“First Principles” Thermal Modeling Improved Freeze/Thaw Operations
- 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.
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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