Applying Heat Transfer Concepts to Evaluate Pre-Qualified Thermal Shippers in the Biopharmaceutical Industry

Applying Heat Transfer Concepts to Evaluate Pre-Qualified Thermal Shippers in the Biopharmaceutical Industry

Heat transfer and thermodynamics concepts can be used to estimate the qualified durations for specific use cases. Pre-qualified ‘off-the-shelf’ thermal packaging systems are commonly used across the biopharmaceutical industry to reduce implementation time and cost by avoiding operational qualification (OQ) testing.

Vendors pre-qualify thermal packaging using preconditioning and pack out procedures, thermal profiles, and minimum/maximum loads intended to include most use cases. However, biopharma companies commonly use shipping configurations different from the tested parameters. Many may re-test the thermal packaging system in this scenario; however, heat transfer and thermodynamics calculations can be used to estimate the qualified durations for the specific use case.

Carson Dickey discusses thermal mass analysis, the impact of dry-ice sublimation rate, and thermal profile conversions. These techniques can be applied to use cases that are worst-case compared to the tested configuration. They can also increase the estimated qualified duration of the thermal packaging system when the use case is milder than the qualification testing parameters.