Propuestas para el perfeccionamiento de los documentos regulatorios en la Droguería de Villa Clara para disminuir el riesgo de contaminación fúngica
Fecha
2017
Autores
Rodríguez Arboláez, Adislen
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Editor
Universidad Central "Marta Abreu" de Las Villas. Facultad de Química Farmacia. Departamento de Farmacia
Resumen
En la Cámara Refrigerada de la Droguería de Villa Clara se detectó bioensuciamiento por Cladosporium sp., cifras altas de propágulos fúngicos en el aire y condiciones de humedad elevadas. Sin embargo se desconocía si los documentos regulatorios de la entidad se enfocaban en la disminución de los riesgos por hongos, lo que fundamenta el presente trabajo que pretendió: identificar acciones en documentos regulatorios nacionales e internacionales con este fin y verificar su cumplimiento mediante una observación científica del almacén, una encuesta a los Dependientes Manipuladores y una entrevista a especialistas en Gestión de la Calidad y Seguridad y Salud del Trabajo. Por último describir las insuficiencias de los documentos regulatorios de la entidad y aspectos derivados de la entrevista y la encuesta, para proponer acciones para perfeccionarla. Existen normativas públicas que pueden ser empleadas para diseñar un Sistema de Calidad dinámico, según las exigencias de las Buenas Prácticas de Almacenamiento. En los documentos regulatorios existentes en la entidad no se identificaron acciones relacionadas con los indicadores Calidad del aire y Riesgo para la salud. Tampoco se orienta el uso de un sistema de alarmas continuo para advertir temperaturas fuera de los intervalos establecidos, ni se define un límite de humedad relativa permisible. En los Procedimientos Operacionales se obvian la realización de mapas térmicos para ubicar idóneamente los equipos de registro de temperatura, la construcción de gráficos de control de este parámetro y la humedad relativa para el análisis de tendencias y la descripción del procedimiento de control de la limpieza.
In the Refrigerated Chamber of the Drugstore of Villa Clara was detected biofouling by Cladosporium sp., high numbers of fungal propagules in the air and high humidity conditions. However, it was not known if the regulatory documents of the entity focused on the reduction of fungal risks, which is the basis of the present work had as objectives: Identify actions in national and international regulatory documents for this purpose and verify their compliance by means of a scientific observation, a survey of the Manipulating Dependents and an interview with specialists in Quality Management and Occupational Safety and Health. Finally, describe the inadequacies of regulatory documents of the entity and matters arising from the interview and survey, to propose actions to improve it. There are public regulations that can be used to design a dynamic Quality System, according to the requirements of the Good Practices of Storage. The existing regulatory documents in the entity did not identify actions related to the indicators Air quality and Health risk. Neither is the use of a continuous alarm system to warn temperatures outside the established intervals, nor is a permissible relative humidity limit defined. The Operational Procedures obviate the performance of thermal maps to ideally locate the temperature recording equipment, the construction of control charts of this parameter and the relative humidity for trend analysis and the description of the cleaning control procedure.
In the Refrigerated Chamber of the Drugstore of Villa Clara was detected biofouling by Cladosporium sp., high numbers of fungal propagules in the air and high humidity conditions. However, it was not known if the regulatory documents of the entity focused on the reduction of fungal risks, which is the basis of the present work had as objectives: Identify actions in national and international regulatory documents for this purpose and verify their compliance by means of a scientific observation, a survey of the Manipulating Dependents and an interview with specialists in Quality Management and Occupational Safety and Health. Finally, describe the inadequacies of regulatory documents of the entity and matters arising from the interview and survey, to propose actions to improve it. There are public regulations that can be used to design a dynamic Quality System, according to the requirements of the Good Practices of Storage. The existing regulatory documents in the entity did not identify actions related to the indicators Air quality and Health risk. Neither is the use of a continuous alarm system to warn temperatures outside the established intervals, nor is a permissible relative humidity limit defined. The Operational Procedures obviate the performance of thermal maps to ideally locate the temperature recording equipment, the construction of control charts of this parameter and the relative humidity for trend analysis and the description of the cleaning control procedure.
Descripción
Palabras clave
Cámara Refrigerada, Droguería de Villa Clara, Biodeterioro, Hongos, Cladosporium sp.