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Related Experiment Videos

Water permeability of elastomers

H R Held, S Landi

    Journal of Biological Standardization
    |January 1, 1977
    PubMed
    Summary

    Moisture in freeze-dried BCG vaccine may come from rubber stoppers. Using dry stoppers, especially grey butyl or silicone, is recommended to minimize moisture uptake and preserve vaccine stability during storage.

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    Area of Science:

    • Pharmaceutical Science
    • Materials Science

    Background:

    • Free moisture content in freeze-dried BCG vaccine increases during storage.
    • The source of this moisture increase was investigated, focusing on rubber stoppers.

    Purpose of the Study:

    • To determine the water permeability of various rubber stoppers.
    • To assess the water content of grey butyl stoppers during manufacturing processes.
    • To identify stoppers with minimal moisture uptake for BCG vaccine vials.

    Main Methods:

    • Studied water permeability of 12 types of rubber stoppers.
    • Determined water content of grey butyl stoppers during autoclaving, oven-drying, freeze-drying, and storage.
    • Evaluated moisture uptake in a water-saturated atmosphere with Indicating Drierite.

    Main Results:

    • Grey butyl and silicone stoppers exhibited the lowest water uptake.
    • Stoppers showed rapid water uptake during autoclaving and release during oven-drying.
    • Slow water uptake occurred during freeze-drying, with slow permeation observed during storage.
    • Moisture-resistant wrappings significantly reduced Drierite moisture uptake.

    Conclusions:

    • Rubber stoppers can be a source of moisture in freeze-dried BCG vaccine.
    • Dry stoppers, particularly grey butyl and silicone types, are recommended.
    • Minimizing stopper moisture content is crucial for vaccine stability.

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