Oxoid™ Cold Filterable Tryptone Soya Broth (TSB) is a gamma-irradiated, dehydrated medium developed for microbiological Media Fill Trials (MFT) in the pharmaceutical industry. This highly nutritious, general-purpose medium conforms to formulations specified in the European, British, United States and Japanese Pharmacopoeias.
Designed for aseptic process simulation, it can be used in place of powdered components in aqueous drug production to help assess potential microbial contamination during manufacture. It is particularly suited to processes involving heat-sensitive products, where sterilisation by filtration and aseptic filling is required.
The medium is sterilised using a validated gamma irradiation dose (minimum 25 kGy), ensuring it is free from yeasts, moulds, bacteria, bacterial spores and mycoplasma prior to use. It is also carefully selected to provide excellent filterability with a known Vcap value, allowing the maximum filterable volume to be determined in advance.
Following processing, the medium is incubated and evaluated to determine contamination levels, supporting assessment of aseptic manufacturing performance. It may also be used in testing aseptic processes for solid dosage forms through sterile addition after processing.
Oxoid™ Cold Filterable Tryptone Soya Broth (TSB) is a gamma-irradiated, dehydrated medium developed for microbiological Media Fill Trials (MFT) in the pharmaceutical industry. This highly nutritious, general-purpose medium conforms to formulations specified in the European, British, United States and Japanese Pharmacopoeias.
Designed for aseptic process simulation, it can be used in place of powdered components in aqueous drug production to help assess potential microbial contamination during manufacture. It is particularly suited to processes involving heat-sensitive products, where sterilisation by filtration and aseptic filling is required.
The medium is sterilised using a validated gamma irradiation dose (minimum 25 kGy), ensuring it is free from yeasts, moulds, bacteria, bacterial spores and mycoplasma prior to use. It is also carefully selected to provide excellent filterability with a known Vcap value, allowing the maximum filterable volume to be determined in advance.
Following processing, the medium is incubated and evaluated to determine contamination levels, supporting assessment of aseptic manufacturing performance. It may also be used in testing aseptic processes for solid dosage forms through sterile addition after processing.
