Our commercial plant in Mannheim, Germany is designed based on a containment concept utilizing closed systems and Rapid Transfer Ports (RTPs) as well as a strict zone concept with pressure cascades, airlocks and access control. This puts us in a position to handle high potent compounds and cytotoxic material in a safe way. The manufacturing of highly potent APIs with an OEL < 1 µg/m3 is daily business in this plant.
A variety of reaction vessels (100 l – 1000 l, stainless steel and glass lined) enables us to perform a vast collection of chemical synthesis from -70°C up to 140°C. Distillation processes, extractions and crystallizations are used for the purification of the final products. For challenging purification tasks a commercial high pressure chromatography system with dedicated columns is installed.
After crystallization of the final product the crystals are isolated in closed Nutsch filters with containment discharging systems. Final product is handled in glove boxes.
The productivity of the production lines ranges per batch from several hundred grams up to the multi kg scope depending on the process. The plant is appropriate for sophisticated multi step manufacturing of HPAPIs.
All activities in the plant are designed to be in full compliance with cGMP.