Media Fill Testing Media

A New Vision on the Media Fill Test

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. 

 

 

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 AND SPECS

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

USES

Biopharma:

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

MEDIA FILL TESTING MEDIA FEATURES & SPECS

Biomerieux has developed 2 culture media lines of Tryptic Soy Broth specifically designed for Media Fill Tests:

  • Tryptic Soy Broth with Animal Peptones
  • Tryptic Soy Broth with Vegetable Peptones and Color Indicator for Contamination Detection

Both products offer:

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

Downloads:

MEDIA FILL TESTING MEDIA USES

Biopharma:

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

Aseptic manufacturing is an intricate process for the pharmaceutical industry and a risk management plan must be designed to ensure final product safety. Media Fill Testing (MFT) is a systematic control that should be included in this plan to build quality into the product and not rely only on the final product sterility test.

Reading Media Fill units can be a real bottleneck and a difficult part of MFT since it requires qualified technicians and much time to manually read up to several thousands of filled units.

Such a manual operation can lead to risks of failed readings, hence the need for improved culture media that can facilitate reading and reinforce the safety of the pharmaceutical industry.

Biomerieux brings a new dimension to the MFT with a unique color indicator:

  • Easier contamination detection
  • Greater ease of use
  • Less false positive and false negative results

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Pioneering diagnostics