The FDA has purchased a GEA Consigma 1 OSD development unit, for their continuous manufacturing research within the OPQ Office of Testing and Research and Emerging Technologies Team.
Düsseldorf/Germany — The FDA/CDER/OPQ mission is to ensure that safe, effective, high quality drugs are available for the American public. Established in 2015, OPQ encourages and supports development and adoption of emerging technology to modernize pharmaceutical development and manufacturing.
In development, scientist and engineers need to investigate the capability of their processes and develop strategies to avoid or manage the effects variability from various sources.
The GEA Consigma 1 enables development of granules following QbD principles via fast DOE approaches with controlled continuous operation, providing an opportunity to explore a wider range of process parameters with less product and less time. According to the company, the result is better process understanding in a shorter time and with lower costs.
The machine consists of a continuous high shear granulator, equipped with auxiliaries that allow the development of the granulation process. A small dryer equal to one drying segment of the Consigma production dryer and capable of handling 0.5 to 1.5 kg of granules, can be added to the lab machine, creating a combination with integrated controls for the development of continuous processes.