Bayer MaterialScience LLC has added particulation testing at its affiliated research and development facility, the Medical Coatings Development Centre in Sheffield, England. Company officials say the added capability will allow it to better assess the quality and safety of the customer parts it coats, while “enhancing the reputation for durability” of its Baymedix CL 100 lubricious surface modification product.

Particulation, or particle generation, refers to the tendency for a material to shed wear particles during use. For coatings, it is related to both physical properties and the strength of adhesion to the substrate. Medical device manufacturers have become increasingly aware of this phenomenon and its relevance in designing new products. It is especially relevant for medical devices like catheters that are used in the bloodstream and often contain a hydrophilic lubricious coating for ease of handling or enhanced performance. As safety-related performance measures have become a growing focus, device manufacturers are including particulation data more often when applying for market approval.

Researchers at the Medical Coatings Development Centre have integrated a particulation measurement system into the coating qualification process and have developed a series of relevant protocols to generate the particulates. “We have established a range of methods, ranging from quick, high-throughput particulation screens, up to full simulated use testing in models that simulate physiological anatomy,” says Jeff Motley, R&D manager of the site.

Paul Nowatzki, business development manager for Bayer MaterialScience LLC, says, “Customers of hydrophilic coatings have several demands: low coefficient of friction, good adhesion, good durability, and resistance to particulation. With our wide range of coating and testing capabilities, we’re able to demonstrate product performance, value, and consistency to customers.”