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Pharmaceutical manufacturing requires that most substances used must be homogeneously distributed and finely ground. In order to accomplish this, third-party pharma chemicals as well as Bayer AG’s own specialty ingredients are sieved, homogenized if necessary, and / or subsequently micronized.
This production process is carried out using jet mills in Bayer AG’s FDA- and EU- approved drug substance finishing unit in Berlin-Charlottenburg. The modular construction of these facilities is a pioneering achievement. The micronization plant consists of several independent milling compartments, each of which has its own milling room, observation room, equipment cleaning room, and weighing room.
The milling and the observation room are separated by a decontamination chamber. To avoid cross-contamination, each module may only contain one substance. After the processing of one substance has been completed, the entire equipment and all rooms within the module are cleaned in strict accordance with cGMP guidelines.