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Increased use of single-use systems has led to a need to redefine safe, stable and integral systems for shipping biopharmaceuticals around the world. This article provides qualification data under international ASTM D4169 norms.
Biotechnology industries have adopted single-use systems in their manufacturing processes. The adoption started with applications for managing peripheral fluids and is now moving towards the main drug manufacturing process. This transition is leading to more challenging safety and quality requirements especially in very demanding or high stress applications such as transportation of bulk drug substances (BDS). There is a need to define safe, stable and integral systems for shipping biopharmaceutical solutions around the world. This article provides qualification data under the very severe conditions contained within international ASTM D4169 norms.
eBook: Single-Use Systems 2018
When referring to this article, please cite it as E. Vachette, F. Bazin, M. Barbaroux, and J. Cappia, "An Integrated Approach to Shipping Liquid in Single-Use Systems," BioPharm International Single-Use Systems eBook (June 2018).