Carrera Ingeniería Bioquímica

Permanent URI for this collectionhttp://repositorio.uta.edu.ec/handle/123456789/809

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    Validación del método de limpieza aplicado a la ruta de fabricación de tabletas de matico en el Laboratorio NEOFÁRMACO del Ecuador Cía. Ltda.
    (Universidad Técnica de Ambato. Facultad de Ciencia e Ingeniería en Alimentos y Biotecnología. Carrera de Ingeniería Bioquímica, 2022-09) Guevara Freire, Karen Adriana; Carrera Cevallos, Jeanette Verónica
    The Laboratory Neofármaco of Ecuador is a pharmaceutical company, which stands out for producing a wide variety of products, especially based on natural active ingredients, one of its natural products is the box of Matico tablets, made from Matico extract as API (Aristiguietia glutinosa), which, having flavonoids among its compounds, acts as an anti-inflammatory, antifungal and gastroprotective. However, Neofármaco, being a drug manufacturing company, must comply with good manufacturing practices (GMP) for its correct operation, standards established by the WHO, FDA and ARCSA. One of the many standards they must comply with is to validate their cleaning processes, mainly to avoid cross-contamination and microbiological contamination, especially if the same areas and equipment are used to manufacture different products. For the same reason, the cleaning validation of the Matico tablet manufacturing route has been carried out. It was demonstrated that the cleaning process does not leave soap residues, through the analysis of traces of detergent, and visual verification was also carried out. For sampling through the swabbing method, the characteristics of the swab were determined: absorption capacity (0.3401 mL), absence of swab interference, recovery test 96.54 percent, determination of the acceptance limit (75 ppm). On the other hand, in the analysis of samples, it was determined that the limit is not exceeded, in addition, no microbiological contamination was witnessed.
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    Diseño de un manual de buenas prácticas de manufactura para la empresa Laboratorio Génesis ubicada en la provincia de Tungurahua en la ciudad de Ambato
    (Universidad Técnica de Ambato. Facultad de Ciencia e Ingeniería en Alimentos y Biotecnología. Carrera de Ingeniería Bioquímica, 2021-09) Villacís Arcos, Ana Gabriela; Pérez Aldas, Lander Vinicio
    The main objective of this work is the development of a manual of Good Manufacturing Practices (GMP) for the company Génesis Laboratory LABGENESIS CIA. LTDA. For its effect, a diagnosis of the initial situation of the company was carried out, having an average compliance of 48 percent, a value that indicates that the company requires an intervention to improve certain aspects of non-compliance. Once the inconsistencies were determined, an improvement plan was developed to develop them in the company, thus the execution of the changes was carried out generating an increase of 40 percent of compliance with the GMP regulations for pharmaceutical laboratories of medicines in general. Finally, the improvements achieved were evaluated, resulting in a final total compliance of 88 percent, which highlights that the work carried out was assertive in the aspects of greatest deficiency found in accordance with the GMP regulation.
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    Calificación de diseño, instalación, operación y desempeño del sistema de generación, almacenamiento y distribución de aire comprimido en el laboratorio Neorfármaco del Ecuador Neorfármaco Cía. Ltda.
    (Universidad Técnica de Ambato. Facultad de Ciencia e Ingeniería en Alimentos y Biotecnología. Carrera de Ingeniería Bioquímica, 2021-03) Barros Villacrés, Leslie Melanie; Arancibia Soria, Mirari Yosune
    In this study the compressed the qualification of the compressed air system was carried out from its generation, storage and distribution in the Neorfármaco Laboratory in Ambato city. Air system was qualified starting from its generation, storage and distribution in the Neofármaco Laboratory. Compressed air is widely used in various drug production processes. Impurities in compressed air may jeopardize products. Therefore, it is mandatory to satisfy the quality criteria that govern this type of critical support systems. For the qualification, the protocols and reports of design qualification (DQ), installation qualification (IQ), operation qualification (OQ) and performance qualification (PQ) were implemented. For DQ protocols, it was supports that the design satisfies the user requirements, in the same way the IQ was verified the physical conditions of the air, characteristics and components of the system. In the operation qualification, the correct operation of the system was verified and the results of the operational tests show that the compressed air system accomplish the quality attributes as established the ISPE and ISO 8573 standards, Thus, class 2 in particle content, class 4 for dew point and class 2 for oil content and without the presence of microbial growth. Finally, in the performance qualification, the same parameters were evaluated for 3 days, showing that the system is continuous, reproducible and distributes quality compressed air.