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Related Experiment Videos

Particulate contamination in ampoules.

D M Alexander, A M Veltman

    The Journal of Pharmacy and Pharmacology
    |January 1, 1985
    PubMed
    Summary
    This summary is machine-generated.

    Particulate contamination in South African injectable solutions was low. Manufacturers maintained high standards, with issues likely stemming from formulation or raw material quality.

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    Area of Science:

    • Pharmaceutical Science
    • Analytical Chemistry

    Background:

    • Parenteral drug products require stringent control over particulate contamination.
    • Ensuring the quality of injectable solutions is critical for patient safety.

    Purpose of the Study:

    • To assess the level of particulate contamination in South African injectable solutions.
    • To evaluate manufacturing standards for ampoules and solutions.

    Main Methods:

    • Analysis of 19 solution formulations from 8 South African manufacturers.
    • Utilized a HIAC PC 320 light blockage particle analyzer with a CMB 60 sensor.

    Main Results:

    • Generally low levels of particulate contamination were observed.
    • Manufacturers of both ampoules and solutions demonstrated high, comparable standards.

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  • Identified formulation and raw material quality as potential sources of contamination issues.

    • Conclusions:

    • The overall quality of injectable solutions regarding particulate contamination is high in South Africa.
    • Focusing on formulation and raw material sourcing can further improve product safety.