11/08/2011 | Author / Editor: Christopher Haug / Anke Geipel-Kern
“Production using bioreactors that have capacities as high as 15,000 liters would be inconceivable without dependable automation systems,” explained Gabriele Wulf who is responsible for the buffer systems at the new biotech facility during the development and startup phase. It is essential to constantly monitor and control the environment inside the bioreactors very carefully (oxygen supply, temperature, pH and stirring speed) so that the cells can propagate.
Automation makes it possible to monitor and document the entire process fully automatically. A process control system logs the data and forwards it to a higher-level IT system. Process validation is essential for any company that wants to be one of the leaders and comply with the regulatory requirements defined by EMA (EU), Swissmedic and FDA.
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