Analytical Considerations Surrounding Extractables and Leachables Testing of Drug-Delivery Devices
Drug-delivery devices release a drug product over time into the human body. Depending on whether the product is intended to be submitted as a medical device or as a pharmaceutical drug product, the requirements for extractable and leachable (E&L) testing may differ. E&L testing for medical devices is typically defined as chemical characterization of medical device materials per ISO 10993-18. An E&L study for pharmaceutical drug products typically follows USP <1663> and <1664> for extractables and leachables associated with pharmaceutical packaging/delivery systems.
This presentation will overview E&L studies, comparing and contrasting E&L requirements between pharmaceutical products and medical devices. Key elements regarding E&L study design of drug-delivery products will be discussed. Case studies on the E&L testing of drug-delivery products will be presented, including implantable infusion pumps and prefilled syringes.
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