WirelessGT

Traceable and validated glove testing for different glove ports

The most reliable glove tester for pharmaceutical isolators

Fully automated workflow

Automated glove test from connection through documentation
Fast test cycles

Inflation times of less than 30 seconds and optimized pressure control reduce downtime
Precise leak detection

Reliable detection of pinholes up to 100 µm using validated test recipes
Wireless operation

Wireless data transfer and an integrated battery for maximum flexibility
Network capability

Up to 48 devices can be centrally managed and operated in parallel
Validated software

Audit trail and functions supporting 21 CFR Part 11; developed in accordance with GAMP 5 category 3
Cleanroom-compatible

Hygienic design with IP54 protection for use in regulated production environments
Universal compatibility

Compatible with isolator and RABS systems from different manufacturers

For pharmaceutical isolators

WirelessGT is used for testing gloves in isolator systems. Pressure decay tests help ensure barrier integrity in aseptic production environments and are suitable for routine checks.
For RABS

In Restricted Access Barrier Systems (RABS), WirelessGT enables reproducible glove tests with validated parameters.

1

Port identification and installation

The test system connects wirelessly to the control software and identifies the glove port to be tested via RFID. The device is placed inside the glove port, and the seal is automatically inflated to ensure a secure test setup.
2

Test setup

The test program starts automatically and runs the predefined parameters. An integrated pump generates the specified test pressure.
3

Stabilization

The pressure is maintained over a defined period to account for temperature effects and material properties. This phase ensures reproducible measurement conditions.
4

Pressure decay measurement

During the measurement phase, the pressure is continuously monitored. At the end of the test cycle, the pressure drop is evaluated to determine whether it falls within the acceptable range.
5

Result documentation

After completion, the device is removed from the glove port and positioned on the next port. A report containing the results is then generated and securely stored. The data is available for audits and internal quality control.

Fast test cycles

Optimized inflation and measurement times reduce interruptions in the production process. The high testing speed supports efficient quality control in systems with many glove ports.
Centralized data management

OPC or SQL interfaces enable integration into existing IT infrastructures. Audit trails and signed reports ensure full traceability of all tests.
Easy handling

Smooth surfaces and a cleanroom-compatible housing facilitate cleaning and disinfection. The easy handling ensures smooth, reproducible processes.

ISO-compliant pressure testing

The measurement method is based on pressure-decay testing in accordance with ISO 10648-2. This enables standardized assessment of glove integrity in regulated production areas.
Software compliance

The software ensures compliance with 21 CFR Part 11, including audit trails, user management, and access control via Active Directory.
Cleanroom suitability

The hygienic enclosure with IP54 protection is suitable for Grade B, C and D.

Extended documentation

Specifications (e.g. functional, mechanical, software design), P&ID, etc.
Trolleys

Available in various sizes
Cleanroom tablet

For mobile access to glove tester software

Leaks with diameters of 100 µm and above are detected.
Up to 48 units can be managed wirelessly as a standalone network and operated simultaneously.
Yes. The technial unit is standardized, and the test disc is adapted to the respective glove-port design.
We support on-site Installation Qualification (IQ) and Operational Qualification (OQ), provide operator training, develop test parameters and qualify them on-site.