GMP ANNEX 1 – FEW COMMENTS ABOUT MICROBIOLOGY ENVIRONMENTAL MONITORING OF AIR IN CLEANROOM

ORUM International, the Italian Company specialist in microbial environmental monitoring, has presented a new impartial investigation about the effect of continuous monitoring on agar culture plates of different international producers.

The comparative investigation of 90 mm agar plate from four different media supplier had the scope to see which is the maximum volume of air to aspirate from an air sampler without lose the fertility. In fact the impact of air on the agar surface produces the dehydration with consequent difficult for the growth of microorganisms.

The study report concludes that the ideal volume of agar medium in a 90 mm Petri dish should be at least 30 ml and the total volume of aspirated air should be 4.500 litres (for 3 hours of continuous working time).

This specific investigation, requested by the new GMP Annex 1 2022 edition, should be executed by all the pharmaceutical companies during their QRA and the related SOP with protocol of the test is available from ORUM International.