Crystallization &
Particle Engineering
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Crystallization Process Development
WuXi STA’s dedicated crystallization teams are experienced in crystallization process and particle size reduction development including but not limited to polymorphism, purity, residual solvents, particle size distribution, morphology, filtration, and drying investigation to ensure delivery of drug substance with desired properties. The facilities are located at Shanghai Waigaoqiao, Shanghai Jinshan and Changzhou sites.
WuXi STA crystallization teams are equipped with powder X-ray diffractometers (pXRD), differential scanning calorimeters (DSC), thermal gravimetric analyzers (TGA), polarized light microscopes (PLM), scanning electron microscopes (SEM), particle size distribution analyzers (PSD), and dynamic vapor sorption (DVS) for solid state analysis. PAT tools, such as focused beam reflectance measurement (FBRM), reactor IR (online IR), and BlazeMetrics, are also used for the development.
In 2023, crystallization teams supported 1,100+ steps for API process development.
Milling and Micronization
WuXi STA has a dedicated process engineering team responsible for all particle size reduction activities.
We routinely provide four types of micronization support from laboratory scale to production scale under GMP.
The batch size is up to 1,000 kg / 20,000 L.
Wet Mill
- IKA Process Pilot 2000/4
- 2000/10 (SS and HC)
- 2000/20 (SS)
Pin Mill
- Pilot scale pin-mill
- Commercial scale pin-mill
Jet Mill
- Lab scale jet-mill
- Pilot scale jet-mill
- Commercial scale jet-mill
Cone Mill
- Pilot scale cone-mill
- Commercial scale cone-mill
