Extractables and Leachables: Determining Risk in Single-Use Systems

Published on: 
BioPharm International, BioPharm International-06-15-2019, Volume 2019 eBook, Issue 2
Pages: 20–23

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.

Read this article in BioPharm International's Single-Use Systems 2019 eBook.


Article Details

BioPharm International
eBook: Single-Use Systems 2019
Vol. 32
June 2019
Pages: 20–23



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).