Trade press release

FDA acquires GEA ConsiGma 1 unit for their CDER/OPQ Continuous Lab

02 Feb 2018

The FDA has purchased a GEA ConsiGma™ 1 OSD development unit, which is housed in the CDER/OPQ (Office of Pharmaceutical Quality). The GEA ConsiGma™ 1 will be an important asset for continuous manufacturing research within the OPQ Office of Testing and Research and Emerging Technologies Team.

FDA acquires GEA ConsiGma 1 unit for their CDER/OPQ Continuous Lab (img)

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. The result is much better process understanding in a shorter time and with lower costs.

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About GEA

GEA is one of the world’s largest suppliers of systems and components to the food, beverage and pharmaceutical industries. The international technology group, founded in 1881, focuses on machinery and plants, as well as advanced process technology, components and comprehensive services.

With more than 18,000 employees, the group generated revenues of about EUR 5.4 billion in more than 150 countries in the 2023 fiscal year. GEA plants, processes, components and services enhance the efficiency and sustainability of customer’s production. They contribute significantly to the reduction of CO2 emissions, plastic usage and food waste. In doing so, GEA makes a key contribution toward a sustainable future, in line with the company’s purpose: ”Engineering for a better world“. GEA is listed on the German MDAX the European STOXX® Europe 600 Index and is among the companies comprising the DAX 50 ESG, MSCI Global Sustainability as well as Dow Jones Sustainability World and Dow Jones Sustainability Europe Indices.
 
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