Quality by Design - Smart Manufacturing

Selecting a Process Strategy by Identifying Critical Process Parameters (CPP)

In order to select the correct process strategy, an initial diagnostic step must be carried out to evaluate the process itself. Microinnova identifies critical process parameters (CPP) for a process or a chemical synthesis by looking at mass transfer, heat transfer, process conditions, as well as the reaction system itself.

A critical process parameter is any physical or chemical characteristic of the process that affects the production of the product (such as temperature, concentration etc).

The MIC-Fish methodology was developed in-house to carry out such a diagnostic exercise. Some experimentation in the lab may also deliver additional information for the needs of a certain process. Special tools such as a calorimeter support the generation of process-specific knowledge and can be applied to relevant to safety considerations.

“We give the chemistry what the chemistry needs, and we intend to give all molecules the same processing conditions.”

Dr. Dirk Kirschneck, Strategic Director

That means that the main considerations are based on the process requirements and not on the equipment capabilities. Often there are issues with batch processes in which concentration spots, heat transfer or mass transfer capabilities limit the process performance and could be improved by using continuous manufacturing technology. A better process strategy could reduce effort significantly in work-up steps.

Process Technology Selection

Continuous manufacturing offers a diverse range of technology that corresponds to the needs of a chemical or physical process. The engineers of Microinnova select the technology according to the generated knowledge about the process. Our toolbox enables new process conditions to be determined such as increased mass and heat transfer, new workup strategies and new processes with a strong impact on reducing the carbon footprint.

Smart Manufacturing and Advanced Process Control (APC)

Digital processing enables superior process control strategies for smart manufacturing. Different tools enable an increased knowledge-based manufacturing using a deeper understanding of the process development.

Process Analytical Technology PAT & Digital Twin

The application of Process Analytical Technology (PAT) tools in the process development increases the knowledge about a process. This can be demonstrated with process models like Digital Twin, where chemometric models are preferred. These models can be used for various purposes, such as process simulation and implementing advanced control strategies.

Quality by Design (QbD) & Control Strategy (CS)

Quality by Design (QbD) models describe the relationship and the impact of critical process parameters on quality product parameters such as the Critical Quality Attributes (CQAs). QbD models are often used to develop a control strategy for the process and may be based on Model Predictive Control (MPC) as an example.