Drug manufacturing is an ultra-sterile process. Numerous regulations need to be complied with when pharmaceuticals are sold worldwide, as is the case at this Belgian plant, where a global pharmaceutical company makes cardiac and cancer drugs – naturally under optimally sterile conditions. Even taking photos for this article inside the cleanroom – which is still in its test and startup phase – was a complicated process. But let’s start at the beginning.
Especially for its drugs, which are produced for heart and cancer therapies, this pharmaceutical company applies for itself, as a self-image, manufacturing methods that exceed the standards. In addition, for the quality standard, according to an FDA guideline, the human factor, as a non-sterile source, had to be excluded for these drugs and therefore switched to a completely machine production.
In the Belgian production plant of the pharmaceutical company, a new clean room area is currently being put into operation. A clean room? No! We are talking about up to four movable cleanrooms in the cleanroom itself. The idea came from Hürth near Cologne, from the experts at GEA Lyophil. Drawing on the wide-ranging experience of GEA's experts and the systems already in operation at this manufacturer, GEA was entrusted with the challenge: "How can the process steps of an existing plant be expanded and integrated in such a way that it secures the site for the next 10 to 20 years?"