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Container and Reconstitution Systems for Lyophilized Drug Products

  • T. Page McAndrewEmail author
  • Douglas Hostetler
  • Frances L. DeGrazio
Protocol
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 

Notes

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.

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  • T. Page McAndrew
    • 1
    Email author
  • Douglas Hostetler
    • 2
  • Frances L. DeGrazio
    • 2
  1. 1.Scientific Communications, Scientific Affairs & Technical ServicesWest Pharmaceutical Services, Inc.ExtonUSA
  2. 2.West Pharmaceutical Services, Inc.ExtonUSA

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