Skip to main content

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

This is a preview of subscription content, access via your institution.

Buying options

Protocol
USD   49.95
Price excludes VAT (USA)
  • DOI: 10.1007/978-1-4939-8928-7_9
  • Chapter length: 22 pages
  • Instant PDF download
  • Readable on all devices
  • Own it forever
  • Exclusive offer for individuals only
  • Tax calculation will be finalised during checkout
eBook
USD   169.00
Price excludes VAT (USA)
  • ISBN: 978-1-4939-8928-7
  • Instant PDF download
  • Readable on all devices
  • Own it forever
  • Exclusive offer for individuals only
  • Tax calculation will be finalised during checkout
Hardcover Book
USD   219.99
Price excludes VAT (USA)
Fig. 1
Fig. 2
Fig. 3
Fig. 4
Fig. 5
Fig. 6
Fig. 7
Fig. 8
Fig. 9
Fig. 10
Fig. 11
Fig. 12
Fig. 13
Fig. 14
Fig. 15
Fig. 16
Fig. 17

Springer Nature is developing a new tool to find and evaluate Protocols. Learn more

References

  1. Rey L (2004) Glimpses into the realm of freeze-drying: fundamental issues. In: Rey L, May J (eds) Freeze drying/lyophilization of pharmaceutical and biological products, 2nd edn. Marcel Dekker, Inc., New York, NY. (ISBN: 0-8247-4868-9, pp 1–32

    Google Scholar 

  2. Castellan GW (ed) (1971) Physical chemistry, 2nd edn. Addison-Wesley, Reading, MA, p 272

    Google Scholar 

  3. Linde D (ed) (1995) Handbook of chemistry and physics, 76th edn. CRC Press, Inc., New York, NY, pp 6–14 15

    Google Scholar 

  4. http://glassproperties.com/glasses/

  5. Scutella XB, Passot S, Bourles E, Fonseca F, Trelea IC (2017) How vial geometry variability influences heat transfer and product temperature during freeze-drying. J Pharm Sci 106:770–778

    CAS  CrossRef  Google Scholar 

  6. https://www.fda.gov/Drugs/DrugSafety/ucm248490.htm

  7. Mungikar A, Ludzinski M, Kamat M (2010) Effect of the design of the stopper including dimension, type, and vent area on lyophilization process. PDA J Pharm Sci Technol 64:507–516

    CAS  PubMed  Google Scholar 

  8. Parenteral Drug Association Technical Report No. 76: Identification and classification of visible nonconformities in elastomeric components and aluminum seals for parenteral packaging. https://store.pda.org/TableOfContents/TR76_TOC.pdf

  9. DeGrazio F (2018) A holistic strategy for container closure integrity: selecting and evaluating an integral packaging system. PDA J Pharm Sci Technol 72(1):15–34

    CrossRef  Google Scholar 

  10. DeGrazio F (2010) Closure and container considerations in lyophilization. In: Rey L, May J (eds) Freeze drying/lyophilization of pharmaceutical and biological products, 3rd edn. CRC Press, Inc., New York, NY. (ISBN: 9781439825754, pp 396–412

    Google Scholar 

  11. Kofler H (2015) Selecting stoppers for use in the lyophilisation of moisture-sensitive drugs. Manufacturing Chemist p 47–49

    Google Scholar 

Download references

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

Authors

Corresponding author

Correspondence to T. Page McAndrew .

Editor information

Editors and Affiliations

Rights and permissions

Reprints and Permissions

Copyright information

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

About this protocol

Verify currency and authenticity via CrossMark

Cite this protocol

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

Download citation

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

  • Published:

  • 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