On September 22, 2016, Renaud Janssen, Ph.D., Senior Manager Global Scientific Affairs, together with Bram Jongen, Ph.D., Head of Material Development, will lead a one-day workshop on elastomers organised by the European subsidiary of Parenteral Drug Association (PDA).
What are the consequences of elastomeric compound selection for extractables and leachables? Which are the specific considerations pharmaceutical packaging development has to take into account when designing elastomeric components? And what are the advantages of ready-for-sterilisation (RfS) and ready-to-use (RTU) closures? These are but a few crucial questions that our experts will provide valuable responses and unique insights to. “At Datwyler, we consider it our responsibility to help educate the pharmaceutical and biopharmaceutical community by creating awareness and understanding of important issues. In our workshop, participants will learn about the potential impact of component sterilization on closure properties and about the effect of closure washing on visible particle reduction. We want them to understand the origin of extractables and leachables from elastomeric closures and past and upcoming regulatory changes for elastomeric closures. We are looking forward to an interesting discussion,” says Renaud Janssen.
Renaud Janssen graduated as a chemical engineer from Leuven University, Belgium. In 1988, he joined Helvoet Pharma, now integrated in the Datwyler Group, in Belgium, where he has been holding various positions in R&D, Quality, and Technical Support on a local and global level. Currently, he is Senior Manager Global Scientific Affairs for Datwyler’s Healthcare segments. Renaud Janssen serves on several standardisation and pharmacopoeia committees. Bram Jongen holds a master degree in polymer chemistry and a Ph.D. in water soluble polymers used for advanced drug administration from the University of Louvain, Belgium. Within the Datwyler Group, he has been holding various positions within global technical and product support management and currently acts as Head of Material Development in R&D.
The Parenteral Drug Association is the leading global facilitator of science, technology and regulatory information.