Proteins and peptides are sensitive organic substances. For special dosage-forms they need to be micronized. However, using conventional size-reduction equipment results in product degradation.
Superfine can micronize Proteins from human source with no degradation, at ambient conditions. PSD of d(0.9)=8 microns can be achieved.
Superfine’s technology is installed in an aseptic production line, processing two human proteins: Fibrinogen and Thrombin.
The products are produced in a commercial scale under GMP conditions and are processed to a commercial FDA approved medical device – EVARREST tm.