llenado aséptico simulado

English translation: aseptic process simulation/media fill test

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
Spanish term or phrase:llenado aséptico simulado
English translation:aseptic process simulation/media fill test
Entered by: E Minogue

23:15 Oct 30, 2014
Spanish to English translations [PRO]
Medical - Medical: Pharmaceuticals
Spanish term or phrase: llenado aséptico simulado
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!
JoshuaV-M
Mexico
Local time: 08:09
aseptic process simulation/media fill test
Explanation:
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
Selected response from:

E Minogue
New Zealand
Local time: 03:09
Grading comment
Selected automatically based on peer agreement.
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +2aseptic process simulation/media fill test
E Minogue


  

Answers


27 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +2
aseptic process simulation/media fill test


Explanation:
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


    Reference: http://www.biomerieux-usa.com/upload/BIOPHARMA%20NOV%2009-1....
    Reference: http://www.picscheme.org/pdf/26_pi007-6recommendationonasept...
E Minogue
New Zealand
Local time: 03:09
Native speaker of: English
PRO pts in category: 4
Grading comment
Selected automatically based on peer agreement.

Peer comments on this answer (and responses from the answerer)
agree  David Hollywood
0 min
  -> Thanks, David :)

agree  Muriel Vasconcellos
25 mins
  -> Thanks, Muriel :)
Login to enter a peer comment (or grade)



Login or register (free and only takes a few minutes) to participate in this question.

You will also have access to many other tools and opportunities designed for those who have language-related jobs (or are passionate about them). Participation is free and the site has a strict confidentiality policy.

KudoZ™ translation help

The KudoZ network provides a framework for translators and others to assist each other with translations or explanations of terms and short phrases.


See also:
Term search
  • All of ProZ.com
  • Term search
  • Jobs
  • Forums
  • Multiple search