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Particulate contamination in plastic ampoules.

R C Oppenheim, I R Gillies

    The Journal of Pharmacy and Pharmacology
    |May 1, 1986
    PubMed
    Summary
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    Plastic ampoules for Water for Injections and Injection Sodium Chloride showed minimal particle load. These containers effectively reduce particulate contamination compared to glass ampoules when opened clinically.

    Area of Science:

    • Pharmaceutical Technology
    • Drug Delivery Systems
    • Sterile Manufacturing

    Background:

    • Particulate contamination is a critical quality attribute for injectable drug products.
    • Traditional glass ampoules can introduce particles during the opening process.
    • The use of alternative packaging like plastic ampoules warrants investigation for particle generation.

    Purpose of the Study:

    • To quantify the particle load in plastic ampoules (JP) of Water for Injections and Injection Sodium Chloride.
    • To compare particle generation from opening plastic ampoules versus glass ampoules.
    • To assess compliance with established injectable product standards.

    Main Methods:

    • Four batches of plastic ampoules were tested.
    • Ampoules were opened using a clinical twist-open method.

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  • Particle counts were determined using a HIAC 420 particle counter with a CMB 60 sensor.
  • Comparison with data from snap-opened and heat-opened glass ampoules.

    • Main Results:

    • The total particle content in opened plastic ampoules was minimal.
    • Particle load complied with global Large Volume Parenteral (LVP) standards and USP XXI Small Volume Parenteral (SVP) standards.
    • Significantly fewer particles were generated from opened plastic ampoules compared to clinically opened glass ampoules.
    • Slightly fewer particles were generated compared to laboratory heat-opened glass ampoules.

    Conclusions:

    • Plastic ampoules are effective in minimizing particulate contamination for Water for Injections and Injection Sodium Chloride.
    • When used for suitable drugs, plastic ampoules offer a significant advantage over glass ampoules in reducing particle generation during opening.
    • Plastic ampoules represent a viable option for reducing particulate contamination in specific parenteral preparations.