Jetpharma - Micronization & Particle Size Reduction Experts

Services Offered :

o         Jet-milling Micronization:

• 4 dedicated cabins (APIs; Antibiotics (No B-Lactams); Psychotropics);
• 1 dedicated cabins (Steroids);
• 2 dedicated cabins (HPAPIs; Cytotoxics; Cytostatics);

o    De-Lumping;

o    Dispensing;

o    Packaging under Inert Atmosphere;

o    Blending;

o    Sieving;

o    Co-Micronization;

o    Cryogenic Micronization;

o    Mechanical Milling;

o    Micronization into Isolated Enviroment, our plant is equipped with two isolators : Glove box & Half Suite box. The first one is equipped with a MC Jetmill 50 instead the second one is equipped with a MC Jetmill 200, a MC Jetmill 300 and also a Pin Mill UPZ 160.

• Level of Containment < 25 ng/m3 (8h-TWA)

Quality control Lab. Activities :

o    Identification analysis;

o    Cleaning validation study;

o    Particle size distribution analysis;

o    Microbiological monitoring of environment, water and equipment surface;

o    Analytical method transfer;

o    Analytical method comparison study;

o    Contract laboratory for PSD analysis;

o    Process parameter study, to define and support the validation activity;

o    Process validation;

o    Analytical method validation;

o    Analytical method correlation study

 We know very well the importance to build a long lasting relationship with our Costumers based on an open and clear communication and a flexible business model.

Our deep understanding of Micronization process and our own micronization technology allows us to optimise key success factors very early in the process avoiding any waste (Process yield between 98-99 %).

 Micronization is performed at the client specified quantities from small scale (0.2 grams) for basic research and initial phase of the clinical trials, up to very large commercial scale (>1 Tons).

Finally, the reputation that JETPHARMA has with the Authorities is confirmed by Swiss Medic, by the successful FDA 

Inspection history, as well as by the achievement of AFM (Accreditation of Foreign Manufacturer) filed at the Japanese PMDA and the positive outcome of the routine domestic inspections.less