In the pharmaceutical cold chain, labels must perform from +8 °C down to –196 °C in liquid nitrogen. At such extremes, conventional adhesives lose tack and ice films hinder adhesion.
Melsungen, August 26, 2025
Biopharmaceuticals such as vaccines and advanced therapy medicinal products (ATMPs) often require storage under extreme temperature conditions. “Anyone producing adhesive labels for biologics, vaccines, or ATMPs faces the same challenge every day,” explains Frank Jäger, Commercial Director CCL Clinical worldwide. Cold and cryogenic environments alter the properties of label substrates such as paper and film as well as the rheology and adhesion of pressure-sensitive systems.
Material Qualification Under Real Conditions
Labels in the cold chain must remain accurate and durable throughout the entire product lifecycle, enduring repeated freeze–thaw cycles down to –196 °C. Selecting the right combination of substrate and adhesive is essential. While materials from suppliers are certified, CCL Clinical conducts in-house validation under defined quality protocols.
Testing considers the temperature during application, the time between application and freezing, the moisture condition of the container surface (dry, moist, frosted), and its morphology (flat, curved, smooth, rough). Product Development and Quality Management teams carry out these tests using standardized, industry-aligned criteria.
Design Solutions for Low Temperatures
Once the materials are qualified, label structure is adapted to the process. For cylindrical containers, wrap around labels are common. In cryogenic applications, the choice of adhesive and design depends heavily on the process step and the temperature at which labeling occurs. “Even minimal ice formation on the surface can drastically reduce wettability,” notes Jäger. “We therefore use cold-active adhesive formulations that maintain tack without crystallizing.”
Transfer Labels for Two-Stage Labeling
In cases where containers must be frozen before final label content is available, CCL Clinical uses transfer labels applied prior to freezing. These interim labels act as a protective layer, preserving the adhesive surface for the final label, which can then be applied — even inside deep-freeze storage.
Manual application at such low temperatures is complicated by cold-protection gloves, which reduce dexterity. To solve this, CCL Clinical developed transfer labels with large, silicone-coated grip tabs protruding from the packaging. These tabs enable easy removal of the interim label without damaging the adhesive surface beneath. “Transfer labels with engineered grip tabs may seem like small design elements, but they make a decisive contribution to process reliability and label durability under subcryogenic conditions,” concludes Jäger.
Caption: Transfer labels protect the adhesive layer intended for final labeling and ensure secure, compliant marking even at –196 °C.
For any questions or further information, please feel free to contact:
Miriam Bertel
Communication Manager
CCL Faubel GmbH – Center of Excellence in Clinical Trial Labeling
Schwarzenberger Weg 45
34212 Melsungen, Germany
Tel.: +49 5661 7309-219
Email: m.bertel@faubel.de
