Pharmaceutical labels are functional by nature. They must exhibit extreme durability – as they often need to perform in harsh temperature and conditions – while boasting excellent adhesive properties. Adhesives must have good initial tack and a balance of high peel and shear properties. Shear is so important because it allows for high performance and adhesion to tight radius containers. According to FLEXcon, many critical labeling materials are clear films backed with clear polyester liners.
“Films must be conformable and flexible to wrap and contour to tight radius containers yet have some dimensional stability for high-speed dispensing,” notes Lori Bitar, product manager, healthcare, FLEXcon. “The film’s surface coating must also provide a smooth uniform surface to allow for multiple printing methods.”
Since counterfeiting can pose life-or-death ramifications to consumers, brand protection and security are making significant inroads in pharma labeling. Tamper-evident features are continuing to change the landscape in the pharmaceutical industry. Plus, smart labeling is finding a home here.
“There are a full range of overt, covert and forensic solutions, including destructible and semi-destructible films, holographic films, fluorescent adhesives, and micro-taggants, available,” explains Bitar. “Smart label technology introduces new elements beyond the barcode and serialization of product. Increased usage of RFID and RAIN technology, as well as sensors incorporated into label systems, provide enormous benefits to the OEM. Items can be tracked and located at any time during transit or in storage without the need to manually scan.
“There is also a need to track – backwards and forwards – for biologics that will require piggyback type labeling,” she adds.
Smart labels can help validate authentication, manage the flow of inventory to prevent shortages, indicate shock or sudden drastic movement, indicate temperature extremes, and more. This is vital when validating a drug’s efficacy for use.
Another trend, Bitar notes, is the increase of aseptic filling processes in clean room environments. This trend increases the need for plastic films and plastic liners as compared to paper films and paper liners because paper is prone to processing dust debris. Therefore, it is typically not an option for these environments.
“Films are a preferred choice for pharmaceutical applications because they can better withstand harsh conditions such as water baths or other sources of moisture and condensation,” comments Bitar. “They can offer security or tamper-evident features. They are also more suitable for clean room environments because there is no build-up of debris in the converting and application process.”
Due to the sensitive nature of these labels, there are a number of challenges to navigate. For starters, the pharmaceutical industry is notoriously slow at adopting changes, even for labeling components.
“Timing is critical, and the qualification of new materials can take time,” says Bitar. “As a result, converters and OEMs will often revert to the labelstock they know for new applications with a goal oflessening the time required for testing and qualification. However, this tactic does not allow for the qualification of new materials that may be more appropriate for the application requirements. In light of our current situation with limited raw material availability, including stock outs and allocations, a review of the application details is advisable to identify the best choice components for a given application. This allows for converters and OEMs to have multiple acceptable options in the case of stock outs. Furthermore, a performance versus cost evaluation can be conducted to examine if some off the shelf material will work or if customization should be considered.”
Regulations are a critical aspect of pharmaceutical labelling, as well. Most of the regulations apply to what is printed on the label such as those elements necessary for tracking and tracing and product identification.
“The Drug Supply Chain Security Act dictates that linear and/or 2D barcoding, serialization (dependent on product) must be printed on the label,” states Bitar. “Label manufacturers should also consider the raw materials that make up the labels, being FDA approved for indirect food contact and or ISO 10993-5, -10 compatible for plastic container labeling, as well as other durability requirements. All of these are important, but one should ask about adhesion requirements. What regulations encompass the issue of labels not adhering to the container? There is so much focus on what is printed on the label and little to no focus on the survivability of the label – the ultimate adhesion to the container for the life of the product.”