Glove Leak Testers (GLT)
Glove Leak Testers (GLT)
Minimize contamination risk with Getinge´s wireless Glove Leak Tester (GLT).
Security at your fingertips
In-situ glove testing for complete integrity with traceability.
Overview
Gloves constitute the most vulnerable link in the containment barrier. Gloves 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.
Wireless for ease of use
Wireless and pipeless (no cables and pipes between the remote head and the main control unit). HMI available either with external tablet or with onboard version, integrated (through SCADA) for Getinge isolators.
Charging station for 4 plugs on trolley and 1 plug stand alone are supplied.
Designed for simplicity
The GLT uses lightweight plugs equipped with inflatable gaskets allowing for easy fastening to glove ports.
This avoids the need for specific tools to fasten the tester plug. Instead, the GLT allows you to push a button and the gasket inflates, securing an airtight seal. The same push-button operation at the end of the test deflates the gasket prior to plug removal.
Preventive Maintenance
The GLT supports the glove management system and preventive maintenance.
It 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.
International Guidelines
Full traceability compliant to FDA 21 CFR part 11.
A modern tool compliant to the Guidelines and annex 1 of the GMP.
Pressure Decay Method
The GLT is compliant to ISO 14644-7 Annex E.5 which constitutes the international standard for integrity tests using the pressure decay method.
Applications
Sterile Transfer
To support the basic principle of isolation technology – to separate a process from the environment – there is a need to check the integrity of gloves and transfer systems before starting a manufacturing batch.
Sterility testing
Be certain about your sterile products. Contamination of samples during sterility testing can be a costly problem, leading to false positive test results. Getinge’s sterility testing isolators and patented DPTE® sterile transfer systems provide a safe and sterile self-contained environment for the most critical steps of the testing process.
API-handling
Active Pharmaceutical Ingredients (APIs) and Highly Potent Active Pharmaceutical Ingredients (HPAPIs) may be highly toxic substances contained in a significant proportion of today’s drugs. Getinge isolation technology and cleaning systems helps protect laboratory staff and the environment, ensuring the safe handling of APIs and HPAPIs.
Aseptic filling
Protect operators and reduce the risk of product contamination with DPTE® Containers. Modern filling lines increasingly incorporate full-barrier isolators or restricted-access barrier systems (RABS) around the filling equipment. Getinge supports you with solutions for a safe and contamination-free aseptic filling process.
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