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Containment Options for the Freeze-Drying of Biological Entities and Potent Materials

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Lyophilization of Pharmaceuticals and Biologicals

Part of the book series: Methods in Pharmacology and Toxicology ((MIPT))

Abstract

This chapter examines the characteristics and use of containment systems to perform various applications of freeze-drying. Specific consideration is given to containment system design, effects on mass and heat transfer, containment of microorganisms, and recommendations for the future application of containment options.

An assessment is made of previously characterized containment systems developed for freeze-drying which include a reusable aluminum box and the disposable Gore Lyoguard. Common design features of both were determined and a suitable, cost-effective, off the shelf alternative identified in the form of sterilization pouches. Further consideration is given to previous studies that have characterized and compared the effects on mass and heat transfer that barriers cause by increasing resistance to water vapor movement. In addition, the subsequent increases to heat transfer brought about by resistance to mass transfer are also further considered.

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Authors and Affiliations

  1. PDR, Cardiff Met University, Cardiff, UK

    Chris Cherry

Authors
  1. Chris Cherry
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Correspondence to Chris Cherry .

Editor information

Editors and Affiliations

  1. Biopharma Process Systems Ltd., Winchester, UK

    Kevin R. Ward

  2. National Institute for Biological Standards & Control (NIBSC), Potters Bar, Hertfordshire, UK

    Paul Matejtschuk

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Cherry, C. (2019). Containment Options for the Freeze-Drying of Biological Entities and Potent Materials. In: Ward, K., Matejtschuk, P. (eds) Lyophilization of Pharmaceuticals and Biologicals. Methods in Pharmacology and Toxicology. Humana Press, New York, NY. https://doi.org/10.1007/978-1-4939-8928-7_6

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  • DOI: https://doi.org/10.1007/978-1-4939-8928-7_6

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  • Publisher Name: Humana Press, New York, NY

  • Print ISBN: 978-1-4939-8927-0

  • Online ISBN: 978-1-4939-8928-7

  • eBook Packages: Springer Protocols

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