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Particulate contamination of Australian ampoules.

I R Gillies, W J Thiel, R C Oppenheim

    The Journal of Pharmacy and Pharmacology
    |February 1, 1986
    PubMed
    Summary

    Achieving low particulate contamination variability in small volume parenterals (SVP) is challenging. Heat-sealed ampoules show significantly less contamination than snap-opened ones, though both remain within acceptable limits.

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    Area of Science:

    • Pharmaceutical Science
    • Quality Control
    • Drug Manufacturing

    Background:

    • Particulate contamination is a critical quality attribute for parenteral medications.
    • Existing limits for small volume parenterals (SVP) may not fully address variability.
    • Large volume parenterals (LVP) typically exhibit lower coefficients of variation for particulate matter.

    Purpose of the Study:

    • To investigate the level and variability of intrinsic particulate contamination in Australian-manufactured SVPs.
    • To compare particulate contamination between snap-opened and heat-opened ampoules.
    • To assess if SVP contamination levels meet established pharmaceutical standards.

    Main Methods:

    • Analysis of particulate contamination in 5, 10, and 20 ml ampoules of Water for Injections and Sodium Chloride Injection.
    • Comparison of particle counts (5, 10, 20 micron) between snap-opened and heat-opened ampoules.
    • Statistical analysis of particle count data, including coefficient of variation and batch differences.

    Main Results:

    • Snap-opened ampoules exhibited high particulate contamination, though within USP XXI SVP limits.
    • Heat-opened ampoules demonstrated significantly lower contamination, often below LVP limits.
    • Coefficients of variation for 5-micron particles ranged from 30-70%, indicating batch variability.
    • Significant differences in particulate contamination were observed between batches.

    Conclusions:

    • Achieving the low variability seen in LVPs for particulate contamination in SVPs is difficult.
    • Heat-opened ampoules offer superior control over particulate contamination compared to snap-opened ones.
    • While variability exists, particulate contamination levels in the studied SVPs were not deemed clinically significant.

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