Validation of Sterilizing Grade Filters - ASQ Long Island Section
Validation of Sterilizing Grade Filters - ASQ Long Island Section
Validation of Sterilizing Grade Filters - ASQ Long Island Section
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Integrity Test CorrelationDestructive MethodsFor producers; applied todetermined limits:Bacteria-Challenge-Test(according to ASTM)Non-Destructive MethodsFor users; applied to everysterilizing filter before andafter each filtration:• Bubble Point Test• Diffusion Test• Multipoint Diffusion Test• Pressure Decay Test• Water Intrusion Test (WIT)Direct correlation <strong>of</strong> diffusion,bubble point, and intrusion-limitvalues to bacteria-challenge test.36
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