claim 24, wherein said exposing step comprises exposing said article to negative pressure between 0 and 100 Torr.

44. The method of claim 24, wherein the contacting step is repeated one or more times.

45. The method of claim 24, wherein the exposing step is repeated one or more times.

46. The method of claim 44, wherein the entire method is repeated one or more times.

47. The method of claim 24, wherein said diffusion-restricted environment has the same or more diffusion restriction than provided by a single entry/exit port of 9 mm or less in internal diameter and 1 cm or greater in length.

48. The method of claim 24, wherein said diffusion-restricted environment is sufficiently diffusion restricted to completely sterilize a stainless steel blade within a 2.2 cm by 60 cm glass tube having a rubber stopper with a 1 mm by 50 cm stainless steel exit tube therein at a vacuum of 10 torr for one hour at 40°

C.

49. A method for sterilizing a device having a lumen, comprising:

contacting the interior of said lumen with a liquid solution comprising hydrogen peroxide; and

exposing said device to a selected negative pressure and a selected temperature to vaporize said hydrogen peroxide,

wherein said lumen has a length and a diameter which provide the same or more diffusion restriction than provided by a reference lumen having a length to internal diameter ratio of 50 at said selected pressure and said selected temperature,

and wherein said hydrogen peroxide vapor diffuses from inside to outside of said lumen, for a time period sufficient to effect sterilization of said lumen by hydrogen peroxide vapor.

50. The method of claim 49, wherein said liquid solution is an aerosol.

51. The method of claim 49, wherein said solution is peracetic acid.

52. The method of claim 49, wherein said contacting comprises delivery of said liquid solution via one or more methods selected from the group consisting of injection, static soak, liquid flow-through and aerosol spray.

53. The method of claim 49, further comprising exposing said device to a plasma while exposing the device to negative pressure.

54. The method of claim 53, wherein said method is performed within a first chamber and wherein said plasma is generated in a second, separate chamber and said method further comprises flowing said plasma into said first chamber.

55. The method of claim 53, wherein said method is performed within a sealed chamber and said plasma is generated within said chamber.

56. The method of claim 49, wherein the contacting is repeated one or more times.

57. The method of claim 49, wherein the exposing is repeated one or more times.

58. The method of claim 49, wherein both the contacting and the exposing are repeated one or more times.

59. The method of claim 49, wherein said solution is at a concentration of less than 25% by weight.

60. The method of claim 49, wherein the exposing is performed for 60 minutes or less.

61. The method of claim 49, further comprising heating said device during said exposing.

62. The method of claim 49, wherein said exposing occurs within a chamber, and wherein said method further comprises heating said chamber during said exposing.

63. The method of claim 62, wherein said chamber is heated to between about 40°

C. and about 45°

C.

64. The method of claim 49, additionally comprising heating said solution prior to said contacting.

65. The method of claim 64, wherein said solution is heated to between about 40°

C. and about 45°

C.

66. The method of claim 49, wherein said exposing comprises exposing said device to pressure less than the vapor pressure of hydrogen peroxide.

67. The method of claim 66, wherein said pressure is between 0 and 100 torr.

68. The method of claim 66, wherein said pressure is approximately 10 torr and the exposing is conducted at a temperature of approximately 23°

C. to approximately 28°

C.