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