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Spanish to English: Informe de Calificación de la Instalación de Equipo Mezclador-Granulador Detailed field: Medical: Pharmaceuticals
Source text - Spanish Criterios de Aceptación
a) Los componentes evaluados deben ser los especificados o los requeridos para el normal funcionamiento del Equipo.
b) Los materiales evaluados deben ser los especificados y/o no contraponerse a los cri-terios propuestos o establecidos para este tipo de equipos por las Buenas Prácticas de Fabricación vigentes.
c) Todos los elementos en contacto directo con los productos a procesar deberán estar construidos en Acero Inoxidable (calidad AISI 316) y tener una terminación (soldaduras, pulido, etc.) que asegure la facilidad y efectividad de su limpieza bajo los procedimientos establecidos.
d) El estado de conservación general del Equipo debe resultar acorde con la tarea que realiza (incluida su limpieza).
Translation - English Acceptance Criteria
a) The assessed components shall be the ones specified or required for the normal performance of the Equipment.
b) The assessed materials shall be the ones specified and/or shall not be contrary to the criteria suggested or established for this kind of equipment by the current Good Manufacturing Practices.
c) All the elements in direct contact with the products to be processed shall be made of AISI 316 Stainless Steel and have a finish (welds, polish, etc.) that ensures cleaning ease and effectiveness in accordance with the established procedures.
d) The Equipment’s general maintenance status shall be in accordance with the task it performs (cleaning included).
Expertise 