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.

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Features

Contamination Control：

• In-Situ Glove Integrity Testing, No Removal Required

Enables glove and sleeve testing directly on isolators and RABS systems without removal, maintaining barrier integrity and minimizing contamination risk in aseptic environments.

• Built-In Air Pump, No External Compressed Air Required

Eliminates dependency on external compressed air systems, reducing cleanroom infrastructure exposure and minimizing contamination risk during setup and operation.

• Ultra-Fast Inflation System with Airtight Adapter

High-speed inflation with sealed connection minimizes air leakage risk and ensures stable pressure conditions for reliable integrity testing in GMP environments.

• Compatible with RABS and Isolator Systems

Designed for glove and sleeve integrity testing in both RABS and isolators before or after use, supporting contamination control strategies in aseptic manufacturing.

 

Operational Efficiency:

• Compact and Portable Design

Lightweight and compact structure enables easy movement between isolators and production areas, supporting flexible routine testing workflows.

• Quick Switching Test Ports

Allows rapid switching between multiple test ports, enabling efficient multi-glove testing and reducing downtime during routine operations.

• Replaceable Battery, No Charging Downtime

Supports continuous field operation with quick battery replacement, eliminating delays caused by charging cycles in production environments.

• Up to 8 Hours Standby Time

Extended standby capability supports full-shift operation for routine glove integrity testing across multiple systems.

• Microcontroller-Based Control with Color LCD

Stable microcontroller system with intuitive color LCD interface simplifies operation and reduces training requirements for cleanroom staff.

• Automatic Port Adaptation & Fast Connection System

Enables fast setup and switching between glove interfaces, improving workflow efficiency in multi-isolator environments.

 

Data Integrity & Compliance

• RFID-Based Automatic Glove Identification

RFID technology automatically links each glove with its test record, ensuring complete traceability and reducing manual documentation errors.

• Wireless Communication to Monitoring System

Wireless data transmission enables centralized real-time monitoring and supports digital GMP documentation workflows.

• Upper-Level Control and Data Acquisition Software

Centralized software platform enables data acquisition, visualization, and management for improved traceability and operational oversight.

• GMP/FDA-Compliant Design Supporting IQ/OQ/PQ

System is designed for regulated pharmaceutical environments and supports validation activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

• Clean and GMP-Compliant Operation

Designed for controlled cleanroom environments with simplified operation to reduce human error and support GMP-compliant workflows.

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Founded in 2002, Tailin is a leading company in the aseptic isolation technology and sterility test field.

Talin's core competency is technological innovation and strong manufacturing ability.

In order to provide the whole solutions for customers, we manufacture most of the critical equipment by ourselves including the aseptic isolator, VHPS decontamination system, glove leak tester, sterility test pump, and consumables.

Up to today, Tailin has got more than 100 Chinese patents and drafted many National and Industry standards in the name of the first author.

Tailin has nearly 1,000 employees, of which there are more than 200 R&D engineers, accounting for 20%.

Furthermore, Tailin has experienced validation teams working closely with customers and developed qualification strategies based on regulations to guarantee fast approvals by the authorities.

Due to the high quality and excellent service, Tailin become a well-known company in the fields with high standard requirements such as biopharmaceutical, cell& gene therapy, P3 labs, manned space, etc.

In the future, Tailin will keep going all out to serve customers better and grow together with our partners.