Low dose gamma sterilization of liquid adhesives
AssigneeAdhezion Biomedical, LLC
InventorsSheng Zhang, Rafael Ruiz, Sr.
Life of this patent
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Abstract
Disclosed is a method for sterilizing adhesive 1.1-disubstituted alkylene monomer compositions, including alpha-cyanoacrylates, using low dose gamma irradiation.
Claims17
A method for sterilizing a cyanoacrylate monomer adhesive composition, comprising adding a filtered cyanoacrylate monomer adhesive composition comprising monomeric 2-octyl cyanoacrylate, about 2 to about 50 ppm of sulfur dioxide, about 200 to about 15,000 ppm of butylated hydroxyl anisole and, optionally, 18-crown-6 crown ether to individual packaging elements, each individual packaging element comprising multiple layers, wherein the inner-most layer comprises a copolymer of acrylonitrile and methyl acrylate in a ratio of acrylonitrile to methyl acrylate of 75:25;
- packaging the individual packaging elements into a container, thereby forming a package;
- and irradiating the package with gamma radiation at a dose of from about 5 to about 10 k Gy, thereby sterilizing the package, wherein the-cyanoacrylate monomer adhesive contained within the container does not cure upon gamma irradiation and for at least two years of shelf storage thereafter.
A method for sterilizing a cyanoacrylate monomer composition, comprising adding a filtered cyanoacrylate monomer composition comprising monomeric n-butyl cyanoacrylate, monomeric 2-octyl cyanoacrylate, or a mixture of monomeric n-butyl cyanoacrylate and monomeric 2-octyl cyanoacrylate, from about 5 ppm to about 50 ppm of sulfur dioxide, from about 1000 to about 15,000 ppm of butylated hydroxyl anisole and, optionally, 18-crown-6 crown ether to a package comprising multiple layers, wherein the inner-most layer comprises a copolymer of acrylonitrile and methyl acrylate in a ratio of acrylonitrile to methyl acrylate of 75:25;
- and
- irradiating said package containing said cyanoacrylate monomer composition with gamma radiation at a dose of from about 5 to about 10 kGy, wherein the cyanoacrylate monomer adhesive contained within the package does not cure upon gamma irradiation and for at least two years of shelf storage thereafter.
Dependencies are inferred from the claim text.