This article presents the risk-based and value-based approaches developed during the single-use implementation with a focus on validation aspects.
Read the full article.
The article is featured in Pharmaceutical Engineering, issue May/June 2011 which was published on 20 May.
Two of the article's authors are from NNE Pharmaplan: Peggy Sander and Jean-Baptiste Milandri.
Pegge Sander is part of NNE Pharmaplan's French organisation, where she works as process engineer with reponsibility for process package from design until commissioning. Her areas of expertise are downstream process, wash and sterilisation and single-use implementation.
Ms Sander has an educational bakground in bioprocess engineering and started her carreer at Novo Nordisk working as a process engineer responsible for qualification/validation activities on washing machine and CIP/SIP equipments from SAT to production. She has also worked on process packages, for example fractionation process with buffer preparation, ultrafiltration and chromatography steps including single-use technology.
Jean-Baptiste Milandri is biotech process engineer at NNE Pharmaplan in Denmark. Mr Milandri joined NNE Pharmaplan's in France in 2004 acting as process engineer and project manager, in charge of designing several biotech facilities.
He is now part of our consulting group in Denmark, leading and supporting innovative biotech process design and implementing and developing new advanced solutions for the biotech market.
Mr Milandri received an MS in cell biology and biochemistry from Paris-XI University, France and an MS in biotech engineering from the Compiegne University of Technology, France.
Feel free to contact Peggy Sander or Jean-Baptiste Milandri