Scale up simulation technology
Using a scale-up simulation technology based on accumulated experiences in chemical engineering, SPERA PHARMA can identify/solve a scale-up challenge in advance, ensuring process robustness and the productivity.
For example, a robust crystallization method for API, with a character of easy oil-downed and a large variation of the distribution of crystal particle size, has been established by our simulation technology. (Cryst. Growth Des., 2014, 14 (11), 6006)
Moreover, a robust and efficient drying process for a hydrate API with high quality in commercial scale has been developed by considering the vacuum drying conditions in detail as a process simulation study. (Separation Process Engineering, 2013, 43, 375)
| Item |
Examples of simulation technology |
| Reaction |
- Scale-up and down experiments using glass separable model reactors (0.3 ~ 6 L) and Reactor-Ready™ (1 ~ 5 L)
- Scale-down experiments using various types of agitator impellers
- Scale-down experiments using EasyMax (Mettler)
– Experiments with automatic control of stirring and temperature
– Measurement of thermal properties with the calorimeter (HFCal)
– Identification of potential thermal-control issues in a manufacturing process, leading to the proposal of suitable solutions.
|
| Crystallization |
- Scale-up and down experiments considering changes in supersaturation and agitation power
- Develop a method to obtain the desired crystal form and particle size
- Support LCM in terms of API development as cocrystal and optimal salt
|
| Filtration |
- Evaluate filtration characteristics using self-developed software
- Propose optimal filtration methods based on the evaluation of filtration characteristics
|
| Drying |
- Develop a drying method for obtaining hydrate
- Reduce amount of solvent which is hard to remove
- Prevent aggregation in drying
|
| Milling |
- Propose optimal milling methods and scale-up operating conditions
|