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USP 61 microbiological testing servicesUSP 61 microbiological testing lab
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USP 61 microbiological testing anaylsis

USP <61> Microbial Enumeration Tests


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USP 61 Microbiological Examination of Nonsterile Products

  • Soybean-Casein Digest Agar (TAMC)
  • Sabouraud Dextrose Agar (TYMC)

USP 61 Microbial Enumeration Test Methods

Membrane Filtration

Plate Count Methods

  • Pour-Plate Method
  • Surface-Spread Method

Most-Probable-Number-Method

  • Tubes are used for microbial growth

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Interpretation / Analysis of Results for USP <61> Microbial Enumeration Tests

TAMC - Total Aerobic Microbial Count

  • equal to number of cfu found using Soybean-Casein Digest Agar
  • if colonies of fungi are apparent, they are counted and included in TAMC
TYMC - Total Combined Yeasts and Molds Count
  • equal to number of cfu found using Sabouraud Dextrose Agar
  • if colonies of bacteria are apparent, they are counted and included in TYMC

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More information about this test can be viewed at the following other locations:
-U.S. Pharmacopeia (Chapter <61> PDF)
-The Harmonization of the Microbial Limits Test - Enumeration by Scott Sutton, Ph.D.
-USP Updates <61> and <62> for Microbial Testing of Non-Steriles

  • The United States Pharmacopeia (USP) has significantly changed the USP XXXI <61> Microbial Limits Test, updating it and dividing it into two parts


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Last Updated: 5/18/12

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