Nanoparticles under fully GMP conditions

Particle size reduction is a topic generating increasing interest by pharmaceutical companies.

Traditional technologies for reducing particle size such as hammer, ball, pin, jet-mills have been in use for many years.

However the smallest final granulometric size attainable with such processes is only in the range of a few microns.

An alternative technology, Supercritical Fluid Precipitation, enables production of particles with nanodimensions.

SAA (Supercritical Assisted Atomization)Patented

Both techniques are available, and the choice essentially depends on the given products affinity towards CO2 and solvent.



The plant has been designed in order to process and perform the atomization under fully GMP conditions. An automatic system controls and records all the process parameters. The cleaning is performed by CIP system (Clean In Place). The plant is able to perform the atomization under sterile conditions, (via VHP biodecontamination and SIP) providing the possibility of producing sterile nanoparticles.



Characteristics of final product

• The powder obtained from the supercritical atomization presents a very narrow particle size distribution (see figure above).
• The product can be produced in cristallinic or amorphic forms.

Advantages and benefits

• Possibility of preparing injectable suspensions for poorly soluble products.
• Better dissolution profile of the finished form (resulting from the narrow particle size distribution)
• Possibility of performing new delivery system (e.g. skin adsorption).

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