Validation study of Modified Letheen Broth method for bacteria detection in antibacterial hand sanitizer
Objective To validate the practicability of Modified Letheen Broth(MLB)method for bacteria detection in antibacterial hand sanitizer.Methods According to the verification requirements of qualitative test methods in the guiding principles for validation of alternative methods for microbiological testing in Chinese Pharmacopoeia(2020),equivalence study between MLB method and GB 15979-2002 standard methods for Coliform and Hemolytic streptococcus were conducted in three parameters,including specificity,limit of detection and ruggedness.Results The results demonstrated that the MLB method had good specificity and ruggedness.The 50％detection limit for positive specimens of the representative strains of Coliform and Hemolytic streptococcus detected by this method was 1.76 and 17.44 cfu/g,respectively.According to the statistical analysis,the detection sensitivity of the MLB method was significantly better than that of the standard method(P＜0.05).Conclusion The MLB method is equal to the standard method,and can be applied to the detection of bacteria in antibacterial hand sanitizer.
Modified Letheen Brothantibacterial hand sanitizerbacterial detectionmethod validation
NETL
NSTL
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