Carry out microbiological Media Fill Trials (MFT) in the pharmaceutical industry with gamma-irradiated Thermo Scientific™ Oxoid™ Cold Filterable Vegetable Peptone Broth (Dehydrated). The highly nutritious general purpose medium conforms to the formulation stated for MFT in the European1, British2, US3 and Japanese4 Pharmacopoeias.
Cold Filterable Vegetable Peptone Broth can be substituted for the powdered components that go into making aqueous drug products to provide an index of the level of microbial contamination occurring in aseptic manufacture.
‘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.
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
Not all products are available for sale in all territories. Please inquire.
Remel™ and Oxoid™ products are now part of the Thermo Scientific brand
1. European Pharmacopoeia 4th Edition 2002
2. British Pharmacopoeia 2003
3. US Pharmacopoeia 27 NF22 2004
4. Japanese Pharmacopoeia XIV 2001
5. Microbiological Media Fills Explained by Nigel Halls, 2002. Sue Horwood Publishing Ltd., UK.