Bioburden Testing

 
 

Reliable Bioburden Testing for Increased
Product Safety


Ready-to-Use Culture Media for Testing Non-Sterile Products, Raw Materials and Water

For bioburden testing (including microbial limit testing) of non-sterile raw materials, water and finished products, MilliporeSigma provides all the culture media required to detect viable aerobic microorganisms. The ready–to-use solid and liquid media are prepared according to the corresponding, harmonized standards of the European, US and Japanese Pharmacopeias.

For the microbial enumeration test TAMC (total aerobic microbial count), MilliporeSigma provides the recommended culture media based on casein soy bean digest, such as tryptic soy agar (TSA), while for TYMC (total yeast/mold count), culture media based on Sabouraud dextrose (e.g. SDA) are available. Specialized culture media are available for the detection of specified aerobic microorganisms (test for specified microorganisms.

  • Solid culture media
    • 90 mm LI (Long Incubation) plates for the determination of the total cell count and for the tests for specified microorganisms
    • 90 mm standard plates to determine the total cell count in bottles and tubes for the pour plate method and for maintenance of stock cultures
  • Liquid media in a selection of bottles and tubes for enrichment cultures
  • NaCl-Peptone buffers

For the complete MilliporeSigma product range of dehydrated and ready-to-use culture media, proven filtration equipment and alternative rapid solutions, please see also:
 

Bioburden Testing

Bioburden Testing

Our bioburden testing range covers rapid testing solutions, filtration devices, culture media and comprehensive services.

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About Bioburden Testing

Bioburden testing is used to determine the number of viable aerobic microorganisms in finished products or raw materials which have not been sterilized. Bioburden testing consists of two parts: 1. Determination of the total number of aerobic microorganisms as well as the total yeast and mold count (microbial enumeration) 2. the test for specified microorganisms is designed to determine the presence or absence of specific microorganisms.

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

Click here to see all ready-to-use media products for bioburden testing

 
 
Culture Media for Testing Non-Sterile Pharmaceuticals Brochure

Brochure
Culture Media for Testing
Non-Sterile Pharmaceuticals


Download Here

Events

Feb 06
02/06/18 - 02/08/18
LOUNGES 2018
Arena, Messe Karlsruhe
Karlsruhe, Germany
Industrial Biomonitoring Europe 20180206
Mar 15
03/15/18 - 03/16/18
LABORAMA Expo 2018
Brussels Kart Expo, Groot-Bijgaarden
Brussels, Belgium
,Reagents Chemicals and Labware,Industrial Biomonitoring,Analytics and Sample Preparation Europe 20180315
Apr 10
04/10/18 - 04/13/18
Analytica 2018
Messe München
Munich, Germany
Industrial Biomonitoring,,Life Science Research,Biopharmaceutical Manufacturing,Analytics and Sample Preparation Europe 20180410