Danger of infection: WHO increases risk category for milk
TSB of non animal origin from Merck Millipore can replace bovine culture media.
The culture medium TSB (tryptic soy broth) is vital for microbiological quality control. Because of its high nutrient content, it supports the growth of a large number of microorganisms. Classic TSB, however, contains casein peptone, a protein from milk. Around two years ago, BSE pathogens were detected in milk for the first time. In 2010, the World Health Organization therefore rescinded the “lowest” category for milk and classified it as a substance at a medium level of infectivity. The EU and other countries are yet to react in law. However, with TSB of non animal origin, Merck Millipore is already offering an alternative – in particular for the pharmaceuticals industry, which is set to be particularly affected by any new EU regulation.
Validation: media fills without risk of contamination
Pharmaceuticals manufacturers have to document their aseptic production conditions regularly. To do so, they use so-called media fills. Here, culture media replace the pharmaceutical product usually filled. They run through the entire process and can then be tested for microbiological contamination. TSB non animal origin eliminates the possibility of contamination of the plants being tested from pathogens which can be transmitted through casein peptone. That means that pharmaceutical companies are already on the safe side.
Quality in accordance with international standards
All Merck Millipore culture media comply with the requirements in the Note for Guidance (EMEA/410/01 Rev. 02), which minimizes the risk of infection from animal spongiform encephalopathy via pharmaceutical products. In addition, they meet the strict USDA standards and – if containing TSB of bovine origin – already comply with the future EU Directive on minimizing the risk of BSE, which could emanate from these products. Furthermore, Merck Millipore sources its bovine ingredients exclusively from countries which are classified by the EU as low-risk in relation to BSE/TSE.
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