Prospective Process Validation Protocol (PVP):

the validation of the micronization process ensures constant critical process parameters are used for the micronization of an API (Active Pharmaceutical Ingredient).

Three validation batches are used in order to evaluate the homogeneity between batches (interlot validation) and from the beginning to the end of the micronization of each batch (intralot validation).

At least five in-process controls samples are taken for each validation batch. At the end of the validation a Master Batch Record is issued.

If you are interested in validating the micronization of your product, please contact our QA department.

Possibility to produce nanoparticles by super- critical fluid precipitation under fully cGMP conditions.