Microbial Limits Testing

For non-sterile products, we can perform microbial contamination testing using harmonised pharmacopoeial or client-supplied methods to determine the bioburden within the sample.

Microbial enumeration – Total Yeast and Mould Count (TYMC) and Total Aerobic Microbial Count (TAMC) analysis and tests for specified microorganisms are employed for this.

  • Determine compliance to compendial specifications for microbial quality (Ph. Eur/USP)
  • Quantitative testing – how many microorganisms are present
  • Qualitative testing – specifying which microorganisms are present
  • Apply pour plate and membrane filtration methods

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