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Creative Commons License

Creative Commons Attribution 4.0 International License
This work is licensed under a Creative Commons Attribution 4.0 International License.

Abstract

This study builds upon methodologies established in a 2024 investigation of the combined effects of physical distribution stresses and thermal environments on cold chain packaging performance. Prior results showed that moisture-resistant gel packs generally maintained a vaccine storage range of +2°C to +8°C. However, when exposed to extreme combined stresses, thermal performance degradation of up to 13.5% was observed. The present work applies a similar experimental framework to transportation systems that rely on dry ice as the primary cooling medium, addressing the distinct challenges associated with ultra-cold distribution.

Pharmaceutical products requiring dry ice are highly temperature-sensitive and vulnerable to performance losses caused by handling and transportation stresses. Despite this sensitivity, current industry qualification practices typically assess dry ice shippers under best-case conditions using undamaged packaging components. In this study, dry-ice-based shipping systems were subjected to various distribution stresses and scenarios followed by the ISTA 7E summer profile to evaluate changes in thermal performance resulting from mechanical stress exposure along with different packing scenarios. Results demonstrate accelerated decay rates associated with dry ice sublimation when container integrity is compromised. These findings highlight limitations in existing qualification approaches and support the inclusion of stress-conditioned testing protocols to more accurately evaluate the performance of ultra-cold pharmaceutical shipping systems.

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