Glove Integrity Tester Glove leak test

Product Overview

Within aseptic manufacturing environments, isolator gloves act as one of the most critical contamination barriers separating operators from sterile products. Even minor glove leakage can break sterility assurance, raise contamination hazards, and cause non-compliance against EU GMP Annex 1.

The GIT-WLAN02 Wireless Glove Integrity Tester is developed for automated in-situ glove leak testing on isolator and RABS systems. Adopting advanced pressure decay test technology, it provides reliable, repeatable and traceable glove integrity verification without removing gloves from the barrier unit.

Integrated with RFID glove recognition, wireless communication and built-in data management functions, GIT-WLAN02 assists pharmaceutical manufacturers to streamline routine glove testing, strengthen contamination control and get ready for audits.

This instrument is engineered in compliance with EU GMP Annex 1 and ISO 14644-7. It supports 21 CFR Part 11 compliant electronic record management for GMP-regulated manufacturing sites.

Compared with manual visual checks, automated glove integrity testing delivers more consistent and objective leak detection, lowering operational risks in critical aseptic processes.

Features

Contamination Control

• In-Situ Glove Integrity Testing, No Removal Required Test gloves and sleeves directly mounted on isolators and RABS systems without detaching gloves, preserving barrier integrity and cutting contamination risks in aseptic zones.
• Built-In Air Pump, No External Compressed Air Required No reliance on external compressed air supply. It reduces exposure of cleanroom utilities and minimizes contamination risks during setup and operation.
• Ultra-Fast Inflation System with Airtight Adapter High-speed inflation and sealed connection reduce air leakage risks and maintain stable pressure to guarantee dependable integrity testing under GMP.
• Compatible with RABS and Isolator Systems Supports glove and sleeve integrity testing for isolators and RABS before and after operation, serving contamination control strategies in aseptic manufacturing.

Operational Efficiency

• Compact and Portable Design Lightweight and compact construction for easy transfer between isolators and production areas, enabling flexible routine test workflows.
• Quick Switching Test Ports Rapid switch among multiple test ports for efficient multi-glove testing and less downtime in daily routines.
• Replaceable Battery, No Charging Downtime Fast battery swap supports continuous on-site operation, avoiding production delays caused by charging cycles.
• Up to 8 Hours Standby Time Long standby duration to cover full-shift routine glove integrity checks across multiple barrier systems.
• Microcontroller-Based Control with Color LCD Stable microcontroller plus user-friendly color LCD interface simplifies operation and lowers training workload for cleanroom operators.
• Automatic Port Adaptation & Fast Connection System Fast setup and quick switching for different glove interfaces to boost workflow efficiency in multi-isolator workshops.

Data Integrity & Compliance

• RFID-Based Automatic Glove Identification RFID technology automatically associates each glove with its test record to achieve full traceability and reduce manual logging errors.
• Wireless Communication to Monitoring System WIFI wireless data transmission enables centralized real-time monitoring and digital GMP documentation.
• Upper-Level Control and Data Acquisition Software Central software platform realizes data collection, visualization and management for better traceability and production supervision.
• GMP/FDA-Compliant Design Supporting IQ/OQ/PQ Built for regulated pharmaceutical environments and supports validation including Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
• Clean and GMP-Compliant Operation Optimized for controlled cleanroom spaces with simplified operation to reduce human error and maintain GMP-aligned workflows.

Specifications

表格

Applications

Isolator Systems

GIT-WLAN02 performs glove tests for isolator units via pressure decay method. It verifies barrier integrity in sterile production and fits routine inspection schedules.

Restricted Access Barrier Systems (RABS)

For RABS applications, GIT-WLAN02 offers reproducible glove integrity testing with configurable parameters for routine qualification and periodic verification.

FAQ 

Q1: What test principle does GIT-WLAN02 adopt? A: It uses pressure decay technology to carry out in-situ glove integrity testing on isolators and RABS. Gloves do not need to be taken off.

Q2: Does this tester require external compressed air? A: No, it comes with a built-in air pump and no external compressed air supply is required.

Q3: Which standards does GIT-WLAN02 comply with? A: It follows EU GMP Annex 1 and ISO14644-7, and supports 21 CFR Part11 electronic records, with IQ/OQ/PQ validation available.

Q4: What is the minimum detectable hole size? A: The smallest detectable hole is 100μm.

Short Product Snippet 

GIT-WLAN02 Wireless Glove Integrity Tester is designed for automated in-situ glove leak testing of isolator and RABS systems with pressure decay technology. No glove removal required; built-in air pump removes reliance on external compressed air. Equipped with RFID glove ID, WIFI communication and color LCD. Compliant with EU GMP Annex1, ISO14644-7 and 21 CFR Part11, supporting IQ/OQ/PQ validation. Compact portable unit (≈3kg) for aseptic cleanrooms, ideal for routine glove integrity qualification in pharmaceutical isolator and RABS production.

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