Skip to main content
SpringerLink
Log in

A New Rapid and Nondestructive Means for Determining the Moisture Content in Elastomer Closures used to Seal Lyophilized Products

  • Research Letter
  • Published:
Journal of Pharmaceutical Innovation Aims and scope Submit manuscript

Abstract

This paper describes an alternative means for determining the free moisture in elastomer closures used to seal lyophilized products that is rapid (in seconds) and nondestructive in nature. The advantages and disadvantages of the Karl Fischer method will be briefly discussed, especially in light of current efforts to implement Process Analytical Technology into the lyophilization process. A general description of the dielectric properties of the elastomer materials and the impact that moisture will have on the quality factor (Q) will be described. The analytical equipment and method used for correlating the Q of the elastomer closure to its average free moisture content will also be described. Examples of the histogram and frequency distributions for the average moisture content and individual moisture content in both 13- and 20-mm closures will be shown and discussed.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4
Fig. 5
Fig. 6
Fig. 7
Fig. 8

References

  1. Donovan PD, Corvari V, Burton MD, Rajagoplan N. Effect of stopper processing conditions on the moisture content and ramifications for lyophilized products: comparison of “Low” and “High” moisture uptake stoppers. PDA J Sci Tech. 2007;61:51.

    CAS  Google Scholar 

  2. Coveleyn S, De Smedt S, Paul Reon J. Moisture absorption and desorption of different rubber lyophilization closures. Int J Pharm. 1997;159:57.

    Article  Google Scholar 

  3. Wang Z, Frankel BA, Lambert WJ. Determination of moisture in rubber stoppers: effect of Karl Fischer oven temperatures. PDA J Sci Tech. 2001;55:162.

    CAS  Google Scholar 

  4. DeGrazio F, Flynn K. Lyophilization closures for protein based drugs. PDA J Sci Tech. 1992;46:54.

    CAS  Google Scholar 

  5. Jennings TA. Lyophilization—introduction and basic principles. Englewood: Interpharm; 1999. p. 510.

    Google Scholar 

  6. Ibid. p. 359.

  7. Jennings TA. Apparatus and method for monitoring and determining the moisture content in elastomer materials, US Patent 7,205,779.

  8. Suh NP, Sudbury SDS, Kim BH. Determination of moisture levels in closures, US Patent 4,352,059.

  9. Novoa I. Importance of the knowing and means of measuring the diffusion coefficient activation energy of elastomer closures, 4th International Conference on Lyophilization and Freeze Drying, Dublin, Ireland, October 17 - 19, 2007

Download references

Acknowledgments

I would like to extend a special thanks to Jenny Sprung and the Labconco Company for their donation of the special vacuum vessels used in the construction of the drying oven. Thanks to Kenneth Lomartire of Cardinal Health for his input and council during these studies and also providing much needed closures. I must also thank my good friend Dr. Isabella Manjud Maluf of DEPFI/Bio-Manguinhos in Brazil for providing me with closures and also Mrs. Charlotte Morgan of BTF Precise Microbiology in Australia for a generous supply of closures.

Author information

Authors and Affiliations

  1. Phase Technologies, Inc, Bala Cynwyd, PA, 19004, USA

    Thomas A. Jennings

Authors
  1. Thomas A. Jennings
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Thomas A. Jennings.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Jennings, T.A. A New Rapid and Nondestructive Means for Determining the Moisture Content in Elastomer Closures used to Seal Lyophilized Products. J Pharm Innov 4, 143–151 (2009). https://doi.org/10.1007/s12247-009-9068-0

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s12247-009-9068-0

Keywords

Search

Navigation