Abstract
Small batch sizes are a consequence of more personalized medicine and reflect a trend in the biopharmaceutical industry. Freeze drying of vials nested in a rack system is a tool used in new flexible pilot scale processing lines. Understanding of heat transfer mechanisms in the rack loaded with vials not in direct contact with each other is necessary to ensure high quality. Lyophilization in the rack vial system enables a homogeneous drying with a reduced edge-vial-effect and shielding against radiation from surrounding components, e.g., the chamber wall. Due to the separation effect of the rack, direct shelf contact contributes approx. 40% to the overall energy transfer to the product during primary drying. Hence overall the rack is a flexible, robust tool for small batch production, which ensures a controlled heat transfer resulting in a uniform product.
Highlights
Patient centered manufacturing instead of a bulk approach is trending in the biopharmaceutical industry [1]
Lyophilization in the rack vial system enables a homogeneous drying with a reduced edge-vial-effect and shielding against radiation from surrounding components, e.g., the chamber wall
Heat transfer for sublimation in vials nested in a rack system is dominated by direct contact between vial and shelf and radiation coming from the rack itself
Summary
Patient centered manufacturing instead of a bulk approach is trending in the biopharmaceutical industry [1]. Time, and cost-effective aseptic fill/finish manufacturing at high quality, new machinery with high automation and control is being developed [4,5]. Rambhatla noted radiation from the freeze dryer walls as the main driving force for the edge vial effect [7]. It leads to higher product temperature (TP) during lyophilization and higher potential for collapse. Freeze-drying processes may be run more conservative than is necessary for the vast majority of product vials. This must be considered most especially for freeze dryers with a cleaning-in-place system
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