Leak tester for the pharmaceutical industry GLT

for gloves

Ensure safe production and process control with a reliable, repeatable, traceable leak detection system that enables seamless in-situ glove testing. Integrity testers for isolator gloves and sleeves Simple and easy to operate Wireless, paperless and pipeless Full connectivity and traceability Compliant with FDA 21 CFR part 11, EU Annex 11, and GAMP 5 Supports the equipment integrity and preventive contamination control strategy Minimize contamination risk with the Glove Leak Tester Gloves constitute the most vulnerable link in the containment barrier. They are the most critical part of your aseptic filling line because they are in direct contact with the operator, the main source of potential contamination. Wireless, paperless, and pipeless, the GLT allows for accurate and repeatable testing for glove and sleeve integrity, i.e. detecting perforations not visible to the naked eye. Leak test performed with a pressure decay method. The Glove Leak Testers support the glove management system and preventive maintenance. Check the leak tightness of your isolator gloves and sleeves to ensure that your processes are compliant with international standards and regulations. The GLT is a reliable instrument in the maintenance management program, ensuring the system’s performance over time and allowing the end-user to recognize when it is time to change system parts. It is a modern tool compliant with: FDA 21 CFR part 11 Guidelines and annex 1 of the GMP ISO 14644-7 Annex E.5