All Solutions
All Solutions
Home > Glove Integrity Tester (GIT) > Glove Integrity Tester
GIT-WLAN02
In aseptic manufacturing environments, isolator gloves serve as one of the most critical contamination barriers between operators and sterile products. Even minor glove leakage may compromise sterility assurance, increase contamination risks, and impact compliance with EU GMP Annex 1 requirements.
The GIT-WLAN02 Wireless Glove Integrity Tester is designed for automated in-situ glove leak testing in isolators and RABS systems. Utilizing advanced pressure decay testing technology, the system delivers reliable, repeatable, and traceable glove integrity verification without removing gloves from the barrier system.
Equipped with RFID glove identification, wireless communication, and integrated data management capabilities, the GIT-WLAN02 helps pharmaceutical manufacturers simplify routine glove testing while improving contamination control and audit readiness.
The system is designed in accordance with EU GMP Annex 1, ISO 14644-7 and supports 21 CFR Part 11 compliant electronic record management for GMP-regulated manufacturing environments.
Compared with manual visual inspection, automated glove integrity testing provides more consistent and objective leak detection, helping reduce operational risks in critical aseptic processes.
Enables glove and sleeve testing directly on isolators and RABS systems without removal, maintaining barrier integrity and minimizing contamination risk in aseptic environments.
Eliminates dependency on external compressed air systems, reducing cleanroom infrastructure exposure and minimizing contamination risk during setup and operation.
High-speed inflation with sealed connection minimizes air leakage risk and ensures stable pressure conditions for reliable integrity testing in GMP environments.
Designed for glove and sleeve integrity testing in both RABS and isolators before or after use, supporting contamination control strategies in aseptic manufacturing.
Lightweight and compact structure enables easy movement between isolators and production areas, supporting flexible routine testing workflows.
Allows rapid switching between multiple test ports, enabling efficient multi-glove testing and reducing downtime during routine operations.
Supports continuous field operation with quick battery replacement, eliminating delays caused by charging cycles in production environments.
Extended standby capability supports full-shift operation for routine glove integrity testing across multiple systems.
Stable microcontroller system with intuitive color LCD interface simplifies operation and reduces training requirements for cleanroom staff.
Enables fast setup and switching between glove interfaces, improving workflow efficiency in multi-isolator environments.
RFID technology automatically links each glove with its test record, ensuring complete traceability and reducing manual documentation errors.
Wireless data transmission enables centralized real-time monitoring and supports digital GMP documentation workflows.
Centralized software platform enables data acquisition, visualization, and management for improved traceability and operational oversight.
System is designed for regulated pharmaceutical environments and supports validation activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Designed for controlled cleanroom environments with simplified operation to reduce human error and support GMP-compliant workflows.
| Inflation Pressure: 500~2500Pa | Test Time: 3min~6min |
| Pressure Display Resolution: 0.1Pa | Smallest Detectable Hole: 100μm |
| N.W.: ≈3kg | Dimensions: Ф280mm×150mm |
| Battery: 12V Lithium battery | Power: ≤20W |
| Continuous Working Time: ≥4 hours | Communication: WIFI |
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. …”
GIT-WLAN02 is designed for glove testing in isolator systems. Pressure decay testing helps ensure barrier integrity in sterile production environments and is suitable for routine inspections.
In Restricted Access Barrier Systems (RABS), GIT-WLAN02 delivers reproducible glove integrity testing with configurable test parameters suitable for routine qualification and periodic checks.
Yes. For gloves in different areas, the GIT-WLAN02 can be wired over a network for group control. Test results from each area are transmitted over the wireless network for server-side file sharing, centralized monitoring, and streamlined data management across multiple isolators or RABS zones.
Yes. The GIT-WLAN02 is compatible with all standard glove types, including CSM, EPDM, and Nitrile, as well as custom flange configurations. Its ultra-fast inflation and airtight connection system ensure consistent, repeatable results across glove materials.
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-WLAN02 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.
The GIT-WLAN02 supports both wired and wireless communication, allowing unlimited glove testers to be monitored simultaneously from a central platform.
It also supports OPC UA and Modbus protocols for seamless integration with SCADA, MES, and other automation systems, enabling unified data management and interoperability within modern pharmaceutical production environments.
An optional cleanroom tablet PC is available for on-site operation and visualization.
