Sterile API production is possible whenever a sterile environment can be assured during all production steps. Full understanding and integration of all manufacturing steps are necessary to obtain the desired results.
Isolation technology maintains the sterile environment around the process with minimal space requirements.
FPS designs isolators for the following API manufacturing processes:
Filtration and drying
Filter dryer discharge
Mechanical screening
Milling
Micronization
Hybrid solutions
More and more HPAPIs are requested to be manufactured under sterile conditions.
The requirements for sterile manufacturing and operator safety and protection can be met by custom designed isolators.