New Medium for Pharmaceutical Media Fill Trials
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Microbiology specialists, Thermo Scientific Limited, have launched gamma-irradiated, Cold Filterable Tryptone Soya Broth (CM1065) - a highly nutritious general purpose medium which is ideal for microbiological Media Fill Trials (MFT) in the pharmaceutical industry.
Dehydrated Cold Filterable Tryptone Soya Broth (TSB) can be substituted for the powdered components that go into making aqueous drug products. After carrying out MFT, including the filter-sterilisation process, the medium is incubated for the recovery of contaminating bacteria, yeasts and moulds1. This provides an index of the level of microbiological contamination occurring in aseptic manufacture and can be used to identify problems in contamination control.
The components of Thermo Scientific Cold Filterable TSB have been specially screened and selected to ensure a highly filterable solution. Each batch will have a known Vcap (minimum 2,800 litres/m2) tested using three different filter types (0.2mm pore size): PVDF, PES and nylon. This allows the maximum filterable volume to be calculated before starting a MFT.
Thermo Scientific Cold Filterable TSB 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.
Gamma-irradiation of the medium ensures that it is free from all yeasts, moulds and bacteria, including bacterial spores and mycoplasmas, prior to use.
The Thermo Scientific Cold Filterable TSB formulation conforms to that stated for MFT in the European2, British3, US4 and Japanese5 Pharmacopoeias.
1. Thermo Scientific Manual 8th Edition, 1998, p2-208.
2. European Pharmacopoeia 4th Edition 2002.
3. British Pharmacopoeia 2003.
4. US pharmacopoeia 27 NF22 2004.
5. Japanese Pharmacopoeia XIV 2001.
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