If you are in the medical devices industry, are you ready for FDA Unique Device Identification (UDI) Compliance? With the FDA’s Unique Device Identification being rolled in over the next few years, this is a good time to get prepared – there is a lot of info on the topic of UDI at the FDA’s website and you can also read the ID Technology UDI eBook.
Since UDI requires that each level of packaging is identified with its own UDI, a number of different technologies will be needed to ensure that everything is printed and labeled correctly. This is where ProMach Labeling & Coding can help.
We have a number of solutions for applying UDI labels to products and packaging. Let’s take a look at some:
UDI Labeling at Unit Level
Direct Part Marking – DPM. For marking UID codes directly to products, a great solution is our range of Macsa Lasers. With both CO2 and YAG lasers, ID Technology can successful mark just about any substrate with quality, permanent codes.
Macsa is a leader in the laser coding and marking business and has a comprehensive line-up of products for just about every application. A Macsa CO2 or YAG laser can print text, graphics and barcodes, both 2D and linear barcodes being supported. Regardless of whether you are using GS1 or HIBCC as your standards organization, ID Technology’s Macsa laser can print compliant verifiable UDI marks directly onto your products – they are also excellent for printing onto chipboard and other carton types as well.
Printing on Unit Packaging
In many cases, the UID mark will need to be printed onto unit packaging, rather than onto the product directly. Unit level packaging for medical devices often consists of cartons or flexible materials, such as film or Tyvek. ID Technology has some good solutions for doing this:
As already mentioned, our Macsa lasers can produce excellent quality UDI marking on chipboard cartons – our Citronix continuous inkjet printers can also print GS1 and HIBCC barcodes onto cartons (and other types of packaging as well.)
Does it make more sense to use labels to identify your cartons? ID Technology is a leading manufacturer of labeling equipment and labels so we can certainly help with that.
Thermal inkjet (TIJ) is another technology that provides printing of high-quality barcodes, graphics and text onto unit packaging, including cartons, labels and Tyvek. We have several models of HP based TIJ printers in our portfolio, including the new ClearMark, specially designed to print to both porous and non-porous materials. Combined with a large, simple to use, graphical interface, ClearMark represents the new generation in high-quality coding systems.
Tyvek and Flexible Packaging
A lot of medical devices are packaged on thermoforming or other types of packaging machines. Because these often package the products in lanes, we have developed a range of printers that are specially designed to be able to print across the web on these horizontal machines. Our Greydon printers can print UDI and other variable information on Tyvek, paper and flexible films.
While we have Greydon flexographic printers for printing static information on these packages, for the variable UDI marking, we use our thermal transfer, TIJ, or digital UV inkjet printers.
Greydon thermal transfer printers, come in print widths of two, four and five inches and can print webs of up to 25 inches wide.
Our thermal printers can print text, graphics as well as barcodes – including both the linear and 2D barcodes needed for UDI labeling.
The printers can be installed on all horizontal packaging machines and can print on both the top and bottom web as needed.
Greydon flexo printers are designed to be installed on horizontal packaging machines and produce excellent print quality at minimal cost per print.
Unlike most flexo printers, our’s prints across the web during the dwell part of the cycle – this allows for a compact design and the best print registration. One or two colors can be printed and a secondary digital printer is usually incorporated to allow the printing of variable data such as date/lot codes and UDI barcodes.
Our Greydon Genesis system is revolutionizing printing for medical devices. Genesis can print high-resolution text, barcodes and graphics onto most substrates, using low cost, safe, UV cured inks.
If you need color printing for your medical device packaging, Genesis can handle that easily. The system is available with color options from simple monochrome up to full color CMYK.
See Genesis in action in this video:
Genesis prints at 360 DPI, the print can be changed to your next job in a few seconds and is compatible with both GS1 and HIBCC barcode standards.
Already in use with some of the most demanding medical device manufacturers, Genesis sets a new standard when it comes to digital printing.
UDI Labeling for Secondary Packaging
Because each layer of packaging needs to have its own UDI data, it is important to be able to print the UDI machine readable barcodes onto your shipping cases as well as your primary packaging.
ID Technology can provide labeling systems that are perfect for printing and applying labels with UDI barcoding to your secondary packaging.
Our new Wipe-on module is designed to be able to print and apply GS1 or HIBCC barcode labels to shipping cases and has no moving parts or need for plant air. The system is designed to use any of the popular OEM print engines.
As an alternative to labeling, using our Macsa CO2 laser coder with Datalase treated cases is a viable option.
UDI Pallet Labeling
At the top of your packaging levels, the pallets you ship also need to be labeled with the appropriate UDI barcodes.
ID Technology specializes in robust labeling equipment for labeling pallets. Up to three sides of the pallet can labeled by a single labeling system.
Barcode Scanning Systems
Our ID See! suite of barcode solutions is built around Datalogic scanning heads and can be used for scanning and validating linear and 2D barcodes as well as carrying our OCR print inspection.
Software for UID Labeling
It is important that you are able to efficiently get your UDI data from your production database to your labels. ID Technology uses the latest label software from companies such as NiceLabel and Seagull Scientific to help design your label formats and to manage your data.
With NiceLabel we are able to control your UDI label printing from a single touchscreen HMI, creating a simple and elegant way to manage your UDI labeling.
How to Get Started
If you need to get started (or to expand) your UDI labeling capabilities, getting in touch with your local ID Technology specialist would be a smart move. With our in-depth knowledge of barcode and printing, we can work with you to come up with the best solution that meets your operational needs and budgets.
Contact us today – 888-438-3242 Option#3 or you can contact me directly at firstname.lastname@example.org. We’ll get you in touch with one of our ID Technology specialists right in your area.