Articles with "scaling calculations" as a keyword



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Using Extractables Data of Sterile Filter Components for Scaling Calculations

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Published in 2019 at "PDA Journal of Pharmaceutical Science and Technology"

DOI: 10.5731/pdajpst.2018.009647

Abstract: Users of single-use (SU) components need extractables data to demonstrate material safety for regulatory bodies before incorporation in the biopharmaceutical process. In this context, the correct use of such extractables data is key to deriving… read more here.

Keywords: sterile filter; use; paper; data sterile ... See more keywords