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Energy Transfer in Vials Nested in a Rack System During Lyophilization.

Sarah Daller¹, Wolfgang Friess², Rudolf Schroeder¹

¹AbbVie Deutschland GmbH & Co. KG, Knollstraße 50, 67061 Ludwigshafen, Germany.

|January 17, 2020

Summary

Freeze drying vials in a rack system supports personalized medicine trends. This method ensures uniform product quality through controlled heat transfer, reducing the edge-vial effect in small batch biopharmaceutical production.

Keywords:

TP direct contact edge–vial-effect freeze drying heat transfer lyophilization pressure rack system radiation sublimation rates

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Area of Science:

Biopharmaceutical Manufacturing
Chemical Engineering
Materials Science

Background:

Personalized medicine drives demand for small batch biopharmaceutical production.
Flexible pilot scale processing lines utilize freeze drying vial rack systems.
Understanding heat transfer in vial rack systems is critical for product quality.

Purpose of the Study:

To investigate heat transfer mechanisms in vial rack systems during freeze drying.
To evaluate the impact of rack systems on drying homogeneity and product uniformity.
To assess the suitability of rack systems for small batch lyophilization.

Main Methods:

Utilized a vial rack system for freeze drying experiments.
Analyzed heat transfer contributions, including direct shelf contact (approx. 40%) and radiation shielding.
Evaluated drying homogeneity and the reduction of the edge-vial effect.

Main Results:

Rack systems provide shielding against radiation, reducing the edge-vial effect.
Direct shelf contact accounts for approximately 40% of energy transfer during primary drying.
Lyophilization in rack systems promotes homogeneous drying and uniform product quality.

Conclusions:

Vial rack systems are flexible and robust tools for small batch lyophilization.
These systems ensure controlled heat transfer, leading to uniform product quality.
Rack-based freeze drying is well-suited for the evolving biopharmaceutical industry.