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Lynn Zhang (Senior Technical Specialist, Eurofins EAG Laboratories)
Location: Booth 637
Date: Tuesday, February 11
Time: 11:30am - 12:15pm
Track: Tech Theater
Vault Recording: TBD
Audience Level: All
Regulatory agencies continue to be more stringent on evaluating impact of particulate matter on medical devices. Particles present unintentionally are considered particulate matter and on medical devices (e.g. implantable) may pose potential risks to patients in contact. The quantity, size and shape of particulate matter, along with the chemical composition of the particles all contribute to the risk level. The source of particulate matter may include raw materials, manufacturing components, packaging processes, and contamination. EAG Laboratories can provide data on the quantity, size and chemical characterization of particulate matter, and propose solutions to reduce particle matter.