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Glove testing system
Efficient and standardised leak testing for isolator gloves in accordance with GMP standards
FASTER
Description
Isolator gloves are essential interfaces between operator and product in closed systems such as isolators or cRABS (Restricted Access Barrier Systems). Due to their constant use, they are subject to a high risk of wear - particularly in the event of mechanical stress, repeated sterilisation and chemical contact. An intact glove is therefore a key element for personal, product and process protection. In accordance with international GMP guidelines, regular testing of glove integrity is mandatory. The software-supported glove testing system from FASTER provides you with a highly developed yet user-friendly tool that can be integrated into existing processes quickly, reliably and with documentation.
Efficiency & speed
- Testing of up to 35 gloves simultaneously (simultaneous & parallel)
- Total test time per glove: only 8-15 minutes, depending on the material
- Wireless testing via WLAN, centralised control via GITS® software
- Mobile system with compact design for in-situ use in the isolator or cRABS
Safety & accuracy
- Detection of ultra-fine leaks (< 100 µm) with high repeat accuracy
- Reliable pressure drop test with fully automatic filling via internal air pump
- Automatic port sealing via pneumatic cuffs
- RFID-based identification of gloves and ports for life cycle tracking
- cGMP-compliant test sequences and audit trail-capable logging
- Digital display of all process data: Pressure, battery status, test result, port number
Ergonomics & flexibility
- Lightweight, slim housing with a diameter of just 2.5 cm for manual initial filling
- Optional model with 5 cm diameter for automatic filling
- Simple two-button operating system for intuitive handling
- Replaceable 0.3 µm filter for cleanroom air protection (IP64-certified)
- Easy-to-clean surface design with minimal edges and gaps
- Battery operation with external or integrated power supply
Software functions & documentation
- Complete integration into GMP documentation systems
- Automatic creation and archiving of individual test reports
- Porter recognition software with position assignment on the screen and in the measurement report
- Glove detection software with lifetime monitoring and failure prediction
- Audit trail-compliant data records, compatible with CSV, XML or PDF export
- Data transfer via WLAN to central database or network drive
Compatibility & accessories
Suitable for all common glove types and port systems:
- Neoprene, CSM, EPDM, ISOflex and many more.
- Port sizes with 300 mm Ø
- Optionally adaptable to special port sizes and shapes
Optional accessories
- Glove filling gun or portable pharmaceutical pump
- Single or 5-fold charging station
- Transport and storage trolley
- Spare gloves and glove ports
- Software packages and licence extensions
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