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Estudio de los factores asociados a la presencia de Burkholderia cepacia en el sistema de tratamiento de agua utilizado para la fabricación de productos farmacéuticos
dc.contributor.advisor | Santos Ruiz, Paola Andrea | |
dc.contributor.author | Orjuela Vargas, Luisa Fernanda | |
dc.date.accessioned | 2023-07-11T19:42:27Z | |
dc.date.available | 2023-07-11T19:42:27Z | |
dc.date.issued | 2022-10 | |
dc.identifier.uri | https://repositorio.unicolmayor.edu.co/handle/unicolmayor/6545 | |
dc.description.abstract | En los últimos años, la industria farmacéutica, se ha visto amenazada por el riesgo de contaminación por Burkholderia cepacia (B. cepacia), bacteria Gram negativa que tiene la capacidad de crecer en condiciones de privación de nutrientes y tiende a colonizar todas las superficies del sistema de tratamiento del agua. A su vez, el agua es considerada una de las principales fuentes de contaminación en la industria farmacéutica, generando así mayor preocupación en la fabricación de productos estériles y no estériles, lo que ha llevado a los organismos internacionales y nacionales a incluir en sus políticas, la identificación y detección de este patógeno. Por lo anterior, en este trabajo se realizó una revisión sistemática en diferentes bases de datos sobre los factores asociados a la persistencia y virulencia de B. cepacia en esta industria y los métodos diagnósticos que permitan su identificación, utilizado para la fabricación de productos. De acuerdo con lo reportado por la FDA, en los Estados Unidos en los años 2004 a 2011 se identificaron 64 retiros de productos por contaminación microbiológica, de los cuales el 70% correspondieron a B. cepacia. Para el periodo 2012 a 2022, esta cifra aumentó a 109 retiros de producto. Por su parte, en Colombia no se han reportado retiros de producto por esta causa. La capacidad de B. cepacia de sobrevivir y resistir a estos ambientes está dada principalmente por factores como quorum sensing, la formación de biopelículas y lipopolisacáridos. Estos mecanismos le permiten detectar señales, realizar procesos de comunicación y regulación bacteriana, y contribuir a la resistencia a los antibióticos. La implementación de métodos de diagnóstico sensibles como PCR cuantitativa o espectrometría de masas (MALDI-TOF MS), podría mejorar la identificación y notificación más oportuna de la contaminación para la industria farmacéutica, lo que a su vez ayudará a contener una posible infección en pacientes inmunosuprimidos por causa de estos productos contaminados. | spa |
dc.description.abstract | In recent years, the pharmaceutical industry has been threatened by contamination by Burkholderia cepacia (B. cepacia), a Gram-negative bacteria that grows in conditions of nutrient deprivation and tends to colonize all surfaces of the water treatment system. Water is considered one of the main sources of contamination, thus generating concern in the manufacture of sterile and non-sterile products, which has led international and national organizations to include in their policies the identification and detection of this pathogen. Therefore, in this work, a systematic review was carried out in different databases on the factors associated with the persistence of B. cepacia in the pharmaceutical industry and the diagnostic methods that allow its identification in the water treatment system used for the manufacture of products. According to reported by the FDA, in the United States from 2004 to 2011, an analysis of 64 recalls of products with microbiological contamination was carried out, 70% of which occurred in non-sterile products. In Colombia, according to the information published by INVIMA and the Instituto Nacional de Salud (INS), to date no product recalls have been reported for this cause. The ability of B. cepacia to survive and resist these environments is mainly due to factors such as quorum sensing, biofilm formation and lipopolysaccharides. These mechanisms allow it to detect signals, carry out the process of bacterial communication and regulation, and contribute to antibiotic resistance. The implementation of sensitive diagnostic methods such as quantitative PCR or mass spectrometry (MALDI-TOF MS) could improve the identification and more timely reporting of contamination to the pharmaceutical industry, which in turn will help to contain possible infection in immunosuppressed patients due to these contaminated products. | eng |
