Due to their numerous benefits, single-use systems (SUS) have been increasingly implemented in biopharmaceutical processes in the past decades. Originally used in applications for the preparation and storage of buffer and media, SUS have become more and more important in the commercial production of biopharmaceuticals.
Today, biopharmaceutical manufacturers use this technology in critical drug substance or drug product process steps such as formulation, bulk storage, bulk transport, and final filling of drug product. By using single-use technologies, manufacturers can reduce costs, increase their manufacturing flexibility and options for closed processing. Especially through the COVID pandemic, we learned that single-use solutions can enhance speed and flexibility. Nevertheless, despite all their advantages, there are still some risks associated to SUS, such as potential leakages during use.