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Open AccessArticle

Energy Transfer in Vials Nested in a Rack System During Lyophilization

1
AbbVie Deutschland GmbH & Co. KG, Knollstraße 50, 67061 Ludwigshafen, Germany
2
Department of Pharmacy, Pharmaceutical Technology and Biopharmaceutics, Ludwig-Maximilians Universität München, Butenandtstrasse 5, D-81377 Muenchen, Germany
*
Author to whom correspondence should be addressed.
Pharmaceutics 2020, 12(1), 61; https://doi.org/10.3390/pharmaceutics12010061
Received: 9 October 2019 / Revised: 18 December 2019 / Accepted: 7 January 2020 / Published: 11 January 2020
(This article belongs to the Special Issue Pharmaceutical Freeze Drying and Spray Drying)
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. View Full-Text
Keywords: lyophilization; freeze drying; rack system; heat transfer; sublimation rates; edge–vial-effect; TP; pressure; radiation; direct contact lyophilization; freeze drying; rack system; heat transfer; sublimation rates; edge–vial-effect; TP; pressure; radiation; direct contact
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MDPI and ACS Style

Daller, S.; Friess, W.; Schroeder, R. Energy Transfer in Vials Nested in a Rack System During Lyophilization. Pharmaceutics 2020, 12, 61.

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