Printing with sterilisation resistance at 200°C.
Within the context of ensuring compliance with UDI (Unique Device Identifier) regulations in the USA under which every medical device must be identified, this surgical suture equipment manufacturer has introduced a print solution using Thermal Transfer.
The difficulty for this user is achieving a durable print of the wide range of data and diagrams required under the UDI standard on a porous substrate, Tyvek®, prior to sterilising everything via a high-pressure/high-temperature sterilisation process (in excess of 200°C).
These extreme conditions require the use of a Resin ink, among which only the inkanto Thermal Transfer ribbon AXR®600 successfully passed the various testing stages conducted by this US ribbon manufacturer.
When necessary, ARMOR-IIMAK is able to provide support to health industry companies with their Drug Master File (DMF) submissions to the FDA.