Manufacturers meet Device Identification Requirements with thermal transfer overprinter
A pioneer in their industry, PAC Machinery Group was one of the first companies in the world to provide machinery that could do packaging—and validation—for the medical device industry. “Our approach has always been to provide solutions that are tailored to the user’s needs," said PAC Machinery Group Chief Operating Officer Mark Goldman.
“We started experimenting … through a lot of testing, and found that Domino were the only ones who had the capability to be able to do this,” Goldman declared. By integrating the Domino V320i high-speed thermal transfer overprinter on their Medical Magnum pouch-making bagger, Clamco can now print on the Tyvek side of this rollstock material, eliminating need for an additional label on the clear side of the film.
Ordered by the FDA, Unique Device Identification Requirements dictate all U.S. medical device manufacturers must print serialized codes on every product package to ensure traceability from manufacturer to the end user. To meet these requirements, Clamco must print serialized codes onto their customer’s medical device packaging which includes challenging substrates such as Tyvek/Poly rollstock.
Tyvek is a synthetic material composed of embedded fibers resulting in an especially challenging print surface. This solution, using Domino’s V320i, is a repeatable, dependable benchmark that can now set the standard for meeting the customers’ and the government’s requirements.