A CHRISPRO® JET-MILL MC 100 W, GLOVE BOX has been chosen as dedicated equipment to the micronisation of cytostatic compounds. The equipment is placed in plant M1 into a classified class C room with separated HVAC system. Dedicated closed canister and HEPA filters are installed.

The room has independent access, a ventilated dressing interlock with different flow for personnel and materials. The Glove Box works under nitrogen atmosphere with negative pressure.

A washing in place system is installed, and the waste media is separately collected in a 20 lt. stainless steal drum and sent to be incinerated.

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.