Bioburden Testing

 

Reliable Bioburden Testing

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for safe final products

Bioburden testing (microbial limit testing) has become a challenge in fields such as municipal water, food & beverage, clinical, cosmetics and pharmaceuticals. At Merck Millipore, we provide complete bioburden testing solutions that include services into which we bring our technological and regulatory expertise. These microbiological solutions are based on a comprehensive range of state-of-the art products and services:

  • Proven filtration equipment and devices based on 50 years of expertise in membrane manufacturing
  • Broad selection of dehydrated and ready to use culture media covering all bioburden applications across all industries, backed by decades of experience in microbiology
  • Rapid bioburden testing platforms that dramatically reduce time to result and enable fast corrective actions
  • Validation and maintenance services to facilitate the implementation of our products and set efficient test procedures for specific samples and applications

To find out more about Merck Millipore’s product range for bioburden (microbial limit) testing in a specific industry or work environment, click the appropriate link:

Bioburden Testing for Food & Beverage 
Bioburden Testing for Pharmaceutical & Cosmetics
Bioburden Testing for Municipal & Environmental Water 


The need for Bioburden Testing

Bioburden testing (also known as microbial limit testing) determines the number of viable aerobic microorganisms that live on or in end products or raw materials which have not been sterilized. Bioburden testing is conducted in two parts: In the first, quantitative phase (microbial enumeration), the total number of aerobic microorganisms as well as the total yeast and mold count is determined. The second, qualitative phase (test for specified microorganisms) is designed to determine the presence or absence of specific microorganisms.

For quality control in manufacturing, bioburden testing of raw materials, water and end products has become a challenge. QC labs need to follow company guidelines which are driven by the stringent regulations of the pharmacopeias (Europe, US and Japan) while constantly optimizing laboratory workflow and delivering both reliable and consistent results. The relevant standards for the bioburden test (microbial limits test) have recently been harmonized for the US, Europe and Japan and are laid down in USP <61> and <62>, EP Chapter 2.6.12 and 2.6.13 and JP XV 1st Supplement, respectively.

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