Material compatibility of epoxies exposed to repeated low temperature vaporized hydrogen peroxide sterilization

• Published in: Polymer-plastics technology and engineering 2024-12, Vol.63 (18), p.2511-2520
• Main Authors: Padhee, Shruti, Fingar, Christine, Patel, Ankit, Eveland, Randal, Rantucci, Jordan, Ward, Tawana, Nandivada, Venkat, Ramnath, Rohit
• Format: Article
• Language: English
• Subjects: Biocompatibility; Design; Exposure; Hardness; Hydrogen peroxide; Low temperature; Medical devices; Medical equipment; Medical materials; Medical technology; Performance evaluation; Sterilization
• ISSN: 2574-0881; 0360-2559; 2574-089X; 1525-6111
• DOI: 10.1080/25740881.2024.2376209

Through technological advancements, medical devices have evolved in their designs and have become more complex in both their design and materials of construction. Medical grade biocompatible epoxies are widely used in reusable medical devices. Choosing an epoxy that maintains its performance characteristics when subjected to repeated sterilization throughout the reusable medical device’s lifespan is a known challenge for medical device manufacturers. This study evaluated the material compatibility of seven cured 2-part and 1-part epoxies used in medical devices following exposure to 100 cycles in a low temperature vaporized hydrogen peroxide sterilizer. Six of the seven epoxies tested were found to be compatible with vaporized hydrogen peroxide sterilization based on qualitative, hardness and weight measurements conducted post exposure to 100 VHP cycles. The epoxies deemed to be compatible displayed no visual signs of physical defects, minimal reduction in hardness (≤2%) and total weight gain (≤2.9%). One of the epoxy samples did not maintain its texture and exhibited 17% loss in hardness post exposure to 100 VHP sterilization cycles and was found to be incompatible with the low temperature vaporized hydrogen peroxide process. This study verifies the need for material compatibility evaluations of epoxies prior to designing and developing a medical device while keeping in mind the application, lifecycle and intended use of medical devices.