CSL Plasma

“First Principles” Thermal Modeling Improved Freeze/Thaw Operations

Challenge

CSL Plasma (https://www.cslplasma.com) is a subsidiary of the global biotech leader CSL Behring (https://www.cslbehring.com)andoperates one of the largest plasma collection networks in the worldthatsafely collect, store, and ship donated plasma from their state-of-the-art logisticscenters.

Objectives

  1. Review testing data and equipment specifications for the current and new collection bottles to define the heat transfer process’s key attributes;
  2. Calculate plasma freeze/thaw times under worst-case conditions and compare to optimum operating conditions;
  3. Provide a thermodynamic evaluation of the collection bottles’ critical-to-quality attributes regarding their impact on the freezing and thawing processes;
  4. Review validation documentation for the current freeze/thaw processes;and
  5. Provide a technical report outlininga 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. Thecomplete, 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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