Calificación de salas limpias Área: Línea de producción 2 – BFS 624 en laboratorio nacional de soluciones y suspensiones oftálmicas
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Date
2022
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Universidad Nacional de Trujillo
Abstract
Este informe de prácticas pre-profesionales, tiene como objetivo calificar salas limpias área: LÍNEA DE PRODUCCION 2 – BFS 624 en un laboratorio nacional de productos farmacéuticos oftálmicas. En la calificación del área productos oftálmicos se realizó pruebas en reposo: integridad de filtros HEPA, medición de velocidad de aire, cambios de aire por hora (C.A.H.), direccionalidad de flujo de aire, medición de presiones diferenciales, determinación de la caída de presión a través del filtro HEPA, clasificación de aire por partículas, medición de temperatura y humedad relativa, tiempo de recuperación de sistema, monitoreo de partículas viables, también pruebas en operación: medición de temperatura y humedad relativa, clasificación de aire por concentración de partículas, monitoreo de partículas viables. Esta calificación se basa en estándares internacionales como ISO 14644-1:2015, Informe 45- OMS (2011), manual de buenas prácticas de manufactura productos farmacéuticos DIGEMID-2018. Quedando así documentado que cumple con las pruebas en reposo y operación. Por lo cual se concluye que el área de salas limpias línea de producción 2 – BFS 624 de productos oftálmicos está calificada para la fabricación y envasado de dichos productos.
ABSTRACT This report of pre-professional practices, aims to qualify clean rooms area: PRODUCTION LINE 2 - BFS 624 in a national laboratory of ophthalmic pharmaceutical products. In the qualification of the ophthalmic products area, tests were carried out at rest: integrity of HEPA filters, measurement of air speed, air changes per hour (C.A.H.), directionality of air flow, measurement of differential pressures, determination of pressure drop through the HEPA filter, classification of air by particles, measurement of temperature and relative humidity, system recovery time, monitoring of viable particles, also tests in operation: measurement of temperature and relative humidity, classification of air by concentration of particles, monitoring of viable particles. This qualification is based on international standards such as ISO 14644-1:2015, Report 45- WHO (2011), manual of good manufacturing practices for pharmaceutical products DIGEMID-2018. Thus, it is documented that it complies with the tests at rest and operation. Therefore, it is concluded that the clean room area production line 2 - BFS 624 of ophthalmic products is qualified for the manufacture and packaging of said products.
ABSTRACT This report of pre-professional practices, aims to qualify clean rooms area: PRODUCTION LINE 2 - BFS 624 in a national laboratory of ophthalmic pharmaceutical products. In the qualification of the ophthalmic products area, tests were carried out at rest: integrity of HEPA filters, measurement of air speed, air changes per hour (C.A.H.), directionality of air flow, measurement of differential pressures, determination of pressure drop through the HEPA filter, classification of air by particles, measurement of temperature and relative humidity, system recovery time, monitoring of viable particles, also tests in operation: measurement of temperature and relative humidity, classification of air by concentration of particles, monitoring of viable particles. This qualification is based on international standards such as ISO 14644-1:2015, Report 45- WHO (2011), manual of good manufacturing practices for pharmaceutical products DIGEMID-2018. Thus, it is documented that it complies with the tests at rest and operation. Therefore, it is concluded that the clean room area production line 2 - BFS 624 of ophthalmic products is qualified for the manufacture and packaging of said products.
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Limpieza en salas oftálmicas