Launching in the U.S.: FDA Transport Validation Compliance Essentials for European Manufacturers
Entering the U.S. market comes with a unique set of regulatory challenges, particularly when...
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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.
Entering the U.S. market comes with a unique set of regulatory challenges, particularly when...
read DetailsCompeting priorities, changing expectations, cost pressures, sustainability initiatives, and emerging markets are some of...
read DetailsToday, four leading life science companies—Suttons Creek, Modality Solutions, CLINTREX, and ToxStrategies—announce their unification...
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