Abstract
| Language | English |
|---|---|
| Number of pages | 9 |
| Journal | International Journal of Pharmaceutics |
| Early online date | 15 Sep 2015 |
| DOIs | |
| Publication status | Published - 2015 |
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Keywords
- twin screw granulation
- in-line image analysis
- shewhart control charts
- continuous pharmaceutical manufacturing
- process analytical technology
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Investigation of an 11mm diameter twin screw granulator : screw element performance and in-line monitoring via image analysis. / Sayin, Ridade; Martinez Marcos, Laura; Osorio, Juan G.; Cruise, Paul; Jones, Ian; Halbert, Gavin W.; Lamprou, Dimitrios A.; Litster, James D.
In: International Journal of Pharmaceutics, 2015.Research output: Contribution to journal › Article
TY - JOUR
T1 - Investigation of an 11mm diameter twin screw granulator
T2 - International Journal of Pharmaceutics
AU - Sayin, Ridade
AU - Martinez Marcos, Laura
AU - Osorio, Juan G.
AU - Cruise, Paul
AU - Jones, Ian
AU - Halbert, Gavin W.
AU - Lamprou, Dimitrios A.
AU - Litster, James D.
PY - 2015
Y1 - 2015
N2 - As twin screw granulation (TSG) provides one with many screw element options, characterization of each screw element is crucial in optimizing the screw configuration in order to obtain desired granule attributes. In this study, the performance of two different screw elements - distributive feed screws and kneading elements - was studied in an 11mm TSG at different liquid-to-solid (L/S) ratios. The kneading element configuration was found to break large granules more efficiently, leading to narrower granule size distributions. While pharmaceutical industry shifts towards continuous manufacturing, inline monitoring and process control are gaining importance. Granules from an 11mm TSG were analysed using the EyeconTM, a real-time high speed direct imaging system, which has been used to capture accurate particle size distribution and particle count. The size parameters and particle count were then assessed in terms of their ability to be a suitable control measure using the Shewhart control charts. d10 and particle count were found to be good indicators of the change in L/S ratio. However, d50 and d90 did not reflect the change, due to their inherent variability even when the process is at steady state.
AB - As twin screw granulation (TSG) provides one with many screw element options, characterization of each screw element is crucial in optimizing the screw configuration in order to obtain desired granule attributes. In this study, the performance of two different screw elements - distributive feed screws and kneading elements - was studied in an 11mm TSG at different liquid-to-solid (L/S) ratios. The kneading element configuration was found to break large granules more efficiently, leading to narrower granule size distributions. While pharmaceutical industry shifts towards continuous manufacturing, inline monitoring and process control are gaining importance. Granules from an 11mm TSG were analysed using the EyeconTM, a real-time high speed direct imaging system, which has been used to capture accurate particle size distribution and particle count. The size parameters and particle count were then assessed in terms of their ability to be a suitable control measure using the Shewhart control charts. d10 and particle count were found to be good indicators of the change in L/S ratio. However, d50 and d90 did not reflect the change, due to their inherent variability even when the process is at steady state.
KW - twin screw granulation
KW - in-line image analysis
KW - shewhart control charts
KW - continuous pharmaceutical manufacturing
KW - process analytical technology
UR - http://www.sciencedirect.com/science/article/pii/S0378517315302222
U2 - 10.1016/j.ijpharm.2015.09.024
DO - 10.1016/j.ijpharm.2015.09.024
M3 - Article
JO - International Journal of Pharmaceutics
JF - International Journal of Pharmaceutics
SN - 0378-5173
ER -