Experience with Artificial Leaks and Dye Ingress Container Closure Integrity Testing (CCIT)

Experience with Artificial Leaks and Dye Ingress Container Closure Integrity Testing (CCIT)
•Void, gap, crack, hole, porosity or breach in a container closure system allowing the passage of microorganisms
•Main factor that affects critical leak size is whether or not the micro-leak is filled with liquid: microorganisms penetrate a liquid filled defect by motility or pressure differentials
•Still a lot of controversy discussions about the leak size at which the sterility may be jeopardized
–10 μm for fused silica capillary (Burrel, 2000)
–50 μm for channel leaks (Yam, K. 1995)
–0.4 μm Glass Micro-Pipettes (Kirsch, 1997)
–4 μm pinhole in steel plate (Morrical, 2007)
–20 μm OD Wire (Morrical, 2007)