Wireless glove leak tester for isolation environments

Achieve effortless contamination control in sterile environments with a leak tester designed to ensure glove integrity, providing precision and reliability in detecting invisible perforations crucial for aseptic processes.

The Wireless Glove Leak Tester (GLT) by Getinge offers a comprehensive solution for maintaining aseptic conditions in pharmaceutical and biotech environments. This device stands out with its wireless, paperless, and pipeless design, enabling efficient and seamless in-situ glove testing directly on the production line. Utilizing a pressure decay method for leak detection, the GLT identifies even the smallest perforations, ensuring the integrity of gloves used in aseptic filling, sterile reprocessing, and research laboratories. It is particularly suited for manufacturing vaccines, monoclonal antibodies, and sterile intravenous fluids, aligning with international standards like FDA 21 CFR part 11 and ISO 14644-7.

The device’s user-friendly interface, supported by a multi-functional tablet and inflatable gaskets, facilitates easy operation without the need for special tools. This integration with SCADA systems ensures full connectivity and traceability, connecting seamlessly to site IT infrastructure and SQL databases. Moreover, the GLT supports preventive maintenance by providing critical insights into the condition of gloves and sleeves, enabling timely interventions to maintain process compliance. Optional configurations include integrated SCADA or standalone versions, with multi-plug capability for enhanced operational efficiency. The rugged design and compatibility with various isolator systems underscore its versatility and reliability in demanding production settings.

Benefits

  • Minimizes contamination risk by ensuring glove integrity in aseptic production.
  • Eliminates manual errors with wireless, paperless operation, enhancing process reliability.
  • Ensures compliance with international regulations like FDA 21 CFR part 11 and ISO standards.
  • Simplifies maintenance and reduces downtime with easy-to-use, tool-free operations.
  • Enhances data management and traceability through full connectivity with site IT systems.
Applications
Research laboratories,Biopharmaceuticals,Sterile reprocessing,Aseptic filling,Pharmaceutical production
End products
Lab-on-a-chip devices,Cytotoxic drugs,Vaccines,Gene therapy vectors,Monoclonal antibodies,Plasma derivatives,Sterile intravenous fluids,Injectable antibiotics,Stem cell therapies,Parenteral nutrition solutions
Steps before
Aseptic Filling,Glove Management System Setup
Steps after
Preventive Maintenance,Data Recording and Analysis
Input ingredients
isolator gloves,isolator sleeves
Output ingredients
test results,traceable data
Automation
Wireless,paperless,pipeless
Leak Detection Method
Pressure decay method
Compliance
FDA 21 CFR part 11
Compliance
EU Annex 11
Compliance
GAMP 5
Connectivity
Fully connected to site IT system
Data Traceability
SQL Database
Integration
SCADA
HMI Availability
External tablet or onboard
Instrument Type
Wireless Glove Leak Tester
System Type
Operator-friendly
Operation Method
Simple,easy,and push-button operation
Multi-Plug Capability
Tests multiple plugs simultaneously
Configuration Type
Fully integrated or stand-alone
Automation level
Wireless,paperless,and pipeless
Testing Method
Pressure decay method
Integration
Integrated with isolator SCADA
Maintenance Program
Supports preventive maintenance
Connectivity
Full site IT system connectivity
Traceability
SQL Database traceability
Density/particle size
0.5–2.5 g/cm³ / 50–1000 µm
Machine Footprint
Compact
Control Panel Type
Multi-functional tablet with touch screen
Discharge Method
Push-button operation to deflate gasket
Integration
Fully integrated or standalone
Construction
Wireless,paperless and pipeless
Mounting Options
Integrated into isolator compartment or side
Plug Type
Lightweight with inflatable gaskets for easy fastening
Control panel type
HMI with tablet or integrated
Integration possibilities
SCADA integration
Customization type
Wireless,paperless,and pipeless
Market info
Getinge is known for providing innovative healthcare and life sciences products, specializing in medical technology, infection control, surgical workflows, and critical care solutions. They maintain a strong reputation for quality and technological advancement in these sectors.