Analytical Development Protocol and Report (ADP + ADR)

In the laboratories of micromacinazione SA the particle size analyses are performed using an instrument which operates on the principle of pure diffraction of a Laser beam. These studies are intended to verify that the method developed and used for the determination of the particle size of each product produces accurate results.


Analytical Validation Protocol and Report (AVP + AVR)

These validation studies are intended to verify robustness, intermediate precision and repeatability of the method developed and used for the determination of the particle size of the product.



All the operations are conducted following micromacinazione's Standard Operating Procedures (SOP) and every instrument involved in the process is regularly calibrated.

If you are interested in validating the method of analysis of your product, please contact our QC department.

We are glad to announce that recently (28-30 March 2012) we passed a 3-day FDA inspection successfully at both our manufacturing sites, Molinazzo di Monteggio and Madonna del Piano, without any observation.

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