Bioburden Testing


Reliable Bioburden Testing for Safer Final Products

Bioburden 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

The Need for Bioburden Testing

Bioburden 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.

Milliflex® Quantum Application Note

Application Note
Milliflex® Quantum

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Culture Media for Bioburden Testing

Culture Media
for Bioburden Testing

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May 31
31/05/15 - 02/06/15
American Society for Microbiology (ASM)
New Orleans Ernest N. Morial Convention Center
New Orleans, LA, USA
Water Purification,Reagents Chemicals and Labware,Life Science Research,Industrial Biomonitoring,IVD/OEM Materials and Reagents,Analytics and Sample Preparation North America 20150531
Jun 06
06/06/15 - 09/06/15
IACP Compounders on Capitol Hill
Renaissance Washington DC
Washington, DC, USA
Industrial Biomonitoring North America 20150606
Jun 09
09/06/15 - 10/06/15
PDA Aseptic Processing – Sterilization Conference
Loews Coronado Bay
San Diego, CA, USA
Industrial Biomonitoring,Biopharmaceutical Manufacturing North America 20150609
Jun 07
07/06/15 - 10/06/15
Anaheim Convention Center
Anaheim, CA, USA
Reagents Chemicals and Labware,Analytics and Sample Preparation North America 20150607
Jun 10
10/06/15 - 12/06/15
Palacongressi Della Riviera | Ingresso B | Via della Fiera, 23
Rimini (Italia), Italy
Water Purification,Small Molecule Pharmaceuticals,Reagents Chemicals and Labware,Life Science Research,Industrial Biomonitoring,IVD/OEM Materials and Reagents,Biopharmaceutical Manufacturing,Analytics and Sample Preparation Europe 20150610