Material Understanding for Continuous Manufacturing of Solid Dosage Forms

23rd August 2018 | 10AM EST | Dr Yifan Wang, Regulatory Research Scientist, FDA CDER and Dirk Leister, Leader Technical Marketing Thermo Fisher Scientific |WATCH FOR FREE

Material Understanding for Continuous Manufacturing of Solid Dosage Forms

In continuous manufacturing of solid dosage forms, continued assurance of process performance and product quality is based on accurate and consistent flow of solid materials. Acknowledging the multidimensionality of material flow properties is often the first step to explore the material knowledge space. In addition, modular operations such as feeding and continuous blending often requires additional material testing for better understanding of process dynamics. As a key element of control strategy, tolerance of incoming material variations needs to be considered. The FDA’s Division of Pharmaceutical Quality Research is working to understand the impact of material properties and explore the material knowledge space for continuous manufacturing of solid dosage forms.

Presented by Dr Yifan Wang, Regulatory Research Scientist, FDA CDER

Yifan Wang is a regulatory research scientist at the FDA CDER’s Office of Testing and Research, Division of Pharmaceutical Quality Research. She serves as a technical expert for solid dosage forms using both batch and continuous manufacturing technologies. She is a member of the advanced manufacturing science team to expand the continuous manufacturing knowledge base. Yifan is certified by the American Society for Quality as a Six Sigma Black Belt, as well as a pharmaceutical GMP professional. With her expertise in advanced data analytics, Yifan has worked with continuous manufacturing in various aspects such as material characterization, formulation development, process optimization, and real time release testing. Yifan Wang received her B.S. in Pharmaceutical Engineering from Dalian University of Technology, China, and a Ph.D. in Chemical Engineering from Rutgers University, US. She also received certificates of completion in chemical technology and biotechnology from the Royal Institute of Technology, Sweden.


followed by

Twin-screw granulation for continuous manufacturing of solid dosage forms

For continuous manufacturing projects, twin-screw granulation (TSG) is currently the technique of choice. To leverage the full advantages of TSG for commercial use, it’s important to have a sound understanding of all process parameters and how they influence final product quality. This presentation introduces TSG as it’s used for solid dosage manufacturing; it also explains the interdependencies of key process parameters. The speaker describes the development of a robust, economical production process using a case study on a laboratory scale with online analytics.

Presented by Dirk Leister, Leader Technical Marketing Thermo Fisher Scientific

Dirk_Leister_smallDirk Leister is the head of the application team for extruders and compounders at Thermo Fisher Scientific in Karlsruhe, Germany. The team focuses on applications for extrusion-based processes used in the pharmaceutical, food, and polymer industries. Dirk holds an engineering degree in biotechnology and started his professional career in pharmaceutical research and development. After moving to the instrument manufacturing side of the industry, he had several positions in technical sales and product management. His expertise is developing applications for process equipment used to conduct formulation research, process development and manufacturing scale-up for pharmaceutical and bulk material handling. Dirk is adept at helping companies minimize optimization time, costs and efforts of their continuous process scale-up.


Sponsored by Thermo Fisher Scientific

Thermo Fisher Scientific provides reliable extrusion and granulation solutions in pharmaceutical processing. We can help you switch from batch to continuous processing with twin-screw extrusion technology and analytical expertise, and we give scientific support for scale-up of such operations. Our wide range of extruders and granulators, plus our rheometer systems, can help you meet goals faster.


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