In recent years, newer technologies have improved the pharmaceutical labeling process. New inks and inspection tools have enhanced the process tenfold. Substrates are no exception, either.
UPM Raflatac, based in Mills Rivers, NC, USA, has developed a number of solutions and services designed to optimize pharmaceutical labeling. When it comes to pharmaceuticals, UPM Raflatac offers a wide product portfolio. The most common substrates include gloss coated papers, BOPP and PET films.
As Paavo Sillanpää, manager, Specials Business Segments, Americas, UPM Raflatac, notes, substrate selection depends on the application and the market segment. For example, OTC (over the counter) utilizes many gloss or semi-gloss papers. On the Rx side, there is a preference for lower gauge papers and films for tight mandrel applications. These often include items like test tubes, vials, ampoules and pre-filled syringes.
In addition, pharmaceuticals requiring temperature and chemical resistance often necessitate PET films.
“The labeling materials for pharmaceutical labeling have gone through extensive testing and validation processes,” says Sillanpää. “Labels contain important drug and dosage-related information, therefore it is of vital importance that the label stays in place and remains legible throughout the lifetime of the product to guarantee patient safety.”
Sillanpää adds that UPM Raflatac relies on decades of R&D to ensure its products meet the most demanding pharma, healthcare, and laboratory applications. This not only applies to pharmaceutical labels, but also vials and test tubes, cold and cryogenic storage, sterilization, security and more.
The substrates must remain clear and legible while providing excellent durability. “When labeling plastic containers containing liquid materials, such aseye drops, IV-containers etc., attention needs to be paid to potential migration risk according to FDA guidelines,” says Sillanpää. “In order to secure patient safety, it is important to choose an adhesive that has been tested for low leachable characteristics. Several different sterilization methods are being used in the pharmaceutical industry, and therefore it is important to choose the right labeling material that can withstand those conditions without any adverse effect on the label performance.”
When dealing with cryogenic atmospheres, the label substrates must adhere to temperatures ranging from dry ice (-80 C) to cryogenic storage (-196 C).
According to UPM Raflatac, they must be in tune with ever-changing governmental regulations. As of late, more of those alterations have come in Europe.
“While there have not been major regulatory changes lately in the US, that is not the case in Europe, with the Falsified Medicines Directive (2011/62/EU) for packaging of prescription drugs and high-risk over-the-counter medicines,” explains Sillanpää. “The EU’s Falsified Medicines Directive, which comes into force in February 2019, has been designed to prevent the counterfeiting of prescription and high-risk over-the-counter drugs packed in cardboard boxes. Packs should include an anti-tampering feature that exposes attempts to open the packaging.”
In dealing with security and tamper-evident packaging, UPM Raflatac has a product range to meet multiple needs, as well as new solutions designed for missing label detection. The labeling solutions must be suitable for newer technologies, which enable various functionalities.
“The pharmaceutical industry has always been very serious concerning track and trace and the authentication of products,” says Sillanpää. “New regulations, such as the EU’s Falsified Medicines Directive, mandates unique serial number for authentication and a tamper-evident device to guarantee package integrity. UPM Raflatac has developed several solutions to comply with these requirements, and additional levels of security features can be added in order to further enhance the brand protection and authentication.”