Fermion micronization capability expansion for OEB5 API’s
Fermion has finalized investment to micronization capability expansion at Oulu plant in late 2017. With these new equipment which are located inside isolators, we can optimize physical properties for API’s which belong to high potency categories of OEB4 and OEB5 (OEL values above 0,2 μg/m3).
First micronization validations have been done with good results in this new module. The first validated product was Salmeterol Xinafoate, where particle size distribution results have been consistently good.
Fermion equipment in micronization unit for highly potent API’s includes two spiral jet mills of different sizes and a Pin Mill. Conical mill, hammer mill and a cylindrical mill are used as a pre-micronization equipment. With these equipment we are able to micronize different volumes of API’s (batch sizes from 50g to 60kg) to different target physical properties. We can operate also in low temperatures down to -10C with spiral jet mill and pin mill.
Optimizing API physical properties is important for a wide range of drug product formulation types, including solid dosage, injectable, opthalmic, and inhaled products. Micronization, which reduces particles down to the micrometer size, can be used to improve for example the bioavailability, formulation homogenity and particle size distribution of APIs.
Fermion offers our micronization services also to external customers. In case that you are interested in this or other CDMO services, please contact:
Business Development Manager
Contract Development and Manufacturing (CDMO)