Extractables and Leachables Assessment of Single Use Systems Used for Biologics

Rubrik: Praxis

(Treffer aus pharmind, Nr. 09, Seite 1200 (2020))

Mogler L | Mahler H | Jahn M

Extractables and Leachables Assessment of Single Use Systems Used for Biologics / Mogler et al. • Extractables and Leachables Assessment · Mogler L, Mahler H, Jahn M · Lonza Drug Product Services, Basel, Switzerland
mapping of the process, including a description of the relevant contact conditions between the materials and the product stream, material risk evaluation, resulting in risk categorization of materials, evaluating existing and prior results (“vendor data”) from quantitative laboratory studies on high risk materials against analytical thresholds derived from safety thresholds, performing quantitative E&L laboratory studies, if the previous step is not conclusive and if quantitative data are required, and proceeding with E&L compounds exceeding safety thresholds, i.e. structure elucidation and toxicological assessments. Abbildung des Prozesses mit einer Beschreibung der relevanten Kontaktbedingungen zwischen Materialien und Produktstrom, Risikobeurteilung des Materials mit dem ...