Sterility Test Validation of Gentamicin Injection: Overcoming Antimicrobial Activity Via Membrane Filtration with Magnesium Chloride

Profarma Sh.a Pharmaceutical Company, Tirana, Albania

^*Corresponding Author: Eva Troja, Profarma Sh.a Pharmaceutical Company, Tirana, Albania, Email: [email protected]

Received Date: September 28, 2026

Published Date: October 15, 2026

Citation: Troja E. (2026). Sterility Test Validation of Gentamicin Injection: Overcoming Antimicrobial Activity Via Membrane Filtration with Magnesium Chloride. Mathews J Pharma Sci. 10(2):65.

Copyrights: : Troja E. © (2026).

ABSTRACT

Introduction: Gentamicin may inhibit microbial growth during sterility testing, potentially interfering with the detection of microorganisms. This study evaluated the suitability of a membrane filtration procedure designed to overcome the antimicrobial activity of gentamicin injection.

Materials and Methods: Gentamicin injection was tested by membrane filtration using a 0.45 μm low-binding PVDF membrane. The procedure included pre-wetting with Fluid A, treatment with 0.5 M magnesium chloride, and subsequent rinsing with Fluid D and Fluid A. Method suitability was assessed using low levels of specified challenge microorganisms, together with positive and negative controls and growth promotion testing.

Results: Growth of the specified challenge microorganisms was observed in the presence of the product following magnesium chloride treatment and rinsing. Positive controls demonstrated growth, while negative controls remained free from microbial growth.

Conclusion: Under the evaluated conditions, the procedure sufficiently reduced gentamicin-associated antimicrobial inhibition to permit microbial detection. The findings support the suitability of the optimized membrane filtration procedure for sterility testing of the investigated gentamicin injection formulation.

Keywords: Gentamicin, Sterility Testing, Membrane Filtration, Magnesium Chloride, Method Suitability