Understanding the Testing Behind Drug Delivery DevicesUnderstanding the Testing Behind Drug Delivery Devices

Katie Grayson, of EKG Labs, is set to speak about analytical considerations surrounding extractables and leachables testing of drug-delivery devices at BIOMEDevice Silicon Valley.

MDDI Staff

November 22, 2022

1 Min Read
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Image courtesy of Andrii Dragan / Alamy Stock Photo

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.

Katie Grayson, a general manager at EKG labs, will present an 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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