Marc Pelletier, PhD was a co-author on this case study that examined functional closure of a hybrid connection system.
This study is an empirical, data-driven approach to support risk-based decisions for facility design and thus relocate closed biopharmaceutical bioprocessing operations from cleanrooms of Grade C or Grade B classifications to a Grade D or CNC environment, with increased use of closed systems. The goal of this study was to demonstrate that functional closure of a hybrid system using common cleaning methods in a non-classified environment is feasible and more effective at preventing bioburden contamination than making an open connection in a classified cleanroom without a subsequent cleaning step. Prior to this study, there was no data available regarding the performance of these methods of functionally closing our processes.
Read the full white paper here: https://www.biophorum.com/data-driven-equipment-and-facility-design-case-study-white-paper/
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