Wednesday 17 August 2016
Mixing Consultants Inc Presents - "Design & Implementation of Continuous Pharmaceutical Manufacturing Processes" by Academic Experts from Rutgers University and Recognised Industry Leaders. Sponsored by Coperion K-Tron, Freeman Technology, Gericke, Glatt & Optimal
Day 1: Fundamentals / Regulatory / Main Process Components.
Review of main technology options for continuous direct compression, continuous dry granulation via roller compaction, continuous wet granulation, and hot melt extrusion. Regulatory issues in continuous manufacturing. Expectations, batch definition, compliance with in-process testing requirements, process validation. Ongoing efforts to develop regulatory documents. Review of process components: conveying systems, feeders, mills, blenders, granulators, tablet press.
Day 2: Integrated Product and Process Development / Material Properties / Process Parameters.
The C-SOPS/Janssen collaboration and lessons learned from Prezista CM. Role of material properties in continuous manufacturing. Critical process parameters. Experimental design and fast product and process development.
Day 3: PAT, RTR, Process Modeling and Control.
PAT strategies. RTR methods. Dissolution prediction. Modeling of individual process operations. Process integration. Attributes of a properly designed control system. Sensitivity and robustness. Process validation. Future trends.
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