InterLock Technology™ Eliminates Coating Delamination in Medical Devices
Boston, MA -- (ReleaseWire) -- 11/07/2014 --Precision Coating Company, Inc. (PCCI), a leader in the application of polytetrafluoroethylene (PTFE) medical device coatings, has qualified InterLock Technology™, a pre-treatment process that solves an industry-wide coating adhesion issue, which resulted from the EPA’s mandated removal of perfluorooctanoic acid (PFOA) from aqueous-based PTFE formulations.
In 2006, PTFE manufacturers were obliged by the U.S. Environmental Protection Agency (EPA) to eliminate PFOA from all aqueous-based PTFE formulations by 2015. The new formulations were initially touted as drop-in replacements, and Precision Coating endeavored to take the lead in complying with those changes. With time, customers began observing intermittent delamination when coated product was exposed to saline solutions or high-alkaline cleaners. Precision Coating responded by reaching out to those customers and working tirelessly with them to solve the problem. In early 2014, PCCI determined the root cause of delamination failure and developed the solution, InterLock Technology™, a pre-treatment process that eliminates the occurrence of coating delamination.
This pre-treatment process has the ability to restore the wire surface to a pristine state, imparting optimum surface conditions for the coating to wet-out, adhere, and form a stable, cohesive coating layer. InterLock Technology™ does not introduce any new chemistry to the process, does not change the current chemical structure of the applied coating, leaves no residual chemicals behind, and does not affect the properties of the wire or the frictional properties of the coating.
InterLock Technology™ was a critical component in the qualification of a PTFE coated neurovascular guide wire. PCCI worked in conjunction with a global medical device manufacturer of neurovascular wires that became the first customer to qualify the InterLock Technology™ process. To solidify the results, Precision Coating submitted and received an Interlock Technology™ Master File with the FDA, the first for any PTFE coating applicator. This collaborative effort led to the development of a definitive and validated testing protocol to ensure a tenacious adhesion of the coating to the substrate. Precision Coating, working with medical device customers, introduced the Saline Soak and Tape Test (SSTT), which is now an industry standard.
Robert DeAngelis, President of Precision Coating, said that the lengthy process in determining the most effective pre-treatment made them look at their existing processes from all angles. It pointed their engineers to the substrate pre-condition and gave them the insight they needed to create InterLock Technology™. “When we understood the chemical properties, we were able to overcome the challenges associated with the change in formulation,” DeAngelis said.
PCCI’s hard work has enabled them to provide documented evidence that the InterLock process consistently produces products that meet pre-approved specifications, including adhesion to the substrate and surface friction. These efforts have led to the development of a definitive and validated test method that ensures a tenacious adhesion of the coating to the substrate.
InterLock Technology™ provides consistent high bonding strength for PTFE coatings on medical devices. From suppliers to CMOs to OEMs, Precision Coating’s InterLock Technology is the medical device industry’s solution to achieve the desired adhesion on the products coated with aqueous-based PTFE coating.
About Precision Coating, Co., Inc.
Precision Coating Co., Inc., a Katahdin Company, serves global health care and medical device companies around the world, coating medical devices such as guide wires, core wires, hypotubes, and forming mandrels. PCCI has the ability to work with customers from concept to commercialization and has two facilities—one dedicated to flexible prototype work and one dedicated exclusively to high-volume medical device coating applications.
For more information, visit www.precisioncoating.com, call (877) 207-2737, or send an email.