Glove leak tester AGLTS 2

for laboratory isolatorscompactautomatic

AGLTS 2 is the brand new fully automatic GMP compliant glove integrity testing system for isolators and RABS in the pharmaceutical industry, developed referring to the Positive Pressure Decay Method which follows the international standard ISO 14644-7 Annex E.5. A new generation device way beyond the mere execution of glove testing, supporting the operators and pharmaceutical companies in the management of all glove testing related operations. 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. With the increase in the number of tests depending on production batches, it is even more crucial to avoid the risk of running into both false positives and false negatives as much as possible. There is no doubt that speed during testing plays a key role in not slowing down the production cycle. But this is not the only parameter to be taken into account: instrument set-up times are also important and can play a key role in streamlining the procedure.