Ahead of the Extractables & Leachables USA 2016 conference in Bethesda this May, we sat down with Clariant's Steve Duckworth to talk risk management in E&L testing, the importance of managing risks and what the biggest risks are right now.
1. Steve, you’ll be looking at identifying and managing risk along the supply chain whilst focusing on plastic container materials, why is it so important to manage risk and what are the effects if you don’t?
The first point about ‘risk management’ is to understand where risk can come from and its potential impact. Once understood where risk can come from, one can define strategies to reduce and control them. Extractables and leachables testing is one way of managing risk, by testing the final packaging materials pharmaceutical. This is a requirement of the regulators to demonstrate reduced risk of drug contamination / adulteration, i.e by a potential leachable. However, this tends to be a set of ‘one-time’ qualification tests, and there is a risk that tends not to managed; i.e. where an ‘unannounced’ change may happen to the raw materials used to make the packaging. Most of the conference is covering the importance of methodologies and better understanding how to design and carry-out E&L testing, but in designing a study, maybe it is important to understand the limitations caused by ‘market dyanamics’.
2. What would you say is one of the biggest risks that you’ve come across when researching and building your presentation?
After my 8 years involved with this market, what has surprised me is ‘faith’ that nothing in these materials changes, and a lack of awareness of all the changes that go on routinely. So for me the biggest risk I see is not knowing or anticipating change. The problem also comes is that the regulators start to have more knowledge on this subject than the industry, and you start to see some pressures building in the supply chain.
3. Can you provide a brief summary of what your presentation will cover and why it’s important for delegates interested in E&Ls to attend?
I will try to address points 1 and 2 and explain where the various risks in the supply chain come from that impact on the quality and reliability of extractables and leachables testing. I will try to dispel some myths on ‘medical polymers’ and ‘pharmacopeia listed substances’. I will explain potential impact of new regulations and regulator’s views that impinge on pharmaceutical packaging materials. Finally, I will touch on how, with some of these risk management and control techniques, well established technologies from other sectors can be used to solve some current problems with packaging materials. It may not provide a comfortable feeling to the delegates, but at least I hope to give them some thoughts on more robust risk assessment an management process.
4. This year’s programme is looking very exciting, who are you most looking forward to hearing present and why?
The first thing for me is to learn, discuss and gather different view-points. One such paper from Dennis Jenke from Baxter where he seems to address the question of what to do with the information from E&L once you have it.. This seems to link very nicely with my topic because it focuses on practical matters. In addition I am looking forward Daniel Norwood’s presentation on the updates to the USP chapters, because this has a direct impact on the materials evaluations that we do.
Steve will presenting on 'Identifying and managing risk along the supply chain in plastic container materials while exploring new opportunities in functionality' at E&L USA 2016 on Tuesday 10th May.
View the full agenda >>
Book your ticket >>