Examinando por Materia "Validation Study"

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Acceso abierto
Eficacia del reprocesamiento con validación de laboratorio y ATP, para optimizar la desinfección de alto nivel en endoscopios
(Universidad Privada Norbert Wiener, 2018-08-25) Apaza Idme, Olga Beatriz; Calsina Diaz, Yrma Renida; Matta Solis, Hernán Hugo
Objetivo: Analizar sistemáticamente las evidencias sobre la eficacia del reprocesamiento con validación de laboratorio y ATP, para optimizar la desinfección de alto nivel en endoscopios. Material y Métodos: Revisión sistemática de estudios experimentales, de cohorte, ensayos aleatorios controlados y no controlados, sometidos a selección critica, hallados en las siguientes bases de datos: PubMed, Cochrane, Scielo, Wiley Online Library, Elsevier, Redalyc. Resultados: En la selección definitiva se eligieron 10 artículos, encontramos que el 60% (06) corresponden a EEUU, con un 20% (2) corresponden a Brasil y 10% a México y Chile. Asimismo entre los estudios, se obtuvieron que el 50 % indican que la prueba de Bioluminiscencia es rápida y económica para la identificación de microorganismos, asimismo el 10% indica que el ATP no puede sustituir a los cultivos realizados de endoscopios en laboratorio, para el 100% de estudios la limpieza es fundamental para un reprocesamiento de endoscopios adecuado y así evitar las infecciones cruzadas. Conclusiones: Según los artículos revisados, no existe eficacia del reprocesamiento con validación de laboratorio y ATP, para optimizar la desinfección de alto nivel en endoscopios, ya que la mayoría de los casos no se hace limpieza adecuada de los endoscopios; el lavado automatizado es más efectivo que el lavado manual de endoscopios. Palabras clave:
Acceso abierto
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.
Acceso abierto
La validación de una técnica analítica para determinar la potencia de cannabidiol, tetrahidrocannabinol y cannabigerol en aceite por cromatografía líquida de alto rendimiento en laboratorio farmacéutico. Lima – 2022
(Universidad Privada Norbert Wiener, 2023-02-02) Lujan Pucuhuaylas, Hairo Enrique; Meza Melo, Ximena Rosario; Félix Véliz, Luis Miguel Visitación
The objective of this research was to evaluate the validation of an analytical technique, according to international standards, for determining the potency of cannabidiol (CBD), tetrahydrocannabinol (THC), and cannabigerol (CBG) in oil using high-performance liquid chromatography (HPLC) in a pharmaceutical laboratory. Methodology: The validation of the analytical method was deductive, quantitative, applied, and non-experimental in design, observational, and cross-sectional. Results: The RSD for instrumental precision of peak areas and retention times was less than 2.0%. For accuracy, recoveries of 99.7%, 100.6%, and 100.7% were obtained for the analytes CBD, THC, and CBG, respectively. For intermediate precision, the RSD between analysts was measured, yielding RSD values of 1.0, 1.1, and 0.9 for CBD, THC, and CBG, respectively. For the linearity tests of the method and system, correlation (r) and determination coefficients (r²) of 0.999 were obtained for all three analytes. Conclusion: The implementation of the analytical method for determining the potency of CBD, THC, and CBG in oil through high-performance liquid chromatography (HPLC) meets the required statistical results, ensuring reliability and quality for the intended uses.
