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EVALUATION OF HYDROGEN PEROXIDE VIRUCIDAL EFFICACY AGAINST YELLOWFEVER VIRUS 17DD VACCINE STRAIN FOR APPLICATION IN A VACCINEMANUFACTURING INDUSTRY
Validação de limpeza
Vacina
Vírus da Febre Amarela
Desinfecção
Inativação de Vírus
Cleaning validation
Vaccine
Yellow fever virus
Disinfection
Virus inactivation
Autor
Afiliación
Resumen en ingles
The aim of this study was to evaluate the inactivation performance of hydrogen peroxide to the yellow fever virus 17DD vaccine strain, used for the production of attenuated yellow fever vaccine, in two matrixes: formulated yellow fever vaccine (FYV) and yellow fever viral suspension - active pharmaceutical ingredient (API). The samples were dried on stainless steel and exposed to hydrogen peroxide liquid (HPL) at concentrations of 30, 10, 3 and 1% for 20 and 60 min; and to hydrogen peroxide vapour (HPV) in an isolator. The exposure to HPL 30 and 10 %, within 20 min, reduced the virus titre at least 3.85 log10 PFU/mL (74.8 %). During 60 min of exposure, the HPL 30, 10 and 3% reduced the virus titre by at least 3.18 log10 PFU/mL (62.6 %). HPV exposure resulted in complete virus inactivation in FYV (≥ 4.42 log10 PFU/mL reduction) and for API samples 3.17 log10 PFU/mL (64.3 %) reduction. Hydrogen peroxide showed to be a promising disinfectant for elimination of yellow fever virus. However, the optimum concentration and contact time will vary depending on the type of application, and as such may complement individual risk assessments of biological production processes.
Palabras clave en portugues
Peróxido de HidrogênioValidação de limpeza
Vacina
Vírus da Febre Amarela
Desinfecção
Inativação de Vírus
Palabras clave en ingles
Hydrogen peroxideCleaning validation
Vaccine
Yellow fever virus
Disinfection
Virus inactivation
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