Extractables and leachables (E&L)

Extractables are compounds that can be extracted from a material, such as single-use bags, tubing, filters or container components, under aggressive laboratory conditions; leachables are those that actually migrate into the process fluid or product under normal use. E&L assessments evaluate the risk to patients and product quality. Single-use suppliers usually provide extractables data, often generated with the BPOG standardized protocol, and the user then assesses leachables for its own process. USP <665> and <1665> address plastic components used in manufacturing. Japanese documents also use the abbreviation E&L.