Examinando por Autor "Rafaele Huamani, Cristina"

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    Validación de procesos de limpieza basado en las Buenas Prácticas de Manufactura en el área de productos naturales en Laboratorios Barton – Callao, Perú 2024
    (Universidad Privada Norbert Wiener, 2025-03-03) Flores Cóndor, Blanca Nelida; Rafaele Huamani, Cristina; Parreño Tipián, Juan Manuel
    This study was carried out with the aim of determining the level of compliance with the validation parameters based on Good Manufacturing Practices in the natural products area at Barton Laboratories, Callao - Peru, 2024. A deductive methodology with an applied quantitative approach was used, with a non-experimental and cross-sectional design. The validation parameters were analyzed in 3 consecutive production batches. The results showed that the disinfectants are effective against the strains studied (S. aureus, P. aeruginosa, E. coli, A. brasiliensis and C. albicans) and that the microbiological controls complied with the established limits: for environments < 100 CFU for bacteria and < 10 CFU for fungi and yeasts, on surfaces < 20 CFU for bacteria and < 5 CFU for fungi and yeasts. Likewise, the absence of detergent residues is evident, using the 0.04% bromothymol blue indicator solution, a test for oxidizable substances and obtaining a conductivity of less than 1.3 us/cm, confirming the effectiveness of the cleaning processes. In addition, the impregnation oven hose (EI-02) was identified as high-risk equipment with a risk priority number (RPN) of 27. Conclusion, the validation parameters reached a very high level of compliance, which demonstrates that the cleaning methods are highly efficient and reproducible.