초록 ▼

Adhesive compositions, particularly medical adhesive compositions, often include several components that may react differently to different sterilization processes, particularly when combined with one another. The present invention is directed to methods of sterilizing different components or group

Adhesive compositions, particularly medical adhesive compositions, often include several components that may react differently to different sterilization processes, particularly when combined with one another. The present invention is directed to methods of sterilizing different components or groups of components of a final adhesive composition. The different components or groups of components may be sterilized in separate containers before packaging the components or groups of components within a kit, and thereafter sterilizing the kit.

대표청구항 ▼

What is claimed is: 1. A method for sterilizing an adhesive kit comprising: providing a first container containing at least a polymerizable monomer of a polymerizable adhesive composition which has not been sterilized; providing a second container containing at least one additional component of the

What is claimed is: 1. A method for sterilizing an adhesive kit comprising: providing a first container containing at least a polymerizable monomer of a polymerizable adhesive composition which has not been sterilized; providing a second container containing at least one additional component of the polymerizable adhesive composition; subjecting the second container containing at least one additional component to a first sterilization process to reduce the bioburden on contents of said second container; combining the first unsterilized container and the second sterilized container in a kit packaging element; and subjecting the kit packaging element, containing the first unsterilized container and the second sterilized container, to a second sterilization process that terminally sterilizes contents of said first and second containers. 2. The method according to claim 1, wherein the first sterilization process does not terminally sterilize contents of said second container. 3. The method according to claim 1, wherein the first and second sterilization steps cause substantially no initiation of polymerization of the polymerizable adhesive composition. 4. The method according to claim 3, wherein the polymerizable adhesive is in the form of a liquid, gel or gel-like composition. 5. The method according to claim 1, wherein the at least one additional component is at least one of a plasticizer, a thickening agent, a radiopaque agent, and an initiator. 6. The method according to claim 1, wherein the at least one additional component is at least one of an initiator, a thickening agent, and a radiopaque agent. 7. The method according to claim 1, wherein the at least one additional component is an initiator. 8. The method according to claim 1, wherein the polymerizable monomer comprises a 1,1-disubstituted ethylene monomer. 9. The method according to claim 1, wherein the polymerizable monomer is an α-cyanoacrylate. 10. The method according to claim 1, wherein at least one of the first and second containers is sealed to maintain contents of said first container separate from contents of said second container. 11. The method according to claim 1, wherein at least one of the first and second containers is made of glass. 12. The method according to claim 1, wherein at least one of the first and second containers is made of plastic. 13. The method according to claim 1, wherein the first and second containers are independently selected from the group consisting of ampoules, vials, syringes, pipettes, tubes and applicators. 14. The method according to claim 1, wherein the first and second containers are compatible with e-beam. 15. The method according to claim 1, wherein the first container contains said polymerizable monomer, and said second container contains a plasticizer, a thickening agent, a radiopaque agent, and an initiator agent for said polymerizable monomer. 16. The method according to claim 1, wherein the first container contains said polymerizable monomer and at least one of a plasticizer, a thickening agent, and a radiopaque agent, and said second container contains an initiator agent for said polymerizable monomer and at least one other of the plasticizer, the thickening agent, and the radiopaque agent not packaged in the first container. 17. The method according to claim 1, further comprising sealing said kit packaging element prior to said second sterilization process. 18. The method according to claim 16, further comprising, prior to said sealing step, a third sterilization process to sterilize exposed surfaces in said kit packaging element. 19. The method according to claim 18, wherein said third sterilization process comprises exposure to ethylene oxide or hydrogen peroxide vapor. 20. The method according to claim 1, wherein at least one applicator for said polymerizable adhesive composition is included in said kit packaging element. 21. The method according to claim 1, wherein at least one material contained in said first container is incompatible with at least one material contained in said second container, at least prior to said first sterilization process. 22. The method according to claim 1, wherein at least one material contained in said first container is incompatible with at least one material contained in said second container, at least after said first sterilization process but not before said first sterilization process. 23. The method according to claim 1, wherein the first container is a glass ampoule and the second container is a plastic syringe. 24. The method according to claim 1, wherein the first and second sterilization processes are independently selected from the group consisting of irradiation, physical treatment, or chemical treatment. 25. The method according to claim 1, wherein the first sterilization process comprises e-beam irradiation at a dosage of from about 5-25 kGy. 26. The method according to claim 1, wherein the second sterilization process comprises e-beam irradiation at a dosage of from about 5-25 kGy. 27. The method according to claim 1, wherein at least one of said first sterilization process and said second sterilization process comprises dry heat. 28. The method according to claim 1, wherein said kit is sterilized to provide a Sterility Assurance Level of at least 10-3. 29. The method according to claim 1, wherein the second container contains at least one material that at least partially degrades during sterilization to become incompatible with the polymerizable monomer. 30. The method according to claim 29, wherein said at least one material that at least partially degrades is a plasticizer.