The influence of product factors on the migration in soft polyvinyl chloride infusion fluid bags.
The concentration of epoxidized vegetable oils (EVO) and di(2-ethylhexyl) phthalate (DEHP) in infusion fluids in soft polyvinyl chloride (PVC) bags has been determined by gas-liquid chromatography prior to and after agitation. Normal saline, isotonic glucose and Ringer acetate from four different manufacturers were investigated. Agitation resulted in an increased concentration of EVO and DEHP. Significant differences in contamination level were observed between solutions of different compositions and in synonymous preparations from different manufacturers. The results indicated that the total amount of migrating EVO and DEHP was affected by the pH of the solution and by the age of the plastic material. It is suggested that the migration of EVO and DEHP during agitation is influenced by the concentration of plastic degradation products.
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D002626:Chemistry, Pharmaceutical; D004051:Diethylhexyl Phthalate / Q000032:analysis*; D004340:Drug Contamination; D007262:Infusions, Intravenous / Q000295:instrumentation*; D010795:Phthalic Acids / Q000032:analysis*; D010938:Plant Oils / Q000032:analysis*; D011143:Polyvinyl Chloride / Q000032:analysis*; D011145:Polyvinyls / Q000032:analysis*
D010795:Phthalic Acids; D010938:Plant Oils; D011145:Polyvinyls; D011143:Polyvinyl Chloride; D004051:Diethylhexyl Phthalate