Container monitoring system

• US 5,834,313 A
• Filed: 09/19/1997
• Issued: 11/10/1998
• Est. Priority Date: 09/19/1997
• Status: Expired due to Fees

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Johnson & Johnson Medical Incorporated (Johnson & Johnson)
• Inventors: Lin, Szu-Min
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US08/934,496
• Time in Patent Office: 417 Days
• Field of Search: 422/28, 422/26, 422/34-37, 422/61, 436/1, 436/127-131
• US Class Current: 436/1
• 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: Y10T 436/196666 Carbon containing compound [e.g., vinylchloride, etc.]
• CPC Class Codes: Y10T 436/20 Oxygen containing
• CPC Class Codes: Y10T 436/200833 Carbonyl, ether, aldehyde or ketone containing

Abstract

A sterilization system using a sterilization process monitoring device which is capable of indicating the efficacy of the sterilization process in an enclosed sterilization container while still maintaining the sealed state of the sterilization container. The process monitoring device comprises at least one biological indicator and/or at least one chemical indicator. Upon completion of the sterilization cycle, the process monitoring device can be advantageously removed from the system to determine chemical and/or biological efficacy of the sterilization process. The removal of the biological and/or chemical indicators does not disturb the sterilized state of the articles inside the sterilization container.

Claims

1. A system for monitoring a sterilization process comprising:

a container having an interior space to receive articles to be sterilized wherein said container comprises at least one gas permeable material on an outer wall of said container so as to allow a sterilant gas to diffuse from said interior space through said gas permeable material;

a sterilant source adapted to provide said sterilant gas in said interior space; and

at least one indicator wherein said indicator is positioned adjacent said at least one gas permeable material so that said indicator is in fluid communication with said interior space through said gas permeable material to receive said sterilant gas that diffuses through said gas permeable material, and wherein said gas permeable material prevents the penetration of microorganisms therethrough so that said at least one indicator can be removed from said container without disturbing sterility of the articles within the container.

2. The system of claim 1, wherein said gas permeable material is spun-bond polyethylene or non-woven polypropylene.

3. The system of claim 1, wherein said outer wall of said container defines a cartridge opening such that a first surface of said cartridge opening is said gas permeable material, and wherein said at least one indicator is placed into a cartridge.

4. The system of claim 3, wherein said cartridge has a gas permeable material and is positioned in said cartridge opening so that said gas permeable material of said cartridge is in fluid communication with the gas permeable material of said cartridge housing.

5. The system of claim 1, wherein said indicator is placed within an enclosure having an openable or removable top.

6. The system of claim 5, wherein said top is translucent or clear.

7. The system of claim 3, wherein said cartridge comprises a clear or translucent top.

8. The system of claim 1, wherein said indicator is a biological indicator.

9. The system of claim 1, wherein said indicator is a chemical indicator.

10. The system of claim 1, wherein said system additionally comprises a fan adapted to circulate sterilant gas inside said container.

11. The system of claim 1, wherein said container is a flexible pouch made of a gas impermeable material.

12. The system of claim 11, wherein said pouch further comprising a first window and a second window, each of said windows comprised of gas permeable material.

13. The system of claim 1, wherein said sterilant source is a liquid sterilant source.

14. The system of claim 13, wherein said liquid sterilant source is liquid hydrogen peroxide or peracetic acid.

15. The system of claim 1, wherein said sterilant source is a solid sterilant source.

16. The system of claim 15, wherein said solid sterilant source is urea hydrogen peroxide complex or a sodium pyrophosphate hydrogen peroxide complex.

17. The system of claim 1, wherein said sterilant source is placed inside said sterilization container.

18. The system of claim 1, wherein said sterilant source is placed into an enclosure in fluid communication with said interior space.

19. The system of claim 18, wherein said container is detachable from said enclosure.

20. The system of claim 19, additionally comprising a connector between said enclosure and said interior space.

21. The system of claim 1, wherein said sterilant gas is produced by applying heat to said sterilant source.

22. The system of claim 1, wherein said sterilant gas is produced by applying vacuum to said sterilant source in an vacuum chamber.

23. The system of claim 1, additionally comprising a plasma generator adapted to provide plasma in or to said container.

24. The system of claim 1, wherein the indicator and the container each contain a unique identifier pairing the indicator with the container.

25. A method of monitoring a sterilization process comprising:

providing a container having an interior space to receive articles to be sterilized, wherein said container comprises at least one gas permeable material on an outer wall of said container in fluid communication with said interior space so as to allow a sterilant gas to diffuse through said gas permeable material;

providing a sterilant source adapted to provide said sterilant gas inside of said container; and

positioning at least one indicator exterior of said interior space in fluid communication therewith through said gas permeable material of said container so that said indicator receives said sterilant gas that diffuses through said gas permeable material from said interior space, and wherein said gas permeable material prevents the penetration of microorganisms therethrough so that said at least one indicator can be removed from said container without disturbing sterility of the articles within the container.

26. The method of claim 25, wherein said at least one indicator is placed into a cartridge, and wherein said cartridge is positioned in said cartridge opening so that said gas permeable region is in fluid communication with said cartridge having said at least one indicator.

27. The method of claim 25, wherein said indicator is a biological indicator, and additionally comprising the step of assaying said biological indicator for the presence or absence of microorganisms to determine if sterilization has occurred.

28. The method of claim 25, wherein said indicator is a chemical indicator, and additionally comprising the step of identifying a chemical change in said chemical indicator to indicate that a sterilization process has been completed.

29. The method of claim 25, wherein said sterilant source is a solid sterilant source, and additionally comprising the step of heating said solid sterilant source or exposing said solid sterilant source to vacuum so as to release sterilant gas therefrom.

30. The method of claim 25, wherein said sterilant source is placed into an enclosure and said enclosure is placed into fluid communication with said interior space.

31. The method of claim 30, additionally comprising attaching said container to said enclosure through a connector and flowing sterilant gas released inside said enclosure through said connector to said sterilization container.

32. The method of claim 25, additionally comprising generating a plasma and contacting said articles with said plasma.