1. What is a Micronization Excellence Center (MEC) and what is it for?
It is a laboratory for micronization tests with ISO8 clean rooms. It has 2 missions: a R&D center to design new equipment and a test center to study the behavior of micronized products. We have several analytical instruments such as DSC25, Malvern Hydro S 2000 and an optical microscope (to monitor the characteristics that the product acquires during the micronization process). The micronization process takes place using compressed air or nitrogen as a process gas and we can run in controlled air conditions but also under cryogenic conditions. Finally, the MEC has an isolator which is used to handle potent products and to operate in an inert environment.
2. What types of tests does FPS offer to its customers?
FPS is very flexible and always adapts to the customer needs. The goal of our highly qualified and experienced staff is to reach specific technical specifications and either:
We can also perform micronization service as a third party (not under GMP)
3. What are the mills available? Is it possible to rent them?
We offer 3 technologies:
For each technology we have mills for R&D, pilot and production. They reflect FPS extensive product line. The mills can be rented with or without our staff technical support.
Here is the breakdown of the available equipment:
Sometimes products are very hard or sticky or have other characteristics that require specific treatments to the mills so we offer inserts in hardened steel, superlattice or PTFE.
4. What is the advantage for a company like FPS to have an internal Micronization Excellence Center?
It is a big bonus for our customers to run trials with their product before committing to a purchase. They can witness the trials and get familiar with the equipment. In other cases, our customers already have our equipment but either need the expertise of our PhD staff to optimize their process parameters and need to run in specific conditions (cryogenic or in an isolator) to reach their final specifications. It also allows to gain a lot of experience and to use that expertise to design the best performing equipment. One example is our LaboFeeder-TS. It is a high-performing Twin-Screw feeder specifically for small quantities for the lab which makes it very unique. Finally, our staff is also very involved with the mills sold by FPS. They test the equipment to ensure it meets the customer needs and support the customer for the execution of the FAT.
Here you can find the complete interview about our MEC: Milling and Micronization Excellence Center, to Davide Frascio, FPS R&D and Test Center Manager: