Pharma-Dedicated Labels Close a Safety Gap

By Yasmine Pierre, Product Manager for Pharma & Healthcare at UPM Adhesive Materials

Pharmaceutical packaging is undergoing a transformation. Growth in injectables, biologics and other self-administered therapies is driving the adoption of prefilled syringes, injection pens, autoinjectors, wearable devices and on-body injectors. Here, Yasmine Pierre, Product Manager for Pharma & Healthcare at UPM Adhesive Materials, explains why pharma-dedicated labels matter for these more challenging labeling applications. She also covers how to avoid potential label failure and reputational risk across the outsourced pharmaceutical supply chain.

Packaging innovation exposes a weak link

As pharmaceutical packaging formats evolve, regulatory scrutiny is intensifying. Plastic packaging materials, such as polypropylene (PP) and cyclic olefin polymers (COP/COC), are now more common in pharma packaging. Combined with increasingly sophisticated combination drug devices, these changes have focused greater attention on potential migration risks and device biocompatibility. Regulators now evaluate every material in the packaging system more closely.

Pharmaceutical development and manufacturing have become highly sophisticated. Stringent controls are applied throughout the product lifecycle. Regulators such as the FDA and EMA [1] set clear expectations for container closure and labeling system design, qualification and change control. Yet many pharmaceutical products are still labeled with standard-grade materials originally developed for general industrial or consumer applications. This mismatch is where the safety gap opens. For CDMOs and converters applying labels on a brand owner’s behalf, managing that risk often falls on them.

Injectables labeling challenges

Injectable products provide a clear example of this mismatch. Containers with diameters below 0.91 inches, and especially between 0.3 and 0.5 inches, require adhesives engineered for tight mandrel hold and cold-chain performance. Materials proven adequate for ambient conditions can fail once moisture and curved surfaces enter the picture. The result is edge lifting, peeling or loss of legibility, visible on the label itself.

Standard label materials create unnecessary risk

Labels are an integral part of pharmaceutical packaging and medical devices. They carry the critical information patients and healthcare professionals rely on. However, what is less visible, and too often underestimated, is that labels can also contribute to extractables and leachables (E&L). When the wrong label materials are used, unwanted substances may appear in E&L studies or ISO 10993 biocompatibility testing. This can lead to requalification, added costs, delayed approvals and, in the worst case, supply interruptions.

Standard-grade label materials are suitable for many non-regulated applications. In most pharmaceutical packaging scenarios, they introduce real risk. These materials are rarely tested on small-diameter surfaces for sterilization resistance, extreme temperatures or cold-chain conditions. Validation for pharmaceutical packaging formats is often overlooked as well.

Other safety gaps exist, too. Sourcing and change management often aren’t controlled to pharma standards. Documentation may not align with FDA and EMA expectations, and these materials aren’t always prioritized in supply chains during raw material shortages.

Label failure and brand risk

When these risks materialize, the consequences extend beyond compliance. If a label fails through migration, loss of adhesion, print degradation or instability during extreme temperatures, the problem becomes evident to regulators, healthcare professionals and patients. The reputational and financial impact typically lands on the brand owner, whose product appears unsafe or non-compliant, and on the converter who supplied the labels. Even if the root cause is the selection of a standard material, the damage is shared across the value chain.

What extractables, leachables and migration mean for labels

Three concepts are crucial for understanding the relevance of low migration labels: extractables, leachables and migration. Extractables are compounds that can be extracted from materials under aggressive laboratory conditions. They represent a worst-case scenario. Leachables are compounds that migrate into drug products under normal or accelerated storage conditions. They are directly relevant to patient safety and product quality. Migration is the process by which substances move from packaging or label materials into the product. Contact, temperature, solubility and storage time all influence this process.

All label components, including the label material, adhesive, inks and topcoats, must be considered for E&L risk. Plastic vials and syringes carry a potential risk, since the label adhesive is in direct contact with the packaging surface across a large label-to-container area. UPM PharmaSure™ low-migration adhesives address this at the formulation level. They use polymer structures with a higher molecular weight and no residual monomers.

At the process level, controlled raw material selection, locked formulations and strict change management allow low-migration adhesives and label constructions to address E&L risks. Standard operating procedures (SOP) prevent cross-contamination. Low-migration adhesives and label constructions do not eliminate the need for E&L studies. They do provide a safer starting point for risk-based evaluation supported by a drug master file (DMF).

