The Importance of Extractables & Leachables Testing for Injectable Drug Delivery Systems
نویسنده
چکیده
Copyright © 2009 ONdrugDelivery Publishing Ltd 22 Suppliers of pharmaceutical packaging components and delivery devices have been working closely with the industry in an effort to provide solutions for mitigating the risk associated with extractables and leachables. This effort includes managing both the technical and regulatory aspects of the subject. The following example illustrates the challenges faced by the industry. A company that produces and fills an injectable drug product wanted to move from a glass vial with a bromobutyl stopper to a prefilled syringe delivery system. With a prefilled syringe system, there is direct contact between the elastomeric plunger and the drug product in the syringe system. The same bromobutyl elastomer used for the vial stopper was also used for the syringe plunger.
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