NEW YORK — Working with specialty materials supplier Solvay SA, German label-maker S+P Samson GmbH has engineered a new label suitable for medical devices and instruments that can survive extreme sterilization processes.
The Structobond labels incorporate ribbons of thin-but-strong Radel brand polyphenylsulfone (PPSU) film, made by Solvay Specialty Polymers' subsidiary Ajedium, sandwiched between layers of Samson's epoxy, the companies explained when introducing the labels at the MD&M East trade show, held June 9-11 in New York.
The Solvay-Samson partnership comes at an opportune time, with the medical device market facing increasing demands for improved identification and tracking of surgical instruments and devices. In the United States, the Food and Drug Administration is phasing in an identification system that will eventually require both a bar code for machine scanning and readable text on nearly all medical devices.
Structobond labels can withstand steam and gamma sterilization and have strong chemical resistance, said Maria Gallahue-Worl, Solvay's global healthcare business manager, making long-term labeling possible on devices and even on multiple-use surgical instruments.
After curing the epoxy resin top layer, anything printed on the 0.2-inch by 0.2-inch (5-millimeter by 5-mm) PPSU middle layer is protected, Gallahue-Worl explained, even through multiple, rigorous sterilizations.
On its own, RadelPPSU film can withstand repeated chemical disinfection and more than 1,000 autoclave steam sterilization cycles, according to Solvay. In new tests targeting the polymer's performance for S+P Samson's medical labeling application, the three-layer construction withstood more than 700 autoclave cycles with no delamination. The cycles include disinfection using acid and alkaline sterilants, ultrasonic cleaning and temperatures up to 273° F (134° C) at a pressure of 2 bar, according to the company.
The custom labels will first be available in the European market, Gallahue-Worl said, before going global under Samson's newly established medical-specific flagship, Clinic-ID GmbH.