Downloadable Resources

Currently available resources include:

  • Presentation: Automation possibilities for E&L studies (by GSK and Anatune)
  • USP <661> compared with USP <661.1> and USP <661.2>
  • White paper: Nitrosamines - Analysis for Extractables and Leachables
  • White paper: Sterilization And Biocompatiblity Of 3D-Printed Orthopedic Devices - Testing Considerations
  • White paper: FDA finalizes guidance on medical devices safety evaluation
  • White paper: Drug resistance of materials used in Corvida Halo® Closed System Transfer Device
  • White paper: E&L Studies, designed and performed to meet all intended needs
  • Video: Interviews with E&L experts
  • Video: The importance of E&L testing, the challenges faced by the industry and more
  • Smithers Rapra technical poster on 'Examples of extractables assessments performed to assess changes in packaging sterilisation methods'
  • White paper and journal article on ICH M7 guidelines and implementation
  • Merck Serono presentation on 'Extractables study approaches for the biotech manufacturing materials'
  • A New Era of E&L Analysis - The Medicine Maker article
  • Introduction to Extractables & Leachables Infographic by Thermo Fisher

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