Activities

Micronization is performed by our spiral jet mills (MC JETMILL®) and our services are requirable for APIs, steroids, cytotoxics and cytostatics, HPAIs, antibiotics (not Beta-lactams). Our spiral jet mills have been designed to guarantee precise scalability. This enables the active ingredient to be followed from its first R&D phases through to commercial launch; it allows us to operate with the same product from batches of 0.2 g up to several tons. We guarantee to reduce product build-up and achieve yields higher than 99% for the industrial process, starting from quantities of 1 kg. Thanks to our technology, we are able to obtain a very fine and precise particle size distribution with only a single micronization passage for nearly all pharmaceutical ingredients. Thanks to the isothermal feature of our jet mills, we can micronize any pharmaceutical ingredients, even those with a very low melting point (30-40 °C).

 

RANGE OF SERVICES

Quality control laboratory activities:

  • Identification analysis
  • Cleaning validation study
  • Particle size distribution analysis
  • Microbiological monitoring of environment, water and equipment surface
  • Analytical method transfer
  • Analytical method comparison study
  • Contract laboratory for PSD analysis
  • Process parameter study, to define and support the validation activity
  • Process validation
  • Analytical method validation
  • Analytical method correlation study
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