Microsphere refiner for aseptic drug manufacturing

Processes and Refines Microspheres for Drug Delivery Systems

The MSR™ MicroSphere Refiner by Powder Systems Limited (PSL) is a comprehensive solution for pharmaceutical and biotechnology manufacturers focused on drug delivery via microspheres. This fully automated system integrates multiple stages of processing, including classification, filtration, de-watering, washing, drying, freeze-drying, sampling, and recovery. Designed for aseptic, batch operations, it addresses the challenge of handling valuable microspheric products by maximizing product recovery and maintaining batch consistency.

Featuring capabilities for both liquid and solid product types, the MSR™ accommodates various vessel sizes, with options supporting product cake volumes from 1.25 to 21.8 liters. The flexible design of the MSR™ supports multi-product applications, making it adaptable to rapidly changing production requirements. Enhanced process control is ensured through the integration of Process Analytical Technology (PAT), allowing for real-time quality monitoring and adherence to Good Manufacturing Practices (GMP), GAMP5, and 21 CFR Part 11 regulations.

The unit’s modular design supports seamless integration into existing pharmaceutical production lines, with vessel materials ensuring chemical compatibility and corrosion resistance. Maintenance is simplified via a Clean-In-Place (CIP) option, promoting contamination-free operations. The MSR™ is engineered for scalability, enabling a smooth transition from R&D to commercial production, ensuring critical process parameters are maintained throughout scale-up.