An effective process control strategy forms the basis for stable and efficient processes – particularly in continuous manufacturing. On the basis of CMAs, CPPs and CQAs, we define the parameters making your process safe and reproducible and assess the risks along the entire value-added chain. Through targeted test runs, we develop a practical process design space, taking into account product, process, and system dynamics. This results in clear guidelines for process control, a robust understanding of process stability, and the basis for a state of control that meets regulatory requirements, facilitates scale-up, and supports continuous process optimization – ensuring your production can be controlled reliably and transparently.

In ePAT development, we support you in successfully introducing Process Analytical Technology (PAT) and deepening your understanding of your products and processes in the long term. From feasibility studies and model development to test planning, data generation, and Design of Experiments (DoE) to the analysis of complex products, we accompany you every step of the way. We record calibration spectra, develop multivariate models, and validate them against reference methods. After transfer to production, we support the integration of ePAT into your process control strategy so that measurement data can be used specifically for stable and efficient processes during operation.