The current output allows to accept orders for micronisation of approximately 2000 kg of different substances annually. The installation for particle size reduction can be used for conducting of micronisation of various kinds of APIs or other substances like excipients and dietary supplements. In order to be with accordance of GMP rules each new substance has to be evaluated regarding its toxity and risk of potential contamination.
The worst case might require a cleaning validation. In order to check how a new substance behave itself during the process and to determine operation parameters trial micronisation on approx. 5 kg will be required. For sensitive solid materials particle size reduction can be performed in a nitrogen atmosphere. Polfa Tarchomin S.A. will provide also necessary documentation needed for authorization processes. The batch size of micronisation service can vary from 5 kg to 15 kg in respect to homogeneous solid materials. There is also feasibility to conduct continuous process of micronisation of the solid materials.