FPS has collaborated with industry experts to research jet mill practices in the pharmaceutical industry.
FPS sincerely believes in sharing and constant improvement, at all levels. For this reason, FPS president Eng Gianola and vice-president Mr Corsini, who are both experts in milling and micronisation technologies, worked together with M Nakach PhD (Head of formulation and process development – Biologic Drug Product Development of Sanofi) in research published in the Pharmaceutical Development and Technology Magazine.
Jet mills are particularly useful in the pharmaceutical industry where micronisation is used to raise drug activity by increasing particle specific surface or by allowing active substances to reach their site of action by reducing particle size. By increasing the specific surface area (in terms of m²/g) the dissolution rate is improved. The purpose of the article is to define a scale-up methodology for sticky Active Pharmaceutical Ingredients (APIs) using Quality by Design (QbD) and a scientific best practices approach. Therefore, a commercial manufacturing process of sticky APIs and its industrialisation has been described.
Particular attention has been paid to the cleanability of the system, which must be suitable for processing multiple products, avoiding cross-contamination when batch changes are required.
The studies are conducted for sticky Active Pharmaceutical Ingredients on the complete production process that was developed following two industrial Key Performance Indicators (KPIs): high process yield and compliance with Environmental Hygiene and Safety (EHS) regulations.
Finally, an industrial installation was proposed to deliver the product with high production yield, compliant with safety regulation and cleanable in place.
The cooperation with Mr M.Nakach PhD is set to continue. FPS is proud to announce the next edition of a Micronization Workshop focused on this project.
It will be held on 15 October at the FPS Production Plant (Fiorenzuola d’Arda (PC) Italy) and all the authors will be present and available to discuss it.