With the latest roll out of the EU Medical Devices legislation, it is important to uncover the latest in coding and marking technologies. Depending on the medical device and the coding surfaces involved, several different technologies can be deployed for the delivery of Unique Device Identification (UDI) in this sector.
Direct Part Marking
The most prominent technology for Direct Part Marking (DPM) on to medical devices is laser. While DPM is more commonly known as an industrial manufacturing application, it is most appropriate for medical device identification.
The presence of reprocessing devices throughout the supply chain can cause product items to be separated from their intended packages, which is why a permanent mark needs to be applied to the medical device. This way, a UDI code is readily available through the device’s distribution and use, even in the absence of packaging or labels.
With code durability being the key priority, a laser marker is a preferred solution thanks to the contrast that can be achieved. A laser system can permanently mark a variety of materials with the utmost precision, producing unlimited lines of texts, graphics or even 2D data matrix codes, resulting in crisp, sharp codes that will not deteriorate over time.
In contrast to DPM, a variety of coding and marking technologies, as well as a laser, can be used for applying unique device identifiers onto primary packaging. These technologies include Thermal Ink Jet (TIJ) and Thermal Transfer Overprinting (TTO).
TTO is the preferred choice for coding onto flexible, web based packaging materials. These materials and packaging applications include flexible laminated films to create pouches, sachets and bags or to lid rigid trays and apply labels to the surface of other primary packs or coding directly onto speciality flexible materials, such as medical paper or Tyvek®.
TTO systems have the capability to print high resolution (300 DPI) human and machine-readable codes. This capability satisfies the UDI requirements, while also being able to print graphics, logos and other variable text fields over large areas that can be used to decorate and customise the pack. The additional advantage of printing details and graphics of the packaging contents gives the manufacturers the opportunity to reduce their operating costs. By minimising the number of packaging material Stock Keeping Units (SKUs) and reducing the downtime incurred by changing the packaging SKU during packaging job change-overs.
Specialised for printing high-resolution codes at high speed, TIJ proves to be an ideal solution for all cartons and particular foils. These systems use solvent- and water-based ink to print complex and durable codes at a fast repeat rate, while still delivering the required legibility that manufacturers have come to expect for UDI codes. The ability to easily integrate a TIJ print head into multilane applications also make this system suitable for wider web coding applications. Employing multiple print heads to deliver individual codes can offer manufacturers significant cost and productivity benefits.
Secondary and Tertiary Packaging
Where larger label information needs to be printed and applied to cases, or a label is the only option due to the substrate or the shape of a product, PALM proves to be an effective alternative to TIJ and TTO.
PALM can be deployed for secondary and tertiary packaging applications and distinguishes itself by being able to provide full GS1 codes (used to encode information such as product numbers, serial numbers and batch numbers) and offers multiple applicator options which includes corner wrapping of cases.
By taking action ahead of the deadline and partnering with a reliable supplier and partner that can provide the guidance and industry knowledge required, compliance can be successfully achieved. To see more on how you can take action, download our whitepaper.