Master Bond and Steris collaborated in research to determine the compatibility of Master Bond’s specialty epoxies with Vaporised Hydrogen Peroxide (VHPTM) using V-PRO s2 Low Temperature Sterilisation System. This study was published in a peer-reviewed journal Polymer-Plastics Technology and Materials.
As medical devices have evolved through technological advancements, they have become more complex in both their design and materials of construction. Medical grade biocompatible epoxies are used in reusable medical devices. Choosing an epoxy that maintains its performance characteristics when subjected to repeated sterilisation throughout the reusable medical device’s lifespan is a known challenge for medical device manufacturers. This study evaluated the material compatibility of seven cured two part and one part epoxies used in medical devices following exposure to 100 cycles in a low temperature vaporised hydrogen peroxide steriliser.
Six of the seven epoxies tested were found to be compatible with vaporised hydrogen peroxide sterilisation 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%). This study highlights the importance of conducting material compatibility studies, and continued collaborations among medical device manufacturers, steriliser manufacturers and epoxy manufacturers during the early stages of medical device development to ensure a successful reusable medical device that will withstand repeated sterilisation.
The Master Bond EP42HT-2Med, EP42HT-4AOMed Black, EP62-1HTMed, EP41S-5Med, EP4CL-80Med and UV10TKMed epoxies are compatible with low temperature vaporised hydrogen peroxide, as they maintained their surface texture, exhibited less than 2% change in hardness, and displayed less than a 2.5% weight gain post exposure to 100 VHP cycles.
