Vapor sterilization

• US 6,036,918 A
• Filed: 03/17/1993
• Issued: 03/14/2000
• Est. Priority Date: 03/17/1993
• Status: Expired due to Fees

• Current Assignee: Enviromedical Systems Incorporated
• Original Assignee: Enviromedical Systems Incorporated
• Inventors: Kowanko, Nicholas
• Primary Examiner(s): MCKANE, ELIZABETH L
• Application Number:
  US08/032,606
• Time in Patent Office: 2,554 Days
• Field of Search: 422/28, 422/33, 422/37, 252/106, 252/142
• US Class Current: 422/33
• CPC Class Codes: A01N 37/16 containing the group; Thio analogues thereof
• CPC Class Codes: A61L 2/202 Ozone
• 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

Abstract

The present invention discloses the use of peracid vapor as a sterilant. A process is disclosed for sterilizing a load by exposure to peracid vapor, the load being disposed in a sterilization chamber adapted to contain the peracid vapor, including the steps of exposing the load to the peracid vapor in the sterilization chamber at reduced pressure, i.e., below atmospheric pressure and introducing a quantity of another gas, the gas being of a type which does not interfere with the sterilization procedure, to increase the pressure in the chamber to a value above that at which the chamber was when the peracid vapor alone was present but below atmospheric pressure, whereby the penetration of any vapor penetrable portions of the load to be sterilized by the peracid vapor is enhanced.

Claims

1. A process for sterilizing a load of items to be disinfected by exposure to peracid sterilant vapor, comprising the steps of:

(a) introducing a load comprising items to be disinfected into a sterilization chamber adapted to contain and confine a sterilizing atmosphere;

(b) introducing an amount of peracid sterilant vapor into the sterilization chamber at a pressure below atmospheric pressure;

(c) introducing a quantity of a non-interfering gas, the gas being of a type which does not interfere with the sterilization procedure, to increase the pressure in the chamber to a value above that at which the chamber was after the peracid sterilant vapor was introduced but below atmospheric pressure, and forming, with the peracid sterilization vapor, a sterilization atmosphere; and

(d) exposing the load to the sterilization atmosphere for a desired period of time to sterilize the load.

2. The process of claim 1 wherein the sterilization chamber is connected to a vaporization chamber and wherein step (b) further comprises:

(e) generating the peracid sterilant vapor in the vaporization chamber and allowing it to pass into the sterilization chamber; and

(f) maintaining the sterilization chamber at a pressure equal to or less than that of the vaporization chamber during introduction of the peracid sterilant vapor.

3. The process of claim 2 wherein the peracid is selected from the group consisting of peracetic acid (peroxyacetic acid), performic acid (peroxyformic acid), perpropionic acid (peroxypropionic acid), perfluoroperacetic acid, perfluoroperpropionic acid, perfluoroperbutyric acid, and mixtures thereof.

4. The process of claim 3 wherein the peracid vapor is generated in situ by evaporation from a solution thereof.

5. The process of claim 3 wherein the peracid vapor is generated in situ by chemical reaction.

6. The process of claim 2 wherein the peracid is selected from peracetic acid (peroxyacetic acid), performic acid (peroxyformic acid), perpropionic acid (peroxypropionic acid), and mixtures thereof and wherein the peracid is generated by evaporation from a solution thereof.

7. The process of claim 6 wherein the peracid is peracetic acid.

8. The process of claim 7 wherein the pressure during step (d) is maintained within the range of 50-650 torr.

9. The process according to claim 8 wherein the reduced pressure for vaporizing the peracid is below about 100 torr.

10. The process of claim 2 further comprising the step of:

(e) removing the sterilant vapor by vacuum after exposure of the load for the desired period of time.

11. The process of claim 10 including repeating any of steps (b)-(e) as desired.

12. The process of claim 10 wherein evacuation is followed by flushing the chamber with a gas.

13. The process of claim 2 including repeating any of steps (b)-(d) as desired.

14. The process of claim 2 wherein the non-interfering gas is air.

15. The process of claim 2 wherein the pressure during step (d) is maintained within the range of 50-650 torr.

16. The process of claim 15 wherein the chamber pressure during step (d) is about 600 torr.

17. The process according to claim 2 wherein the reduced pressure for vaporizing the peracid is below about 100 torr.

18. The process according to claim 17 wherein the pressure is less than about 10 torr.

19. The process according to claim 17 wherein the pressure is less than about 1 torr.

20. The process according to claim 2 wherein the amount of peracid sterilant vapor introduced into the sterilization chamber is enough to raise the total pressure therein by at least about 1 torr.

21. The process of claim 1 wherein the peracid is selected from the group consisting of peracetic acid (peroxyacetic acid), performic acid (peroxyformic acid), perpropionic acid (peroxypropionic acid), perfluoroperacetic acid, perfluoroperpropionic acid, perfluoroperbutyric acid, and mixtures thereof.

