Ahead of this November's Extractables & Leachables Europe we spoke to Alan Hendricker, Manager - Chemical Sciences at Becton Dickinson, about his presentation on the examination of extraction process variables on medical device component extractables, why this is an important topic to discuss, where the industry is heading and more.
Q1. You will be discussing the examination of extraction process variables on medical device components for your presentation at E&L Europe 2017; could you explain in further detail what this entails?
While the best practices of controlled extraction studies are well established, we've encountered challenges with understanding how potential variables in the extraction process affects the quality of the extraction itself, especially given a diverse nature of starting materials. We've started exploring some extraction variables (solvent, time, temperature) with respect to material and will present initial findings at the conference. Eventually we'd like to have a sharable guideline for material types versus optimal or recommended extraction conditions. In addition we're looking at the "exhaustiveness" of the extraction process and on extraction solvent ratio variables to aid in the development of this information.
Q2. Why is an important topic to discuss and share with the E&L community?
I think industry groups and even regulatory bodies may struggle to understand appropriate controlled extraction study conditions to achieve optimal results. There simply can’t be a “one size fits all” approach, and the considerable knowledge which exists in the industry as a whole may not be compiled enough for all to fully benefit. We hope this helps facilitate discussion and progress in helping others think about better starting places for performing their studies.
Q4. Where do you foresee the industry headed in the next 5 years and why?
I do believe the Pharma E&L community and thought process is mature. While refinement will occur, I see bigger progress in other industries who are trying to “catch up”, such as the medical device industry, single use systems or manufacturing industry. Thankfully the road has been paved by the hard work of those who have spent careers on these topics, thus the approaches can be tailored from the highest risk scenarios to address the unique aspects of these other industries.
Q5. What are you most looking forward to at E&L Europe 2017?
E&L Europe is the single event that I consider “must attend”. For myself, being in the USA, the European perspective is hard to obtain and this event is the best place to hear it. As a global company we are bound by an ever changing international perspective with unique geographical considerations. The new voices and faces that appear alongside the standard-bearers are welcome additions. I love the chance to take an extra weekend to see the venues as well, the history and locales chosen are always an attractive prospect for exploration.
Alan will be presenting as part of the Medical Devices session. Other presenters in the session include Clariant and GLR Laboratories.
Representatives from Apple, AstraZeneca, GSK, Mylan, FDA, MHRA, Novo Nordisk, Allergan, Sonceboz, Bayer, Baxter, Solvias and many more have already confirmed their attendance, so book today to ensure you stay ahead of the competition. Tickets are currently €1,499 but this price will rise after 13 October.
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