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.
Subject(s)
Drug Packaging , Polyethylenes/chemistry , Polyurethanes/chemistry , Polyvinyls/chemistry , Buffers , Chromatography, Liquid , Drug Storage , Gas Chromatography-Mass Spectrometry , Hydrogen-Ion Concentration , Mass Spectrometry , Reference Standards , Solutions , Solvents , Spectrophotometry, Ultraviolet , TemperatureABSTRACT
Chromatographic methods for the identification of organic compounds leached from a plastic material used in solution containers in the pharmaceutical industry are described. Based on a set of compounds identified in extracts of a multilayered polyolefin film, targeted leachables are delineated for accumulation assessments, and methods to perform target quantitation are developed and validated.
