New particulation testing at Bayer's Medical Coatings Development Centre in Sheffield, England allows the company to better assess the quality and safety of the customer parts it coats.
Bayer MaterialScience LLC has announced the
establishment of particulation testing at its affiliated research and
development facility, the Medical Coatings Development Centre in Sheffield,
England. This capability allows Bayer to better assess the quality and safety
of the customer parts it coats, and Bayer scientists believe the results will
enhance 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.
Said Jeff Motley, R&D Manager of the site for Bayer plc, “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.”
According to Motley, measuring particulation has become an integral tool in
identifying appropriate processing conditions to apply the Baymedix™ CL 100 to
various surfaces. He explained, “Where before we tended to focus on lubricity
and durability of our coating, we now optimize for particulation requirements
as well.” Furthermore, the site now uses particulation in its quality
management system.
Paul Nowatzki, Business Development Manager for Bayer MaterialScience LLC,
commented on the significance of this new measurement capability, saying,
“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.”
Bayer MaterialScience’s Medical Coatings Development Centre works exclusively
on applications technology for the Baymedix™ portfolio of materials for medical
devices.
