Evaluating single-use systems for extractables and leachables is new territory for many end-users. This paper presents a risk-based approach for evaluating extractables and leachables from single-use systems. Approaches are described that have been accepted by various regulatory agencies utilizing risk assessments and sound scientific principles. Biopharmaceutical processing materials must be evaluated to determine whether they impact the final drug product with regard to safety and efficacy. For single-use and reusable systems, this usually leads to evaluations that demonstrate compatibility with…