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2005
Journal Article
Titel
Migration of radiolysis products from radiation-sterilized plastics
Abstract
During sterilization of pharmaceutical packaging materials with ionizing radiation degradation products of polymer and polymer additives were generated. Therefore irradiation might influence the migration of compounds from packaging materials into the pharmaceutical product. From HDPE the migration of radiolysis compounds is increasing with increasing radiation dose. In contrast the migration of polymer additives is decreasing due to the fate of these additives. Compared to HDPE the polyester PEN shows no significant differences after irradiation. Even after a relatively high dose of 30 kGy virtually the same amount of extractables were obtained as for the untreated reference sample.