How do you assess and manage extractables and leachables risk in single-use systems?

Extractables/leachables (E&L) assessment ensures patient safety from plastic-derived contaminants. Extractable studies: aggressive solvent extraction under exaggerated conditions, comprehensive analytical profiling (GC-MS, LC-MS, ICP-MS for metals), identification and quantification of extracted compounds. Leachable studies: product contact under actual process conditions, focusing on compounds with toxicological concern. Risk assessment: toxicological evaluation using permitted daily exposure (PDE) thresholds, consideration of patient population and dosing regimen, safety margins calculation. Control strategy: supplier qualification (BPOG guidelines), incoming QC testing, process parameter limits (time, temperature), and routine product testing. Documentation requirements: following PQRI guidance for regulatory submissions. For novel materials, comprehensive studies are required; established materials may leverage platform data. Material changes require reassessment.