Extras Isolator technology
Glove testing system
The isolator glove is exposed to high mechanical stresses and therefore has a particularly high risk potential for damaged areas. GMP guidelines for sterile production prescribe regular testing of the gloves.
By using the software-supported glove testing system, you can quickly and efficiently test the built-in gloves of your pharmaceutical equipment directly in the isolator or cRABS with the help of a pressure decay test.
The data and results are transmitted via WiFi, stored in a database and are available locally for review and documentation purposes. All necessary tests can be performed centrally and simultaneously.
Features
WiFi interface
for software-supported and wireless glove testing with GITS® software
Simultaneous and parallel testing
of more than 35 gloves for time-saving glove inspections
Reliable detection
of holes smaller than 100 μm while maintaining short measurement times
Fast testing of glove integrity
Depending on glove material, in only 8-15 minutes total test time
Simple in-situ testing inside the isolator or RABS
No risk to glove integrity due to glove on and off or incorrect handling
Mobile and flexible system
High mobility due to compact size and wireless operating principle
Individually configurable
Adapts to individual requirements in terms of size, contour, shape and material
Suitable for clean rooms
IP64-certified and equipped with easily replaceable 0.3-μm filter for drawn-in air
Easy cleaning and sterilization
Due to surface design with minimal grooves and edges
Digital display
Pressure indication, battery status, measurement information and result are easily visible on the digital display
Intuitive operation
thanks to simple two-button system
cGMP-compliant testing
Verification of glove integrity according to GMP guidelines
Customizable measurement reports
with option for automatic printing or digital storage
Long operating time
for validation of the entire device without interruptions due to charging time or battery changes
Automatic fixation and sealing of the glove port
Electronic control via pneumatically filled rubber seal
Slim and ergonomic design
2.5 cm housing diameter for manual initial filling or 5 cm housing diameter for automatic glove filling
Advanced functions
Automatic glove filling
with integrated glove filling pump, no additional air pressure connection necessary
alternatively: manual initial filling via filling valve integrated in the handle
Port and glove recognition
automatic machine validation and glove life cycle tracking via integrated RFID technology
Port recognition software
reliable traceability of glove testing, especially useful for large isolators or RABS;
automatic assignment of measured data to a position of a glove shoulder ring in the measurement report and on the screen;
fully automatic machine validation
Glove recognition software
Monitoring of the glove holding process;
possibility to predict a possible defect of the gloves;
automatic tracking of the "lifetime" of the glove
Battery
easily replaceable, available as external or internal battery
Selected accessories
- Glove filling gun or portable pharmaceutical pump
- Transport and storage cart
- Single charger or 5-port charger
- Gloves (CSM, EPDM, ISOflex and more)
- Glove ports
Our service
- Custom glove testing parameters
- Qualification services (IQ, OQ and more)
- Regular service and maintenance of glove testers and accessories
- WiFi site analysis and WiFi installation planning