The GIT-WLAN Glove Integrity Tester is a specialized device designed to test the integrity of sleeves and gloves used in isolators and RABS systems. It can be customized with test ports compatible with the isolator’s operation ports. The device operates in positive pressure mode, requires no manual intervention, and automatically displays the test results on the screen to determine the glove’s sealing integrity.
| Test time: 3-6 minutes | Continuous Working time: ≥4 hours |
| Inflation pressure: 500Pa-2500Pa | Smallest Hole Detectable: 100μm |
| Pressure readability: 0.1Pa | Communication: WIFI |
| Dimensions: Ø280mmx150mm | Net weight: ≈2.6Kgs |
| Battery: 12V Lithium battery | Power: ≤ 20W |
ISO14644-7 Annex E.5
“The pressure decay tests described are only a few of many tests that can be used for glove testing and are intended to illustrate glove leak test procedures.”
EU GMP Annex 1 (2022) 4.21
“For isolators, leak testing of the glove system should be performed using a methodology demonstrated to be suitable for the task and criticality. The testing should be performed at defined intervals. ”
“For RABS… Gloves should be visually examined with each use, and integrity testing should be performed at periodic intervals.”
FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing (2004) Appendix 1
“…Physical integrity tests should also be performed routinely. A breach in glove integrity can be of serious consequence. …”
The GIT-WLAN is designed for in-situ integrity testing of gloves and sleeves in RABS and isolator systems. It verifies glove airtightness without removal, ensuring sterile operations and compliance with GMP and ISO 14644-7 standards.
No. It includes a built-in air pump, allowing independent operation without external air sources. This compact and portable design makes it ideal for cleanroom glove leak testing.
The tester features RFID glove identification, automatic pressure monitoring, and wireless data transmission to the control software. All results are digitally stored with timestamps, ensuring traceable, repeatable, and verifiable testing in compliance with FDA and GMP data integrity requirements.
Two modes are available:
Internal Test: Checks the integrity of the glove or sleeve itself.
External Test: Evaluates both the glove and the flange seal.
True in-situ testing (no glove removal)
Wireless operation and data management
RFID-based glove ID recognition
Built-in air pump and replaceable battery
Compact, GMP-compliant design with up to 8 hours of operation
