Media Fill Testing Media

 
 
 

Good Manufacturing Practices require pharmaceutical companies to regularly perform Media Fill Tests in order to verify the adequate microbiological state of their aseptic production process.  Media fill tests are critical microbiological tests carried out to simulate the normal manufacturing conditions by replacing the pharmaceutical product with culture media.  Manual reading of several thousands of pharmaceutical containers is the current practice and this can be extremely time-consuming and be a source of potential errors.  A new Tryptic Soy Broth culture medium offering a color indicator can optimize and facilitate the reading step and lead to less false readings.
 
The patented color indicator was selected as it showed to be a broad indicator of microbiological growth.  The compound is reduced by microbial metabolism.  Contamination and turbidity can easily be seen with a color change from pink to yellow if growth occurs after incubation.
 
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Features & Specs

  • Dehydrated media
  • Irradiated with at least 25 kGy
  • Cold-filterable
  • TSE and BSE free
  • Tested for the absence of Mycoplasma
  • Tamper-proof seal

 

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Uses

Biopharma:

  • Method Validation
  • Microbial Detection
  • Product Testing
  • Root-Cause Investigation
  • Sterility Testing

 

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