Understanding the Testing Behind Drug Delivery Devices - Medical Device and Diagnostics Industry

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Katie Grayson, of EKG Labs, is acceptable to talk astir analytical considerations surrounding extractables and leachables investigating of drug-delivery devices astatine BIOMEDevice Silicon Valley.

MDDI Staff | Nov 22, 2022

Drug-delivery devices merchandise a cause merchandise implicit clip into the quality body. Depending connected whether the merchandise is intended to beryllium submitted arsenic a aesculapian instrumentality oregon arsenic a pharmaceutical cause product, the requirements for extractable and leachable (E&L) investigating whitethorn differ. E&L investigating for aesculapian devices is typically defined arsenic chemic characterization of aesculapian instrumentality materials per ISO 10993-18.

An E&L survey for pharmaceutical cause products typically follows USP <1663> and <1664> for extractables and leachables associated with pharmaceutical packaging/delivery systems.

Katie Grayson, a wide manager astatine EKG labs, will contiguous an overview E&L studies, comparing and contrasting E&L requirements betwixt pharmaceutical products and aesculapian devices. Key elements regarding E&L survey plan of drug-delivery products volition beryllium discussed. Case studies connected the E&L investigating of drug-delivery products volition beryllium presented, including implantable infusion pumps and prefilled syringes.

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