SCT-ICE | Crystallization unit

The cGMP SCT-ICE unit is designed for easy access and exchange of modules, depending on the customers needs. Its’ versatility enables the production of different compounds by simply exchanging the modules in between production runs and clean-in-place activities. It is designed to abide to the advices set out in the ICH Q13.

The number of parallel placed reactors depend on the batch definition, filtration strategy and production need. Secoya will design together with the client the optimal instrument for their needs and to fully incorporate the unit into a factory 4.0 environment, thanks to the open communication software programmed specifically for the instrument.

The SCT-ICE equipment can accommodate both reactive, cooling and antisolvent crystallization. Different versions are available for isolators, ATEX proof, high temperatures, and corrosive solvents.

Even at the larger execution, the SCT-ICE can be coupled with different crystal slurry treatment strategies, depending whether the unit’s purpose is single or multi-compound.

A highly controlled process

Unlike any alternative process, the Secoya crystallization technology is based on the precise control of spontaneous nucleation through the use of millifluidic tubular reactors upon cooling and different antisolvent addition possibilities. Using such capillaries, any parameter influencing the nucleation is ideally optimized and controlled.

Secoya’s crystallization technology is unique, enabling crystallization of molecules in a single process step avoiding difficult work-up when performed with conventional batch systems.

Lactose crystallization tests: extrapolation of results using identical parameters for both lab scaled testing (R1-R5) and pilot testing (P1 and P2).

Seamless scale up from lab test
to production validation

Thanks to the robustness of the crystallization technology, the parameter set is determined during the laboratory scale screening phase to achieve the desired particle size and distribution. This set is validated at pilot scale during kilogram testing before parallelization towards production scale.