Development of a Novel Continuous Filtration Unit for Pharmaceutical Process Development and Manufacturing |
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Authors: | Sara Ottoboni Chris J Price Christopher Steven Elizabeth Meehan Alastair Barton Paul Firth Andy Mitchell Furqan Tahir |
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Affiliation: | 1. EPSRC Centre for Innovative Manufacturing in Continuous Manufacturing and Crystallisation, University of Strathclyde, Glasgow, G1 1RD, UK;2. Department of Chemical and Process Engineering, University of Strathclyde, Glasgow, G1 1RD, UK;3. Alconbury Weston Ltd, Stoke-on-Trent, ST4 3PE, UK;4. AstraZeneca, Pharmaceutical Technology & Development, Macclesfield, SK10 2NA, UK;5. Perceptive Engineering Ltd, Sci-Tech Daresbury, Warrington, WA4 4AB, UK |
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Abstract: | The lack of a commercial laboratory, pilot and small manufacturing scale dead end continuous filtration and drying unit it is a significant gap in the development of continuous pharmaceutical manufacturing processes for new active pharmaceutical ingredients (APIs). To move small-scale pharmaceutical isolation forward from traditional batch Nutsche filtration to continuous processing a continuous filter dryer prototype unit (CFD20) was developed in collaboration with Alconbury Weston Ltd. The performance of the prototype was evaluated by comparison with manual best practice exemplified using a modified Biotage VacMaster unit to gather data and process understanding for API filtration and washing. The ultimate objective was to link the chemical and physical attributes of an API slurry with equipment and processing parameters to improve API isolation processes. Filtration performance was characterized by assessing filtrate flow rate by application of Darcy's law, the impact on product crystal size distribution and product purity were investigated using classical analytical methods. The overall performance of the 2 units was similar, showing that the prototype CFD20 can match best manual lab practice for filtration and washing while allowing continuous processing and real-time data logging. This result is encouraging and the data gathered provides further insight to inform the development of CFD20. |
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Keywords: | continuous filtration washing drying agglomeration impurity optimisation |
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