Reliable Bioburden Testing for Increased
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.
For the complete MilliporeSigma product range of dehydrated and ready-to-use culture media, proven filtration equipment and alternative rapid solutions, please see also:
Our bioburden testing range covers rapid testing solutions, filtration devices, culture media and comprehensive services.
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.
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