Medical device designers and manufacturers have a new resource for product testing, with the opening of EAG Laboratories’ additional 20,000-square-foot lab in St. Louis, MO. The new facility, which began operations in January 2021, features a dedicated medical device polymer analysis laboratory, a cleanroom for particle isolation and identification, and state-of the-art instrumentation for ISO 10993-18 biocompatibility testing.
“Our aim and expertise is understanding the chemistry of the polymers and plastics that our clients are using in their products,” Stefan Karnavas, President of EAG Laboratories, told PlasticsToday. “The types of analysis can range from spectroscopic and thermal testing of the base polymers to extractables/leachables (E/L) and chromatography, to determine if the product is going to be safe for its intended purpose.
“Currently, we are seeing a large increase in demand for E/L studies in support of ISO 10993-18,” he added. “This demand is driven by our ability to provide best-in-class turnaround times for program completion. This is a testament to the investment that we have made and are continuing to make in meeting the needs of our clients and the medical device industry.”
The medical devices tested range from short-term exposure devices — such as surgical tools and drug-coated balloons — to high-profile, Class 3 implants, valves, stents, and catheters.
For medical device companies in later stages of product development, EAG also can demonstrate the products’ compliance with appropriate International Organization for Standardization (ISO), US Food and Drug Administration (FDA), and European Union (EU) regulations.
“For start-ups or clients that are in the early stages of product development, we are able to help by performing materials assessments to choose those that are going to provide the best balance of performance and E/L profiles. EAG has other laboratories that work together with the St. Louis location to support the client’s performance and engineering testing needs,” Karnavas said, noting that the St. Louis laboratory focuses on material characterization.
The new lab performs chromatographic and thermal testing using methods that include chromatography–mass spectrometry (LC-MS), gas chromatography–mass spectrometry (GC-MS), and gas chromatography/flame ionization detection (CG/FID).
“Our E/L work is supported by state-of-the art LC-MS systems, as well as several GC-MS and GC-FID instruments,” Karnavas explained. “We also have an ISO 7 cleanroom with an ISO 5 sample-preparation/isolation area, complete with a Raman microscope, to analyze foreign particulates and characterize active pharmaceutical ingredient and excipient particles in combination devices.”
EAG’s St. Louis laboratory will create more than 30 additional highly paid scientific positions in the next 12 to 18 months to support market demand.