Process Analytical Technology (PAT)
Preliminary Research and System Development
- Analysis of the active pharmaceutical ingredient (API) and a suitable solvent for crystallization.
- Determination of solubility curve and metastable zone width for different cooling rates.
Development of Chemometric (Calibration) Models Using PAT Tools
- Collection of data from process spectrometers in different concentration and temperature conditions for the development of calibration models.
- Development of robust calibration models that estimate the concentration of solute in suspension from spectral data and temperature.
Research of Crystallization Processes
- Collection of data required for the development of a kinetic model of crystallization.
- Determination of the method of process control and quality parameters of the final product (crystals).
- Conducting model validation experiments.
Modelling and Control of the Crystallization Process
- Determination of the optimal crystallization temperature profile to achieve the desired particle size distribution.
- Determining the model of the control system (thermostat cooling) and controller parameters.
- Monitoring the set temperature profile in time using PAT tools.
System Integration – Software Development and Instrument/Hardware Customization
- Development of control programs for spectrometers and thermostats.
- Central server configuration for device access and data acquisition.
- Development of programs for guiding the crystallization process and integration with GMP standards of PAT in industry.
Diagnostics of Spectrometers and Control Systems
- Selection of variables related to process equipment that significantly affect the quality of collected data.
- Data collection for model development.
- Development of empirical models for predictive diagnostics and alarming in case of irregularities.
