Apparatus for testing sterilization methods and materials

• US 7,090,808 B2
• Filed: 07/09/2001
• Issued: 08/15/2006
• Est. Priority Date: 07/09/2001
• Status: Expired due to Fees

• Current Assignee: Care Biopharma LLC
• Original Assignee: Pharmaceutical Systems, Inc.
• Inventors: Thrash, Robert J., Cullen, Thomas F., Reich, Robert R. Jr., Caputo, Ross A., Fisher, Jimmy, Khorzad, Davoud
• Primary Examiner(s): Crispino, Richard
• Assistant Examiner(s): Chorbaji, Monzer R.
• Application Number:
  US09/901,389
• Publication Number:
  US 20030012689A1
• Time in Patent Office: 1,863 Days
• Field of Search: 422/1, 422 3- 4, 422/28, 422 32- 34, 422/55, 422 61- 62, 422/119, 422/186.04, 422/300, 422/305, 356/437, 356/442
• US Class Current: 422/305
• CPC Class Codes: A61L 2/208 Hydrogen peroxide
• 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
• 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: G01N 21/3504 for analysing gases, e.g. multi-gas analysis

Abstract

Apparatus and method for testing one or more sterilization indicators (e.g., biological indicators or chemical indicators) or other articles by contacting them under controlled sterilization conditions with a flowing antimicrobial gas containing hydrogen peroxide vapor are disclosed. This invention also provides apparatus and method for testing sterilization processes that use a flowing antimicrobial gas containing hydrogen peroxide vapor under controlled sterilization conditions, or for testing materials for such processes under controlled sterilization conditions, or for testing both such processes and such materials under controlled sterilization conditions. There can be an essentially square-wave contact of the sterilization indicators or other articles with the antimicrobial gas (i.e., short rise time to reach full concentration of the antimicrobial gas in contact with the sterilization indicators or other articles and short fall time to remove all of the antimicrobial gas from contact with the sterilization indicators or other articles). A preferred way of generating a substantially constant flow of antimicrobial gas of substantially constant hydrogen peroxide concentration may be used to generate the antimicrobial gas. A preferred way of determining the hydrogen peroxide concentration in the antimicrobial gas may be used.

Claims

1. An apparatus for testing one or more sterilization indicators by contacting them under controlled sterilization conditions with a flowing antimicrobial gas comprising hydrogen peroxide vapor, the apparatus comprising:

(a) antimicrobial gas generating means for providing the flowing antimicrobial gas comprising hydrogen peroxide vapor, the antimicrobial gas generating means comprising;

(1) a vaporization plenum having an inner surface;

(2) means for breaking a vaporizable liquid comprising hydrogen peroxide into fine particles and for flowing the fine particles in the vaporization plenum, the bulk flow of the fine particles flowing in the vaporization plenum being in a first direction;

(3) means for flowing a gas or vapor comprising a first substance in the vaporization plenum and for flowing at least some of the first substance between the inner surface of the vaporization plenum and substantially all of the fine particles to create a curtain of first substance between the inner surface of the vaporization plenum and substantially all of the fine particles, the bulk flow of the first substance in the vaporization plenum flowing in substantially the same direction as the first direction; and

(4) means for causing substantially all of the fine particles to vaporize in the flow of the first substance to produce a substantially continuous flow of a gas-phase mixture of the first substance and vaporized hydrogen peroxide of substantially constant hydrogen peroxide concentration as a function of time, the antimicrobial gas comprising the gas-phase mixture;

(b) a chamber in which the one or more sterilization indicators can be contacted with the flowing antimicrobial gas;

(c) means for rapidly placing the one or more sterilization indicators in the chamber while the flow of the antimicrobial gas in the chamber is substantially continuous and the concentration of hydrogen peroxide in the antimicrobial gas is substantially constant as a function of time;

(d) means for continuing to flow the antimicrobial gas in the chamber to contact the one or more sterilization indicators from substantially the moment they are placed in the chamber, the contact being under substantially uniform conditions for the desired contact time, the flow of the antimicrobial gas during the contact being substantially continuous and the concentration of hydrogen peroxide in the antimicrobial gas during the contact being substantially constant as a function of time; and

(e) means for rapidly removing the one or more sterilization indicators from the chamber after the desired contact time of the one or more sterilization indicators with the antimicrobial gas has elapsed.

2. The apparatus of claim 1 further comprising means for pre-treating the one or more sterilization indicators before their contact with the antimicrobial gas has commenced.

3. The apparatus of claim 1 further comprising means for post-treating the one or more sterilization indicators after they have been removed from the chamber.

4. The apparatus of claim 1 further comprising means for pre-treating the one or more sterilization indicators before their contact with the flowing antimicrobial gas has commenced and means for post-treating them after their contact with the flowing antimicrobial gas has halted.

