The most substantial novelty concerns the definition of the time intervals within which the glove test must be performed, thus defining an aspect that until now was at the discretion of the manufacturer. This newly published revision fills precisely this gap, specifying that, as far as isolators are concerned, glove testing must be performed at defined intervals, at least at the beginning and end of each production batch.

The choice of the right glove integrity testing equipment is a key aspect within the manufacturing process. As it “demonstrated to be suitable for the task and criticality”, as the revised Annex 1 states, there are also some technical and usage characteristics that should not be underestimated, with reference to the new regulatory framework.