Microbial Ingress Through Breaches in Aseptic Manufacturing Systems: Experimental Investigation of Pressure-driven Leaks of Gases | IVT

The results indicate that microbial ingress did not occur under these extreme conditions. This indicates that a pressure-driven leak of a gas can provide an effective barrier against microbial ingress when the pressure drop across the breach (∆P) exceeds 0.03 psi. This observation is attributed to the fact that when ∆P exceeds 0.03 psi, the outward velocity of the air at the sterile boundary— which was estimated to be over 15 m/s—greatly exceeds the net translational velocity of an aerosolized microbe.  The results of this investigation can be used to perform risk assessment analyses...