Today, in line with the evolution of bio-processing techniques to satisfy the concepts on Pharma 4.0, there is heavy emphasis on cell line and expression system improvements. With this background, the demands on bioreactors have become more exacting over recent years, requiring paradigm shifts in manufacturing efficiencies. Continuous optimization, design improvements and characterization of bioreactors are crucial factors placing high demands for innovation in bio-pharmaceutical manufacturing. Therefore, it is inevitable that a focus is placed on new approaches in plant engineering to keep pace with the technological developments of the bio-pharmaceutical industry.
IWT worked to execute an Atorvastatin removal test as the worst-case scenario for a potential new client. The reason for buying a new cleaning system came from failures registered during their own cleaning validation test as a result of the Atorvastatin introduction. In fact, Atorvastatin proved to be resistant to removal due to the high adhesion to the BIN walls, which are used for mixing, with a criticality around the top angles. An integrative test with dihydrate Azithromycin with sugar is requested.
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