Now in its 17th year, E&L Europe is set to take place on 6-7 November in Amsterdam and once again will feature leading industry experts covering the most pertinent topics impacting the industry today. This includes a session on medical devices – find out more below on the latest perspectives, news, and download relevant whitepapers.
E&L examination is continuously growing in importance and given the current scrutiny paid by governing bodies including the FDA and MHRA, understanding the best practice and guidelines to carry out extractables and leachables studies is imperative in order to eliminate risk and potential development delays. Therefore, the E&L Europe 2023 conference has dedicated a session on medical devices.
This session will focus on several perspectives, including the advantages of chromatographic endpoint determination in exhaustive extractions of medical device E&L studies – a toxicological standpoint. The session will also have presentations covering Implantable medical devices: new frontiers in biomonitoring using ICP-MS and ISO 18562 – Biocompatibility evaluation of breathing gas pathway medical devices.
The assessment of patient safety from gas pathway medical devices includes testing for particulate matter, volatile organic compound emissions, and leachable substances in condensate. Whilst there are some similarities with the regulatory requirements for pharmaceutical products and other medical devices the testing requirements for these high-risk devices (as per ISO 18562) are unique. Ahead of the conference we have given you access to Elements ISO 18562 White paper to help you gain insights ahead of their presentation. To download and find out more click here.
Risk management is critical in the evaluation of SUT (Single Use Technology) so that processes are appropriately designed, safe and resources are focused on areas of the greatest risk. USP <665> is mandatory on May 1, 2026 and therefore businesses need to be ready for this implementation and how it will affect them.
The test protocol of USP <665> and BPOG, although standardised, still requires expert knowledge of E&L testing, materials and biopharmaceutical and pharmaceutical manufacturing. Smithers has invested significantly in equipment and people to meet the needs of our clients.
Smithers has put together an expert White paper which provides comprehensive insights into reviewing Single Use Technology (SUT) Extractables and Leachables (E&L) Testing. To download and find out more click here
To download all whitepapers and read E&L articles, visit our news page here.
The 2023 technical conference will cover topics related to the extractables and leachables industry. This technical conference covers the regulatory landscape, advances in science and testing methods, the latest technological developments, biocompability, methods to assess toxicity of E&L compounds, E&L study strategies, characterisation of unknown E&Ls and combination products (a particular hot topic right now) and more.
The event spans over two days and includes a series of presentations on industry insights and collaborative discussions. Our expert speakers hail from across the global supply chain and will share their experiences, insights, and knowledge with you. With speakers from distinguished companies like ELSIE, Element, Cytiva, Octapharma, Sartorius Stedim Biotech, PPD, GSK Vaccines, Smithers, GlaxoSmithKline and more, the agenda is bursting with insights to help shape this year’s conference to be the best one to date.
Tickets starting at just €1,499
We would like to offer Pharma Journalists members a special discount, use code ‘ELEU23PHARMA’ for 10% off.
For more information, please visit: https://www.eandl-conference.com/extractables-and-leachables-europe
About Smithers
Smithers is a global leader in rubber, plastics and polymer testing, consulting services, conferences, training, publications and market reports, focused mainly on the medical, industrial, automotive and consumer industries.
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Contact: Phoebe Regnault E. pregnault[at]smithers[dot]com