Fully automatic Glove Integrity Test (GIT) system interfaced with isolator PLC for 21CFR Part 11 compliance and report generation. Glove-port RFiD identification. Site qualification studies.    

Process:

The wireless glove test system incorporates the Glove Integrity Test System (GITS), featuring both software and hardware modules. This model ensures accurate and repeatable testing of glove and sleeve materials, offering a comprehensive solution to maintain the integrity of critical aseptic environments. Additionally, the system includes an integrated pump for automatic glove inflation, facilitating seamless testing processes.

Benefits:

Sterile Breach Mitigation: The system serves as a proactive measure against sterile breaches, offering a highly accurate and traceable method for testing the integrity of gloves and sleeves, thereby enhancing overall aseptic control.

Features:

Dedicated laptop for data processing – Complying with 21CFR Part 11 regulations, the system includes a dedicated laptop for data processing, ensuring secure and compliant management of test data.

Integrated pump for automatic glove inflation – The inclusion of an integrated pump automates the glove inflation process, streamlining testing procedures and ensuring consistency.

IP54 rated automatic charging station – The system is equipped with an IP54 rated automatic charging station, providing a reliable and protected charging solution for sustained system functionality.

RFiD identification on all glove ports – Radio-Frequency Identification (RFiD) technology is available on all glove ports, enhancing traceability and enabling efficient monitoring of glove usage.

Part of overall glove management strategy (GMS) – The system seamlessly integrates into a comprehensive Glove Management Strategy (GMS), contributing to a holistic approach to glove integrity and aseptic control.

Options:

Tailored software configurations.

RFiD customisations.

Enhanced data security features.