Medical article sterilization method and device

• US 20020119074A1
• Filed: 04/05/2001
• Published: 08/29/2002
• Est. Priority Date: 12/28/2000
• Status: Abandoned Application

• Current Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Original Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Inventors: McGowan,, James E. Jr.
• Application Number:
  US09/826,420
• Publication Number:
  US 20020119074A1
• Time in Patent Office: Days
• US Class Current: 422/26
• CPC Class Codes: A61L 2/07 Steam
• CPC Class Codes: A61L 2/14 Plasma, i.e. ionised gases
• CPC Class Codes: A61L 2/202 Ozone
• CPC Class Codes: A61L 2/206 Ethylene oxide
• CPC Class Codes: A61L 2/208 Hydrogen peroxide
• CPC Class Codes: A61L 2202/18 Aseptic storing means
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps
• CPC Class Codes: B65B 55/025 Packaging in aseptic tunnels
• CPC Class Codes: B65B 55/027 Packaging in aseptic chambers
• CPC Class Codes: B65B 55/103 Sterilising flat or tubular webs
• CPC Class Codes: B65B 55/18 by liquids or gases B65B55/14 takes precedence
• CPC Class Codes: B65B 9/045 for single articles, e.g. tablets

Abstract

A medical article sterilization device has a pretreatment area for medical articles, a device to form a housing in a first web, an article loading station, an alignment device and a sterilization-sealing station. A heat source at the pretreatment area heats the medical articles. At the article loading station a medical article heated in the pretreatment area is loaded into the housing in the first web. The alignment device aligns a second web with the first web. At the sterilization-sealing station the first web and the second web, with the medical article loaded into the housing, are sterilized and then, the first and second webs are sealed together. Gas injection pins may be provided at the sterilization-sealing station to inject gas into the housing, between the first and second webs. The sterilization-sealing station may have a steam source to inject steam into the housing, between the first and second webs.

Claims

1. A medical article sterilization device comprising:

a pretreatment area for medical articles, the pretreatment area having a heat source to heat the medical articles;

a device to form a housing in a first web;

an article loading station where a medical article heated in the pretreatment area is loaded into the housing in the first web;

an alignment device to align a second web with the first web; and

a sterilization-sealing station where the first web and the second web, with the medical article loaded into the housing are sterilized and then the first and second webs are sealed together.

2. A medical article sterilization device according to claim 1, wherein the sterilization-sealing station further comprises gas injection pins to inject gas into the housing, between the first and second webs.

3. A medical article sterilization device according to claim 2, wherein the sterilization-sealing station further comprises a steam source to inject steam into the housing, between the first and second webs.

4. A medical article sterilization device according to claim 1, wherein the sterilization-sealing station further comprises a steam source to supply steam to the housing.

5. A medical article sterilization device according to claim 1, wherein:

substantially no moisture is supplied to the medical articles at the sterilization-sealing station, and

the pretreatment area has a steam source to supply moisture to the medical articles.

6. A medical article sterilization device according to claim 5, wherein:

the sterilization-sealing station comprises a vacuum source and a controller,

the vacuum source evacuates the housing,

evacuating the housing removes moisture from the medical articles, and

the controller maintains the pressure in the housing so as to allow some moisture to remain with the medical articles.

7. A medical article sterilization device according to claim 6, wherein the controller maintains the pressure in the housing so as to allow the relative humidity in the housing to be at least 40% during sterilization gas exposure.

8. A medical article sterilization device comprising:

a device to form a housing in a first web;

an article loading station where a medical article is loaded into the housing in the first web;

an alignment device to align a second web with the first web; and

a sterilization-sealing station where the first web and the second web, with the medical article loaded into the housing are sterilized and then, the first and second webs are sealed together, the sterilization-sealing station comprising gas injection pins to inject gas into the housing, between the first and second webs.

9. A medical article sterilization device according to claim 8, wherein the sterilization-sealing station further comprises a steam source to inject steam into the housing, between the first and second webs.

10. A medical article sterilization device according to claim 9, further comprising a pretreatment area for medical articles, the pretreatment area having a heat source to heat the medical articles.

11. A medical article sterilization device according to claim 8, where in the second web is formed of a gas permeable material.

