The GIT-WLAN03 is used to leak test gloves installed on isolators or RABS. It leverages wireless communication and intelligent software technologies to achieve wireless device communication, paperless data management, and in-situ testing. It supports multi-device group control and data interconnectivity, and it automatically generates GMP-compliant electronic test reports, building a closed-loop data ecosystem that runs through the entire process.
| Temperature Monitoring Accuracy: ±0.1℃ | Test Time: ≤6min |
| Smallest Detectable Hole: 100μm | Continuous Working Time: ≥4 hours |
| Net Weight: ≤3Kgs | Battery: 12V Lithium battery |
| Dimensions: Φ280x125mm | *Glove flange interface can be customized |
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-WLAN03 requires each tester to log in individually, even in group-control mode. The central management software records the operator information for each device and binds it to the corresponding test data, ensuring precise data attribution and maintaining accuracy throughout the testing process.
Current glove integrity testing mainly uses the pressure decay method, but its accuracy is limited by sensitivity and interference, falling short of pharmaceutical standards. Tailin developed a novel leak detection algorithm based on glove deformation and pressure response. Using dual-control experiments and nonlinear regression, the system compares real-time test curves with reference curves, enabling precise detection of 100μm micropore leaks.
The tester performs fully automatic monitoring of glove and flange pressure variations during testing. Real-time data is displayed on the user interface and transmitted wirelessly to the monitoring system for centralized storage and analysis. Monitoring system supports multi-level permission groups.
Yes. The GIT-WLAN03 software meets 21 CFR Part 11 requirements for electronic records and e-signatures, includes multi-level user authority groups, and enforces a secure data review process. All test results are automatically logged and traceable for audit and validation purposes.
