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Sterility testing of antimicrobial-containing injectable solutions prepared in the pharmacy
M J Akers1, G E Wright, K A Carlson
1Lilly Corporate Center, Eli Lilly and Company, Indianapolis, IN 46285.
American Journal of Hospital Pharmacy
|November 1, 1991
Summary
Antimicrobial injectable solutions require sterility testing, even with antimicrobial agents present. Pharmacists must use methods like membrane filtration or direct transfer to ensure product sterility and patient safety.
Area of Science:
- Pharmaceutical Sciences
- Microbiology
Background:
- Antimicrobial-containing injectable solutions are not inherently self-sterilizing.
- Contamination can occur despite the presence of antimicrobial agents.
- Aseptic technique alone is insufficient to guarantee sterility.
Purpose of the Study:
- To discuss the necessity of sterility testing for antimicrobial-containing injectable solutions.
- To describe validated methods for sterility testing of these products.
Main Methods:
- Membrane filtration: filtering the solution, rinsing the membrane to remove antimicrobials, and culturing in two media types.
- Direct transfer: inoculating samples directly into culture media, with antimicrobial deactivation via dilution or chemical/enzymatic agents.
- Utilizing closed filtration systems to minimize false positives.
Main Results:
- Visible turbidity in culture media indicates microbial contamination.
- Both membrane filtration and direct transfer methods are validated by the United States Pharmacopeia.
- Residual antimicrobial activity can interfere with accurate sterility testing.
Conclusions:
- Sterility testing is essential for antimicrobial-containing injectable solutions.
- A combination of aseptic technique and rigorous end-product sterility testing ensures product safety.
- Proper method selection and validation are critical for reliable sterility assessment.