Leak tester for the pharmaceutical industry GloveXpert

for laboratory isolatorsfor glovesdifferential pressure decay

GloveXpert is the new patented wireless glove leak tester from FPS Pharma, designed to eliminate the risk of false positives and false negatives. Engineered to meet the stringent requirements of pharmaceutical environments, including aseptic and toxic processing, it ensures full compliance with industry regulations and guidelines while delivering exceptional ease of use and precision. This innovative glove integrity tester for isolators and RABS requires NO operator calibration, thanks to advanced pressure sensors, and features an integrated RFID reader for enhanced functionality. GloveXpert performs reliable and repeatable leak tests using the positive pressure decay method, accurately assessing the integrity of both gloves and glove ports. Seamlessly integrating with RFID systems, it provides comprehensive test traceability. GloveXpert simplifies data management and, thanks to the integrated WI-FI, enables smooth communication with existing infrastructure, such as SCADA systems or others. GloveXpert ensures full compliance with: • FDA 21 CFR part 11 • EU Annex 11 • GAMP 5 • Guidelines and Annex 1 of the GMP • ISO 14644-7 Annex E.5 Key Benefits: • 1st to check 100% of the glove and glove port • NO calibration required • NO risk of false positives or negatives • Test time: 4–9 minutes • 120 test cycles on a single charge. • Full recharge in just 4 hours • Detects holes as small as 100 microns Unique Design: • Intuitive interface • Screen-free to eliminate display-related issues • Ergonomic and user-friendly • Lightweight: less than 4 kg • Efficient component integration • Durable, wear-resistant materials • Shockproof coating for maximum robustness