The TLW is a glove integrity testing system developed by MGC Life Science for reliable verification of the integrity of gloves used in isolators and controlled environments.
The system utilizes the pressure decay test method (ISO 14644-7 & cGMP Annex 1), providing a reliable, operator-independent, and non-destructive assessment of glove integrity.
In-situ testing eliminates risks associated with glove removal.
Lightweight testers with integrated Wi-Fi communication enable secure data transmission within the validated network, allowing flexible system placement and high operational mobility.
An integrated pump provides fast and automatic glove inflation, eliminating external pressure sources and manual setup while improving repeatability and ergonomics.
Replaceable high-capacity battery (>5 hours operation).
Charger and spare battery included to ensure uninterrupted testing.
Integrated HMI provides real-time test monitoring with graphical display and on-screen results.
Supports system configuration, role-based user access, test reports, audit trails, alarms, and battery/network status.
Clear operator guidance ensures all test information is immediately available without external systems.
Integrated RFID technology enables automatic identification of glove ports, ensuring traceability and correct position of a glove tester in your equipment.
Pneumatically inflated silicone sealing ring ensures secure fixation and reliable sealing in the glove port.
Sealing pressure is continuously monitored and automatically adjusted.
Designed for cleanroom use with IP64 protection and replaceable HEPA 14 air intake filters.
Materials comply with medical- and food-grade requirements, including polyacetal and AISI 304 stainless steel.
Compatible with a wide range of standard glove port sizes and customizable to customer-specific requirements.
| Technical Specs | |
|---|---|
Maximum working pressure inside of gloves system (Pa) | 2000 |
Test Time | 4min~8min |
Maximum working pressure inside of sealing ring (MPa) | 1,5 |
Pressure display resolution (Pa) | 1 |
Size (H × W × D mm | 380*280*200 |
Weight (Kg per unit) | 5,5 |
Working hours (h) | ≥5 |
Built-in Wi-Fi antenna for communication | (802.11 b/g/n – 2,4 GHz) |
Built-in pump | (No air supply needed) |
24V lithium-ion battery | |
Non VHP compatible |
The TLW System Manager is a computerized software system for monitoring, managing, and recording glove integrity leak tests performed by TLW Glove Testers.
Designed for Windows 10 and Windows 11, the system enables centralized supervision of multiple testers and equipment maps while ensuring data integrity, traceability, and secure data storage in compliance with GMP, GAMP 5, and 21 CFR Part 11.
Role-based user accounts with configurable access levels and granular permission control.
Rapid generation of comprehensive test reports with integrated result charts.
Access to individual tester audit trails and alarm logs.
Electronic and printed reports are secure, reliable, and immutable, supporting regulatory requirements for electronic records.
The MGC TLW Glove Integrity Test System is designed in accordance with ISO 14644.
Computer system validation and audit trails are implemented in compliance with 21 CFR Part 11 requirements for electronic records and electronic signatures.
Centralized dashboard with equipment and glove port mapping, providing real-time test status and a clear overview of validation progress.
Role-based user accounts with configurable access levels and granular permission control.
All system activities are recorded in secure, time-stamped audit trails, supporting GAMP 5 and 21 CFR Part 11 compliance.
Talk to our specialists and discover how the TLW – Glove Integrity Test System can be integrated into your process validation and control routines.