Monitoring air quality is important for any facility to ensure sterility of pharmaceutical products and overall cleanliness. With Annex 1 guidelines for manufacture of sterile products requiring air to be sampled over the duration of manufacturing runs, this detailed evaluation of the MAS-100 NT air sampler for microbial air monitoring establishes performance capability with Growth Direct® System environmental monitoring cassettes.
Testing reveals that organism recovery on Rapid Micro Biosystems media is equivalent to traditional contact and Petri plate media after exposure to the same speed of dehydration. Recovery was seen to be equivalent to the compendial method for all tests and the 0.45-micron pore size, establishing the compatibility of the MAS-100 NT air sampler.
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