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, Merck 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), Merck 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 Merck 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

 
 
Brochure sur les milieux de culture pour tester les produits pharmaceutiques non stériles

Brochure
Milieux de culture pour tester
les produits pharmaceutiques non stériles


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