With the capability to print on a long list of challenging substrates such as polysulfones, Delrin®, PEEK, silicone, urethanes, and more, CI Medical takes on the difficult marking challenges that other pad printing companies cannot.
Engineers select the raw materials for their medical device designs by carefully considering the unique characteristics of the materials and how they may enhance or detract from the functionality of the devices. Usually, conventional methods for printing measurement markings and other functional information onto substrates made with these materials are ineffective. Common materials that present this challenge include:
Polysulfones are a family of thermoplastic polymers that are categorized as high-performance plastics known for stability at high temperatures and glass-like strength and transparency.
DELRIN (acetal homopolymer) is a crystalline plastic which offers an excellent balance of properties that bridges the gap between metals and plastics. DELRIN possesses high tensile strength, creep resistance and toughness. It also exhibits low moisture absorption.
PEEK (polyether ether ketone) is a semi-crystalline thermoplastic with excellent mechanical and chemical resistance properties that are retained at high temperatures. As a high-performance plastic, PEEK is used to make top-of-the-line permanent medical implants.
Silicone is an elastomer (rubber-like material) that comes in a multitude of formulations with various characteristics to suit many kinds of medical applications, ranging from instruments to implants.
Polyurethane is an organic polymer with several formulations of varying stiffness, hardness, and density that is commonly used in medical devices.
Why do these materials conflict with medical device marking requirements?
- Marking/labeling is required – yet due to the materials’ natural surface tension properties, medical grade inks do not readily adhere.
- The base characteristics of the substrate must not be permanently altered, so other marking techniques like adhesive labels and solvent or laser etching can’t be used.
- The inks used to mark the substrate must be medical grade USP Class VI certified.
- Marking/labeling must be clear, dimensionally accurate, and permanent.
How does CI Medical overcome the challenges of printing on these substrates?
On many of the above materials, we use our proprietary on-site plasma pretreatment – which allows CI Medical to modify surface tension to create the strongest possible bond of ink-to-substrate. Benefits include:
- There are no lasting effects to the substrate – it reverts to its original characteristics once the ink has cured.
- Permanent ink adhesion is achieved.
- Precise, high-quality printing is attained.
In addition to standard medical grade inks, we can also mark substrates with our proprietary Radiopaque™ inks. Contact CI Medical to discuss printing and marking solutions for your medical devices.