Plasma cycling sterilizing process

• US 5,288,460 A
• Filed: 10/19/1992
• Issued: 02/22/1994
• Est. Priority Date: 03/08/1989
• Status: Expired due to Term

• Current Assignee: DePuy Orthopaedics Incorporated (Johnson & Johnson)
• Original Assignee: Abtox, Inc.
• Inventors: Jones, Jeffrey, Caputo, Ross A., Moulton, Kern A., Campbell, deceased, Bryant A.
• Primary Examiner(s): Warden, Robert J.
• Assistant Examiner(s): JASTRZAB, KRISANNE MARIE
• Application Number:
  US07/962,895
• Time in Patent Office: 491 Days
• Field of Search: 422/22, 422/23, 422/28, 422/32-33, 422/90, 422/29, 422/186.04-186.06
• US Class Current: 422/23
• CPC Class Codes: A61L 2/14 Plasma, i.e. ionised gases
• CPC Class Codes: H05H 1/46 using applied electromagnetic fields, e.g. high frequency or microwave energy H05H1/26 takes precedence

Abstract

A method for plasma sterilization within a controlled temperature range includes exposing the interior of a chamber and any articles therein to a gas plasma flowing from a plasma generating chamber until the temperature in the chamber rises to a preselected maximum temperature. The flow of the plasma gas to the chamber is terminated when the temperature in the chamber falls to a temperature below the preselected maximum temperature. These steps are repeated until sterilization of the interior of the chamber or any articles therein is effected. The temperature below the preselected maximum temperature when gas plasma flow is again initiated is preferably not more than 3° C. below the preselected maximum temperature. The gas plasma can be generated from a gas mixture that includes oxidizing and/or reducing agents. Preferably the pressure in the sterilizing chamber rises to from 0.1 to 10 torr when the gas plasma is flowing into the chamber, and the pressure in the sterilizing chamber falls to a lower pressure when the gas plasma flow into the sterilizing chamber is terminated. The articles to be sterilized include the interior of a vessel or chamber. The vessel or chamber itself serves as a sterilizing chamber and connects to the plasma generating chamber.

Claims

1. A method for plasma sterilization of an interior of a chamber and any articles therein within a controlled temperature range comprising:

a) exposing the interior of said chamber and any articles therein to a gas plasma flowing from a plasma generating chamber until the temperature in said chamber rises to a preselected maximum temperature;

b) terminating flow of the gas plasma to said chamber until the temperature in said chamber falls to a preselected temperature below the preselected maximum temperature; and

c) repeating steps (a) and (b) until sterilization of the interior of said chamber and any articles therein as defined by a preselected probability of survivors is effected; and

wherein said any articles in said chamber are enclosed in porous packaging.

2. A method for plasma sterilization of an interior of a chamber and any articles therein within a controlled temperature range comprising:

a) exposing the interior of said chamber and any articles therein to a gas plasma flowing from a plasma generating chamber until the temperature in said chamber rises to a preselected maximum temperature;

b) terminating flow of the gas plasma to said chamber until the temperature in said chamber falls to a preselected temperature below the preselected maximum temperature; and

c) repeating steps (a) and (b) until sterilization of the interior of said chamber and any articles therein as defined by a preselected probability of survivors is effected; and

wherein the preselected maximum temperature does not exceed 132°

C.

3. A method for plasma sterilization of an interior of a chamber and any articles therein within a controlled temperature range comprising:

a) exposing the interior of said chamber and any articles therein to a gas plasma flowing from a plasma generating chamber until the temperature in said chamber rises to a preselected maximum temperature;

b) terminating flow of the gas plasma to said chamber until the temperature in said chamber falls to a preselected temperature below the preselected maximum temperature; and

c) repeating steps (a) and (b) until sterilization of the interior of said chamber and any articles therein as defined by a preselected probability of survivors is effected; and

wherein;

the step of exposing the interior of said chamber and any articles therein to a gas plasma is performed at a pressure of from 0.01 to 100 torr, until the temperature in said chamber rises to about 63°

C.; and

the step of terminating flow of gas plasma to said chamber is performed as long as the temperature in said chamber remains above 60°

C., said chamber having a reduced pressure when the plasma gas flow is terminated.

4. A method for plasma sterilization of an interior of a chamber and any articles therein within a controlled temperature range comprising:

a) exposing the interior of said chamber and any articles therein to a gas plasma flowing from a plasma generating chamber until the temperature in said chamber rises to a preselected maximum temperature;

b) terminating flow of the gas plasma to said chamber until the temperature in said chamber falls to a preselected temperature below the preselected maximum temperature; and

c) repeating steps (a) and (b) until sterilization of the interior of said chamber and any articles therein as defined by a preselected probability of survivors is effected; and

wherein the gas plasma is generated from a mixture of gases including an oxidizing agent.

