Material Buffer Room

Spanish translation: area de trabajo ISO 7

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:buffer room
Spanish translation:area de trabajo ISO 7
Entered by: Neil Ashby

12:45 May 22, 2020
English to Spanish translations [PRO]
Medical - Medical: Pharmaceuticals
English term or phrase: Material Buffer Room
4.7.1 System HVAC Table 11, Room N°: 112-2C-005; Name: Material flow Buffer Room III
Name: Material Buffer Room III

Buenos días, estoy realizando la traducción de un archivo en inglés que tiene sólo títulos de secciones de un manual de buenas prácticas de un laboratorio. En esta parte me encuentro con esta frase, encontré que buffer room acá en proz lo tradujeron como zona estéril/área blanca, sería zona estéril de materiales III.... zona estéril de flujo de materiales III
Gracias
sebaspedlp
Argentina
Local time: 16:36
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...
Selected response from:

Neil Ashby
Spain
Local time: 20:36
Grading comment
¡Muchisimas gracias! Todo muy interesante, las referencias y los ejemplo, saludos
4 KudoZ points were awarded for this answer



Summary of answers provided
5Sala Blanca de Materiales
Ramon Armora
4area de trabajo ISO 7
Neil Ashby
3almacenamiento de material estéril
Liliana Garfunkel


  

Answers


10 mins   confidence: Answerer confidence 5/5
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-
Ramon Armora
Dominican Republic
Local time: 15:36
Works in field
Native speaker of: Native in SpanishSpanish, Native in EnglishEnglish
PRO pts in category: 4
Notes to answerer
Asker: muchas gracias, ¡saludos!

Login to enter a peer comment (or grade)

2 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
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...


Neil Ashby
Spain
Local time: 20:36
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 229
Grading comment
¡Muchisimas gracias! Todo muy interesante, las referencias y los ejemplo, saludos
Login to enter a peer comment (or grade)

3 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5
material buffer room
almacenamiento de material estéril


Explanation:
Una opción:
http://www.hsjd.cl/Intranet/Calidad/Servicios de Apoyo/APE-1...

Liliana Garfunkel
Argentina
Native speaker of: Native in SpanishSpanish
PRO pts in category: 8
Notes to answerer
Asker: ¡Muchas gracias, saludos!

Login to enter a peer comment (or grade)



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