technology

FBRM PAT

Focused-beam reflectance measurement — an inline laser probe that tracks crystal chord-length distribution in real time, the dominant Process Analytical Technology for closed-loop crystallization control under ICH Q8/Q9/Q10.

Where it's used

Crystallization equipment for pharmaceutical APIs
The stirred, draft-tube-baffled, melt and continuous crystallizers — plus the inline FBRM/PVM probes that close the loop on them — that turn a purified API molecule into a defined polymorph with a target particle-size distribution, the unit operation on which bioavailability, purity and downstream filterability all depend.
downstream-purification 7 min