When the colon cancer diagnostic provider struggled to meet FDA label compliance standards, the researchers approached FLEXcon of Spencer, MA and their staff of technical service professionals. The ampoule labels the diagnostic provider was utilizing were failing in the field and there was no reasonable solution in sight. The diagnostic provider needed a labeling solution that would meet the rigors of lab environments, and provide superior print and bonding characteristics.
FLEXcon, a global manufacturer of pressure-sensitive film products, proposed an opaque polypropylene film. The film had to be conformable enough to go around the ampoule, but rigid enough to automatically dispense. The opacity was critical in producing the appropriate black and white contrast rating necessary for optimal readability and “A” grade ANSI barcode scans. The adhesive was the next challenge. FLEXcon chose their V-367 adhesive to combat the low surface energy of the ampoules. V-367 is an aggressive permanent adhesive with excellent resistance to chemicals, heat, and humidity.
For maximum printability, FLEXcon carries a variety of high performance topcoatings for thermal transfer printing. In the case of the colon cancer diagnostic provider, FLEXcon’s TC-387 was the topcoat choice for the application. FLEXcon’s TC-387 is compatible with a wide range of resin and wax/resin ribbons and offers superior abrasion resistance. More than just enhancing the ability to print, the topcoat protects the label. It is durable while resistant to blood and other possible exposures. The topcoat had to succeed by being soft enough to print, but durable enough to perform under varying conditions.
The construction was backed with a polyester release liner, which aided in the dispensing of the label onto the ampoule. The liner was crucial in minimizing the amount of human contact with the automatic label application equipment and ampoules inside the clean room environment.
The cancer diagnostic provider tested the FLEXcon construction on 2,000,000 vials. Out of these, only two labels began to peel.
FLEXcon was successful in providing a labeling film, topcoat, and adhesive that stand up to the inner and outer elements affecting the identification labels of the ampoule. The colon cancer diagnostic provider continues to use this labeling product as a way to assure the precision and accuracy that is the lifeblood of their business.