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23:15 Oct 30, 2014 |
Spanish to English translations [PRO] Medical - Medical: Pharmaceuticals | |||||||
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| Selected response from: E Minogue New Zealand Local time: 03:09 | ||||||
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4 +2 | aseptic process simulation/media fill test |
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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... |
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