Ruth Barensteiner is Principal Scientist Compliance of Janssen R&D, located in Schaffhausen. She is responsible for all compliance aspects in the FillFinish Pilot Plant (F2P2) especially for Aseptic Process Simulation, gowning concepts and operator qualification for cleanrooms (RABS and isolator). Ruth has more than 25 years experience in microbiology and aseptic processing in the Pharmaceutical Industry and joined J&J in 2005. Currently she is key person for the implementation of a new monitoring strategy for the gloveless robotic filling line MPL1 with focus on the implementation of a continuous monitoring system for viable particles. Within this function she is connected with partners of the Pharmaceutical Industry in the Biotrak User Consortium to guide the Biotrak validation in close collaboration with the supplier.