title: The mechanism of particulate contamination in soft polyvinyl chloride infusion fluid bags.
abstract: In the seventies, it was shown that particles were generated in soft polyvinyl chloride (PVC) infusion fluid bags when they were shaken. In this investigation an exponentially modified log-normal distribution (EMLN) is fitted to the particle data. Using the formula for the volume of a sphere, the number-density distribution is converted into a volume-density distribution. The total particle load in the samples is estimated by integration for total particle volume. The results are expressed as volume concentration in plain SI-units (microliters/l). A four-factor analysis of variance demonstrates that the mechanism of the contamination process is most probably an emulsification of low molecular weight additives in the PVC plastic, i.e. di(2-ethylhexyl) phthalate (DEHP), epoxidized vegetable oils (EVO), and others.
authors.affiliation: Military Pharmaceutical Laboratory, Norwegian Joint Medical Service, Oslo.
authors.forename: P O
authors.initials: PO
authors.lastname: Roksvaag
authors.forename: P
authors.initials: P
authors.lastname: Rydstrøm
authors.forename: G
authors.initials: G
authors.lastname: Smistad
authors.forename: T
authors.initials: T
authors.lastname: Waaler
mesh_terms: D004340:Drug Contamination; D007262:Infusions, Intravenous / Q000295:instrumentation*; D011143:Polyvinyl Chloride / Q000032:analysis*
chemical_list: D011143:Polyvinyl Chloride