WEBINAR

4-5pm CET

TUE 24.06.2025

QUalification AND QUALity control 
of plastic materials for 
pharmaceutical applications

Polymers used to construct pharmaceutical containers / delivery systems / 
packaging should comply or be evaluated to so-called Pharmacopeia 
monographs (compendial) and exhibit an acceptable Extractables profile.  
Compendial Testing on plastic materials assures the starting material is suited 
for intended use and complies with a basic quality level, batch after batch.

SPEAKERS INFO

Anja Gottschalk - Borealis

Anja Gottschalk joined Borealis in 2016 as Application Development Engineer Healthcare, responsible for the European and Asian market. She already has nearly 30 years of experience in the plastics industry in application development, technical service and material management in Automotive, Packaging and Healthcare based on her degree in plastics engineering. She is based in home office near Frankfurt, Germany.

Frank De Smedt - DyFrNd

Frank De Smedt holds a PhD in analytical chemistry (KU Leuven) and has 17+ years of expertise in analytical lab testing under ISO17025/GxP accreditation. Before setting up DyFrNd to provide consulting services, he was the operational director of an analytical laboratory focusing on the Medical Device and Pharmaceutical industry with core testing being Extractables and Leachables (E&L) and chemical characterization studies, method development and validations projects, monograph testing on polymeric materials for pharmaceutical use.  

IN DEPTH

This webinar will provide insights into:

*  Regulatory framework of  compendial testing for plastic materials for pharma applications (EU and US market).
*  Pharm. Eur. and USP monographs, e.g. 3.1 series and <661.1>.
*  Recent updates and upcoming changes in Pharmacopeia monographs.
*  Quality control and respective testing approach of a major polymer producer delivering to the pharmaceutical industry.
* Change Control measures.

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