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Continuous Processing of Active Pharmaceutical Ingredients Suspensions via Dynamic Cross-Flow Filtration

By Gursch, J; Hohl, RToschkoff, G; Dujmovic, D; Brozio, J; Krumme, M; Rasenack, N; Khinast, J

Published on CMKC

Abstract

Over the last years, continuous manufacturing has created significant interest in the pharmaceutical industry. Continuous filtration at low flow rates and high solid loadings poses, however, a significant challenge. A commercially available, continuously operating, dynamic cross-flow filtration device (CFF) is tested and characterized. It is shown that the CFF is a highly suitable technology for continuous filtration. For all tested model active pharmaceutical ingredients, a material-specific strictly linear relationship between feed and permeate rate is identified. Moreover, for each tested substance, a constant concentration factor is reached. A one-parameter model based on a linear equation is suitable to fully describe the CFF filtration performance. This rather unexpected finding and the concentration polarization layer buildup is analyzed and a basic model to describe the observed filtration behavior is developed. (c) 2015 Wiley Periodicals, Inc. a

Journal

Journal of Pharmaceutical Sciences. Volume 104, 2015, 3481-3489

DOI

10.1002/jps.24562

Type of publication

Peer-reviewed journal

Affiliations

  • Research Center Pharmaceutical Engineering (RCPE)
  • Novartis Pharma AG Basel
  • Graz University of Technology

Article Classification

Research Article

Classification Areas

  • API
  • Modeling

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