Extractables and Leachables Evaluation of Single Use Systems for Biopharmaceuticals

Rubrik: Analytik

(Treffer aus pharmind, Nr. 10, Seite 1436 (2017))

Nixdorf A

Extractables and Leachables Evaluation of Single Use Systems for Biopharmaceuticals / New Trends and Critical Considerations · Nixdorf A · SGS Institut Fresenius GmbH, Wiesbaden
Single use systems (SUS) are now widely used in pharmaceutical production [ 1–4 ]. For the most part, SUS are made from plastic materials and can be used to replace many of the fixed stainless steel components that previously predominated in process equipment. The transition has facilitated a much more flexible way of manufacturing pharmaceuticals and led to the current hot topic of continuous manufacturing [ 5–7 ]. This means that active ingredients are produced in compact, closed units, with a higher degree of automation and fewer manual interventions. For this purpose, the production steps that are performed sequentially in ...