Described as a more durable and cost-effective alternative to laser marking, engraving or etching, Structobond labels for medical device applications have been introduced by specialty labels company S+P Samson GmbH (Kissing, Germany). Thin ribbons of Radel PPSU from Ajedium Films, a division of Solvay Speciality Polymers (Alpharetta, GA), are sandwiched between layers of S+P Samson's epoxy materials to create a sterilizable label with chemical resistance and high contrast for imprinted data. The technology was developed to address industry demand for improved identification and management of surgical instruments in the operating theater, said S+P Samson.
To create the labels, Solvay's 25-µm-thick Radel PPSU film is first marked with a dot matrix code, color or other data through a high-contrast, digital, thermal-transfer printing process. S+P Samson then encapsulates the PPSU film between two layers of its Structobond epoxy resin system, which S+P Samson developed in partnership with Lohmann GmbH & Co KG (Neuwied, Germany). The bottom layer forms a strong bond with any type of media, including metal, PPSU and coated surfaces, according to S+P Samson. The 5-x-5-mm (0.2-x-0.2-in.) PPSU film is then laminated with a top layer of the Structobond epoxy. After the curing process, the top layer protects the printed data.
On its own, Radel PPSU film can withstand repeated chemical disinfection and more than 1,000 autoclave steam sterilization cycles without affecting toughness or impact resistance, said Solvay. Recent tests targeting the polymer's performance in S+P Samson's medical application indicate that 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 exposure to temperatures up to 134°C (273°F) at a pressure of 2 bar. Solvay's high-performance thermoplastic film also provides critical tear propagation performance up to 130 G force (1.275 N).
Structobond technology is currently being tested in the European market. S+P Samson recently established a company named Clinic-ID GmbH, which is working closely with medical device manufacturers and full solution providers serving central sterile service departments in medical centers and hospitals. Through Clinic-ID, S+P Samson will introduce its advanced new medical device labels to the European market, primarily in Germany. It is planning to expand availability of the technology to the United States and other key global regions over the next year.
"Initially, S+P Samson thought they wanted to use PEEK in this application," Maria Gallahue-Worl told PlasticsToday at the recent MD&M East and PLASTEC East events in New York City. "We were able to show them from a solutions perspective that this would not be the best application for that material. This collaborative approach to material selection for tracking labels is one example of how Solvay is getting close to the end user and helping customers develop differentiated solutions and compete more effectively," added Gallahue-Worl.