Extractables & Leachables, Food Contact Notifications and Post Consumer Recycle Challenge Testing
How chemicals migrate from an initial source to a final sink (often an undesirable location) is the focus of many studies, many with regulatory implications. My graduate studies involved trying to understand how persistent organic pollutants such as PCB’s, chlorinated dioxins and furans, dieldrin, aldrin, etc were transported throughout the environment ending up ubiquitously in remote waters and terrestrial and aquatic ecosystems. Similar studies apply to the migration of plastic additives from food packaging into food, from pharmaceutical packaging into drug products, and from medical devices into patients. All three of those migrations are heavily scrutinized by governing bodies throughout the world. Other migration studies focus on off gassing of compounds into breathable air spaces such as office air, automobile interiors, industrial workspaces and are the focus of environmental and worker safety regulations. An understanding of chemical migration and how to design studies to assess it often plays a key role in obtaining regulatory approval for product
As our world continues to fill up with plastics that do not degrade, there is a growing emphasis in finding ways to use recycled material. One such value-added use would be to use post-consumer recycled plastic in food packaging. To that end the FDA has issued a guidance document on the testing procedures to be used to get approval for the cleaning processes used to recover the recycled material. That process provides an interesting model of chemical migration in that the plastic is intentionally contaminated with known chemicals, then analysed to determine their final contamination concentration. The contaminated plastic is then taken through the proposed clean-up process and analysed to see if the levels of contaminants are sufficiently low. This process has been deemed “challenge testing” and a portion of this webinar will present case studies for PET, HDPE and PP plastics and some observations made at Aspen Research while conducting these challenge tests. If the final clean-up concentrations of the contaminants are not sufficiently low enough for approval, the applicant can then conduct food contact migration studies (for which the FDA has also issued a guidance document) and potentially still get clearance for their process. This webinar will also share case studies of some of these migration studies conducted at Aspen Research explaining the general testing requirements, analytical methods and outcomes.
The second portion of the webinar will discuss extractables and leachables testing of pharmaceutical container/closure systems and extractables testing of medical devices. Such testing is done for regulatory submissions and is an active and growing field. The proper experimental designs and qualified analytical techniques must be applied to get useful and defensible results. We will discuss approaches that have been taken at Aspen Research and show some examples of results and lessons learned (and still learning). We will try and share some of the similarities and differences between the packaging testing and the medical device testing. One obvious difference is that in the case of the pharmaceutical packaging, it is possible to do actual leachables testing on the aged drug products to see if the extractables become leachables. We will share some of the approaches we have taken when the ride does not go quite as smooth as hoped.
The webinar will focus on real data experiences and will share actual study successes and problems. If you are involved in, or considering undertaking, recycling efforts to reclaim and reuse plastic in food contact, you will want to register. If you are in the planning stages of a new drug product submission or medical device submission, you will most likely need to do extractables testing and this webinar will help you understand what things to consider and you should register. If you are in the testing business and would like to gain insight into some of what your peers have experienced, you are more than welcome to register.
Presented by
Roger Pearson, Ph.D.,
President Analytical Services
Roger Pearson, Ph.D. (President Analytical Services Aspen Research Corporation): Dr. Pearson received his B.S. in Chemistry from Montana State University and his M.S. and Ph.D. in Environmental Chemistry from the University of Minnesota’s School of Public Health. Dr. Pearson joined Aspen Research in 1997 from a post-doctoral position at the University of Minnesota. His prior professional experience includes positions as a Research Chemist and Production Superintendent for Celanese Chemical Corporation. Dr. Pearson has extensive experience in gas chromatographic analysis of volatile and semi-volatile compounds, has coordinated many studies of off gassing phenomena at elevated process temperatures, and is an expert at coupling analytical results back to their process chemistry. He is an industry recognized expert in Food Contact and Extractables and Leachables techniques whose studies have been instrumental in assisting risk professionals in providing guidance for companies navigating in various regulatory arenas.
