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Continuous Processing of Active Pharmaceutical Ingredients Suspensions via Dynamic Cross-Flow Filtration
Johannes Gursch1, Roland Hohl1, Gregor Toschkoff1
1Research Center Pharmaceutical Engineering, Graz, 8010, Austria.
Journal of Pharmaceutical Sciences
|July 7, 2015
Summary
Continuous filtration using a dynamic cross-flow filtration (CFF) device proves effective for pharmaceutical manufacturing. A simple linear model accurately describes CFF performance across various active pharmaceutical ingredients.
Area of Science:
- Pharmaceutical Manufacturing
- Chemical Engineering
- Filtration Technology
Background:
- Continuous manufacturing is increasingly important in the pharmaceutical industry.
- Continuous filtration presents challenges, especially at low flow rates and high solid loadings.
- Dynamic cross-flow filtration (CFF) offers a potential solution for these challenges.
Purpose of the Study:
- To test and characterize a commercially available dynamic cross-flow filtration (CFF) device.
- To evaluate the suitability of CFF for continuous filtration of active pharmaceutical ingredients (APIs).
- To develop a model describing the filtration performance of the CFF device.
Main Methods:
- Testing and characterization of a commercially available CFF device.
- Filtration experiments using model active pharmaceutical ingredients (APIs).
- Analysis of feed and permeate rates, concentration factors, and concentration polarization.
Main Results:
- The CFF device is highly suitable for continuous filtration applications.
- A material-specific linear relationship between feed and permeate rate was identified for all tested APIs.
- A constant concentration factor was achieved for each substance, and a one-parameter linear model effectively described CFF performance.
Conclusions:
- Dynamic cross-flow filtration (CFF) is a viable technology for continuous pharmaceutical manufacturing.
- The filtration performance of CFF can be accurately predicted using a simple, one-parameter linear model.
- Understanding concentration polarization is key to optimizing CFF performance for different APIs.
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