Extractable and leachable testing of ENDS

The FDA PMTA review process has further reinforced the importance of providing extractable and leachable data relating to the ENDS product and/or e-liquid container. Companies who have not provided sufficient extractable and leachable data have received deficiency letters.

This following 15 minute video provides:

  • An overview of extractable and leachables
  • How they are analysed
  • Why they are important
  • Case studies (material selection, extractable studies and targeted & non-targeted leachable studies)

Speaker

Nick Morley, Principal Scientist, Hall Analytical
Nick has over 12 years of experience in the field of extractables and leachables, both in large pharma and at a CRO. He is responsible for providing technical/consultative support to new and existing customers in the field of E&L. Experience working on a range of products including pharmaceutical/biopharmaceutical (inhalation, topical and parenteral), medical device and nicotine delivery systems.
Nick has a BSc in Chemistry, is a BSI Committee member and British representative on the CEN (European standards Committee) working group for extractables and leachables of Electronic Cigarettes & E-liquids.