Compliance management for restricted substances is a dynamic and rapidly changing environment driven by regulatory agencies, retailers, and consumer demand. Manufacturers are challenged with ensuring their chemistries, materials, processes, and finished products meet demand and limit impact on health and the environment. Being prepared is critical.
As the list of restricted substances grows, testing demands customized methods to identify issues early. This is a complex issue that requires a strategic approach and a technical team with extensive knowledge of chemical substance usage and testing plans. For example, some chemicals (e.g. PFAS) can be removed from manufacturing processes, while others (e.g phthalates) are ubiquitous.
Eurofins EAG Laboratories supports clients with regulatory guidance, customized testing, and chemistry expertise. The team at EAG specializes in testing for representative compounds from restricted chemicals lists, such as the chemistries listed in the figure above.
EAG has validated methods for more than 200 specific chemicals that may be of regulatory or toxicological concern. These compounds are representative of those called out in legislation such as REACH, Prop 65, RoHS, CPSC, in addition to FDA, EPA, and MDR/EU directives.
EAG has developed partnerships with industrial consultants, who can offer expertise and recommendations to devise a client-specific risk management approach for their supply chain and product development. Together with these industry leaders, our team can propose a testing program that matches with our clients’ risk-management program and budgetary constraints.
Once results are obtained, we can offer further perspective of the ramifications of a particular result in lieu of the most recent regulatory directives. We interpret and effectively communicate the data for solutions that make a difference to our clients’ bottom line and business success.
Contact our team today for help with your testing needs.
During this “Ask the Expert” webinar, we dive into the fascinating world of Atom Probe Tomography (APT). Our experts address pre-submitted questions from the audience, focusing on the chemical and structural analysis capabilities of APT.
For 3D printed products, XPS can provide composition and bonding information for the top 5-10nm sample surfaces. Oftentimes, surface contamination/oxide thickness would affect the appearance (as well as performance when applicable) of the material, and XPS could help identify the source and/or cause.
In this webinar we will focus on Fourier transform infrared (FTIR) and Raman spectroscopies comparing the two techniques
Knowing the type of stress and how much there is in a small metal component in a medical device can be the determining factor on how well the device will perform, how long the device will last, or even whether or not the device is going to work at all.
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