title: Continuous Processing of Active Pharmaceutical Ingredients Suspensions via Dynamic Cross-Flow Filtration.
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.
authors.affiliation: Research Center Pharmaceutical Engineering, Graz, 8010, Austria.
authors.forename: Johannes
authors.initials: J
authors.lastname: Gursch
authors.affiliation: Research Center Pharmaceutical Engineering, Graz, 8010, Austria.
authors.forename: Roland
authors.initials: R
authors.lastname: Hohl
authors.affiliation: Research Center Pharmaceutical Engineering, Graz, 8010, Austria.
authors.forename: Gregor
authors.initials: G
authors.lastname: Toschkoff
authors.affiliation: Research Center Pharmaceutical Engineering, Graz, 8010, Austria.
authors.forename: Diana
authors.initials: D
authors.lastname: Dujmovic
authors.affiliation: Novartis Pharma AG Basel, Basel, 4056, Switzerland.
authors.forename: Jörg
authors.initials: J
authors.lastname: Brozio
authors.affiliation: Novartis Pharma AG Basel, Basel, 4056, Switzerland.
authors.forename: Markus
authors.initials: M
authors.lastname: Krumme
authors.affiliation: Novartis Pharma AG Basel, Basel, 4056, Switzerland.
authors.forename: Norbert
authors.initials: N
authors.lastname: Rasenack
authors.affiliation: Research Center Pharmaceutical Engineering, Graz, 8010, Austria.|Institute of Process and Particle Engineering, Graz University of Technology, Graz, 8010, Austria.
authors.forename: Johannes
authors.initials: J
authors.lastname: Khinast
mesh_terms: D000465:Algorithms; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000737:chemistry; D003890:Desiccation; D004339:Drug Compounding; D005374:Filtration / Q000379:methods*; D007052:Ibuprofen / Q000008:administration & dosage / Q000737:chemistry; D016014:Linear Models; D008567:Membranes, Artificial; D008962:Models, Theoretical; D010316:Particle Size; D013535:Suspensions / Q000737:chemistry*; D014783:Viscosity
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D008567:Membranes, Artificial; D013535:Suspensions; D007052:Ibuprofen
keywords: continuous manufacturing; cross-flow filtration; drying; mathematical model; membrane filtration; modeling concentration polarization layer; processing; separation science; small-scale; unit operations