Determination of oleamide bulk-to-surface distribution in polypropylene for medical use depending on sterilization method and storage time

Abstract

Oleamide is used as a lubricant in the manufacturing and application of polypropylene (PP) medical devices. Samples of PP were prepared with 0, 1500, and 15 000 ppm oleamide content as lubricant. The samples were either left non-sterile, sterilized with ethylene oxide (ETO), γ-radiation (γ) or autoclaved (A) and stored for up to 4 weeks. To determine the oleamide bulk-to-surface distribution depending on sterilization method and storage time an extraction method and a washing technique were applied. The oleamide content was determined by gas chromatography (GC-FID) and compared with the coefficient of friction (COF). The COF dependent on the measured lubricant content at the surface. The content of lubricant on the surface depends on the type of sterilization: ETO increased the lubricant content to some extent, γ-sterilization and autoclaving reduced it. After storage, no migration of the lubricant to the surface could be detected.