Irradiated fluoropolymer articles having low leachable fluoride ions

摘要

The invention relates to fluoropolymer articles that have been irradiated with at least 5 Kilo Gray of radiation, where the resulting articles have low levels of leachable or extractable fluoride ion. The low fluoride ion migration from the irradiated article is due to the presence of low levels of metallic salts or oxides in the fluoropolymer composition. The invention is especially useful for fluoropolymer articles in which the fluoropolymer layer contacts a biological or pharmaceutical fluid, and that are subjected to sterilization by irradiation.

主权项

1. A sterile, irradiated fluoropolymer article having low leachable fluoride ions comprising at least one fluoropolymer composition layer that will contact a fluid, wherein said fluoropolymer composition consists of a blend of
a) at least one fluoropolymer, wherein said fluoropolymer is selected from the group consisting of polyvinylidene fluoride homopolymers; polyvinylidene fluoride copolymers consisting of greater than 70 percent by weight of vinylidene fluroide monomer units; polyethylene trifluoroethylene homopolymers and copolymers; polytetrafluoroethylene homopolymers, and copolymers; poly(ethylene tetrafluoroethylene), and terpolymers of tetrafluoroethylene, hexatluoropropene and vinylidene fluoride, and blends thereof; and b) from 50 to 50,000 ppm of at least one metal salt or a metal oxide, and c) less than 5 percent by weight of other addditives, wherein said fluropolymer article has been exposed to at least 20 KGray of radiation and is sterile, and wherein said fluoropolymer article has low leachable fluoride ions of as determined by forming said fluoropolymer composition into a 2 mil thick bag, irradiating said bag with 25-50 KGray of gamma radiation, filling said bag with a 80% strill water for injection/20% ethanol solution, with a surface to liquid volume ratio of 2.21 /cm. for 14 days at 40° C., with the measured extracted fluoride ion being less than 10 ppm, and wherein said fluoropolymer composition contains less than 5 weight percent of additives selected from the group consisting of pigments, dyes, fillers, surfactants, flame retardants, antioxidants, heat stabilizers and polymers that are non-fluoropolymers.