The multi-chamber isolator is designed to guarantee a sterile environment for the micronization of up to 20kg of API with a PilotMill-6 spiral jet mill.
What are the issues?
Benefits of FPS Solution:
Description of FPS custom solution:
The rigid wall isolator is composed of a micronization chamber where the volumetric feeding unit and the spiral jet mill are installed. The product is introduced through a rapid transfer port. Before starting the operations, a decontamination cycle is executed to guarantee an aseptic environment inside the chambers. The micronization unit is connected to the SIP line for sterilization of the product contact lines. When the sterilization and decontamination cycles are completed, the product bags are opened and the API is fed in the feeder. The micronized product is collected at the bottom of the separation cyclone, in a dedicated pack-off chamber, where a weight scale is provided. The API bags are then removed from the isolator through a continuous liner installed on a rapid transfer port on the side of the pack-off chamber. The product-gas separation filter is installed in a dedicated chamber to be easily accessed by the operators.
Custom solution highlights: