Fluoropolymers are fluorocarbon-based polymers characterized by a high resistance to solvents, sterilization, alcohol, and heat. Because of these properties, fluoropolymer substrates are excellent for giving medical devices a permanent “non-stick” surface that is resistant to wear. Unfortunately, these properties also prevent ink from adhering to the surface – which makes fluoropolymer pad printing a challenging process.

Medical components that use fluoropolymers include:

  • Catheters
  • Grafts
  • Molded parts, such as handles
  • All types of implanted medical devices including short term, long term, and permanent implants

Engineers select fluoropolymers for their lubricous surface and corrosion resistance. A few types include:

  • PTFE (Polytetrafluoroethylene)
  • PFA (perfluoroalkoxy alkane)
  • FEP (fluorinated ethylene propylene)
  • ETFE (ethylene tetrafluoroethylene)
  • PVDF (polyvinylidene fluoride)
  • ECTFE (ethylene chlorotrifluoroethylene)
  • ePTFE (expanded polytetrafluoroethylene)

Why is fluoropolymer pad printing so challenging

  • Marking/labeling is required – yet due to fluoropolymers’ low coefficient of friction, medical grade inks do not inherently adhere.
  • The base substrate characteristics must not be permanently affected, so adhesive labels and etching techniques cannot be used as an alternative to ink markings.
  • The inks must be medical grade, USP Class VI certified.
  • Markings must visually clear and dimensionally accurate.

How does CI Medical overcome the challenges of printing on fluoropolymer surfaces?

Fluoropolymers cannot be printed without first pretreating the surface. Proprietary on-site plasma pretreatment allows CI Medical to modify the surface tension of fluoropolymer surfaces to create the strongest possible bond of ink-to-substrate. Benefits include:

  • No permanent changes to the substrate’s properties. While the surface of the substrate is temporarily altered, it reverts to its original characteristics once the ink has cured.
  • Permanent ink-to-fluoropolymer adhesion
  • Precise, high-quality markings

In addition to standard medical grade inks, we can also mark fluoropolymer substrates with our proprietary Radiopaque™ inks. CI Medical takes on the difficult challenges that other pad printing companies cannot! Contact CI Medical to discuss printing and marking on your medical devices.