Glossary entry (derived from question below)
Spanish term or phrase:
llenado aséptico simulado
English translation:
aseptic process simulation/media fill test
Added to glossary by
E Minogue
Oct 30, 2014 23:15
9 yrs ago
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Spanish term
llenado aséptico simulado
Spanish to English
Medical
Medical: Pharmaceuticals
I am translating a document for a Mexican pharmaceutical company. I am currently working on a list of definitions. Here is the definition for the term in question:
Llenado aséptico simulado: a la operación de llenado utilizando medio de cultivo en lugar de producto, poniéndolo en contacto con las superficies del equipo, de sistemas de cierre, ambiente y operaciones del proceso para reproducir las condiciones de operación.
Thanks for your help!
Llenado aséptico simulado: a la operación de llenado utilizando medio de cultivo en lugar de producto, poniéndolo en contacto con las superficies del equipo, de sistemas de cierre, ambiente y operaciones del proceso para reproducir las condiciones de operación.
Thanks for your help!
Proposed translations
(English)
| 4 +2 | aseptic process simulation/media fill test |
E Minogue
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Change log
Nov 13, 2014 21:32: E Minogue Created KOG entry
Proposed translations
+2
27 mins
Selected
aseptic process simulation/media fill test
A. What is a media fill?
A “media fill” (sometimes known as a “process simulation”) is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium in place of the drug solution. Microbiological growth medium is used in place of the drug solution during media fills to test whether the aseptic procedures are adequate to prevent contamination during actual drug production. A media fill is one part of the validation of an aseptic manufacturing process. (http://www.fda.gov/downloads/drugs/.../Guidances/ucm273766.p...
Powerpoint on Media Fill Protocol by WHO:
apps.who.int/prequal/trainingresources/pq_pres/.../2-5a_MediaFill.ppt
A “media fill” (sometimes known as a “process simulation”) is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium in place of the drug solution. Microbiological growth medium is used in place of the drug solution during media fills to test whether the aseptic procedures are adequate to prevent contamination during actual drug production. A media fill is one part of the validation of an aseptic manufacturing process. (http://www.fda.gov/downloads/drugs/.../Guidances/ucm273766.p...
Powerpoint on Media Fill Protocol by WHO:
apps.who.int/prequal/trainingresources/pq_pres/.../2-5a_MediaFill.ppt
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