dc.description.tableofcontents | Contenido 1. Introducción 11 2. Marco de referencia .. 14 2.1 Características generales de la industria farmacéutica.. 14 2.2 Sistema de agua en la industria farmacéutica17 2.3 Normatividad vigente del sector farmacéutico19 2.3.1 Normativa Internacional ...20 2.3.2 Normativa Nacional..22 2.4 Contaminación microbiológica en la Industria farmacéutica22 2.4.1. Casos de contaminación bacteriana y retiro de medicamentos ..23 2.5 Burkholderia cepacia como causante de contaminación en farmacia.27 2.5.1. Hábitat y biodiversidad de B. cepacia...28 2.6 Taxonomía ...29 2.7 Características bioquímicas y bacteriológicas de B. cepacia 30 3.Objetivos. 32 3.1 Objetivo General ..32 3.2 Objetivos específicos ..32 4. Diseño metodológico . 33 4.1 Estrategias de búsqueda bibliográfica 33 4.3 Extracción de datos.34 4.3.2 Palabras clave..34 4.3.1 Criterios de inclusión - elegibilidad ..34 4.3.2 Criterios de exclusión...35 5. Resultados .. 36 5.1 Publicaciones seleccionados desde las diferentes bases de datos ...36 5.2 Retiro de producto asociado a la contaminación por B. cepacia...40 5.2.1 Reporte de brotes por B. cepacia en Colombia..45 5.3 Factores de virulencia y capacidad patogénica de B. cepacia ..48 5.3.1 Sistemas de quorum sensing (QS)..49 5.3.2 Biopelículas...51 5.3.3 Lipopolisacárido ...51 5.3.4 Fosfolipasas y lipasas, factor sigma 51 5.4 Métodos de identificación de B. cepacia.53 5.4.1 Pruebas de identificación fenotípicas para B. cepacia ...53 5.4.2 Pruebas Moleculares ...55 5.4.2.2 Secuenciación de genes hisA56 5.4.2.3 Secuenciación de genes rpsU ..57 5.4.2.4 Secuenciación del gen recA ..57 6.Conclusiones.. 58 7. Referencias 59 | spa |
dc.format.extent | 66p. | spa |
dc.format.mimetype | application/pdf | spa |
dc.language.iso | spa | spa |
dc.publisher | Universidad Colegio Mayor de Cundinamarca | spa |
dc.rights | Derechos Reservados Universidad Colegio Mayor de Cundinamarca, 2022 | spa |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-sa/4.0/ | spa |
dc.title | Estudio de los factores asociados a la presencia de Burkholderia cepacia en el sistema de tratamiento de agua utilizado para la fabricación de productos farmacéuticos | spa |
dc.type | Trabajo de grado - Maestría | spa |
dc.description.degreelevel | Pregrado | spa |
dc.description.degreename | Magíster en Microbiología | spa |
dc.publisher.faculty | Facultad de Ciencias de la Salud | spa |
dc.publisher.place | Bogota | spa |
dc.publisher.program | Maestría en Microbiología | spa |
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dc.rights.accessrights | info:eu-repo/semantics/closedAccess | spa |
dc.rights.creativecommons | Atribución-NoComercial-CompartirIgual 4.0 Internacional (CC BY-NC-SA 4.0) | spa |
dc.subject.proposal | Burkholderia cepacia | spa |
dc.subject.proposal | Contaminación | spa |
dc.subject.proposal | Sistema de tratamiento de agua | spa |
dc.subject.proposal | Industria Farmacéutica | spa |
dc.subject.proposal | Productos estériles | eng |
dc.type.coar | http://purl.org/coar/resource_type/c_bdcc | spa |
dc.type.coarversion | http://purl.org/coar/version/c_970fb48d4fbd8a85 | spa |
dc.type.content | Text | spa |
dc.type.driver | info:eu-repo/semantics/masterThesis | spa |
dc.type.redcol | https://purl.org/redcol/resource_type/TM | spa |
dc.type.version | info:eu-repo/semantics/publishedVersion | spa |
dc.rights.coar | http://purl.org/coar/access_right/c_14cb | spa |