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Non-Sterile Testing

SGS performs microbial enumeration and specified organisms testing according to procedures outlined in USP<61> and USP<62>.

USP <61> and USP <62> tests provide harmonization to the European Pharmacopeia methods (2.6.12 and 2.6.13), JP and BP for testing non-sterile pharmaceuticals. Microbial enumeration testing (MET) –also called bioburden testing, or total aerobic microbial count and yeast/mold count – may include assessment of the physical characteristics and inherent antimicrobial properties of the product performed during the suitability of the test method. We provide microbial enumeration testing on pharmaceutical articles of all types – from raw materials to finished forms.

Why choose microbial limits testing from SGS?

We provide:

  • Microbial enumeration and specified organisms testing according to USP<61> and USP<62> procedures
  • Guidance  to ensure appropriate testing is conducted on your specific products
  • Testing of total aerobic microbial count and yeast/mold count (bioburden) using a wide range of techniques
  • Testing for specified organisms

A World-leading Provider of Microbial Limits Testing

As a world leader in microbial limits testing, we offer you unrivaled experience in USP<61> and USP<62> testing procedures. We provide a wide range of methods for the testing of total aerobic microbial count and yeast/mold including:

  • Membrane filtration method
  • Standard plate count, including pour plate and spread plate methods
  • Most probable number

Tests for Specified Organisms

During testing of non-sterile products for specified microorganisms, direct transfer or membrane filtration methods are used, based on the nature of the product and results of the suitability of the test method established for each specific product. These tests are qualitative (presence/absence). Required tests are evaluated with consideration of product use, nature, route of administration, etc. Minimum requirements for acceptance criteria for pharmaceutical preparations and substances for the pharmaceutical use can be found in the USP <1111>. Please contact us for guidance on sampling and sending samples.

To discuss your microbial limits testing requirements, contact us today.


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