Feasibility analysis of automated cleaning in biopharmaceutical production by using cleaning-in-place concepts from food production

Ferdinand Groten¹Chris Henze²Matthias Jopppa²Laura Herbst^1*Marc Mauermann²Bastian Nießing¹Robert Schmitt^1,3

• ¹Fraunhofer Institute for Production Technology (FHG), Aachen, Germany
• ²Fraunhofer Institute for Process Engineering and Packaging IVV, Dresden, Germany
• ³Laboratory for Machine Tools and Production Engineering, RWTH Aachen University, Aachen, Germany

In biopharmaceutical production involving cells, cell-derived products, or tissues the cleaning of surfaces that come into direct or indirect contact with the product is currently performed mostly by hand as the initial step in decontamination. This manual approach leads to production inefficiencies, reduced reproducibility of decontamination processes, and product losses. In food production, automated processes are preferred for the decontamination of interior product contact surfaces. This article studies the feasibility of adapting automated cleaning-in-place concepts used in the food industry to biopharmaceutical production. The focus is on spray cleaning processes and validation by cleaning simulation. An existing automated cell production platform is used as a case study for validation. The results indicate that modifying an existing platform to support cleaning-in-place presents significant challenges. However, the article outlines general design guidelines for developing new biopharmaceutical production platforms that can accommodate automated cleaning.