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Andreas Nixdorf is business development manager Extractables & Leachables Testing at SGS.
As SUS become prevalent in the biologics industry, the question of safety becomes increasingly important.
Single-use systems (SUS) are increasingly becoming the norm in biologics development and manufacturing. Approximately 85% of the pre-commercial biopharmaceutical sector use SUS, and they are increasingly being adopted for commercial manufacturing. SUS have significant advantages but are not without drawbacks. A 2018 survey showed that 73.3% of biologics insiders listed contamination from extractables and leachables to be a major problem.
eBook: Single-Use Systems 2019
When referring to this article, please cite it as A. Nixdorf, "Extractables and Leachables: Determining Risk in Single-Use Systems," BioPharm International Single-Use Systems eBook (June 2019).