Integrity Assurance for Single-Use Systems: An End-User’s Perspective

Senior Manager in Manufacturing Science and Technology GSK Vaccines

Charlotte Masy is a BioEngineer with a Ph.D. in material science on surface chemistry. She has spent her career in material science with over 20 years working on the investigation, research and services for all sectors but mainly for pharmaceutical products at Solvay, Ajinomoto, Pall and GSK Vaccines. She has 15 years of experience in cGMP in various positions including QC, QA and Engineering. She is an expert on single-use at GSK Vaccines since 2010 and has been working on integrity testing for 7 years.

She is a member of the Board of the Bio-Process Systems Alliance (BPSA), and of several working groups in the BioPhorum (previously BPOG). Charlotte is contributing to articles, white papers and ASTM Standard associated with single-use technologies.

Senior Principal Engineer, Single-Use Technologies in Technical Communication and Regulatory Strategy, Pall Corporation

Patrick Evrard joined Pall Corporation in 2017, to provide expert technical support to Pall’s biotech customers on single-use systems. At the end of 2018 he joined the newly formed Technical Communication and Regulatory Strategy team, combining technical content with validation and regulatory perspectives.

Before joining Pall, he led a technical team in charge of developing and implementing at global level single-use technologies in GSK Vaccines’ commercial manufacturing operations, including critical sterile applications, for more than 10 years.

Patrick is author or co-author of several articles, white papers, ASTM Standard and PDA Technical Reports associated with single-use technologies.  He is member of the Board of Directors of the Bio-Process Systems Alliance (BPSA). He has been participating since 2012 in several single-use technology industry work groups from BPSA, BioPhorum (previously BPOG), American Society of Mechanical Engineers (ASME BPE), ASTM International and PDA.