A statistical model for evaluation of air microbes in pharmaceutical production areas. Group for the study of microbiology of the AFI

: In this study it has been proposed a statistic model to evaluate results concerning microbial count of the air obtained in areas of pharmaceutical production. Nowadays both official methods and agreement about limits of microbial count to use in production areas in which non sterile forms has been processed, are absent. The proposed statistic model foresees a processing data that admits a building of "Flow Charts". Two flow chart has been built: the "Mean Flow Chart" and the "Range Flow Chart". The "Mean Flow Chart" shows the data distribution around the mean value, the "Range Flow Chart" points out the data variation. In this way it has been established the process natural tolerance and the relative limits assumed by the variable in exam. If values of microbial count result of limit, the causes have to be investigated and it's necessary to take adequate countermeasures.