Ciencia e Ingeniería en Alimentos y Biotecnología
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Item Desarrollo e Implementación de un Sistema de Análisis de Riesgos y Puntos Críticos de Control (HACCP) en la elaboración de la tableta recubierta de nifuroxazida y atapulgita en el Laboratorio Neofármaco del Ecuador CIA.LTDA.(Universidad Técnica de Ambato. Facultad de Ciencia e Ingeniería en Alimentos y Biotecnología. Carrera de Biotecnología, 2023-09) Manobanda Mainato, Samantha Belén; Tubón Usca, Irvin RicardoCurrently, the Analysis and Critical Control Points System (HACCP) in the pharmaceutical industry is of utmost importance, this is because it allows the identification of errors or hazards that may occur at each stage of the process, affecting the integrity or safety of the product. It should be noted that in 2018 ARCSA annexes HACCP to its system through the Methodology for the implementation of HACCP in Pharmaceutical Laboratories. In the present project, the objective was to develop and implement a HACCP System in the production line of a coated tablet of nifuroxazide and attapulgite in the laboratory Neofármaco del Ecuador, for that, the methodology proposed by the WHO based on 7 principles divided into 12 steps was used, through the use of severity matrices, probability and a tree, biological, chemical and physical hazards were identified. Applying the aforementioned methodology, four critical control points (CCPs) were identified: the count of microorganisms in the weighing process (CCP-B1), in the manufacturing process two CCPs were found, the formation of the frost point (CCP-F1) and the resting time of the granules before drying not to exceed eight hours (CCP-B2), and finally, in the packaging process, the control of the tightness of the blister (CCP-Q1). As the CCPs were established, critical control limits were defined for each of them, assigning qualitative and quantitative values. Finally, a PRO-AS-HACCP-026 protocol was implemented, in which a history log was attached to facilitate monitoring and verification for the CCPs.Item Elaboración de un manual de buenas prácticas de manufactura para la empresa EXPOFRUTS ubicada en el cantón Cevallos en la provincia de Tungurahua(Universidad Técnica de Ambato. Facultad de Ciencia e Ingeniería en Alimentos y Biotecnología. Carrera de Alimentos, 2023-09) González Salazar, Adonis Paúl; Guanoquiza Rivera, Manuel IsraelThis research was focused on the development of a Manual of Good Manufacturing Practices with the purpose to implement and achieve GMP certification for the EXPOFRUTS Company, its located in Cevallos canton in Tungurahua province and its most dedicated to elaboration and comercialitation of Pulp with local fruits. The diagnosis of the company was trough the aplication “check list”following the established requiremnts by the ARCSA-DE-2022-016-AKRG normative, it have 218 items with 3 levels of evaluation. According to the company in its current situation indicates 81,19 percent compliance, 12,84 percent non-compliance and 5,96 percent of parameters not related to its business activities, instead, the Standardized Operating and Sanitation Procedures are developed base don the non-conformities detected and requeriements established by ARCSA resolution 016, these include programs, processes, records and corrective actions, in the same way these procedures seek to maintain hygienic conditions during the production process and thus safeguard the safety of the products. The action plan, as well as the Schedule, were raised with the aspiration of covering the non-conformities in an appropiate period and in accordance with the business resources in order to obtain the BPM certification.Item Evaluación físico-química y microbiológica en el desempeño de las áreas de producción de productos naturales y cosméticos en el laboratorio NEOFÁRMACO del Ecuador Cía. Ltda.(Universidad Técnica de Ambato. Facultad de Ciencia e Ingeniería en Alimentos y Biotecnología. Carrera de Biotecnología, 2022-09) Mosquera Sánchez, Marco Antonio; Tubón Usca, Irvin RicardoIn this study, was evaluated the physicochemical and microbiological performance of the production areas of cosmetics and natural products at Laboratorio Neofármaco del Ecuador, located in the city of Ambato. Pharmaceutical laboratories require legal authorization to produce medicines in general, and they must comply with certain regulations such as good manufacturing practices (GMP) established by national and international health regulatory authorities, ensuring production processes and product