The compliance with strict quality regulations and the associated need for quality control systems plays an essential role in pharmaceutical manufacturing. As the essential building block for continuous manufacturing, the RCPE researches and develops innovative sensor technology und control systems which provide data in real-time.
Our research has the following focus:
Our objective is the development of sensor solutions for process parameters that cannot be captured in real-time as of yet such as the density of moving powders inside a process line (e.g. feeders, blenders) or the utilization of x-ray technology to analyze real time weight variability, content uniformity and even morphology.
OCT is an interferometric technique of generating cross-sectional depth-resolved images of translucent materials. Developed by RCPE, it allows the measurement of the mean coating thickness and quality of tablets and pellets. Without requiring any model development or calibration, this fast and non-destructive method can be easily integrated into existing coating processes.
Advanced pharmaceutical manufacturing and in particular the continuous processing is based on the on-/in-liine and real-time evaluation of critical quality attributes of in-process materials and products. Measurements and evaluations has to be used in in a multi-level control system, controlling the process and associated process parameters.
Within this context the RCPE develops control systems that (I) allow tight control of processes, (II) enable tracking of materials via an understanding of the residence time distribution, (III) make possible decisions as to which materials are out of specification and (IV) form the basis for materials diversion. Our solutions comprise a wide range of different methods, ranging from basic feedback controllers to advanced model-predictive control methods. In addition, soft sensors are constructed that process up to hundreds of measurements together to calculate new quantities that can be measured directly.
LEADING PHARMA INNOVATION
