Integrated Manufacturing process for hydrogels

摘要

A method for producing a sterile packaged adhesive hydrogel product by preparing an aqueous mixture of water, a polymer which can be cross-linked by radiation to form a hydrogel, and a cross-linking inhibitor in an amount sufficient to retard the cross-linking of the polymer when the mixture is exposed to radiation; providing the mixture in a predetermined shape or configuration representative of a hydrogel product; enclosing the shaped mixture in a sealed package; and subjecting the package to a dose of radiation sufficient to simultaneously cross-link and sterilize the mixture to provide a sterile packaged adhesive hydrogel product. The invention also is directed to the sterile packaged adhesive hydrogel product formed by this method, as well as the packaged product prior to sterilization. These products include one of the aqueous mixtures described above in a predetermined shape or configuration representative of a reinforced or non-reinforced hydrogel product and a sealed package enclosing the shaped mixture.