CSL Plasma
“First Principles” Thermal Modeling Improved Freeze/Thaw Operations
Challenge
CSL Plasma is a subsidiary of the global biotech leader CSL Behring and operates one of the largest plasma collection networks in the world that safely collect, store, and ship donated plasma from their state-of-the-art logistics centers.
Objectives
- Review testing data and equipment specifications for the current and new collection bottles to define the heat transfer process’s key attributes;
- Calculate plasma freeze/thaw times under worst-case conditions and compare to optimum operating conditions;
- Provide a thermodynamic evaluation of the collection bottles’ critical-to-quality attributes regarding their impact on the freezing and thawing processes;
- Review validation documentation for the current freeze/thaw processes
- Provide a technical report outlining a scientifically defensible validation approach recommendation for the new collection bottle.
Results
CSL Plasma gained a deeper understanding of the governing mechanisms of heat transfer and thermodynamics applied to their freeze/thaw processes through extensive collaboration with our expert engineering team. The complete, functioning thermal model accurately predicts heat transfer rates for a variety of freeze/thaw process conditions. Most importantly, our thermal model demonstrates that CSL Plasma’s operating procedures adhere to the freezing regulatory requirements, even under worst-case operating conditions.
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