The purpose of MFT is to provide a measure of the likelihood of microbiological contamination occurring in a particular aseptic process. Packs of Cold Filterable TSB have been given a sterilising dose of gamma-irradiation (minimum 25KGy) validated as a lethal dose for all yeasts, moulds and bacteria including bacterial spores and mycoplasmas.Īqueous liquid products that are required to be sterile but cannot be terminally sterilised due to the heat-sensitive nature of one or more component, may be produced by filtering-sterilising the dissolved solution and maintaining sterility by filling and closing the product under aseptic conditions. Each component of this medium has been specially screened and selected to give a highly filterable solution. The formulation of Cold Filterable TSB conforms to that stated in the European Pharmacopoeia 4th Edition 2002 2, the British Pharmacopoeia 2003 3, the US Pharmacopoeia 27 NF22 2004 4 and the Japanese Pharmacopoeia XIV 2001 5. Tryptone Soya Broth is highly nutritious, general purpose medium which can support the growth of a wide range of bacteria, yeasts and moulds when incubated under the appropriate conditions 1. Refer to the appropriate regulatory body for full guidelines 2,3,4,5. Micro-organisms from any contaminated units should be sub-cultured, purified and identified to species level. Visual inspection of the units should be carried out on a daily or every second day basis. Incubation of media fills is usually carried out for 14 days 6 at both 20-25☌ and 30-35☌. The medium may be made at this concentration and then sterilised by filtration or by autoclaving at 121☌ for 15 minutes. COLD FILTERABLE TRYPTONE SOYA BROTH (TSB)Ī gamma-irradiated, cold filterable Tryptone Soya Broth suitable for microbiological Media Fill Trials (MFT) for the pharmaceutical industry.ĭownload product literature on cold filterable Tryptone Soya Broth (192KB) in PDF format.Ĭold Filterable TSB should be used at a working dilution of 30g in 1 litre of distilled water (3% w/v).
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