Broth fills environmental contamination

During a more controlled study carried out within an environment artificially contaminated with high levels of individual nebulized spores of Bacillus subtilis [2], a level of contamination within the environment was achieved which led to the contamination of broth-filled units. The results were extrapolated to suggest a contamination rate of 1 unit in 4 X 10 with a smrounding environmental contamination of 1 cfu/ml... 

Por a new facility, some baekground environmental monitoring data are desirable. It is important that environmental monitoring data are obtained during the eourse of broth fill batches to demonstrate a normal level of environmental contamination. The validity of broth fills earried out in an environment of consistently lower contamination levels than those obtained during routine bateh manufacture eould be questioned. 

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See also in sourсe #XX -- [ ]

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