The Proof Is in the Data:Extractables and Leachables

摘要

Extractables and leachables (E&Ls) must be addressed in material, device, and process validation programs. Extractables are compounds that can be extracted from a material in the presence of solvents with varying polarity under extreme conditions. Materials and device manufacturers should make extractables guides available to end users. Leachables are compounds that migrate from a material in the presence of an actual formulation under normal process operating conditions. Extractables information canbe helpful as a basis for evaluation of potential process-equipment-related leachables (PERLs) testing.