Evaluation of the chemical compatibility of plastic contact materials and pharmaceutical products; safety considerations related to extractables and leachables.
A review is provided on the general topic of the compatibility of plastic materials with pharmaceutical products, with specific emphasis on the safety aspects associated with extractables and leachables related to such plastic materials.
Jenke
Dennis
D
Technology Resources Division, Baxter Healthcare Corporation, Round Lake, Illinois 60073, USA. dennis_jenke@baxter.com
D003257:Consumer Product Safety / Q000331:legislation & jurisprudence; D004340:Drug Contamination / Q000517:prevention & control*; D004349:Drug Packaging; D005060:Europe; D017408:Guidelines as Topic; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D010969:Plastics / Q000737:chemistry*; D012995:Solubility; D013678:Technology, Pharmaceutical / Q000331:legislation & jurisprudence / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration
D004364:Pharmaceutical Preparations; D010969:Plastics