Data-Driven Equipment and Facility Design Case Study by BioPhorum

Data-Driven Equipment and Facility Design Case Study by BioPhorum
Posted: May 24 2018
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:

About BioPhorum: BioPhorum’s mission is to create environments where the global biopharmaceutical industry can collaborate and accelerate their rate of progress, for the benefit of all. Since its inception in 2004, BioPhorum has become the trusted environment where senior leaders of the biopharmaceutical industry come together to openly share and discuss the emerging trends and challenges facing their industry.