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)
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.