The particle size is an important parameter in the development and manufacture of pharmaceutical products. Micronisation serves to significantly improve the dissolution rate of active pharmaceutical ingredients (API). In the case of inhalers (DPI – dry powder inhalers), the particle size of the active ingredients and carriers is a decisive, quality-determining property in the formulation of the dry powder. The optimal particle size ensures the transport of the medicine into the lungs and also its effectiveness.
Flexibility is required with respect to the different fineness values and products. Furthermore, varying batch sizes often call for different handling concepts.
The process transfer is a special challenge: whether it be from development to production scale regardless of the location, or to a toll manufacturer.
The quality is always paramount in the manufacture of pharmaceuticals, achieved through reliable, reproducible and well-documented processes.
Whether continuous production or batch mode, the construction materials, surfaces, the automation and documentation of production systems for pharmaceuticals are all prepared according to cGMP design criteria.