Two production lines are available in the sterile plant for the sterile crystallization of APIs. Batch sizes of 20kg to 300kg can be managed with flexibility in the equipment configuration, so the crystallization process can be readily tailored to the customer’s requirements. Equipment capabilities include high-containment sterile seeding, a portioning aseptic isolator, high performance mixing for post-production homogeneity purposes, milling in a closed sterile cycle, and a high shear mixer.
Micronization is the process of reducing particle size. In jet-milling, material is fed into the circular chamber of the micronizer where compressed air or gas from nozzles located at the periphery of the chamber accelerates the particles into a rapidly whirling vortex. The particles collide and break, reducing their size.
Physical treatments of API, including micronization, are conducted in multiple installations set up in separate ISO 8 suites capable of processing up to 1500 MT/year. Segregation is available for highly potent APIs. Micronization services are available at all three of our Italian manufacturing sites.
Lyophilization is a process where water is removed from API by sublimation under conditions of controlled low temperatures and vacuum. The mild conditions of this process minimizes any thermal degradation of the API.
Lyophilization is one of the technologies present at Montecchio Site.
The availability at FIS of a pilot and a large-scale spray drying unit allows for development of a process that will produce pharmaceutical bulk intermediates with well-defined a particle size distribution range for optimal production performance. The spray drying process is run in a completely closed cycle and within cleanrooms, from API loading to packaging. The equipment is suitable for the production of HPAPIs up to OEB3, using all available spraying techniques.