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Lyophilization of Pharmaceuticals and Biologicals pp 193–214Cite as

Container and Reconstitution Systems for Lyophilized Drug Products

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

Abstract

Lyophilization is the process of dehydrating a material at low temperature and reduced pressure. It is used to extend the shelf life of many biologic drug products. This paper discusses two systems essential to these products: container systems and reconstitution (i.e., rehydrating) systems.

Key words

  • Container systems
  • Closures
  • Container closure integrity
  • Extractables
  • Leachables
  • Reconstitution systems
  • Seals

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  • DOI: 10.1007/978-1-4939-8928-7_9
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References

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Acknowledgments

Mix2Vial® and MixJect® are registered trademarks of West Pharma. Services IL, Ltd., a subsidiary of West Pharmaceutical Services, Inc. FluroTec®, LyoTec®, LyoSeal®, Verisure®, are trademarks or registered trademarks of West Pharmaceutical Services, Inc. FluroTec® and Daikyo Crystal Zenith® technology are licensed from Daikyo Seiko, Ltd. Daikyo Crystal Zenith® and Plascap® are trademarks or registered trademarks of Daikyo Seiko, Ltd. TopPac® is a registered trademark of Schott AG.

Author information

Authors and Affiliations

  1. Scientific Communications, Scientific Affairs & Technical Services, West Pharmaceutical Services, Inc., Exton, PA, USA

    T. Page McAndrew

  2. West Pharmaceutical Services, Inc., Exton, PA, USA

    Douglas Hostetler & Frances L. DeGrazio

Authors
  1. T. Page McAndrew
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  2. Douglas Hostetler
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  3. Frances L. DeGrazio
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Corresponding author

Correspondence to T. Page McAndrew .

Editor information

Editors and Affiliations

  1. Biopharma Process Systems Ltd., Winchester, UK

    Ph.D. Kevin R. Ward

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

    Ph.D. Paul Matejtschuk

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McAndrew, T.P., Hostetler, D., DeGrazio, F.L. (2019). Container and Reconstitution Systems for Lyophilized Drug Products. 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_9

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  • DOI: https://doi.org/10.1007/978-1-4939-8928-7_9

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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

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