PDA Journal of GMP and Validation in Japan
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
Volume 21 , Issue 2
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  • Daisuke Yamakawa, Naomi Hoshino, Hideki Kurashima, Hirotoshi Awatsu
    2019 Volume 21 Issue 2 Pages 27-38
    Published: 2019
    Released: December 23, 2019

    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.

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