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The release of the new Annex 1 has been highly prepared for the last two years. One of the question rosen was "how further and what is still missing in the contamination control for aseptic processing?". Based on this question we started to analyze issues and challenges received by customer/projects. What we did find out was that bellows similarly to the gloves are one of the weak points in the integrity of the Grade A barrier and would therefore deserve a special focus. The presentation will present the journey of an innovation, currently under international patenting path, to implement an automatic leak testing of the boothings (bellows) particularly interesting when automatic machines and isolator technology are used.
