Description
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‘Sterile for use’ liquid drugs often contain heat-sensitive components which means that terminal sterilisation by autoclaving is not an option. Sterilisation by filtering (for soluble liquids) followed by filling under aseptic conditions is the method for preparation of these types of drug. The purpose of Media Fill Trials is to provide a measure of the likelihood of microbiological contamination arising in a particular aseptic process. Packs of Cold Filterable Tryptone Soya Broth have been given a sterilizing dose of gamma-irradiation (minimum 25KGy) validated as a lethal dose for all yeasts, molds, bacterial spores and mycoplasma.
• Gamma-irradiated to ensure that the medium is free from all yeasts, moulds, and bacteria, including bacterial spores and mycoplasmas, prior to use.
• Screened and selected to ensure a highly filterable solution that has a known Vcap value. This allows the maximum filterable volume to be calculated before starting a MFT. The purpose of MFT is to provide a measure of the likelihood of microbiological contamination occurring in a particular aseptic process. Cold Filterable TSB can be used as a substitute for filter-sterilized drug products and is processed in a manner identical to that in which the product would be processed i.e. filtering, filling and closing. The medium is then incubated and the number of contaminated units is scored versus those that are un-contaminated. A decision following pre-determined guidelines can be made based on the proportion of contaminated units and the identity of the microorganisms recovered^5. Cold Filterable Tryptone Soya Broth may also be used to test aseptic production processes for solid presentations by adding the medium as a sterile liquid downstream of processing a placebo^5. For laboratory use, standard Thermo Scientific™ Oxoid™ Tryptone Soya Broth (CM0129) may be more appropriate. Not all products are available for sale in all territories. Please inquire. Remel™ and Oxoid™ products are now part of the Thermo Scientific brand
