Process challenge device for evaluation of contanimation forming and removal process inside of hollow channels and methods for contanimation evaluation

摘要

A process challenge device and method for evaluating and removal processes inside of narrow and hollow channels comprising sample, capsule having an inlet connector, a flow shaping element and an internal cavity, a lock—or end cap—for each capsule securing the sample inside the cavity. The tag being located in the capsule against one of the walls of the internal cavity that is shaped not to change the parameters of the fluid flow while it flows into said cavity and over the face of the sample simulating the flow through an equivalent narrow channel. Methods characterised by said process challenge device being loaded with a matching sample containing contamination for evaluation of effectiveness of a cleaning processes or blank sample for evaluation of contamination formation processes on said sample.