12. A medical article sterilization device according to claim 8, wherein:

substantially no moisture is supplied to the medical articles at the sterilization-sealing station, and

the medical article sterilization device further comprises a pretreatment area having a steam source to supply moisture to the medical articles.

13. A medical article sterilization device according to claim 12, wherein:

the sterilization-sealing station further comprises a vacuum source and a controller,

the vacuum source evacuates the housing,

evacuating the housing removes moisture from the medical articles, and

the controller maintains the pressure in the housing so as to allow some moisture to remain with the medical articles.

14. A medical article sterilization device according to claim 13, wherein the controller maintains the pressure in the housing so as to allow the relative humidity in the housing to be at least 40% during sterilization gas exposure.

16. A method of sterilizing a medical article according to claim 15, further comprising injecting gas into the housing, between the first and second webs, through gas injection pins.

17. A method of sterilizing a medical article according to claim 16, wherein steam is injected into the housing, between the first and second webs, through the gas injection pins.

18. A method of sterilizing a medical article according to claim 15, wherein steam is injected into the housing, between the first and second webs.

19. A method of sterilizing a medical article according to claim 15, wherein:

sterilization and sealing are conducted at a sterilization-sealing station,

substantially no moisture is supplied to the medical article at the sterilization-sealing station, and

steam is supplied to the medical article at the pretreatment area.

20. A method of sterilizing a medical article according to claim 19, further comprising the steps of:

evacuating the housing at the sterilization-sealing station so as to remove moisture from the medical article, and

maintaining the pressure in the housing so as to allow some moisture to remain with the medical article.

21. A medical article sterilization device according to claim 20, wherein the pressure in the housing is maintained so as to allow the relative humidity in the housing to be at least 40% during sterilization gas exposure.

15. A method of sterilizing a medical article comprising:

preheating a medical article in a pretreatment area;

forming a housing in a first web;

loading the medical article heated in the pretreatment area into the housing formed in the first web;

aligning a second web with the first web;

sterilizing the medical article located in the housing and between the first and second webs;

after sterilizing the medical article, sealing the first web to the second web, with the medical article located in the housing and between the first and second webs.

22. A method of sterilizing a medical article comprising:

forming a housing in a first web;

loading a medical article into the housing formed in the first web;

aligning a second web with the first web;

injecting gas into the housing, between the first and second webs, through gas injection pins;

sterilizing the medical article located in the housing and between the first and second webs; and

after sterilizing the medical article, sealing the first web to the second web, with the medical article located in the housing and between the first and second webs.

23. A method of sterilizing a medical article according to claim 22, wherein steam is injected into the housing, between the first and second webs, through the gas injection pins.

24. A method of sterilizing a medical article according to claim 23, wherein the steam is injected into housing to pressurize the housing to a pressure of 60 to 100 psia.

25. A method of sterilizing a medical article according to claim 24, wherein

the housing is evacuated before pressurizing with steam, and

the housing is evacuated after pressurizing with steam and then sterilizing gas is supplied to the housing.

26. A method of sterilizing a medical article according to claim 24, wherein the housing is maintained in a condition pressurized with steam for a time period of 1 to 8 minutes.

27. A method of sterilizing a medical article according to claim 24, wherein

the housing is pressurized with steam and supplied with sterilizing gas within a form, fill and seal device having a sterilization-sealing station, which has an interior volume to contain the housing, and

the housing is pressurized with steam to deliver 10 to 50 Btu of heat per cubic foot of interior volume.

28. A method of sterilizing a medical article according to claim 22, wherein the second web is formed of a gas permeable material.

29. A method of sterilizing a medical article according to claim 23, further comprising preheating the medical article in a pretreatment area.

30. A method of sterilizing a medical article according to claim 22, wherein:

sterilization and sealing are conducted at a sterilization-sealing station,

substantially no moisture is supplied to the medical article at the sterilization-sealing station, and

moisture is supplied to the medical article as steam at a pretreatment area.

31. A method of sterilizing a medical article according to claim 30, further comprising the steps of:

evacuating the housing at the sterilization-sealing station so as to remove moisture from the medical article, and

maintaining the pressure in the housing so as to allow some moisture to remain with the medical article.

32. A medical article sterilization device according to claim 31, wherein the pressure in the housing is maintained so as to allow the relative humidity in the housing to be at least 40% during sterilization gas exposure.