Downloadable Resources

Currently available resources include:

  • Introduction to Extractables & Leachables Infographic by Thermo Fisher
  • A New Era of E&L Analysis - The Medicine Maker article
  • Merck Serono presentation on 'Extractables study approaches for the biotech manufacturing materials'
  • Whitepaper and journal article on ICH M7 guidelines and implementation
  • Smithers Rapra technical poster on 'Examples of extractables assessments performed to assess changes in packaging sterilisation methods'
  • Video: The importance of E&L testing, the challenges faced by the industry and more
  • Video: Interviews with E&L experts
  • Whitepaper: E&L Studies, designed and performed to meet all intended needs
  • Whitepaper: Drug resistance of materials used in Corvida Halo® Closed System Transfer Device
  • Whitepaper: FDA finalizes guidance on medical devices safety evaluation

To access any of the above, please click on the link of the resource you are interested in in the righthand sidebar.