5. The apparatus of claim 4 wherein the means for pre-treating and the means for post-treating comprise at least some of the same members.

6. The apparatus of claim 5 further comprising an antechamber wherein the means for pre-treating and the means for post-treating each comprise the antechamber.

7. The apparatus of claim 6 further comprising a movable member and means for moving the movable member from the chamber to the antechamber and from the antechamber to the chamber.

8. The apparatus of claim 7 wherein the means for rapidly placing the one or more sterilization indicators in the chamber and the means for rapidly removing the one or more sterilization indicators from the chamber after the desired contact time has elapsed are the same and each comprises the movable member.

9. The apparatus of claim 1 further comprising means to maintain the one or more sterilization indicators in a predefined volume in the chamber.

10. The apparatus of claim 9 further comprising means to flow substantially all of the antimicrobial gas flowing into the chamber through the predefined volume.

11. The apparatus of claim 1 further comprising means for monitoring the hydrogen peroxide concentration of the antimicrobial gas.

12. The apparatus of claim 1 further comprising means for maintaining the contact of the antimicrobial gas with the sterilization indicators at a desired temperature.

13. The apparatus of claim 1 wherein the antimicrobial gas generating means is oriented so that the first direction is up and substantially vertical.

14. A method for testing one or more sterilization indicators by contacting them under controlled sterilization conditions with a flowing antimicrobial gas comprising hydrogen peroxide vapor, the method comprising:

(a) rapidly placing the one or more sterilization indicators in the chamber of the apparatus of claim 1 or 4 while the flow of the antimicrobial gas in the chamber is substantially continuous and the concentration of hydrogen peroxide in the antimicrobial gas is substantially constant as a function of time;

(b) continuing to flow the antimicrobial gas in the chamber to contact the one or more sterilization indicators from substantially the moment they are placed in the chamber, the contact being under substantially uniform conditions for the desired contact time, the flow of the antimicrobial gas during the contact being substantially continuous and the concentration of hydrogen peroxide in the antimicrobial gas during the contact being substantially constant as a function of time; and

(c) rapidly removing the one or more sterilization indicators from the chamber after the desired contact time of the one or more sterilization indicators with the antimicrobial gas has elapsed.

15. The method of claim 14 wherein the hydrogen peroxide concentration in the antimicrobial gas during the desired contact time does not vary from the mean time-averaged hydrogen peroxide concentration during that time by more than plus or minus 10%.

16. The method of claim 14 wherein the hydrogen peroxide concentration in the antimicrobial gas during the desired contact time does not vary from the mean time-averaged hydrogen peroxide concentration during that time by more than plus or minus 8%.

17. The method of claim 14 wherein the hydrogen peroxide concentration in the antimicrobial gas during the desired contact time does not vary from the mean time-averaged hydrogen peroxide concentration during that time by more than plus or minus 6%.

18. An apparatus for testing one or more sterilization indicators by contacting them under controlled sterilization conditions with a flowing antimicrobial gas comprising hydrogen peroxide vapor, the apparatus comprising:

(a) antimicrobial aas generating means for providing the flowing antimicrobial gas comprising hydrogen peroxide vapor, the antimicrobial gas generating means comprising;

(1) a vaporization plenum having an inner surface;

(2) means for breaking a vaporizable liquid comprising hydrogen peroxide into fine particles and for flowing the fine particles in the vaporization plenum, the bulk flow of the fine particles flowing in the vaporization plenum being in a first direction;

(3) means for flowing a gas or vapor comprising a first substance in the vaporization plenum and for flowing at least some of the first substance between the inner surface of the vaporization plenum and substantially all of the fine particles to create a curtain of first substance between the inner surface of the vaporization plenum and substantially all of the fine particles, the bulk flow of the first substance in the vaporization plenum flowing in substantially the same direction as the first direction; and

(4) means for causing substantially all of the fine particles to vaporize in the flow of the first substance to produce a substantially continuous flow of a gas-phase mixture of the first substance and vaporized hydrogen peroxide of substantially constant hydrogen peroxide concentration as a function of time, the antimicrobial aas comprising the gas-phase mixture;

(b) a chamber in which the one or more sterilization indicators can be contacted with the flowing antimicrobial gas;

(c) means for suddenly commencing the contact of the flowing antimicrobial gas with the one or more sterilization indicators in the chamber and means for continuing the contact of the flowing antimicrobial gas with the one or more sterilization indicators in the chamber under substantially uniform conditions for the desired contact time, the flow of the antimicrobial gas in the chamber during the contact being substantially continuous and the concentration of the hydrogen peroxide in the antimicrobial gas during the contact being substantially constant as a function of time; and

(d) means for suddenly halting the contact of the antimicrobial gas with the sterilization indicators after the desired contact time has elapsed.

19. The apparatus of claim 18 further comprising means for pre-treating the one or more sterilization indicators before their contact with the flowing antimicrobial gas has commenced.

20. The apparatus of claim 18 further comprising means for post-treating the one or more sterilization indicators after their contact with the flowing antimicrobial gas has halted.

21. The apparatus of claim 18 further comprising means for pre-treating the one or more sterilization indicators before their contact with the flowing antimicrobial gas has commenced and means for post-treating them after their contact with the flowing antimicrobial gas has halted.

22. The apparatus of claim 21 wherein the means for pre-treating and the means for post-treating comprise at least some of the same members.

23. The apparatus of claim 22 further comprising an antechamber wherein the means for pre-treating and the means for post-treating each comprise the antechamber.

24. The apparatus of claim 18 further comprising means for monitoring the hydrogen peroxide concentratiQn of the antimicrobial gas.

25. The apparatus of claim 18 wherein the means for suddenly commencing and then continuing the contact of the flowing antimicrobial gas with the sterilization indicators comprises means for rapidly placing and maintaining the one or more sterilization indicators in the chamber while the flow of the antimicrobial gas in the chamber is substantially continuous and the concentration of the hydrogen peroxide in the antimicrobial gas is substantially constant as a function of time.

26. The apparatus of claim 18 wherein the means for suddenly halting the contact of the flowing antimicrobial gas with the sterilization indicators after the desired contact time has elapsed comprises means for rapidly removing the one or more sterilization indicators from the chamber after the desired contact time has elapsed.

27. The apparatus of claim 18 further comprising means to maintain the one or more sterilization indicators in a predefined volume in the chamber.

28. The apparatus of claim 27 further comprising means to flow substantially all of the antimicrobial gas flowing into the chamber through the predefined volume.

29. The apparatus of claim 18 wherein the antimicrobial gas generating means is oriented so that the first direction is up and substantially vertical.

30. A method for testing one or more sterilization indicators by contacting them under controlled sterilization conditions with a flowing antimicrobial gas comprising hydrogen peroxide vapor, the method comprising:

(a) placing them in the chamber of the apparatus of claim 18 or 21;

(b) suddenly commencing the contact of the flowing antimicrobial gas with the one or more sterilization indicators in the chamber and continuing the contact of the flowing antimicrobial gas with the one or more sterilization indicators in the chamber under substantially uniform conditions for the desired contact time, the flow of the antimicrobial gas in the chamber during the contact being substantially continuous and the concentration of the hydrogen peroxide in the antimicrobial gas during the contact being substantially constant as a function of time; and

(c) suddenly halting the contact of the antimicrobial gas with the sterilization indicators after the desired contact time has elapsed.

31. The method of claim 30 wherein the hydrogen peroxide concentration in the antimicrobial gas during the desired contact time does not vary from the mean time-averaged hydrogen peroxide concentration during that time by more than plus or minus 10%.

32. The method of claim 30 wherein the hydrogen peroxide concentration in the antimicrobial gas during the desired contact time does not vary from the mean time-averaged hydrogen peroxide concentration during that time by more than plus or minus 8%.

33. The method of claim 30 wherein the hydrogen peroxide concentration in the antimicrobial gas during the desired contact time does not vary from the mean time-averaged hydrogen peroxide concentration during that time by more than plus or minus 6%.

50. A method for testing sterilization processes that use a flowing antimicrobial gas comprising hydrogen peroxide vapor, or for testing materials for such processes, or for testing both such processes and such materials, the materials comprising one or more articles, the method comprising:

(a) flowing the antimicrobial gas to provide contact of any one or more articles with the antimicrobial gas when the articles are in the chamber of the apparatus of claim 30 or 38;

(b) flowing the antimicrobial gas in the chamber to contact any such one or more articles under substantially uniform conditions for the desired time, the flow of the antimicrobial gas in the chamber during the desired time being substantially continuous and the concentration of the hydrogen peroxide in the antimicrobial gas during the desired time being substantially constant as a function of time; and

(c) halting the flow of antimicrobial gas after the desired time has elapsed.

51. The method of claim 50 wherein the hydrogen peroxide concentration in the antimicrobial gas during the desired time does not vary from the mean time-averaged hydrogen peroxide concentration during that time by more than plus or minus 10%.

52. The method of claim 50 wherein the hydrogen peroxide concentration in the antimicrobial gas during the desired time does not vary from the mean time-averaged hydrogen peroxide concentration during that time by more than plus or minus 8%.

