A laser marker for medical devices and products can now be optimized to permanently mark plastic disposables or stainless steel reusables without compromising the device surface.
Black Marking for Reusables UDI
There is a growing mandatory requirement for labelling reusables with permanent Unique Device Identifier (UDI) marks that don’t fade with repeated sterilization (autoclaving). Many of these devices are fabricated from stainless steel and it is vital that the UDI marks do not degrade the natural passivation of the stainless steel surface, i.e., its corrosion resistance. Traditional engraving compromises the passivation. Plus, it creates surface features that can irritate tissue while also potentially trapping contamination. Alternatively, traditional dark marks produced by laser oxidation of the metal surface compromise the passivation and will quickly fade/corrode with repeated sterilization.
Fortunately, a newer method based on ultrashort pulse (USP) lasers called “black marking” now creates high-contrast marks suitable for human and machine viewing without compromising passivation. Here the high peak power and short pulse duration of USP lasers causes a permanent nanoscale change in the surface and sub-surface structure of stainless steel products. This has a strong light-trapping (anti-reflection) effect that makes the marks appear black with very high contrast. Because this is a nanostructural change in the steel, it does not corrode or fade during repeated autoclaving – see figure 1.
By adjusting the USP laser output, black marking can also be applied to certain anodized alloys where it produces a light trapping nanostructure in the aluminum that is smooth to the touch and does not compomise the outer clear anodized surface.
Figure 1. Black marks before and after a 20-minute Citrisurf® passivation process. The mark is neither faded nor corroded.
Sub-Surface Marking of Plastic Disposables
Manufacturers of plastic disposables also need an advanced laser marking technique, for devices and/or the device packaging, again because of the limitations of traditional methods. Specifically, labels can be damaged or removed, inks can contaminate, and infrared lasers will cause charring, surface roughness, and other unwanted thermal effects. The latest ultraviolet lasers meet this need, since their high energy photons directly break the molecular bonds in plastic polymers. This can be used to cause a photochemical transformation that changes the color of the plastic, without removing material or causing any damage to the surface.
Figure 2. Ultraviolet lasers can mark inside colorless materials such as silicone rubber without affecting the outer surface.
The most common photochemical transformation is to bleach a colored material, creating a pale mark. But some materials are designed to produce other types of color change. For example, ultraviolet lasers can create dark, high-contrast marks on nylon and polyurethane that are white due to titanium dioxide doping. Examples include UDI marks on disposable catheters as well as QR codes on pharmaceutical bottle caps. As shown in figure 2, ultraviolet lasers can also mark transparent plastics, e.g., inhalation masks, as well as coated colored plastics without damage to overlaying transparent anti-allergen coatings, as used in hearing aids.
Figure 3. The PowerLine E 8 QT includes a multiwatt ultraviolet laser and is ideal for marking medical plastic devices.
Turnkey Laser Markers meet Applications Support
Coherent has long been known as one of the world’s leading providers of laser-based technologies with strong expertise in USP lasers and industrial-grade ultraviolet lasers. But except for laser job shops and specialty tool builders, most medical device applications today need much more than just a laser. In 2016, Coherent acquired ROFIN, a recognized leader in laser markers and laser marking machines and applications. This has enabled the company to provide an expanded range of superior turnkey laser marking solutions optimized for applications including medical devices and disposables.
An example is the PowerLine family of laser markers, originally developed by ROFIN. The PowerLine E 8 QT for example includes a multiwatt ultraviolet laser ideal for marking plastic products, and the PowerLine Rapid NX is based on a USP laser optimized for black marking applications. These proven sub-systems include the laser and modular scan optics, all housed in a tailored solution package. They also feature the Visual Laser Marker (VLM) software suite which consists of a graphic editor to generate the layout plus a CAD extension to import all common file types: DXF, BMP, JPG, PDF, and AI. Special objects and other parameters for marking are all easily configurable.
For any laser application, service and support are also vitally important. Coherent now runs 17 service centers and multiple applications labs, strategically located around the world, all coordinated from the company’s center of excellence near Munich, Germany that acts as a single, centralized hub for all Coherent marking resources.