Radiochemical sterilization

• US 5,422,068 A
• Filed: 01/05/1994
• Issued: 06/06/1995
• Est. Priority Date: 01/05/1994
• Status: Expired due to Term

• Current Assignee: Poly-Med, Inc.
• Original Assignee: Charles L. Linden Jr, Shalaby W. Shalaby
• Inventors: Shalaby, Shalaby W., Linden, Charles L. Jr.
• Primary Examiner(s): Warden, Robert J.
• Assistant Examiner(s): Thornton, Krisanne M.
• Application Number:
  US08/177,872
• Time in Patent Office: 517 Days
• Field of Search: 422/22, 422/23, 422/120, 422/28, 422/29, 422/30, 422/32, 422/36, 422/38, 422/186, 422/186.05, 250/455.11, 206/438, 206/439
• US Class Current: 422/22
• CPC Class Codes: A61L 2/20 Gaseous substances, e.g. vapours
• CPC Class Codes: A61L 2/204 Formaldehyde

Abstract

Radiochemical sterilization is accomplished by exposing a sterilant gas releasing substrate to an effective gas releasing amount of ionizing radiation and contacting an object to be sterilized with the released sterilant gas. Objects to be sterilized may be subjected to a combination of ionizing radiation and gas sterilant which is released by the ionizing radiation.

Claims

1. A method of producing a sterilant comprising providing a sterilant gas releasing substrate and exposing said substrate to an effective gas releasing amount of ionizing radiation which depolymerizes said sterilant gas releasing substrate and releases a sterilant gas.

2. A method of producing a sterilant according to claim 1 wherein said substrate comprises a solid sterilant gas releasing substrate.

3. A method of producing a sterilant according to claim 1 wherein said substrate comprises a liquid sterilant gas releasing substrate.

6. A method of producing a sterilant according to claim 1 wherein gas released from said gas releasing substrate is formaldehyde.

7. A method of producing a sterilant according to claim 1 wherein said ionizing radiation is selected from the group consisting of gamma radiation, x-rays and electron beam radiation.

8. A method of producing a sterilant according to claim 7 wherein the effective gas releasing amount of ionizing radiation is from about 0.1 Mrad to about 2.3 Mrad.

9. A method of producing a sterilant according to claim 8 wherein the effective gas releasing amount of ionizing radiation is from about 0.7 Mrad to about 1.4 Mrad.

10. A method of producing a sterilant according to claim 2 wherein said solid sterilant gas releasing substrate is formed into a material selected from the group consisting of film, mesh, filament, fabric, coating and powder.

21. A method of producing a sterilant according to claim 1 wherein an effective gas releasing amount of ionizing radiation is from about 0.5 to about 2.3 Mrad.

4. A method of producing a sterilant according to 1 wherein said substrate comprises a formaldehyde gas releasing substrate.

5. A method of producing a sterilant according to claim 4 wherein said substrate is selected from the group consisting of paraformaldehyde, polyoxymethylene, melamine-formaldehyde, urea-formaldehyde, phenol-formaldehyde, hexamethylenetetramine, copolymers of ethylene oxide and formaldehyde, and copolymers of trioxane and a member selected from the group consisting of 1,3 dioxolane and an alkylene formal.

11. A method of sterilizing comprising contacting an object to be sterilized with a sterilant which comprises a combination of ionizing radiation and a sterilizing gas generated by irradiating and depolymerizing a sterilant gas releasing substrate with ionizing radiation.

12. A sterilant comprising ionizing radiation in combination with the reaction product of a sterilant gas releasing substrate, capable of depolymerizing on exposure to ionizing radiation and ionizing radiation.

13. A sterilant device comprising means for producing ionizing radiation and an enclosure containing a sterilant gas releasing substrate which depolymerizes on exposure to ionizing radiation and release a sterilant gas.

14. A package for in situ sterilization of articles comprising a sealable pouch containing a sterilant gas releasing substrate capable of depolymerizing and releasing sterilant gas upon exposure to ionizing radiation.

15. A package according to claim 14 further comprising a sterilant gas absorbing substance.

16. A package according to claim 15 wherein said sterilant gas absorbing substance is selected from the group consisting of activated carbon, citric acid based polysaccharide matrix materials, ion exchange resins and polyhydric water soluble polymers.

17. An article sterilized by contacting the article with a sterilant which comprises a combination of ionizing radiation and a sterilizing gas generated by irradiating and depolymerizing a sterilant gas releasing substrate with ionizing radiation.

18. An article according to claim 17 wherein said article is an article used in medicine.

19. An article according to claim 17 wherein said article used in medicine comprises a bioabsorbable material.

20. An article according to claim 17 wherein said article used in medicine comprises polypropylene.