Presentation Request | From Extractables to Leachables – How to deal with complicated Formulations

During the 4th Drug-Device Combination Products Summit, 18th – 19th,  May 2021, our expert, Stefan Heck will present "From extractables to leachables – How to deal with complicated formulations." Extractables and Leachables are a serious problemassociated with the safety of drug device combination products, which is getting worse with increasing complexity of packaging systems and drug matrices. In this presentation, Stefan will discuss the following topics in detail: 

 

  • Best practice study design which covers the whole product cycle from production-process to the final container closure system
  • Practical solutions for E&L including evaluations of complex material combinations and potential difficulties with formulation interference during leachables studies including possible solutions 
  • Unknown extractables and leachables and how to deal with them

Please complete the form to request our presentation: