Adaptation and validation of a method for evaluating the bactericidal activity of ethyl alcohol in gel format 70% (w/w)

• Published in: Journal of microbiological methods Vol. 193; p. 106402
• Main Authors: Cruz, Amanda Fermiano da, Abreu, Alessandra Oliveira de, Souza, Paula Araujo de, Deveza, Bianca, Medeiros, Carolaine Totelote, Sousa, Verônica Santos, Sabagh, Bruna Peres, Villas Bôas, Maria Helena Simões
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01.02.2022
• Subjects: Disinfectants; Ethyl alcohol; Health Surveillance; Quality control; Validation study; Ethyl alcohol; Health Surveillance; Disinfectants; Quality control; Validation study
• DOI: 10.1016/j.mimet.2021.106402
• ISSN: 0167-7012

Ethyl alcohol 70% (w/w) is a broad-spectrum bactericidal agent that is mandatorily marketed as a gel in Brazil since 2002. However, there is no method described for the microbiological quality control of surface disinfectants in the form of gel, which makes it impossible to monitor the effectiveness of these products by the Health Surveillance. Thus, the present study aimed to adapt an analytical method and validate it so that it is possible to evaluate the bactericidal activity of ethyl alcohol-based disinfectants at 70% (w/w) in gel form. The proposed analytical method is an adaptation of a method developed by the Association of Official Analytical Chemists (AOAC), which is currently used to evaluate the bacterial activity of disinfectants in the form of spray and aerosol. The method consisted of challenging the disinfectant by putting it in contact with 60 carriers - previously contaminated with the test microorganism - during the contact time established by the manufacturer. The bacteria used in this work were Staphylococcus aureus CBRVS 00039 ATCC 6538, Salmonella enterica CBRVS 00028 ATCC 10708, and Pseudomonas aeruginosa CBRVS 00025 ATCC 15442. The parameters chosen for the validation of the method were: matrix effect, robustness, and repeatability. The experiments performed with a disinfectant matrix showed that there is no interference of the gel on the effectiveness of alcohol. Satisfactory results regarding the evaluation of bactericidal activity were obtained for the three microorganisms tested when the volume of 100 μL of disinfectant was applied. The method also showed good repeatability, as it proved to be robust with modification of incubation times, equipment and analysts. The development and validation of this method were extremely important for the quality monitoring of these products, besides being the first method described for the evaluation of gel disinfectants. •An AOAC method (961.02) was adapted and validated for use in products in gel form.•The product volume is an important factor when evaluating the antimicrobial activity.•The method showed a good performance for the evaluated parameters.•This technique can be used for other active substances in gel form after validation.