Process analytical technology

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 a model that continuously estimates 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
• Determining 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 in order to achieve the desired particle size distribution
• Determining the model of the control system (thermostat cooling).
  Optimization of controller parameters for monitoring the set temperature profile in time

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 in the operation of instruments and guidance systems