“To be your service partner for scientific and technological solutions in specialized Chemical Laboratory Programs, Process Safety, Process Simulation, Scale up Modeling, Physical Operations and Particle Technologies. By applying a wide range of tools we are able to provide assistance in process development, scale up and production on a manufacturing scale.“
Process Technology is considered to be an interface between laboratory and production. We combine scientific principles with the technological requirements of a production plant. We create the basis to safely and efficiently carry out complex chemical and/or physical processes in the designated production plant and to master technological challenges by employing state-of-the-art laboratory automatization, process analysis technology, statistical experimental design and simulation software.
The group consists of experts that make use of our toolbox in order to find the most efficient approach to resolving a problem. It is envisaged that teams of experts in key technologies meet on a regular basis with interested parties and users of the individual sites. By means of this open approach, we at Siegfried aim to establish a broad knowledge base that can be accessed at any time.
The main areas of our activity spectrum include:
— Laboratory automation, PAT, Simulation
and physical operations
The centerpiece of process technology is the wide range of laboratory work. Here, on a small scale, we examine the reactions and process steps that are to be implemented on a large scale at a later stage. The crucial point is to design experiments that will generate reliable, meaningful and transferable data. For this purpose, we use sophisticated tools, such as online analytics, design of experiments (DoE) and spezialized equipment, used for instance in the analysis of filtration/centrifugation and drying. A scale of up to 30 liters can be processed in a mini pilot.
— Thermal process safety and scale-up
“No problem, we’ve been running the process for 30 years without encountering any problems”.
We get to hear this statement rather often. A closer analysis, however, often shows that a chemical process may include residual risks that have to be minimized.
Evaluation of thermal process safety is consequently an important part of chemical development. Kalorimetric measurements (RC1 and DSC) as well as process analytical tools (PAT) are used to gather information about the energy potential of a chemical transformation and of potential decomposition reactions. With this information, the aim is to develop a safe and easily controllable process.
By using simulation software the chemical process can be simulated on production scale by combining laboratory and reactor data. This provides a precise forecast on how to control the chemical reaction and how to master the released process heat. Moreover, emergency situations can be simulated and measures determined in case of a failure. Use of the software also permits to derive conclusions concerning the behavior of reactions in scale-up that are beyond process safety aspects. For instance, we can forecast the necessary stirring speed in a reaction step to ensure best mixing and performance.
— Particle Technology:
From crystallization to drug product
Each produced ton of drug substance in actual fact represents billions and billions of individual small particles or crystals. Their characteristics decide on the efficacy, processability, quality and performance of the finished product.
Our APIs (particles) are formed during crystallization, isolated on a centrifuge or a filter, then dried, and finally milled or micronized. Mastering these steps represents an integral part of process development. In addition, we develop spray drying processes to improve the bioavailability of a finished product, which are subsequently scaled-up to our large-scale spray dryers in Pennsville..
Our aim is to develop and manufacture particles that are robust and comply with the requirements and quality attributes for the final drug product.