HI-5GT Aseptic Processing
Machine overview
A high-five to glove integrity
Wireless glove integrity tester for isolators & RABS.
A high-five to barrier integrity, designed to make glove integrity testing faster, safer and fully integrated into aseptic processing isolators and RABS. Isolator and RABS gloves are a critical interface between an operator and a Grade A environment. For this reason, glove integrity testing is no longer a stand-alone maintenance activity: it is a documented element of the Contamination Control Strategy and an operating prerequisite for batch release confidence.
HI-5 GT represents not only a device, but an ecosystem: tester units, charging bases, mobile trolley, verification tools, documentation and service routines.
Production plant
IMA Life Bologna
Machine highlights
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High-confidence integrity
a. Positive pressure-decay test principle.
b. 100 µm-equivalent leak detection target.
c. Calibrated reference leak philosophy for PQ. -
High-mobility operation
a. Battery-powered wireless device.
b. Inductive charging base and hygienic trolley concept.
c. No routine utilities connected during testing. -
Human-centric handling
a. Local display, status LEDs and physical start/lock buttons.
b. Ergonomic, left/right-handed usability.
c. Anti-drop safety systems. -
Harmonised integration
a. Central GT PLC and SCADA supervision integrated with isolators.
b. OPC UA-oriented communication and isolator interlocks.
c. Full 21 CFR Part 11 compliance. -
Hygienic validated lifecycle
a. Suitability for Grade B cleanrooms.
b. VPHP/IPA/disinfectant compatibility.
c. GAMP, CSV, FAT/SAT/IOQ/PQ support.
HI-5 GT Supervisor
The Supervisor Layer integrates glove testing with the isolator and production process, transforming individual tests into controlled GMP workflows and complete electronic records. Multiple glove testers can operate simultaneously on the same system, with each test automatically linked to the tester, glove-port RFID, operator, product recipe, production configuration and isolator operating mode.
