کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
5550301 | 1557287 | 2017 | 11 صفحه PDF | دانلود رایگان |
Disturbance propagation during continuous manufacturing processes can be predicted by evaluating the residence time distribution (RTD) of the specific unit operations. In this work, a dry granulation process was modelled and four scenarios of feeding events were simulated. We performed characterization of the feeders and developed RTD models for the blender and the roller compactor based on impulse-response measurements via color tracers. Out-of-specification material was defined based on the active pharmaceutical ingredient (API) concentration. We calculated the amount of waste material at various diversion points, considering four feeder-related process-upset scenarios and formulated considerations for the development of a control concept. The developed RTD models allow material tracking of materials that may be used for following the spread contaminants within the process and for batch definition. The results show that RTD modeling is a valuable tool for process development and design, as well as for process monitoring and material tracking.
176
Journal: International Journal of Pharmaceutics - Volume 528, Issues 1â2, 7 August 2017, Pages 334-344