AGLTS requires no external piping and compressed air. All the essential equipments are integrated into the testing device and powered by a long durable Lithium battery. The custom-designed glove port adaptor allows AGLTS to suit every kind of glove ports, including yours. The integrated AGLTS can be upgraded to any number of testing units for a faster parallel performance. Each glove is recognized by means of Radio Frequency Identification (RFID) Technology. Data can be sent to a control station via TCP/IP-based wireless transmission protocol.
Automatic Glove Leak Test System (AGLTS)
Easy, Autonomour, Customizable, Modular, and Wireless: these unique five features combine to make AGLTS the most advanced GMP compliant glove integrity testing system for isolators and RABs in the pharmaceutical industry; developed in compliancy to the international standard ISO 14644-7 Annex E5.
Easy: A user-friendly interface allows the operator to control the testing unit through basic and intuitive commands. The real time system status can be presented to the supervisor by means of the available control station.
Autonomous: AGLTS requires no external piping and compressed air: all the essential equipment are integrated into the testing device, and powered by a long durable Lithuim battery.
Customizable: The custom-designed glove port adaptor allows AGLTS to suit every kind of glove ports.
Modular: The integrated AGLTS can be upgraded to any number of testing unit for a faster parallel performance. Each glove is recognized by means of Radio Frequency Identification (RFID) technology.
Wireless: Data can be sent to a control station via TCP/IP-based wireless transmission protocol.
- Manufacturing materials resistant to sanitizing agents and bio-decontamination processes
- Automatic complete testing procedures
- Parametric testing formulas
- Integrated pneumatic circuit
- Complete encrypted data/reports storage and download via SD card
- Testing time from 10 minutes, depending on both glove material and dimension
- Travelling ergonomic docking station made of SS304 (configurations for 4 and 8 testing units available)
- Low start-up costs
- Saving production time in isolated filing lines, stand-alone isolator systems, and RABS Technology
- Avoiding operator mistakes
- Detecting small holes in the gloves (≥50 µm)
- Data consulting can be done outside the classified environment
- 12.1″ fanless panel PC Advantech with optional resistive touch screen
- Dedicated Windows based software application for storage and report of the transmitted data available
- Software development according to Good Automation Manufacturing Practice (GAMP 5)
- 21 CFR part 11 compliant
- Operator friendly interface available in different languages
- VPN connection for remote access and assistance, updates, and maintenance available
- Complete documentation package according to Tema Sinergie standards
- Complete validation package, Factory Acceptance Test (FAT) and Site Acceptance Test (SAT)
- Installation Qualification/Operational Qualification (IQ/OQ) protocols and execution
- Performance Qualification (PQ) protocols and execution upon request