A process analytical technology (PAT) for dry milling and handling of pharmaceutical granules

• Research unit: INNOSUISSE
• Project number: 9025.1;5 PFIW-IW

Short description (English)

A process analytical technology (PAT) for dry milling and handling of pharmaceutical granules

Abstract (English)

Pharmaceutical manufacturing is currently in a climate of change. It is a prime goal to design quality into the manufacturing process of the drug product rather than only relying on quality testing. Herein, the monitoring of critical quality parameters is pivotal for process understanding, as well as regarding a control of manufacture. To achieve these objectives, some industries already implemented process analytical technologies (PAT). In the pharmaceutical industry, a regulatory initiative by the FDA (food and drug administration, USA) started this trend towards PAT in 2004. Companies providing manufacturing equipment can either invest or risk being left behind on the business.Frewitt produces machines for dry milling, which is an essential step in the production of pharmaceutical solid dosage forms. Dry milling or sizing of granules provides an intermediate product that can be filled in capsules or compressed to tablets. The milling process is crucial for quality attributes of the final drug product.The current project scope is to establish a process analytical technology for dry milling and handling of pharmaceutical granules. Different mill types and optical sensor technologies (from PS Prozesstechnik) will be evaluated as a proof of concept. Thus, critical process parameters like particle size and shape are monitored and the possibilities of contamination detection and process control will be evaluated. Accordingly, a PAT solution for dry milling is developed that should serve both, increasing the quality of the end product and providing an innovative, but affordable machine for pharmaceutical manufacturing.