Managing API raw material variability in a continuous manufacturing line - Prediction of process robustness
Contributor(s):: Stauffer, F, Vanhoorne, VPilcer, G, Chavez, PF, Vervaet, C, De;Beer, T
Many studies on continuous twin-screw granulation only focus on the granulator without linking this process step to the upstream and downstream unit operations. Product critical quality attributes (CQAs) are however not only determined by the granulation step. In this study, the possibility to...
A very boring 120 h: 15million tablets under a continuous state of control
Contributor(s):: Holman, James, Tantuccio, Anthony, Palmera, Jhon, Doninck, Tom van, Meyer, Robert
The aimof this study is to showthe robustness of a commercial direct compression system running continuously under relevant process conditions for over 120 h. The study will apply a representative commercial control strategy including real time monitoring of process parameters, rejection of OOS...