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Microbiological test that evaluates the ability of aseptic manufacturing personnel to prevent contamination during drug production.
The test uses a sterile microbiological growth medium, such as Triptic Soy Broth (TSB), to assess the technique and competency of personnel to perform tasks such as filling, transferring, and handling without contaminating the material.
The test is performed when a new filling line or product container is introduced to an aseptic process.
The pH of the medium can be adjusted to the filling line criteria (as low as pH 4.1), allowing the growth of fungi and bacteria that are adapted to grow under highly acidic conditions.
Media for media filling test
Culture media used in media fill tests should support the growth of a wide variety of microorganisms, including aerobic bacteria, yeast, and mold (non-selective medium). Soybean casein digest medium (SCDM), also known as tryptone soya broth (TSB), is the most common medium used in pharma media fill tests due to its low selectivity, growth-promoting properties, high solubility, and media clarity.
Media fill tests are also accompanied by surface and air monitoring in the critical production area.
Incubation condition for media filling test
Media-filled containers are incubated at two temperatures – the initial incubation at 20–25 °C for 7 days, and then at 30–35 °C for 7 days.
This two-stage process provides an opportunity for fungal growth, before the plates are overwhelmed by bacterial growth.
Media fill test failure investigation is mandatory in sterile pharmaceutical manufacturing. It should be done to determine the root cause of the failure.
