Addressing extractables and leachables

E&L Europe to revisit London this November; new study looks at interactions with pharmaceutical preparation, including the separation of components from an elastomer mixture.

Freudenberg-NOK seal materials were shown in a recent survey to provide superior hygienic properties.
Freudenberg-NOK seal materials were shown in a recent survey to provide superior hygienic properties.

In its “Current FDA Perspective on Leachable Impurities in Parenteral and Ophthalmic Drug Products,” presented at an Oct. 22-23, 2011 workshop, the agency defined extractables as "compounds that can be extracted from the container closure system when in the presence of a solvent.” Leachables were described as “compounds that can leach into the drug product formulation from the container closure as a result of direct contact with the formulation.”

The U.S. Pharmacopeial Convention provides information on extractables and leachables (E&L) in its <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems and <1664> Assessment of Leachables Associated with Pharmaceutical Packaging/Delivery Systems.

Smithers Rapra’s May 12-14 “Extractables & Leachables USA” event brought together pharmaceutical supply chain experts, chemists, scientists, toxicologists and regulatory professionals to discuss the latest research in minimizing E&L risks. Its website allows visitors to pre-register their interest for the May 2016 event.

Meanwhile, Smithers Rapra’s Extractables and Leachables Europe 2015 will revisit London Nov. 10-12, 2015. The event aims to “provide delegates with current E&L issues facing the pharmaceutical industry. The program will feature the latest developments from industry practitioners and guidance from working groups to ensure the safe delivery of pharmaceuticals. Case studies of E&Ls in numerous drug-package combinations will also be presented, in addition to the latest information on regulatory updates, scientific-based strategies and practical approaches for the evaluation of extractables and leachables for pharmaceutical packaging materials.”

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