title: Accumulation of organic compounds leached from plastic materials used in biopharmaceutical process containers.
abstract: Plastic materials are widely used in medical items, such as solution containers, transfusion sets, transfer tubing, and devices. An emerging trend in the biotechnology industry is the utilization of plastic containers to prepare, transport, and store an assortment of solutions including buffers, media, and in-process and finished product. The direct contact of such containers with the product at one or more points in its lifetime raises the possibility that container leachables may accumulate in the finished product. The interaction between several commercially available container materials and numerous model test solutions (representative of buffers and media used in biopharmaceutical applications) was investigated. This paper summarizes the identification of leachables associated with the container materials and documents the levels to which targeted leachables accumulate in the test solutions under defined storage conditions.
authors.affiliation: Technology Resources Division, Baxter Healthcare Corporation, William Graham Science Center, Round Lake, IL 60073, USA. dennis_jenke@baxter.com
authors.forename: Dennis R
authors.initials: DR
authors.lastname: Jenke
authors.forename: David
authors.initials: D
authors.lastname: Zietlow
authors.forename: Mary Jo
authors.initials: MJ
authors.lastname: Garber
authors.forename: Salma
authors.initials: S
authors.lastname: Sadain
authors.forename: Duane
authors.initials: D
authors.lastname: Reiber
authors.forename: William
authors.initials: W
authors.lastname: Terbush
mesh_terms: D000085:Acetates / Q000032:analysis; D000577:Amides / Q000032:analysis; D002021:Buffers; D002852:Chromatography, Ion Exchange; D002853:Chromatography, Liquid; D004340:Drug Contamination / Q000517:prevention & control*; D004349:Drug Packaging / Q000295:instrumentation*; D004356:Drug Storage; D004867:Equipment Design; D005227:Fatty Acids / Q000032:analysis; D005561:Formates / Q000032:analysis; D006863:Hydrogen-Ion Concentration; D013058:Mass Spectrometry; D009930:Organic Chemicals / Q000032:analysis*; D010969:Plastics / Q000737:chemistry*; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet
chemical_list: D000085:Acetates; D000577:Amides; D002021:Buffers; D005227:Fatty Acids; D005561:Formates; D009930:Organic Chemicals; D010969:Plastics