Fedrigoni addresses evolving pharmaceutical label industry

Pharmaceutical labels maintain different requirements from many of their counterparts. Here, standing out on a crowded shelf is not nearly as important. On the contrary, consumer safety is paramount when dealing with this labeling segment. In order to ensure consumer safety, a host of regulations have been established. And suppliers are leaning into technology to further the advancement of this market.

Most importantly, a pharmaceutical label must serve a function. “A pharmaceutical label has to do much more than carry product information,” states Lisa Ivey, R&D manager, Fedrigoni Self-Adhesives. “It plays a role in product identification, patient safety, regulatory compliance, traceability, brand protection and performance throughout the full lifecycle of the package.

At the most basic level, the label must remain readable, scannable, and securely adhered from application through use. That may sound simple, but pharmaceutical packaging can often introduce demanding conditions.

“Labels may be applied to small-diameter containers, stored in refrigerated environments, exposed to handling throughout the supply chain or required to support variable data, barcodes, serialization or other critical information,” explains Ivey. “For many pharmaceutical applications, the label can help provide evidence of tampering, support authentication and protect against counterfeiting. In this market, the label is part of a larger system of protection. It needs to perform reliably while also supporting the integrity of the product and the confidence of the patient, provider, and brand owner.”

Adhering to regulations

According to Ivey, regulations are central to pharmaceutical labeling. Regulations are critical because the label is directly tied to product safety, correct use, traceability and compliance. Requirements can influence what information must appear on the package, how that information is presented, how products are identified through the supply chain and, in certain cases, how tampering or product authentication is addressed.

For converters and brands, pharmaceutical labeling cannot be approached as a static requirement. Regulations, guidance, and customer expectations continue to shift. Therefore, material selection has to account for today’s package, as well as the way that package moves through the supply chain. Information may also need to be verified, scanned, or protected at different points.

“These requirements continue to evolve as the pharmaceutical supply chain becomes more digital, more global and more focused on end-to-end traceability,” notes Ivey. “Serialization, product tracing and machine-readable codes have increased the need for labels that can support consistent print quality and reliable scanning. At the same time, heightened attention to counterfeit prevention and patient safety continues to place pressure on packaging and label systems to provide additional layers of protection.

Expanding capabilities

Labels are now expected to support more data, more codes and more verification points, often without adding much space to the package. “One of the biggest changes is the increased importance of traceability,” says Ivey. “Small containers, curved surfaces and crowded label panels are common, which makes material performance and print consistency especially important.”

There has also been more emphasis on security and authentication. “Counterfeit prevention, tamper evidence, and brand protection are no longer limited to select high-value products,” adds Ivey. “They are becoming broader considerations across regulated and sensitive markets.”

At the same time, pharmaceutical packaging is becoming more varied. Applications can range from OTC and prescription bottles to injectables, vials, syringes, refrigerated products, blood bag labeling, hang tags, and secondary packaging.

“Each of these applications can require a different balance of adhesion, flexibility, durability, printability, and security,” comments Ivey. “That has pushed the industry toward more application-specific solutions rather than one-size-fits-all material choices.”

Addressing new materials

Converters producing pharmaceutical labels must realize there is rarely a one-size-fits-all solution. In fact, pharmaceutical labels are highly application dependent. According to Ivey, there are numerous variables to consider.

“That is where material expertise and customization become especially important,” explains Ivey. “The value is not simply having a portfolio of pharmaceutical label materials available but being able to understand the specific application and develop a construction around it. For converters, that can mean working through the right combination of facestock, adhesive, liner and performance features to help the label meet the needs of the package, process, and end use.”

Different applications and containers come with different requirements. “For tamper-evident and anti-counterfeiting applications, the material construction may need to do more than adhere,” says Ivey. “It may need to provide visible evidence of interference, support authentication or incorporate overt and covert security features. Void films, destructible materials, safety peel constructions, specialty adhesives, taggants and other security features can all play a role depending on the application.”

Meanwhile, small-diameter containers such as vials, syringes, ampoules, test tubes, and injectable devices, require tight mandrel performance. The facestock and adhesive have to work together to reduce the risk of edge lift and help the label stay in place on curved surfaces.

Plus, cold storage and specialty environments are also important. “Pharmaceutical labels may need to perform through refrigerated storage, handling, transport or other demanding conditions,” notes Ivey. “In those cases, adhesive selection, facestock stability and print durability become especially important.

“Our Applications Development team works closely with converters to evaluate the specific requirements of the application and engineer the right material solution for the package, process and performance demands,” adds Ivey.