53. The method of claim 30 wherein the hydrogen peroxide concentration in the antimicrobial gas during the desired time does not vary from the mean time-averaged hydrogen peroxide concentration during that time by more than plus or minus 6%.

34. An apparatus for testing sterilization processes that use a flowing antimicrobial gas comprising hydrogen peroxide vapor under controlled sterilization conditions, or for testing materials for such processes under controlled sterilization conditions, or for testing both such processes and such materials under controlled sterilization conditions, the materials comprising one or more articles, the apparatus comprising:

(a) antimicrobial gas generating means for providing the flowing antimicrobial gas comprising hydrogen peroxide vapor, the antimicrobial gas generating means comprising;

(1) a vaporization plenum having an inner surface;

(2) means for breaking a vaporizable liquid comprising hydrogen peroxide into fine particles and for flowing the fine particles in the vaporization plenum, the bulk flow of the fine particles flowing in the vaporization plenum being in a first direction;

(3) means for flowing a gas or vapor comprising a first substance in the vaporization plenum and for flowing at least some of the first substance between the inner surface of the vaporization plenum and substantially all of the fine particles to create a curtain of first substance between the inner surface of the vaporization plenum and substantially all of the fine particles, the bulk flow of the first substance in the vaporization plenum flowing in substantially the same direction as the first direction; and

(4) means for causing substantially all of the fine particles to vaporize in the flow of the first substance to produce a substantially continuous flow of a gas-phase mixture of the first substance and vaporized hvdroaen peroxide of substantially constant hvdroaen peroxide concentration as a function of time, the antimicrobial gas comprising the gas-phase mixture;

(b) a chamber in which the antimicrobial gas is flowed to provide contact of any one or more of the articles with the antimicrobial gas when articles are in the chamber;

(c) means for flowing the antimicrobial gas in the chamber to contact any such one or more articles under substantially uniform conditions for the desired time, the flow of the antimicrobial gas in the chamber during the desired time being substantially continuous and the concentration of the hydrogen peroxide in the antimicrobial gas during the desired time being substantially constant as a function of time; and

(d) means for halting the flow of the flowing antimicrobial gas after the desired time has elapsed.

35. The apparatus of claim 34 wherein means (c) comprises means for suddenly commencing and then continuing the flow of the antimicrobial gas in the chamber.

36. The apparatus of claim 35 wherein the means for suddenly commencing and then continuing the contact of the flowing antimicrobial gas with any one or more articles comprises means for rapidly placing and maintaining the one or more articles in the chamber while the flow of the antimicrobial gas in the chamber is substantially continuous and the concentration of the hydrogen peroxide in the antimicrobial gas is substantially constant as a function of time.

37. The apparatus of claim 34 wherein means (d) comprises means for suddenly halting the flow of the antimicrobial gas.

38. The apparatus of claim 37 wherein the means for suddenly halting the contact of the flowing antimicrobial gas with any one or more articles after the desired contact time has elapsed comprises means for rapidly removing the one or more articles from the chamber after the desired contact time has elapsed.

39. The apparatus of claim 34 wherein means (c) comprises means for suddenly commencing and then continuing the flow of the antimicrobial gas in the chamber and means (d) comprises means for suddenly halting the flow of the antimicrobial gas.

40. The apparatus of claim 34 further comprising means for pre-treating any one or more articles placed in the chamber before their contact with the flowing antimicrobial gas has commenced.

41. The apparatus of claim 34 further comprising means for post-treating any one or more articles placed in the chamber after their contact with the flowing antimicrobial gas has halted.

42. The apparatus of claim 34 further comprising means for pre-treating any one or more articles placed in the chamber before their contact with the flowing antimicrobial gas has commenced and means for post-treating any one or more articles placed in the chamber after their contact with the flowing antimicrobial gas has halted.

43. The apparatus of claim 42 wherein the means for pre-treating and the means for post-treating comprise at least some of the same members.

44. The apparatus of claim 43 further comprising an antechamber wherein the means for pre-treating and the means for post-treating each comprise the antechamber.

45. The apparatus of claim 34 further comprising means for monitoring the hydrogen peroxide concentration of the antimicrobial gas.

46. The apparatus of claim 34 further comprising means to maintain any one or more articles placed in the chamber in a predefined volume in the chamber.

47. The apparatus of claim 46 further comprising means to flow substantially all of the antimicrobial gas flowing into the chamber through the predefined volume.

48. The apparatus of claim 34 wherein the means for flowing a gas or vapor of its subparagraph (a)(3) comprises means for flowing substantially all of the first substance fed to the vaporization plenum between the inner surface of the vaporization plenum and substantially all of the fine particles to create the curtain of first substance.

49. The apparatus of claim 34 wherein the antimicrobial gas generating means is oriented so that the first direction is up and substantially vertical.