quality. For performance evaluation, physicochemical tests were carried out to determine the temperature and humidity, the concentration of particles in the air with their respective process capability indexes (Cp), differential pressure, velocity air and exchange air rates. Then, a microbiological environmental monitoring of the air was carried out by means of different samplings such as active sampling in the area, active sampling of the diffuser, and passive sampling. On the other hand, for microbiological evaluation of surfaces, the swab sampling method was applied, where a microbiological count of total aerobes, molds-yeasts, and Salmonella spp was performed. To conclude, it was demonstrated that both areas comply with all the established specifications and maintain consistent results, which ensures the safety in manufacture of non-sterile pharmaceutical products.Item Actualización del Manual de Buenas Prácticas de Manufacturas (BPM) para la empresa INDUNEVALL de la parroquia Totoras - cantón Ambato(Universidad Técnica de Ambato. Facultad de Ciencia e Ingeniería en Alimentos y Biotecnología. Carrera de Alimentos, 2022-09) Zavala Salazar, Joselyn Valeria; Ortiz Escobar, Jacqueline de las MercedesThis final curricular integration report was focused on the development of a Manual of Good Manufacturing Practices in order to implement it and achieve GMP certification for the INDUNEVALL company located in the Totoras town, Ambato city, which is dedicated to the elaboration and commercialization of chochos and mote pasteurized with salt. The initial diagnosis of the company was done through the verification guidance FI-B.5.1.3-ALI-02-02. Well proportioned by the ARCSA which is part of 212 items with 3 levels of evaluation each one. According to this, it was obtained that the company in its current conditions presents 58.02 percent of breach; 33.49 percent of compliance and 8.49 percent of a parameters not applicable to the Company’s activities. The Standardized Operating and Sanitation Procedures were developed based on the nonconformities detected and the requirements established in ARCSA resolution 067 and contains programs, registers and corrective actions, these procedures will allow maintaining adequate hygienic conditions throughout the production process and guarantee the quality and safety of the products. The action plan as the same as the schedule have been prepared with a clear projection to overcoming the nonconformities in an appropriate period of time and according to the resources that the Company has available. All of this is with the purpose to obtain the BPM certificate.Item Elaboración de un manual de Buenas Prácticas de Manufactura de una panadería, caso de estudio: Panificadora del Valle(Universidad Técnica de Ambato. Facultad de Ciencia e Ingeniería en Alimentos y Biotecnología. Carrera de Ingeniería en Alimentos, 2022-09) Moreta Chicaiza, Silvana Isabel; Paredes Escobar, Mayra LilianaAt present, quality is not only measured by organoleptic characteristics, but also by the intrinsic relationship between good flavor and safe production, for which the manual describes the necessary requirements to ensure a productive process. The objective of this document was to prepare a manual of Good Manufacturing Practices in particular relation to Panificadora del Valle. To develop it, it was evaluated through the verification guide or check list in accordance with the substitute standard ARSCA 067-2015-GGG, which consists of eight chapters, thus it was diagnosed that the plant obtained an initial compliance profile of 42.70 percent, value that requires a change within the bakery, on the other hand, the degree of non-compliance was 33.59 percent, a percentage that leads to the improvement of facilities, hygienic requirements and quality assurance. Within the manual there is detailed information on the study company, standardized procedures (POE) and standardized sanitation procedures (POES), which, if implemented, will help the bakery to avoid contamination throughout the production chain. Likewise, this circumstance will require a manual that serves as a guide for the application of BPM in the baking industry, it is a light theoretical and didactic extract that will allow easy understanding of the topic convened.Item Implementación del sistema 5S en las áreas de envasado de yogurt y bolos para la empresa de Productos Lácteos Píllaro PROLACPI ubicada en la parroquia Marcos Espinel del cantón Píllaro(Universidad Técnica de Ambato. Facultad de Ciencia e Ingeniería en Alimentos y Biotecnología. Carrera de