2019 Volume 21 Issue 2 Pages 27-38
Since early 2000s, Single Use Technologies have been implemented rapidly in Biopharmaceutical manufacturing process. One of main reason was giving high benefit of reducing Time to Market by faster start up, lower cost and more flexibility of pharmaceutical drug manufacturing facility. However, there are still some concerns with this technology in the market. We would like to discuss two major industry concerns, Extractables/Leachables and Leak risk of Single Use system by introducing current industry discussion and scientific information.