‘Sterile for use’ liquid drugs often contain heat-sensitive components which means that terminal sterilization by autoclaving is not an option. Sterilization by filtering (for soluble liquids) followed by filling under aseptic conditions is the method for preparation of these types of drug. The purpose of the Media Fill Trials is to provide a measure of the likelihood of microbiological contamination arising in a particular aseptic process.

Packs of Cold Filterable Vegetable Peptone Broth have been given a sterilizing dose of gamma-irradiation (minimum 30KGy) 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, molds 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.

Aqueous liquid products that are required to be sterile but cannot be terminally sterilized due to the heat-sensitive nature of one or more component, may be produced by filtering-sterilizing the dissolved solution and maintaining sterility by filling and closing the product under aseptic conditions.

The purpose of MFT is to provide a measure of the likelihood of microbiological contamination occurring in a particular aseptic process. Cold Filterable Vegetable Peptone Broth 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 recovered⁵

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Remel™ and Oxoid™ products are now part of the Thermo Scientific brand