Media Mikro Gamma Irradated TSB 500 gr, Oxoid CM1016

Gamma-Irradiated TSB is particularly suitable for sterility testing and for the validation of aseptic 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 sterile powder, such as Gamma-Irradiated TSB. The medium is subjected to exactly the same conditions as the product, including filling and closing, to ensure that there is no microbial 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 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.
Gamma-Irradiated TSB is treated at an irradiation level of 40 kGy, as recommended by Annex B of the ISO 11137 Standard1 to ensure the absence of viable vegetative cells and bacterial spores whilst 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 fertility of the medium2.
The formulation of the medium conforms to a range of recognised standards; British Pharmacopoeia Volume II 2000 + Amendment No.1, United States Pharmacopoeia 24 NF19 + 3rd Supplement, European Pharmacopoeia 3rd Edition 2000 + Supplement 2001, Japanese Pharmacopoeia 12th Edition + Supplement II JP XIII.