Oxoid media for process validation
that is designed for use in media fill trials in the pharmaceutical
Media fill trials are a method for evaluating an aseptic process using a microbial growth medium. Media fills are simulations in which a production process is run substituting the usual product for the media, which can then be incubated to see if any contamination has occurred.
The media is available as a liquid or a dehydrated broth that 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 moulds.
"This provides an index of the level of microbiological contamination occurring in aseptic manufacture and can be used to identify problems in contamination control," said Oxoid.
The media 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.
European regulations demand that any aseptic process used in the production of a medicinal product should be validated using a media fill trial. The process simulation test should imitate as closely as possible the routine aseptic manufacturing process and include all the critical subsequent manufacturing steps.