Ingeniería en Alimentos, 2022-09) Chicaiza Moyolema, Germán Israel; Cadena Carrera, Santiago EsmiroThis work was developed with the aim of implementing the 5S system in the yogurt and bolo packaging areas for the company Productos Lácteos Píllaro, located in the parish of Marcos Espinel in the canton of Píllaro. The 5S corresponding to classify (seiri), order (seiton), clean (seiso), standardize (seiketsu) and discipline (shitsuke) were applied. As a measurement method, the productivity of the workforce, the effectiveness per run, the search time for work items and the percentage of items out of place were used. The results showed that the percentage of compliance with the 5S system in the bowling area started with 36.95 percent and reached 100 percent, and the yogurt packaging area started with 51 percent and reached 97.83 percent. Obtaining a percentage increase in the effectiveness indicators per run of 28.40, 10.5, 17.58, 23.52 and 17.58 percent in bowls (80ml and 150ml), yogurt (45ml, 80ml and 90ml) respectively, in the same way, the productivity of the hand of work had an increase of 28.40, 10.51, 16.06, 23.52 and 29.17 percent in bowls (80ml and 150ml), yogurt (45ml, 80ml and 90ml) correspondingly, this occurred by reducing the search time of the work objects to 1 min and have an assigned place with a visual control, in addition, that the documentation found in the 5S manual can be applied in the rest of the production lines.Item Caracterización de bacterias y testeo de métodos de desinfección de botellones de agua de la planta Fuente San Felipe S.A. ubicada en el cantón Latacunga provincia de Cotopaxi(Universidad Técnica de Ambato. Facultad de Ciencia e Ingeniería en Alimentos y Biotecnología. Carrera de Ingeniería en Alimentos, 2022-09) Bonilla Vizuete, Jeniffer Stefania; Pérez Salinas, Ruth NarcisaThe problem of bottled water quality is acute throughout the world, and it has been addressed with water testing that ensures accurate and timely results. Bottled water manufacturers are tasked with testing larger volumes of samples, even dealing with unexpected emergencies, while adhering to more stringent local regulations. The use of returnable bottles has determined that there are contaminants due to improper handling of the containers, exposure to the environment and wear of the bottle materials. This study focused on establishing the microbial load, identifying the microorganisms involved and proposing continuous improvement protocols to ensure the food safety of bottled water from the Fuente San Felipe S.A. plant. Evidence of bacterial contamination was found in the returnable bottles. The presence of aerobic mesophiles was determined, which are indicators of contamination due to exposure to the environment, total coliforms, without finding evidence of fecal contamination and the critical microorganism found to establish the quality of water was Pseudomonas stutzeri. The disinfection protocol was adjusted to eliminate this microorganism with the use of hydrogen peroxide in concentrations of up to 3 percent and applications of up to 15 minutes of contact in the bottles, the latter being considered the best treatment. In order to ensure the quality of the final product, a food quality and safety management system is proposed, based on measurement, analysis and improvement of the disinfection and packaging processes.Item Evaluación de la calidad de un gel antibacterial elaborado a partir de Alcohol Artesanal con hidrolato de manzanilla (Matricaria chamomilla) y aceite esencial de naranja (Citrus spp.)(Universidad Técnica de Ambato. Facultad de Ciencia e Ingeniería en Alimentos y Biotecnología. Carrera de Ingeniería Bioquímica, 2022-03) Merino Castillo, Erick Andrés; Robalino Martínez, Dolores del RocíoThe antibacterial gel has become a complementary product for hand hygiene, preventing infections and the spread of diseases. This research proposes the evaluation of the quality of an antibacterial gel made from artisanal alcohol with chamomile hydrolate (Matricaria chamomilla) and essential oil of orange (Citrus spp. ), the physicochemical properties of the gel were identified, in which a pH value between 5.72 and 6.05 was obtained; a density of 0.876 to 0.885 grams over cubic centimeters and a viscosity of 7320 to 7956 Cps, these being the optimum values for this type of antibacterial cosmetics, complying with the external instructions for low-risk cosmetic products, belonging to the national agency of regulation, control and sanitary surveillance ARCSA. The quantification of the alcohol concentration