Acceso abierto
Validación del ensayo microbiológico de una solución de Amonio Cuaternario al 0,25% para limpieza de superficies, basado en la Farmacopea Americana vigente. Lima 2023
(Universidad Privada Norbert Wiener, 2024-07-09) Reyes Villalobos, Daniel Rafael; Collanque Pinto, Jesús Daniel
This study aimed to validate the analytical technique of microbial count by dilution–neutralization of 0.25% quaternary ammonium, applying the pour plate method for test microorganism recovery. Statistical analyses were performed using SPSS and Minitab software. Results showed microbial counts below 100 CFU for Pseudomonas aeruginosa ATCC 9027, Staphylococcus aureus ATCC 6538, Bacillus subtilis ATCC 6633, Candida albicans ATCC 10231, and Aspergillus brasiliensis ATCC 16404. The suitability test successfully recovered all test microorganisms at the 10⁻² dilution, with growth and identification of specific microorganisms. Validation of the neutralization method demonstrated effective performance of the neutralizer at the 10⁻² dilution, along with the absence of toxicity. Accuracy of recovery percentages was within the 90% confidence interval, while assay precision remained <15% coefficient of variation. The neutralizers proved specific in inhibiting the antimicrobial properties of quaternary ammonium. The detection limit showed recovery of P. aeruginosa > 11 CFU and S. aureus > 17 CFU, while robustness analysis revealed no significant variability in microbial counts across different incubation times. In conclusion, the dilution–neutralization method using 0.5% soybean lecithin and 4% polysorbate 80 allowed effective recovery of test microorganisms at the 10⁻² dilution.
Acceso abierto
Validación del método analítico por cromatografía líquida de alta performance para la cuantificación de nitazoxanida 100mg/ 5ml polvo para suspensión oral
(Universidad Privada Norbert Wiener, 2015) Gomez Leon, Carmen Rosa; Ramos Silva, Hesica; Villanueva Vílchez, Hugo Gilberto
In this research work, the validation of an analytical method for Nitazoxanide 100 mg/5 mL powder for oral suspension was developed using the High-Performance Liquid Chromatography (HPLC) technique. The validation of the method is an indispensable requirement for compliance with Good Laboratory Practices, since it provides reliability to the analytical results obtained in an analytical laboratory, in order to ensure that a medicine complies with the quality parameters established by USP 37. Once the working parameters were defined, the validation protocol of the developed method was carried out, which includes the experimental design and statistical procedures. The quality parameters employed in this validation are: Linearity, which measures the ability of the analytical method to provide results that are directly proportional to the concentration of the analyte, obtaining a correlation coefficient of r = 0.99960. Accuracy, which measures the closeness of the results obtained by this method, with an experimental t (0.633) that is lower than the tabulated t (2.306). Precision, which expresses the degree of agreement or dispersion of the results; the RSD values obtained were 0.697% for method repeatability and 0.913% for intermediate precision. Selectivity, which determines the ability of the method to unequivocally measure the Nitazoxanide content in the presence of other chemical substances that may be present in the sample or degradation products; in the chromatograms of Nitazoxanide, similar retention times were obtained for the sample and the standard. It was demonstrated that the validated analytical method is reproducible, reliable, and can be employed in routine analyses.
Acceso abierto
Validación farmacéutica y uso racional de medicamentos en recetas digitales de pacientes ambulatorios del Hospital San Bartolomé 2023
(Universidad Privada Norbert Wiener, 2026-03-24) Bermudo Gonzales, Juan Carlos; Respicio López, Patricia Milagros
Pharmaceutical validation is an activity performed by pharmacists that involves the clinical evaluation of prescriptions to determine the appropriate dispensing of pharmaceutical products, while the rational use of medicines aims to ensure that patients receive appropriate, safe, and cost effective therapies. The objective of this study was to determine the relationship between pharmaceutical validation and the rational use of medicines in digital prescriptions for outpatients treated at San Bartolomé Hospital during 2023. The study was descriptive, with a non experimental, retrospective, and correlational design, analyzing 2,049 digital prescriptions and evaluating adherence to indications, errors, and prescribing patterns. The results showed 72% compliance and 28% non-compliance in the recording of indications. Regarding the reasons for the rational use of medications, 41% corresponded to prescriptions with previously prescribed medications and 43% to over-prescription, which generated a total savings of S/. 82,489.92. Furthermore, 10,425 units of medication were not dispensed, the specialties with the highest number of interventions during pharmaceutical validation were identified, and significant savings were achieved in high-cost medications. It is concluded that pharmaceutical validation contributed significantly to the rational use of medications, optimizing dispensing, strengthening patient safety, and improving the efficiency of institutional resource management.