White Paper: Medical
How Parylene Crushes Sterilization, Friction & FDA Hurdles
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Discover how thin-film Parylene conformal coatings safeguard medical devices with unmatched biocompatibility, reliability, and performance under extreme conditions. In this insightful interview, SCS (Specialty Coating Systems) Medical Market Manager Dick Molin tackles key engineer concerns: sterilization testing across autoclave, gamma, e-beam, and more; friction coefficients that eliminate syringe breakout surges; FDA submission support via Device Master Files; 10-year shelf life from 85°C/95% RH aging; and zero particulate shedding in blood-contact applications, backed by 50+ years of implant success. Essential reading for advancing regulatory-compliant medtech innovations.
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Overview
The document discusses the manufacturing processes and properties of PTFE (polytetrafluoroethylene) liners used in medical devices, particularly focusing on film-cast liners. It outlines three primary manufacturing methods: free-extrusion, extrusion over-the-wire (OTW), and film-cast.
Free-extrusion results in strong and rigid liners due to the molecular orientation of PTFE chains, while extrusion OTW offers partial molecular orientation, leading to more flexible but slightly weaker liners. Film-cast liners, produced through a process that involves applying a PTFE dispersion onto a metal core wire followed by sintering, exhibit incredible flexibility due to the lack of molecular orientation. This flexibility makes them suitable for applications in small, complex, and tortuous vasculatures, such as those found in catheter designs for delicate anatomical environments.
However, traditional film-cast liners face significant challenges, including susceptibility to surface imperfections and pinholes. These defects can compromise the mechanical performance and reliability of medical devices, leading to unpredictable burst strength and increased manufacturing costs. Issues with liners may not be detected until late in the production process, resulting in scrapped devices and wasted resources.
In response to these challenges, Zeus, a company with nearly 60 years of experience in high-performance PTFE components, has developed a new proprietary film-cast process. This innovative approach aims to reduce surface imperfections and pinholes, resulting in the StreamLiner™ NG catheter liner. This new product promises enhanced flexibility, mechanical performance, and reliability, providing greater design freedom for engineers working on next-generation medical devices.
The document emphasizes Zeus's commitment to quality and innovation, highlighting their goal to improve the performance of film-cast liners while addressing the historical challenges associated with legacy products. By introducing the StreamLiner™ NG, Zeus aims to set a new standard in the industry, enabling engineers to create more effective and reliable medical devices.
Overall, the document provides a comprehensive overview of the evolution of PTFE liners, the challenges faced by manufacturers, and the innovative solutions being developed to enhance the performance and reliability of film-cast liners in medical applications.