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Microbial growth in small-volume pharmaceuticals.

W Whyte, L Niven, N D Bell

    Journal of Parenteral Science and Technology : a Publication of the Parenteral Drug Association
    |September 1, 1989
    PubMed
    Summary
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    Aseptically filled pharmaceuticals can support microbial growth, especially Gram-negative bacteria. Preservatives significantly reduce this risk, highlighting the need for growth testing in sterile product formulation.

    Area of Science:

    • Microbiology
    • Pharmaceutical Science
    • Quality Control

    Background:

    • Aseptically filled pharmaceuticals require stringent microbial control to ensure sterility.
    • Understanding microbial growth potential in parenteral products is crucial for patient safety.

    Purpose of the Study:

    • To evaluate the microbial growth-supporting capabilities of aseptically filled small-volume pharmaceuticals.
    • To assess the impact of preservatives on microbial proliferation in these products.
    • To propose a predictive test for microbial growth in pharmaceutical formulations.

    Main Methods:

    • Testing 43 small-volume pharmaceutical products (parenterals) for microbial growth.
    • Inoculating products with common pharmaceutical contaminants (Gram-negative and Gram-positive bacteria).

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  • Comparing growth in products with and without preservatives.

    • Main Results:

    • Gram-negative bacteria demonstrated higher growth potential than Gram-positive bacteria.
    • Microbial populations could increase from a few cells to 10(7)/mL.
    • Products without preservatives (63%) were more likely to support growth than those with preservatives (12%).

    Conclusions:

    • Pharmaceutical formulation and preservative presence significantly influence microbial growth.
    • Aseptic processing requires robust environmental monitoring and cleanroom standards.
    • Pre-production testing for microbial growth potential is recommended for non-terminally sterilized products.