Pharmaceutical Labels: These labels must satisfy strict quality requirements and government regulations.

Author:Hrinya, Greg

Pharmaceutical labels represent an expansive and complex market for converters. This tightly-regulated market must deliver crucial information to the people reading the label. Unlike a wine or beer label, snazzy graphics and eye-popping enhancements are far less relevant in pharmaceuticals.

In pharmaceutical labeling, print quality requirements must meet a certain standard for font size, legibility, accuracy, material qualification, and 100% print inspection. In addition, traceability and durability are key factors of a high-quality label.

"Pharmaceutical labels are not simple in process, material, printing, quality review and inspection and functionality, especially as compared to other types of applications," says Carl Archambeault, director of R&D at Lux Global Label. "There is typically a destructibility or some type of tamper evidence needed in its function. The adhesives must also be considered for its ultimate bond. Regardless if it needs to have a repositionable window or not, there is still a need for an ultimate and very strong bond to the container."

"Quality requirements for pharmaceutical labels also differ from those in other applications," says Oliver Peitzner, product manager at EyeC. "Any errors, like illegible, incorrect or incomplete information on pharmaceutical labels, puts patients' lives in jeopardy and exposes pharmaceutical companies to a risk of litigation and a damaged reputation. Therefore, quality assurance is so essential for pharmaceutical packaging."

As Archambeault notes, the label is not just a label. It serves as an intricate functional component of the final product.

Avery Dennison, whose substrates are frequently used for pharmaceutical labels, sees several inherent characteristics of this type of label. Pharmaceutical labels are often tested for toxicology and risk of migration, and the substrates must include protection from change. Not only must they meet government guidelines, these labels will need to perform through sterilization, tight mandrel applications and cold chain environments.

According to Maria Jose Castillo, quality manager for Ritrama., quality drives pharmaceutical labeling. "The quality standards in the industry are very high and demanding and, very often, the labels have to comply with specific requirements, like ISO 15137:2005, which details self-adhesive hanging devices for infusion bottles and injection vials," she says.

Many different substrates are applicable in this field. "Papers are the most common substrate, but we are beginning to see a shift to more film with the growth of drug products being packaged in vials and syringes," explains Alison Burns, product manager at Avery Dennison. "Film can provide clarity and better performance for tight mandrel packages. Avery Dennison offers a selection of papers and films that can address a wide variety of applications."

UPM Raflatac also sees a diverse range of materials being used in this space, with gloss coated papers, BOPP and PET films being commonplace. Paavo Sillanpaa, manager, Specials Business Segments, Americas, UPM Raflatac, states that substrate selection depends very much on the application and the market segment. The OTC market mainly uses gloss or semi-gloss papers, while the Rx side features lower gauge papers and films for tight mandrel applications such as test tubes, vials...

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