22. The process of claim 21 wherein the peracid vapor is generated in situ.

23. The process according to claim 21 wherein the peracid is peracetic acid.

24. The process according to claim 21 wherein the peracid is performic acid.

25. The process according to claim 21 wherein the peracid is perpropionic acid.

26. The process according to claim 21 wherein the peracid is a mixture of peracids.

27. The process according to claim 21 wherein the mixture includes performic, peracetic and perpropionic acids.

28. The process according to claim 21 wherein the mixture includes peracetic and perpropionic acids.

29. The process according to claim 21 wherein the mixture includes peracetic and performic acids.

30. The process according to claim 21 wherein the mixture includes performic and perpropionic acids.

31. The process according to claim 21 wherein the peracid is a perfluorinated peracid.

32. The process according to claim 31 wherein the perfluorinated acid is selected from the group consisting of perfluoroperacetic acid, perfluoroperpropionic acid, perfluoroperbutyric acid and mixtures thereof.

33. The process of claim 1 wherein the peracid vapor is generated in situ.

34. The process of claim 1 further comprising the step of:

(e) removing the sterilant vapor by vacuum after exposure of the load for the desired period of time.

35. The process of claim 34 including repeating any of steps (b)-(e) as desired.

36. The process of claim 34 wherein evacuation is followed by flushing the chamber with a gas.

37. The process of claim 1 including repeating any of steps (b)-(d) as desired.

38. The process of claim 1 wherein the non-interfering gas is air.

39. The process of claim 1 wherein the pressure during step (d) is maintained within the range of 50-650 torr.

40. The process of claim 39 wherein the chamber pressure during step (d) is about 600 torr.

41. The process according to claim 1 wherein the amount of sterilant vapor introduced is defined in terms of partial pressure, the maximum amount being limited by its vapor pressure but greater than about 1 torr.

42. The process according to 41 wherein the partial pressure is about 10-15 torr.

43. A process for sterilizing a load of items to be sterilized by exposure to peracid sterilant vapor, comprising the steps of:

(a) introducing a load comprising items to be sterilized into a sterilization chamber adapted to contain and confine a sterilizing atmosphere;

(b) generating an amount of peracid sterilant vapor in a manner such that it is introduced into the cterilization chamber at a pressure below atmospheric pressure, wherein the peracid is selected from the group consisting of peracetic acid (peroxyacetic acid), performic acid (peroxyformic acid), perpropionic acid (peroxypropionic acid), perfluoroperacetic acid, perfluoroperpropionic acid, perfluoroperbutyric acid, and mixtures thereof;

(c) introducing a quantity of a non-interfering gas, the gas being of a type which does not interfere with the sterilization procedure, to increase the pressure in the chamber to a value from about 50 to 650 torr but above that at which the chamber was after the peracid sterilant vapor was introduced but below atmospheric pressure, and forming, with the peracids sterilization vapor, a sterilization atmosphere;

(d) exposing the load to the sterilization atmosphere for a desired period of time to sterilize the load; and

(e) removing the sterilant vapor by vacuum after exposure of the load for the desired period of time.

44. The process of claim 43 including repeating any of steps (b)-(e) as desired.

45. The process of claim 43 including the step of removing liquid residue from the peracid sterilant vapor prior to introducing it into the sterilization chamber.

46. The process of claim 43 wherein evacuation is followed by flushing the chamber with a gas.

47. The process of claim 43 wherein the partial pressure of the peracid vapor after step (b) is 10-15 torr.

48. The process according to claim 43 wherein the reduced pressure for vaporizing the peracid is below about 100 torr.

49. A process for sterilizing a load of items to be sterilized by exposure to peracid sterilant vapor, comprising the steps of:

(a) introducing a load comprising items to be sterilized into a sterilization chamber adapted to contain and confine a sterilizing atmosphere wherein the sterilization chamber is connected to a vaporization chamber;

(b) generating the peracid sterilant vapor in the vaporization chamber maintained at a pressure below atmospheric and allowing it to pass into the sterilization chamber;

(c) maintaining the sterilization chamber at a pressure equal to or less than that of the vaporization chamber during introduction of the peracid sterilant vapor;

(d) wherein the peracid is selected from the group consisting of peracetic acid (peroxyacetic acid), performic acid (peroxyformic acid), perpropionic acid (peroxypropionic acid), perfluoroperacetic acid, perfluoroperpropionic acid, perfluoroperbutyric acid, and mixtures thereof;

(e) introducing a quantity of a non-interfering gas, the gas being of a type which does not interfere with the sterilization procedure, to increase the pressure in the chamber to a value between about 50 and 650 torr but above that at which the chamber was after the peracid sterilant vapor was introduced but below atmospheric pressure, and forming, with the peracid sterilization vapor, a sterilization atmosphere; and

(f) exposing the load to the sterilization atmosphere for a desired period of time to sterilize the load; and

(g) removing the sterilant vapor by vacuum after exposure of the load for the desired period of time.

50. The process of claim 49 including repeating any of steps (b)-(e) as desired.

51. The process of claim 49 including the step of removing liquid residue from the peracid sterilant vapor prior to introducing it into the sterilization chamber.

52. The process of claim 49 wherein evacuation is followed by flushing the chamber with a gas.

53. The process of claim 49 wherein the partial pressure of the peracid vapor after step (b) is 10-15 torr.

54. The process according to claim 49 wherein the reduced pressure for vaporizing the peracid is below about 100 torr.