Media Fill Test
MFT
We assist you in carrying out your Media Fill Test and defining your MFT strategy
Aseptic process simulation (APS) is the ultimate step in verifying that an aseptic process is capable of producing a sterile product. APS programs are mandatory for aseptic processes, but can also be used to test asepsis for axenic processes such as viral culture or fermentation.
The aseptic filling step is the most critical because the product is exposed to the environment with a high risk of microbiological contamination. The use of a media (media) to perform this test (Media Fill Test) has been a well-established practice in the pharmaceutical industry for decades.
Although regulatory requirements require this verification, the manner in which MFTs are conducted remains a subject always open to debate. There is indeed little information in the regulations on how to prepare, carry out and conclude an MFT exercise. The assessment of the quality of an MFT program is therefore subjective and based on the judgment of the people involved, which may give rise to comments during regulatory inspections.
It is imperative to define the conduct of MFTs by surrounding themselves with people who are experts in these fields with broad experience in industry feedback. Placing MFT programs at the top of current industry practices maximizes the chances of success, especially during regulatory inspections.
