More durable medical device labels using PPSU Film

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  • Cost-effective alternative to laser marking, engraving or etching
  • PPSU film can withstand over 1,000 autoclave steam sterilization cycles
  • Focus on medical markets

A new development in the field of medical device labels: S+P Samson GmbH, a leading supplier of specialty labels for industrial applications, has introduced a cost-effective alternative to laser marking, engraving or etching. The German company is using polyphenylsulfone (PPSU) film from Solvay Specialty Polymers for the inlay of its Structobond labels for medical instrument and device applications. Sandwiched between layers of S+P Samson’s epoxy materials, the thin but tough ribbons of the PPSU film deliver very good steam and gamma sterilization compatibility, strong chemical resistance and high contrast for imprinted data used for improved product identification and traceability of surgical instruments.

Cost-effective alternative to laser marking, engraving or etching

The patented, adhesive Structobond labels represent a more durable, cost effective and higher contrast instrument labeling technique than conventional solutions, such as laser marking, engraving or etching. The technology is currently being tested in the European market, and so far the reaction has been extremely positive among instrument manufacturers and end-users alike, according to Karl Tochtermann, Managing Director of S+P Samson GmbH in Kissing, Germany.

medical device label

S+P Samson GmbH, a supplier of specialty labels for industrial applications, selected Solvay’s Radel polyphenylsulfone (PPSU) film for the inlay of its new Structobond labels for medical instrument and device applications (source: S+P Samson GmbH)

Medical device labels address growing need for improved identification

S+P Samson developed the new medical device labels to address the industry’s growing need for improved identification and management of surgical instruments in the operating theater. The U.S. Food & Drug Administration (FDA), for example, is proposing new regulations that will require hospitals to institute more stringent tracking and identification systems over the next two years. In addition to offering an economical solution, S+P Samson’s extremely durable labels enable broader options for more detailed and higher contrast images and data.

How the labels are produced

To create the labels, the 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 Germany-based Lohmann GmbH & Co KG. The bottom layer forms a strong bond between any type of media, including metal, PPSU and coated surfaces. The 5-mm by 5-mm (0.2-in by 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.

PPSU film can withstand over 1,000 autoclave steam sterilization cycles

On its own, Radel PPSU film can withstand repeated chemical disinfection and over 1,000 autoclave steam sterilization cycles while maintaining excellent toughness and impact resistance. 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 temperatures up to 134°C (273°F) at a pressure of 2 bar. The film also provides critical tear propagation performance up to 130 g force (1.275 N).

Focus on medical markets

To support its technology’s success in medical markets, S+P Samson recently established a new 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 new medical device labels to the European market, primarily in Germany. It is planning to expand availability of its technology to the U.S. and other key global regions over the next year.

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