In last week’s article, I broke down the difference between cold chain and cryogenic transport. This week, we’ll look at what makes temperature-sensitive packaging more challenging.
What Makes Temperature-Sensitive Packaging More Challenging?
The difference between conventional sterile barrier packaging and cryogenic packaging extends far beyond temperature alone. Traditional sterile barrier systems are primarily designed to maintain sterility and protect products from physical damage throughout storage, handling, and transportation. While temperature may be controlled during storage, the packaging materials themselves generally operate within normal environmental conditions.
Temperature-sensitive packaging, especially cryogenic, introduces an entirely new set of challenges. Every packaging component including polymers, adhesives, labels, cushioning materials, foams, seals, and closures must continue to perform after prolonged exposure to temperatures approaching -196°C. At that temperature, many common packaging materials experience significant changes in their mechanical properties under these extreme conditions. Potential failure modes include:
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Polymer embrittlement
- Cracking
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Cold shock
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Delamination
- Adhesive failure
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Seal degradation
- Reduced impact resistance
- Material shrinkage
Packaging engineers must therefore evaluate not only thermal performance but also whether packaging materials continue to provide adequate mechanical protection after exposure to ultra-low temperatures.
Testing Cold Chain and Cryogenic Packaging
Because temperature-controlled packaging must maintain its integrity for both environmental and distribution hazards, package qualification typically involves both mechanical and thermal performance testing.
Distribution testing evaluates hazards such as vibration, shock, compression, altitude, and handling events using industry accepted standards including ASTM D4169 and ISTA 3 Series testing protocols. These evaluations verify that shipping systems can withstand real-world transportation regardless of whether the payload is temperature controlled.
Thermal qualification focuses on the package's ability to maintain required temperatures throughout anticipated shipping durations and environmental conditions. Standards such as ASTM D3103 and ISTA 7D/7E evaluate insulated shipping systems under controlled temperature profiles that simulate real-world distribution environments.
For cryogenic systems, qualifications often extend beyond standard thermal testing. Engineers may perform additional evaluations to determine how packaging materials behave following exposure to liquid nitrogen temperatures. Material characterization may include assessments of cracking, embrittlement, delamination, seal integrity, and overall package functionality after thermal conditioning may be added to the evaluation criteria.
The combination of distribution testing and thermal performance qualification provides confidence that packaging systems consistently maintain the required temperature range throughout distribution under defined conditions.
Looking Ahead
The future of advanced therapies depends on the ability to safely deliver those therapies to patients around the world. Even minor temperature excursions can have irreversible consequences. A product may remain visibly frozen while viability has already been compromised, resulting in the loss of valuable clinical material or personalized patient therapies that cannot be replaced.
As cell therapies, gene therapies, and personalized medicines continue to expand, packaging engineers will play an increasingly important role in ensuring product quality throughout distribution. Successful packaging systems must integrate mechanical durability, thermal performance, regulatory compliance, and patient safety into a single validated solution.
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