03 Challenge organism viability assessment Challenge organism selection criteria Historically, Brevundimonas diminuta has been used to rate sterilizing grade filters at a concentration in excess of 107 organisms per cm2 of effective filter area (EFA) with testing carried out following current revision of ASTM F838 test methodology. It is important to determine if the standard challenge organism is viable in the process fluid for the exposure time required, simulating the expected period of filter use. As per ISO13485, where organisms are non-viable, alternative organisms or surrogate process fluids may be recommended. In bactericidal fluids, active ingredients may be removed to simulate process conditions or an inert carrier can be substituted. Testing is carried out by our Laboratory Support Group in our dedicated bio-containment facility. We inoculate your product and assess challenge organism viability over a designated time period. Naturally occurring bioburden can also be isolated and identified at this stage. Determining the organism for your bacterial challenge Verify whether the standard challenge organism is viable and if not determine an alternative organism or surrogate process fluid.
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