RESOURCE

Extractables and leachables

Overview

BioPhorum (BPOG) Extractables Protocol and Leachables Best Practices Guide

Although connected and often used as one term, ‘extractables and leachables (E&L)’ the BioPhorum team has considered extractables and leachables separately in developing its thinking in this area. Resources are provided here relating to both extractables and leachables (E&L).

For clarity an extractable is a chemical entity that is extracted from a component of a process system into a solvent under controlled conditions that are usually more aggressive than normal operating conditions. Understanding what chemical compounds can be forced out of a polymeric system provides useful information in selecting the most appropriate processing materials and identifying risk.

By contrast, a leachable is a chemical entity that comes from single use systems during normal use.

Leachables have the potential to be present in the final drug product. Assessing the risk posed by leachables to deliver safe medicines is a key activity of biopharmaceutical manufacturers. It is also a regulatory requirement.

Although a distinction is made between an extractable and a leachable, the information on these pages represents a holistic approach to extractables and leachables (E&L) developed by experts from the biopharmaceutical industry and supply chain.

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