|
Micro-Sphere SA is a company dedicated to the contract development
of liquid and dry micro-encapsulated formulations of active pharmaceutical
ingredients. Micro-Sphere SA offers the technology of spray drying
having installed a Niro Mobile Minor 2000 (Ex execution EEX de IIC
T1) in a pharmaceutical box in class D (100'000) and its operation
is performed in compliance of the cGMP. The internal surfaces of
the drying chamber, duct, cyclone and cartridge filter are made
of stainless steel AISI 316 electro polished (0.4 µm) to ensure
good cleaning controlled at the end of each campaign by swab test.
Process parameters are continuously saved on a paperless recorder.
The spray-dryer can be used either with compressed air or by nitrogen.
Both process fluids are available in pharmaceutical quality. Nitrogen
will be used in case of molecules sensitive to oxygen and when the
formulations are based on organic solvents. Spray-drying is one
of emerging technology in formulating active substances with particular
interest in field of pulmonary delivery (particle size < 5 µm). |
|