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| 12:45 May 22, 2020 |
| English to Spanish translations [PRO] Medical - Medical: Pharmaceuticals | |||||||
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|  Selected response from: Neil Ashby Spain Local time: 20:36 | ||||||
Grading comment
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| Summary of answers provided | ||||
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| 5 | Sala Blanca de Materiales |
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| 4 | area de trabajo ISO 7 |
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| 3 | almacenamiento de material estéril |
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| material buffer room Sala Blanca de Materiales Explanation: El concepto de Sala Blanca muy fácilmente se ha asociado a quirófanos, a la industria nuclear, microelectrónica o farmacéutica, pues hace años exclusivamente se veían en este tipo de sectores. Las salas limpias, o a lo que en esa época denominaban sala limpia, aparecieron a finales del siglo XIX, cuando cirujanos y microbiólogos se dieron cuenta de que las infecciones que se producían en los quirófanos se reducían considerablemente cuando había una ventilación. También descubrieron la necesidad de esterilizar el instrumental quirúrgico y de aplicar ciertas normas de vestuario e higiene a todo usuario que entrase en la sala. A buffer room must be kept sterile at all times. All workers entering the buffer room must wear a face mask and apron to protect the immediate area from their germs. The buffer room is the only absolutely sterile room in the pharmacy. In order for the pharmacy to remain up to code, it must stay this way. The walls, floors, ceilings and all surfaces must be smooth and easy to clean, and only a minimal amount of furniture may remain in the room. https://es.wikipedia.org/wiki/Sala_blanca https://ecofred.com/es/blog/52/-que-es-una-sala-blanca-y-que-tipo-de-instalacion-necesita-mi-empresa- |
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Notes to answerer
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| material buffer room area de trabajo ISO 7 Explanation: I think you should add "ISO 7" to any Spanish translation to help clarify the level of control. The reference below shows that "buffer room" is ISO 7, in Spanish "sala blanca" is not descriptive enough, because that's also the name given to the criticial work area ISO 5 (both areas are "sala blanca" in Spanish). See this website, it has a clear diagram of the 3 zones: http://www.cleanzonetech.com/cleanrooms.html Gowning Area / Ante Room: This is where the personnel will put on the specified cleanroom garment that will range from a smock, bouffant, face mask, gloves and shoe covers to a full bunny suit, hood and booties. The extent of gowning will be determined by the process. When entering the Gowning Room the cleanroom air will hit you in the face due to the increased pressurization of the room in relation to the non-cleanroom outside area. The cleanliness level of this area will generally be less than the other cleanroom areas. The process area / Buffer Room This is where the product is prepped or built. This area is generally built at a higher level of contamination control than the gowning room and is at a higher pressure level than the gowning room. This means that when you open the door from the gowning room to the process area the cleanroom air hit you in the face. Levels of protocol are higher in this area and will include frequency of cleaning, restrictions on allowable equipment and tools and controlled product transfer in and out. Critical process area: If a part of the cleanroom process required a higher level of contamination control an additional room can be added or a vertical or horizontal flow bench (reference flow benches, this document) can be incorporated. Again this area will be of a higher pressure than the adjoining areas. And this Spanish ref shows the equivalent terms: https://books.google.es/books?id=lc-8DwAAQBAJ&pg=RA1-PT15&lp... ISO 8 en la antesala, ISO 7 en el área de trabajo, ISO 5 en la zona de trabajo crítica This ref may help with further definitions: https://blog.gotopac.com/2018/04/24/cleanroom-and-sterile-co... |
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Grading comment
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| material buffer room almacenamiento de material estéril Explanation: Una opción: http://www.hsjd.cl/Intranet/Calidad/Servicios de Apoyo/APE-1... |
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Notes to answerer
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