Speedy Glove is a battery-powered glove tester that performs leak testing on gloves installed on isolators or RABS where a strict separation between the isolated area and the external environment is required. The system performs pressure decay integrity tests that comply with the requirements of ISO 14644-7 Annex E.5.
Speedy Glove is suitable for all isolators equipped with glove flange such as those dedicated to aseptic processes, containment processes, the manipulation of API and HAPI and the manipulation of radiopharmaceuticals. Speedy Glove is compatible with all currently available glove flanges on the market.
The system boasts a number of peculiar and patented characteristics which make the Speedy Glove unique on the market in terms of performance and flexibility. There is, in fact, a unique system of rapid inflation of the glove that fills it with air in a few seconds during the leak test, saving between 3 and 5 minutes each test (approximately 30% of the total time) compared to the times usually required by similar devices on the market. It does not need to be connected to pneumatic circuits or compressed air tanks but can independently manage all the phases of the glove integrity testing process.
For the first time on the market the concept of “over-port” test is introduced in parallel with the classic “in-port” test that makes possible testing not only of the integrity of the glove but also of the entire mounting flange on which the glove is connected.
The system is also compatible with vaporised hydrogen peroxide, hence meaning it can be completely decontaminated. This important feature, together with the extremely compact dimensions, means it can be introduced through a pre-chamber into the isolator on the gloves to be tested. Once inside it is possible, with appropriate flanges arranged as in the Comecer isolators, to activate a glove testing process that inflates the glove from the inside outwards.
In the case, in fact, of critical processes to avoid breaking the class of isolator during the test it is possible to perform this test in reverse conditions compared to the classical approach, that is by inflating the glove inwards. To avoid fluctuations of pressures that could return false negatives or false positives, the isolator in fact in traditional tests of gloves is deactivated by turning off the ventilation and by normalising the pressure towards the environment. The Speedy Glove system offers the possibility of avoiding this temporary block of the isolator operation both through any test from the inside and through the real-time monitoring of the isolator pressure (if connected with Comecer machines) able to compensate for the effect of statistical fluctuation of the internal pressure thus avoiding false alarms.