Development and Scale-Up of Diversion Strategy for Twin Screw Granulation in Continuous Manufacturing
| Autor: | Alex Hesketh, Lee Gorringe, Pallavi Pawar, Donald J. Clancy, Steve Barlow, Richard Elkes |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
business.industry
Drug Compounding PREVENT (product) Pharmaceutical Science Water 02 engineering and technology Continuous manufacturing 021001 nanoscience & nanotechnology Residence time distribution 030226 pharmacology & pharmacy Unit operation 03 medical and health sciences Granulation 0302 clinical medicine Fluidized bed SCALE-UP Process control Environmental science Technology Pharmaceutical Particle Size Powders 0210 nano-technology Process engineering business |
| Zdroj: | Journal of pharmaceutical sciences. 109(11) |
| ISSN: | 1520-6017 |
| Popis: | Successful implementation of Continuous Manufacturing technology requires real time product quality monitoring that can result into rejection strategies for material manufactured outside process control limits. In a twin screw granulation process, parameters like water content, powder feed rate, and granulator screw speed can influence granule quality. Deviations in any of these parameters from the set-point may affect granule quality. Having a sound diversion strategy in place can help divert these implicated granules to waste. Residence time distribution experiments were conducted on a 16-mm Thermo Fisher twin screw granulator (TSG) for a range of process parameters, and the data was modelled to predict the needed diversion time as a function of process parameters. Scale-up from the 16-mm to 24-mm granulator was evaluated and data was found to scale based on mass per unit volume of granulator (channel fill), thus enabling 16-mm data to scale to 24-mm. The diversion strategy proposed is based on utilizing a wash out curve derived from residence time distribution to quantify the maximum concentration of implicated material that could be present in the next downstream unit operation(s) (e.g. a fluid bed dryer) and ensuring it is less than a suitable threshold to prevent product quality impact. |
| Databáze: | OpenAIRE |
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