Part of Thermo Fisher Scientific
27 May 2004
NEW MEDIUM FOR PHARMACEUTICAL MEDIA FILL TRIALS
Microbiology specialists, Oxoid 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 Oxoid Cold Filterable TSB have been specially screened and selected to ensure a highly filterable solution. Each batch will have a known V cap (minimum 2,800 litres/m2 ) tested using three different filter types (0.2 µm pore size): PVDF, PES and nylon. This allows the maximum filterable volume to be calculated before starting a MFT.
Oxoid 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 Oxoid Cold Filterable TSB formulation conforms to that stated for MFT in the European2, British3, US4 and Japanese5 Pharmacopoeias.