title: Accumulation of extractables in buffer solutions from a polyolefin plastic container.
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 large plastic containers to prepare, transport and store an assortment of solutions including buffers, media and in-process and finished products. The direct contact of such containers with the product at one or more points in its lifetime raises the possibility that container extractables may end up in the finished product. The interaction between a polyolefin container material and several test solutions representative of buffers and media used in biopharmaceutical applications was investigated. This manuscript summarizes the identification of the major extractables associated with the polyolefin container and documents the levels to which targeted extractables accumulate in the test solutions under several storage regimes.
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: Jill M
authors.initials: JM
authors.lastname: Jene
authors.forename: Mitchell
authors.initials: M
authors.lastname: Poss
authors.forename: James
authors.initials: J
authors.lastname: Story
authors.forename: Tom
authors.initials: T
authors.lastname: Tsilipetros
authors.forename: Alex
authors.initials: A
authors.lastname: Odufu
authors.forename: William
authors.initials: W
authors.lastname: Terbush
mesh_terms: D002021:Buffers; D002853:Chromatography, Liquid; D004349:Drug Packaging; D004356:Drug Storage; D008401:Gas Chromatography-Mass Spectrometry; D006863:Hydrogen-Ion Concentration; D013058:Mass Spectrometry; D011095:Polyethylenes / Q000737:chemistry*; D011140:Polyurethanes / Q000737:chemistry*; D011145:Polyvinyls / Q000737:chemistry*; D012015:Reference Standards; D012996:Solutions; D012997:Solvents; D013056:Spectrophotometry, Ultraviolet; D013696:Temperature
chemical_list: D002021:Buffers; D011095:Polyethylenes; D011140:Polyurethanes; D011145:Polyvinyls; D012996:Solutions; D012997:Solvents; C020320:ethylene-vinyl alcohol copolymer