in the antibacterial gel was performed by gas chromatography, complying with the provisions of the ARCSA in its resolution DE-015-2020 where the alcohol concentration was found in the range between sixty and seventy percent performing its antibacterial characteristics. The bacterial effectiveness tests were carried out according to the European standard UNE-EN-1040, applying the microbiological techniques of cosmetic products, where two strains of microorganisms Escherichia coli and Staphylococcus aureus were used, these tests were evaluated by means of a logarithmic scale, determining a high bactericidal activity for its antibacterial characteristics against the microorganisms evaluated, being this product ideal for hand disinfection since it complies with all the quality parameters.Item Validación del método para determinación de detergentes en muestras de agua por espectrofotometría UV-Vis en el laboratorio AqLab de la ciudad del Coca(Universidad Técnica de Ambato. Facultad de Ciencia e Ingeniería en Alimentos y Biotecnología. Carrera de Ingeniería Bioquímica, 2022-03) Aguirre Tubón, Ana Belén; Pérez Aldas, Lander VinicioThe validation of the method for determination of surfactants in water samples by UV-vis spectrophotometry was carried out in the environmental analysis and evaluation laboratory Aqlab in the city of Coca. Its validation was carried out taking into account the analytical need of the laboratory, validation parameters of the INEN ISO IEC 17025 standard and SAE regulations, environmental regulations described in the TULSMA, in its Environmental Quality and Effluent Discharge Standard: Water Resource and the Municipal Ordinances of the Orellana Canton. The method 5540 C corresponding to the determination of anionic surfactants as MBAS described in the Standard Methods was used for the matrices of water for human consumption, natural water and waste water. The validation objectives were established and the corresponding experimental design was proposed under conditions of repeatability and reproducibility. The following parameters were analyzed: Response Function, Limit of detection, Limit of quantification, Precision (repeatability and reproducibility), Veracity, Uncertainty and Working Interval of the method. Through the statistical analysis of data, it was demonstrated that the method is suitable for the intended application, by meeting the validation objectives set for a CVr and CVR less than 30 percent for accuracy, a recovery percentage of 80 to 120 percent for veracity, an uncertainty U less than 30 percent with a 95 percent confidence interval (k is 2) and a method working range comprising concentration levels 0,10 to 8,85 ppm MBAS.Item Desarrollo de un Manual de Buenas Prácticas de Manufactura para la microempresa chocolatera Manabean ubicada en la parroquia Tumbaco del cantón Quito perteneciente a la provincia de Pichincha(Universidad Técnica de Ambato. Facultad de Ciencia e Ingeniería en Alimentos y Biotecnología. Carrera de Ingeniería en Alimentos, 2022-03) Yanchaliquin Chugchilan, Vanessa Carolina; Guanoquiza Rivera, Manuel IsraelThe present research was oriented towards the development of a Manual of Good Manufacturing Practices for the Manabean microenterprise located in the Tumbaco parish belonging to the Quito canton, where an evaluation of the current situation was initially carried out based on a checklist according to the sanitary technical standard of ARCSA 067:2015. Three levels of evaluation were used, Complies, when the requirements are executed, Does not comply, when it does not comply with what is established and Does not apply, when the requirement is not consistent with the activities of the microenterprise. In this initial evaluation, 3130 percent was obtained for Compliance with the BPM, 49,53 percent for Does not comply and 19.16 percent for Does not apply. Subsequently, the corrective actions were established to solve the non-conformities found, the same ones that were classified into short, medium and long term actions, likewise the information analysis was carried out for the creation of the procedures and programs required by the BPM handbook. Depending on the resources available to the microenterprise, short term actions were considered to be implemented. Once the short term actions were implemented, a final diagnosis was made to the microenterprise again with a new checklist, and a general compliance percentage of 63.08 percent was obtained, because the procedures established in the manual were used.
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