Internal Validation Study: Ultra-Low Temperature Labels

Biologics accounted for over 40% of newly approved drugs in 2024, and many require cold or ultra-cold storage to maintain their integrity. At -80°C, however, adhesives can falter, qualified label suppliers are scarce, and label lifting or detachment can compromise clinical trial operations.

This internal validation study was initiated following reports of label failures from an existing client, including lifting and complete detachment under ultra-cold conditions. It evaluates standard, single-panel wrap-around, and booklet wrap-around label formats applied over dry ice using different cart setups. The results show that not every format met the required qualification standard, highlighting the importance of validating label performance for demanding storage environments. Beyond label format, the study examines practical factors that can influence testing outcomes, including CO₂ monitoring, ventilation, glove selection, and the potential for fibers to contaminate the adhesive.

Explore the methodology, review the findings, and discover which label formats held up under the conditions tested.