Glove integrity in RABS and barrier systems is one of the critical control points for maintaining aseptic processing and high-containment applications. Failures in this system pose a direct risk to sterility, operator safety, and regulatory compliance.
With a focus on automation, traceability, and data integrity, MGC Life Science introduces the TLW Glove Integrity Test System, developed to meet the requirements of ISO 14644-7, cGMP Annex 1, and 21 CFR Part 11.
Test Method: Pressure Decay (Leak Test)
The TLW uses the pressure decay method, a recognized non-destructive technique for verifying glove integrity in RABS and barrier systems.
Operational Parameters
• Maximum working pressure in the glove system: 2000 Pa
• Test duration: 4 to 8 minutes
• Reading resolution: 1 Pa
• Integrated automatic pressurization
Testing is performed in situ, eliminating the need to remove gloves and reducing the risks of cross-contamination and unnecessary system interventions.
Automation and Repeatability
One of the main challenges in manual testing is operational variability. The TLW incorporates a built-in pump, eliminating the need for an external air supply, along with automatic pressurization and continuous monitoring of the sealing ring pressure.
The pneumatic system with an inflated silicone sealing ring ensures secure attachment and reliable sealing at the glove port. The sealing pressure is continuously monitored and automatically adjusted, reducing variability, improving test repeatability, and minimizing human interference in the process.
RFID-Based Traceability
Integrated RFID technology enables automatic identification of glove flanges, ensuring correct association of each test with the validated location, reducing human error, and providing traceable records for audits.
For GMP environments, this additional layer of control is essential to ensure documentation integrity and full traceability of executed tests.
Designed for Cleanroom Environments
The TLW was specifically developed for controlled environments, featuring IP64 protection and replaceable HEPA 14 air inlet filters. The materials used comply with medical- and food-grade requirements, including polyacetal and AISI 304 stainless steel.
The equipment includes a 24V lithium-ion battery with over 5 hours of autonomy and Wi-Fi 802.11 b/g/n 2.4 GHz communication, enabling mobility and integration within validated networks.
TLW System Manager and Data Governance
Complementing the hardware, the TLW System Manager enables centralized monitoring of multiple testers, role-based user access control, time-stamped audit trails, and the generation of secure, immutable electronic reports.
The system is designed to operate on Windows 10 and Windows 11 and complies with GAMP 5 and 21 CFR Part 11 requirements, ensuring regulatory compliance related to data integrity and electronic records.
The TLW represents an evolution in the management of physical barrier integrity in RABS and critical systems.
By combining non-destructive in-situ testing, full automation, RFID traceability, international regulatory compliance, and electronic data governance, the system meets current technical demands for validation, qualification, and data integrity in the pharmaceutical industry.
For full technical specifications and application assessment at your facility, visit: https://mgclsc.com/en/tlw-glove-integrity-test-system/