5. A method for plasma sterilization of an interior of a chamber and any articles therein within a controlled temperature range comprising:

a) exposing the interior of said chamber and any articles therein to a gas plasma flowing from a plasma generating chamber until the temperature in said chamber rises to a preselected maximum temperature;

b) terminating flow of the gas plasma to said chamber until the temperature in said chamber falls to a preselected temperature below the preselected maximum temperature; and

c) repeating steps (a) and (b) until sterilization of the interior of said chamber and any articles therein as defined by a preselected probability of survivors is effected; and

wherein the gas plasma is generated from a mixture of gases including a reducing agent.

6. A method for plasma sterilization of an interior of a chamber and any articles therein within a controlled temperature range comprising:

a) exposing the interior of said chamber and any articles therein to a gas plasma flowing from a plasma generating chamber until the temperature in said chamber rises to a preselected maximum temperature;

b) terminating flow of the gas plasma to said chamber until the temperature in said chamber falls to a preselected temperature below the preselected maximum temperature; and

c) repeating steps (a) and (b) until sterilization of the interior of said chamber and any articles therein as defined by a preselected probability of survivors is effected; and

wherein the gas plasma is generated from a mixture of gases including oxidizing and reducing agents.

7. A method for plasma sterilization of an interior of a chamber and any articles therein within a controlled temperature range comprising:

a) exposing the interior of said chamber and any articles therein to a gas plasma flowing from a plasma generating chamber until the temperature in said chamber rises to a preselected maximum temperature;

b) terminating flow of the gas plasma to said chamber until the temperature in said chamber falls to a preselected temperature below the preselected maximum temperature; and

c) repeating steps (a) and (b) until sterilization of the interior of said chamber and any articles therein as defined by a preselected probability of survivors is effected; and

wherein said any articles in said chamber are unpackaged, and the preselected maximum temperature does not exceed 132°

C.

8. A method for plasma sterilization of an interior of a chamber and any articles therein within a controlled temperature range comprising:

a) exposing the interior of said chamber and any articles therein to a gas plasma flowing from a plasma generating chamber until the temperature in said chamber rises to a preselected maximum temperature;

b) terminating flow of the gas plasma to said chamber until the temperature in said chamber falls to a preselected temperature below the preselected maximum temperature; and

c) repeating steps (a) and (b) until sterilization of the interior of said chamber and any articles therein as defined by a preselected probability of survivors is effected; and

wherein said chamber is a lyophilizer.

9. A method of claim 8 wherein the gas plasma is generated from a mixture of gases including argon, helium, nitrogen or mixtures thereof;

from 1 to 21 (v/v) % oxygen; and

from 1 to 20 (v/v) % hydrogen.

10. A method of claim 8 wherein said chamber initially has a pressure of greater or equal to 0.01 torr and rises to not more than 100 torr when the gas plasma is flowing into said chamber.

11. A method of claim 8 wherein said chamber has a pressure that falls when the gas plasma flow into said chamber is terminated.

12. A method of claim 11 wherein said chamber has a pressure that rises to above 1 torr when the gas plasma is flowing into said chamber and falls below 1 torr when the gas flow into said chamber is terminated.

13. A method of claim 8 wherein said any articles in said chamber are enclosed in porous packaging.

14. A method of claim 8 wherein said any articles in said chamber include an organic polymer, and the preselected maximum temperature does not exceed 82°

C.

15. A method of claim 8 wherein the preselected maximum temperature does not exceed 132°

C.

16. A method of claim 8 wherein the preselected temperature below the preselected maximum temperature is not more than 3°

C. below the preselected maximum temperature.

17. A method of claim 8 wherein:

the step of exposing the interior of said chamber and any articles therein to a gas plasma is performed at a pressure of from 0.1 to 100 torr, until the temperature in said chamber rises to about 63°

C.; and

the step of terminating flow of gas plasma to said chamber is performed as long as the temperature in said chamber remains above 60°

C., said chamber having a reduced pressure when the plasma gas flow is terminated.

18. A method of claim 8 wherein the gas plasma is generated from a gas mixture containing from 1 to 10 (v/v) % oxygen and from 3 to 7 (v/v) % hydrogen.

19. A method of claim 8 wherein said any articles in said chamber are enclosed in porous packaging.

20. A method of claim 8 wherein the gas plasma is generated from a mixture of gases including from 1 to 10 (v/v) % hydrogen and from 90 to 99 (v/v) % of argon, helium, nitrogen or mixtures thereof.

21. A method of claim 8 wherein the gas plasma is generated from a mixture of gases including an oxidizing agent.

22. A method of claim 8 wherein the gas plasma is generated from a mixture of gases including a reducing agent.

23. A method of claim 8 wherein the gas plasma is generated from a mixture of gases including oxidizing and reducing agents.

24. A method of claim 8 wherein said any articles in said chamber are unpackaged, and the preselected maximum temperature does not exceed 132°

C.