Calificación de salas limpias de fabricación, envasado y acondicionado de productos farmacéuticos líquidos no estériles
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Date
2020
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Publisher
Universidad Nacional de Trujillo
Abstract
El presente informe de prácticas preprofesionales tiene como objetivo calificar un area de salas limpias de fabricación envasado y acondiciona de farmacéuticos liquidos no esteriles siendo esta clase D, en el area de producción de un laboratorio farmacéutico nacional. En la calificación del area de farmacéuticos liquidos no esteril se realizò el recuento de partículas no viables, renovación de aire por hora, diferencial de presiones, temperatura y humedad relativa, intensidad de la luz y un estudio microbiológico. Dicha calificación se suntenta en las normas internacionales como ISO 14644-1 2015, informe 32 de la OMS, norma Europea UNE 12464-1, entre otros. Asi mismo es estructurada bajo la normativa nacional vigente deacuerdo al nuevo manual de Buenas Prácticas de Manufactura (BPM). Quedando asi documentado que cumple con el recuento de partículas muy por debajo de 3 520 000, asi mismo toda el area con una temperatura no mayor de 30 ºC, con una intensidad de luz muy por encima de los 500 grados LUX, y sobre todo con un recuento microbiano con ≤ 3 UFC/PLACA demostrando que es un area completamente limpia y sanitizada; es por lo cual se llega a una conclusión que el area de salas limpias de farmacéuticos liquidos no esteriles cumple con todas las especificaciones establecidas y demostrando asi que dicha area esta calificada y esta apta para la fabricación de productos farmacéuticos.
ABSTRACT The objective of this pre-professional practice report is to qualify an area of clean rooms for manufacturing packaging and conditioning of non-sterile liquid pharmaceuticals, this being class D, in the production area of a national pharmaceutical laboratory. In the qualification of the non-sterile liquid pharmaceutical area, the non-viable particle count, air renewal per hour, pressure differential, temperature and relative humidity, light intensity and a microbiological study were performed. Said qualification seventy in international standards such as ISO 14644-1 2015, WHO report 32, European standard UNE 12464-1, among others. Likewise, it is structured under the current national regulations according to the new manual of Good Manufacturing Practices (BPM). Thus being documented that it complies with the particle count well below 3,520,000, likewise the entire area with a temperature no greater than 30 ºC, with a light intensity well above 500 degrees LUX, and especially with a microbial count with ≤ 3 CFU / PLATE showing that it is a completely clean and sanitized area; This is why a conclusion is reached that the non-sterile liquid pharmaceutical clean room area complies with all the established specifications and thus demonstrating that said area is qualified and suitable for the manufacture of pharmaceutical products.
ABSTRACT The objective of this pre-professional practice report is to qualify an area of clean rooms for manufacturing packaging and conditioning of non-sterile liquid pharmaceuticals, this being class D, in the production area of a national pharmaceutical laboratory. In the qualification of the non-sterile liquid pharmaceutical area, the non-viable particle count, air renewal per hour, pressure differential, temperature and relative humidity, light intensity and a microbiological study were performed. Said qualification seventy in international standards such as ISO 14644-1 2015, WHO report 32, European standard UNE 12464-1, among others. Likewise, it is structured under the current national regulations according to the new manual of Good Manufacturing Practices (BPM). Thus being documented that it complies with the particle count well below 3,520,000, likewise the entire area with a temperature no greater than 30 ºC, with a light intensity well above 500 degrees LUX, and especially with a microbial count with ≤ 3 CFU / PLATE showing that it is a completely clean and sanitized area; This is why a conclusion is reached that the non-sterile liquid pharmaceutical clean room area complies with all the established specifications and thus demonstrating that said area is qualified and suitable for the manufacture of pharmaceutical products.
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Keywords
Calificación, salas limpias, liquidos.