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Pharmaceutical Continuous Manufacturing: Content Uniformity With PAT And RTR
| Contributor(s):: Richard Steiner
In pharmaceutical continuous manufacturing (PCM), technical solutions ensuring critical quality attributes for content uniformity and unit dose exist for online, in-line, and at-line measurements. Process analytical technology (PAT) allows in-line measurement and control of critical process...
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Development and Application of Control Concepts for Twin-Screw Wet Granulation in the ConsiGmaTM-25: Part 2 Granule Size
| Contributor(s):: Selma Celikovic, Johannes Poms, Johannes Khinast, Martin Horn, Jakob Rehrl
Traditional operation modes, such as running the production processes at constant process settings or within a narrow design space, do not fully exploit the advantages of continuous pharmaceutical manufacturing. Integrating Quality by Control (QbC) algorithms as a standard component of...
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A Focused and Flexible Analytical Strategy is Key to Unlocking the Benefits of Continuous Manufacturing
| Contributor(s):: Bikash Chatterjee
Continuous manufacturing processes promise shorter manufacturing cycle times without the need for intermediate storage, sampling testing and release of intermediate process steps, and shorter product release times through the intelligent application of in-line and at-line testing strategies....
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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...