This specialist sterile medium is particularly suitable for sterility testing and for the validation of aseptic media filling procedures
Oxoid has announced the addition of gamma-irradiated tryptone soya broth (TSB) [CM1016] to its standard range of dehydrated culture media, making this specialist sterile medium more widely and easily available.
Oxoid gamma-irradiated TSB is particularly suitable for sterility testing and for the validation of aseptic media filling procedures.
In the media fill test (MFT), a validation method used to assess the performance of aseptic processing in the pharmaceutical industry, pharmaceutical products are substituted by a sterile powder, such as Oxoid gamma-irradiated TSB.
The medium is subject to exactly the same processing conditions as the product, including filling and closing, to ensure that there is no bacterial contamination occurring during the process.
The powder is readily soluble in sterile water, either as part of or at the end of the procedure, then incubated for detection of any organisms present.
The use of Oxoid gamma-irradiated TSB simplifies media preparation for MFTs and other applications, and is less time consuming, since it eliminates the need for in-house media sterilisation prior to use.
Oxoid treat gamma-irradiated TSB at a level of 40kGy, as recommended by Annex B of ISO 11137, to ensure the absence of viable vegetative cells and bacterial spores while achieving minimal reduction in performance.
Quality control testing is carried out before and after irradiation to carefully monitor performance and to check the sterility of the final product. Gamma-irradiation at higher levels, as used by some manufacturers, has been shown to reduce the fertility of the medium.
Oxoid gamma-irradiated TSB is available in 500g (CM1016B), 2.5kg (CM1016R) and 5kg (CM1016T) packs.
