PDA Journal of GMP and Validation in Japan
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
Review
Recent topics for Single-Use Technology
Daisuke YamakawaNaomi HoshinoHideki KurashimaHirotoshi Awatsu
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2019 Volume 21 Issue 2 Pages 27-38

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Abstract

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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© 2019 Parenteral Drug Association Japan Chapter
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