Currently available resources include:
- White paper: Is it safe - Assessment of material changes
- 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.