Pharma-dedicated label materials

So, what are pharma-dedicated label materials and why do they matter? Pharma-dedicated label materials are designed to perform across common pharmaceutical packaging types. They withstand demanding conditions and comply with relevant regulatory expectations. They are particularly important for injectable products, which are sensitive to uncontrolled material changes. Adjustments to adhesion, printability, biocompatibility or supply can cascade into product failures, expanded testing, updated filings or delayed releases.

For converters and pharmaceutical brand owners, pharma-dedicated materials reduce uncertainty in E&L studies. They support risk-based testing and smoother interactions with regulatory agencies. These materials also provide reliable performance for sterilization, low temperatures and real-world handling, while delivering consistent adhesion and durability across plastics, glass, small-diameter containers, cartons and medical devices. For brand owners, this simplifies internal quality and risk assessments and reduces the likelihood of stability and manufacturing issues.

UPM’s comprehensive pharma-ready label portfolio, built on UPM PharmaSure adhesives, meets these requirements and makes reliable pharmaceutical label performance easy.

Hidden costs associated with standard materials

The choice between standard and pharma-dedicated labels often appears, at first, to be a simple cost comparison. In reality, standard materials can carry a number of hidden costs on high-risk or demanding applications. These include additional E&L and stability studies, delays in marketing authorization, product holds or batch rework, costly revalidation when label material suppliers alter formulations, follow-up actions during audits and potential recalls. A single significant delay or recall can outweigh the marginal savings of using standard materials across many production runs, even if such events are rare.

Why early collaboration prevents label failures

Pharma packaging risk management is most effective when the label material supplier, converter and brand owner collaborate, and the earlier the collaboration, the better. An experienced label material supplier brings formulation stability, regulatory awareness, documented test data and global supply consistency to the partnership. The right converter brings converting and printing excellence and guidance on label material selection. The brand owner brings product knowledge, quality requirements and regulatory compliance needs.

When the three parties collaborate early, they make correct material selections from the start, and label validation is smoother. These benefits disappear when converters use standard materials from suppliers who cannot deliver regulatory documentation, do not prioritize formulation stability, or shift raw materials without controlled notification.

Pharma-grade change management protects long product lifecycles

One of the most important benefits of choosing pharma-dedicated label materials from a reliable supplier is strong change management. Pharmaceutical products have long lifecycles, and unplanned material changes can be highly disruptive. The stability window required by pharma companies is often several years. As a leading supplier of pharma-dedicated label materials, UPM commits to stable formulations over extended periods. Formalized change notification frameworks back this commitment, aligned with pharmaceutical requalification needs. Detailed documentation covers every modification, its potential impact and rationale. Pharma materials also receive priority during manufacturing and raw material shortages, to ensure supply security.

Material integrity supported by experienced partners

Converters play a critical role in how labels are applied, processed and printed. The foundation of reliable performance begins with the materials themselves, and with the quality systems and manufacturing discipline behind the labelstock. A supplier with a long regulated-markets history, such as UPM, offers brand owners and converters more than reliable materials. They gain formulations that remain unchanged over long product lifecycles, an extensive support package with data for E&L studies and regulatory submissions, and robust systems to provide traceability to the raw materials.

A pharmaceutical label might not even cover a square inch, but it represents consumer safety and trust that spans the globe. As pharmaceutical packaging continues to evolve, pharma-dedicated labels are becoming a non-negotiable tool for reducing performance and compliance risks throughout the product lifecycle.

Find out more

Learn how to specify the right high-performance pharmaceutical label material to keep your brand, products and consumers safe by downloading UPM Adhesive Materials’ complimentary pharmaceutical label selection guide: https://go.upm.com/4dJXMAL

[1] FDA (U.S. Food and Drug Administration), “Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics” and EMA (European Medicines Agency) “Guideline on Plastic Immediate Packaging Materials”

About the Author

Yasmine Pierre, Product Manager for Pharma & Healthcare at UPM Adhesive Materials, has years of experience in the label and biomedical industries. Her work spans labeling and sustainability needs across multiple sectors, with a current focus on developing solutions for pharmaceutical and healthcare labeling applications. Based in Asheville, North Carolina, Yasmine supports converters and brand owners through label material selection and qualification. Her work across the Americas gives her a close, hands-on view of market requirements.

About UPM Adhesive Materials

UPM Adhesive Materials provides high-performance, innovative self-adhesive products, including label materials for pharmaceutical packaging and medical devices such as pre-filled syringes and injection pens. Brand owners and converters choose UPM for its long history in regulated markets. They benefit from the stability and transparency that underpin dependable pharmaceutical packaging.

Learn more at https://www.adhesivematerials.upm.com/