What is an MFT and how can I implement in my process?

In the pharmaceutical industry, ensuring the sterility of products is a critical aspect that requires special attention. Implementing effective practices to guarantee the integrity of sterile products during their manufacturing process is essential to meet the quality and safety standards required in the sector.

The Media Fill Test (MFT) has become a key tool for assessing the effectiveness of aseptic procedures used in the manufacturing process of sterile products. This method involves simulating the entire manufacturing process, replacing the real product with a sterile growth medium. By replicating real production conditions, the MFT allows verification of whether aseptic procedures are adequately implemented to prevent product contamination during regular manufacturing.

“Lastly but not least, what culture medium should I use?

The culture media can be obtained pre-prepared or prepared on-site and must naturally be sterile to avoid contaminating the aseptic production space. If preparing on-site, it is preferable to use an autoclave for sterilization, as filtration is not recommended.

The most commonly used culture medium is Soybean Casein Digest Medium (TSB), although other general media like Vegetable TSB or Thioglycollate Liquid Medium can also be utilized.

Culture media should undergo quality and sterility controls and allow for the selective growth of aerobic microorganisms such as Staphylococcus aureus, Bacillus subtilis, or Pseudomonas aeruginosa.

It is necessary to confirm through a growth promotion test, among other tests, that the media meets specifications and complies with its respective certificate of analysis. The growth promotion test confirms the medium’s ability to support the growth of the target microorganisms.”

The USP 71, a reference in pharmaceutical standards, recommends specific conditions during the execution of the Media Fill Test. It states that aerobic conditions should be maintained between 20°C and 25°C to ensure process effectiveness. However, it is acknowledged that a wider temperature range, between 20°C and 35°C, can also work, as long as it is precisely controlled within a margin of +/- 2.5°C. These details should be clearly specified in the procedure to ensure reliable and accurate results.

At Asiagel, we understand the importance of maintaining high-quality standards in the sterility of pharmaceutical products. Our products and solutions are designed to support your Media Fill Test processes efficiently and safely.

Feel free to contact us for more information on how we can collaborate to meet the requirements and regulations of the pharmaceutical industry.