Tryptone Soya Broth (TSB), Cold-Filterable, Syrup

Enrichment and sterility test medium suitable for media fill trials in the pharmaceutical industry.

• Gamma-irradiated dehydrated medium to ensure that the medium is free from all yeasts, moulds, and bacteria, including bacterial spores and mycoplasmas, prior to use.
• Screened and selected dehydrated medium to ensure a highly filterable solution.

‘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.

Pre-Poured Cold Filterable TSB from SGL IS a convenient ready to use product, manufactured and tested in accordance with Pharmacopeia standards, which 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