Quality Control & Management
Institute of Applied Medical Engineering
Director: Univ.-Prof. Dr. med. Dipl.-Ing. Thomas Schmitz Rode
Helmholtz Institute of RWTH Aachen University & Hospital

Quality Control & Management


For the introduction of tissue-engineered structures in the clinical setting, high standards of quality are essential. As tissue engineering is a relatively young discipline, minimal standards of quality exist to date. For this reason, tissue development must be completely documented from the outset. Above all, online documentation of culture conditions is particularly important. Integrated measuring devices allow the monitoring and recording of pH, pO2, pCO2 & temperature, as well as the pressure difference within a closed loop system. Using these parameters, the flow of the main pump along with the medium exchange pump can be regulated.

A further aspect is a non-destructive test for tissue development in the bioreactor system. „Online markers“ of tissue development are particularly important for continuously monitoring the growth and development of the structure. We have identified procollagen-III-peptide as such an „online marker“.

Fig. 1: Bioreactor System for Heart Valve Cultivation

Fig. 2: Integrated Measuring Devices for Online Documentation of pH, pO2, pCO2 & Temperature

 
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