Facilities for Micronization

Concept

  • The plant has been built subject to the latest regulations and requirements for the processing of APIs.
  • The mills are in completely separated cabins with locks for material and for personnel.
  • The concept has been discussed with the FDA and accepted before construction.
Clean Room (front view)
Due to the large windows all visitors can look at the production without disturbing the personnel.



Clean Rooms

Each micronization line has a segregated air handling and conditioning system to avoid any cross-contamination. The layout guaranties best handling according to the predefined flow of material.

Warehouses

Micronized and unmicronized products are stored in separated warehouses. The implemented stock control prevents confusion of dates. The QA-responsible makes sure, that only released material will be micronized.


Equipment

mcko uses for micronization mainly fluidized bed jet mills.

The Classifier Technology provides for high quality results:

  • A classifier secures the desired particle size distribution.
  • All components in touch with the product are made of stainless steel. Surface quality meets pharmaceutical requirements.
  • The micronization cell isn't coated which avoids any electrostatic charging.
  • Cleaning can be done easily.
  • The equipment is fully qualified according to cGMP.
Fluidized Bed Jet Mill