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Rocking the Cradle or Rattling the Cage?

As I mentioned in my previous blog, Extractables and Leachables (E&L) for pharmaceutical packaging systems is a relatively new science, and what is true for pharma systems is just as true for Chemical Characterization of Medical Devices. While E&L was introduced into the Pharma world more than a decade ago (and for some applications, even earlier than that), the Medical Device market is only recently catching up with the principles of E&L.

Needless to say, that in such a young discipline everyone is trying to put the right science (prepping, selection of methodologies and instruments, interpretation of data, and reporting) in place to assist in submissions to the regulatory authorities, whether in-house labs or contract laboratories are providing services to the Pharma and Medical Device industries. Some of us have been doing this work for a long time – in the case of Nelson Labs Europe, almost 20 years – while others are quite new to this field.

Everyone who has started an E&L lab has struggled with the same or similar issues, will have made the same mistakes, and will have encountered many of the same problems. Like I confessed in my first blog, we had our share of issues at our lab in Leuven; mistakes and problems—there is no doubt about that.  It even feels like of all the mistakes that could have been made, well we made them. However, we learned from that, and we systematically improved our approaches – trying to make every mistake only once –getting us to the point where we are now.

However, when talking to others in the industry or listening to presentations of other E&L practitioners at conferences, I often observe that many are still struggling with some of the very things that challenged us in Leuven more than 15 years ago. It would not at all be fair to criticize these practices as we struggled with the same issues ourselves. However, the times when we faced those problems may have been a little more “forgiving,” as Extractables & Leachables testing was new to everyone.

The industry needs to move quicker now, and E&L practitioners need to evolve more rapidly to achieve a level of good and sound scientific services in an accelerated way.  Since providing sub-optimal science and services may affect the credibility of new approaches, such as chemical characterization for medical devices. This is exactly what I want to address, not just on this blog, but also with white papers, webinars, and very soon with peer-reviewed articles (written jointly with our principal consultant—Dennis Jenke).  The intent of all of this activity is to help explain the science and identify the pitfalls that one can make when performing E&L studies based upon our own experiences.

Our ultimate goal is the safety of patients, whether we do the testing, or someone else does it. The mission of our company is “Safeguarding Global Health.” Do we provide this level of service to just our own customers, or do we contribute at a global level to assist in guaranteeing the safety of all people? Sure, this is the role of the FDA (CDRH, CBER, CDER), EMA, MHRA, or any other health authority around the globe. However, can we expect that they know in detail what the potential issues are with the analytics for E&L?

Like all E&L practitioners, we take pride in providing good science and supporting submissions accepted by the regulatory authorities with the first filing. That is our goal—the flag we want to plant.  We know that time to market is often crucial for our customers and delays in the submission process are very costly and counterproductive. With that in mind, we need to be very methodical how we design each study, how we prep samples, how we conduct the study, how we perform the qualitative and quantitative analysis, and how we report the results obtained from our study.

Conclusions should be clear and make sense for everyone who is reading the report. We cannot expect FDA or any other health authority reviewers to be experts in the detailed and complex analytics of Extractables and Leachables. We need to be the experts for them. We should be the keepers of good practices and sound science in Extractables & Leachables research. But above all, we should be the nonsense filters. We should know what makes sense and what does not; it is not up to the reviewers to determine that. They should be able to focus on their job, and that is to review the provided data and verify if the device or pharmaceutical container is safe for its intended use. That is the flag we need to plant.