Yahtanhoya Moreno, MarCom specialist for consumer goods and healthcare at Syensqo, talks about revolutionizing medical devices through the use of PPSU, which combines performance with visual appeal.
The field of medical device manufacturing has seen significant advances in recent decades, largely due to the advancement of materials used in production. A notable milestone in this evolution was the introduction of Radel PPSU (polyphenylsulfone) over 30 years ago. This advanced polymer has gradually replaced traditional materials such as metals, offering a combination of durability, reliability and aesthetic appeal.
Sterilization resistance
The Radel family of products, particularly Radel PPSU, has demonstrated remarkable durability and resilience, outperforming conventional materials in key areas. Accelerated aging studies of Radel PPSU show that it remains stable under typical storage conditions, ensuring a long product life. In addition, Radel PPSU’s compatibility with various sterilization methods – including gamma radiation, steam and ethylene oxide (ETO) – allows it to maintain its mechanical, thermal and chemical integrity over repeated cycles. This makes Radel PPSU the ideal choice for medical devices that require frequent sterilization, improving patient safety and device reliability.
Biocompatibility and reliability
Biocompatibility is a key requirement for materials used in medical applications. Radel PPSU meets the stringent ISO 10993:5 and 10993:18 standards for cytotoxicity and physicochemical properties. These certifications confirm its suitability for applications involving direct contact with body tissues and fluids for periods of less than 24 hours and ensure its reliability and effectiveness in clinical settings.
Mechanical properties and colour stability
Radel PPSU is characterized by its ability to maintain its strength and toughness even under harsh sterilization conditions. Tests have shown minimal changes in its tensile strength and elongation, demonstrating its robustness under stress. In addition, steam sterilization, a common method for Radel PPSU, has no effect on the color of the product even after 1,000 cycles. Consistent color fidelity is critical for devices that rely on color coding to improve functionality and reduce errors, improving both ease of use and process efficiency.
Impact on medical device manufacturing
The integration of Radel PPSU into medical device manufacturing has enabled the development of lighter, more ergonomic medical instruments that reduce fatigue and improve procedural efficiency. Availability in a range of transparent and opaque colors has facilitated the development of color-coded surgical instruments that improve operational efficiency and reduce the risk of errors in hectic surgical environments.
Diploma
Radel PPSU represents an advance in materials science and drives innovation in medical device manufacturing. Its durability, compliance with biocompatibility standards and adaptability to stringent sterilization processes set new standards for performance and reliability in healthcare applications. As the medical industry continues to evolve, Radel PPSU will play a critical role in developing innovative and efficient medical devices that meet the complex demands of modern medicine.
