Leak Tester
A Leak Tester is a device designed for the automated testing of glove and RTP port integrity in aseptic or closed systems.
General
The device enables fast, simple, and reliable leak testing of gloves and RTP ports in isolators and RABS systems, ensuring full compliance with GMP standards and the highest levels of safety and quality in the pharmaceutical and biotechnology industries.
The system also features RFID communication, allowing automatic identification of gloves and test ports. This ensures precise traceability, simplified batch recording, and seamless integration with the user’s quality management system.
Advantages
- Automated glove testing with clear on-screen result display
- Compact and portable design with a built-in battery (over 100 tests per charge)
- User-friendly interface featuring an LCD display and intuitive navigation buttons
- Inflatable silicone seal ensuring secure fixation and precise leak testing
- Flexible operation – option for manual or fully automated testing
- Versatile charging options – contactless or contact charging via desktop or wall-mounted station
- RFID-enabled tracking for automatic glove and port identification, ensuring seamless test management
- Automated report generation – reports created according to predefined templates for standardized documentation
- Server integration – automatically save generated reports to the client’s server for centralized archiving and full integration with the quality management system
Working principle
The device uses precise pressure regulation to inflate the glove to a predefined pressure and then measures pressure decay over a set time interval, enabling reliable detection of potential glove leaks. The system is equipped with two pressure sensors – one monitoring glove pressure and the other seal pressure – ensuring highly accurate and repeatable test results. Upon completion, a detailed test report is automatically generated and displayed on the screen.
With integrated RFID technology, each glove is automatically identified, and every test is linked to a specific batch or product. Test reports are generated according to predefined templates and can be automatically stored on the client’s server, ensuring complete traceability and compliance with quality management standards.
Specifications
- Glove testing in isolators for aseptic and closed system environments
- Standalone operation with an independent charging station
- Designed for the pharmaceutical, biotechnology, and related industries
- Optional connection to the central control system for integrated operation
- Flexible installation – can be mounted directly as part of the isolator or used as a standalone unit
- RFID communication for automatic glove and port identification
- Automated report generation and storage – compatible with client server systems to ensure traceable documentation
- Fully compliant with ISO 14644-7 and GMP Annex 1 requirements
|
Type |
LeakTester Lite |
LeakTester Pro |
| Dimensions |
360 × 360 × 75 mm |
|
| Battery |
more than 100 tests per charge |
|
| Charging |
charging station (desktop or wall-mounted), wireless charging option |
|
| RFID |
No |
Yes |
