The GT-8W handheld glove integrity tester is a high-end portable device that integrates high-precision detection, wireless communication, intelligent
management, and user-friendly operation. It is designed for testing the integrity of isolation gloves on equipment such as glove boxes, isolators, and RABS.
This tester is designed in accordance with the ISO 14644-7 international standard, complying with the 2020 edition of the China Pharmacopoeia and the
electronic record and electronic signature compliance requirements of 21 CFR Part 11. It adopts the principle of high-sensitivity pressure drop method
utilizing built-in high-precision pressure sensors and intelligent algorithms to achieve rapid, non-destructive detection of glove micro-leaks(with a
minimum detectable aperture of 200μm). The testing process requires no disassembly of gloves, truly enabling online in-situ detection, avoiding the risks
of secondary contamination and cumbersome operations caused by disassembly and assembly, thereby significantly improving detection efficiency and
safety.
The device features an integrated portable design with lightweight construction, equipped with detachable lithium batteries and a built-in air pump
for wireless standalone operation, adaptable to various mobile testing scenarios. Its 7-inch color touchscreen displays a user-friendly HMI interface with
multilingual support, enabling real-time visualization of parameter settings, test procedures, and pressure trends for intuitive operation. The system
incorporates four-tier user permission management, audit trails, and electronic signature functions to ensure data authenticity and traceability, meeting
GMP compliance requirements. It supports local storage of over 10,000 test data sets and provides USB export and Wi-Fi transmission capabilities for
efficient data management and audit review.
The test instrument housing is constructed from easy-to-clean and corrosion-resistant materials, featuring a smooth surface with no dead zones, meeting
the hygiene standards of clean areas. The testing medium is air, posing no pollution risk, and is suitable for various high-demand scenarios such as sterile
preparations, cell therapy, vaccine production, and handling of highly active pharmaceuticals.
Printer
Computer/mobile phone/tablet
Main Features:
Online in-situ detection, no need for disassembly, avoiding cross-contaminationand damage
from disassembly.
High-precision pressure drop method, high sensitivity, good reproducibility.
Wireless and portable design, with built-in power supply and air source, allowing for flexible mobility.
Complies with multiple standards such as ISO,GMP,and 21 CFR Part 11.
Intelligent data management, supporting audit tracking and electronic recording.
Friendly human-computer interaction, easy operation, and low maintenance cost.
Multi-device networking management, supporting centralized management of multiple devices.
Power management with large capacity and low power consumption, capable of continuous operation for over 10 hours on a single chargee.
It has a self-checking function.
Parameter item Technical indicators
Detection Principle Pressure drop method
0~2000 Pa
Inflation pressure range
0.1 Pa
Display resolution
Test time
Detection accuracy(minimum aperture)
Positive pressure holding mode
Test mode
Test medium
clean air
Storage capacity
DC24V,8Ah
Power supply
φ380*150mm
Overall dimensions
Weight
Charging time
About 8 hours (0?00%)
Aseptic lsolator Equipment
Utility model patent: ZL201220002291.4 ZL201220136991.2