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An overview of our customized barrier isolator systems for aseptic and containment processes.
Automatic Glove Leak Test System
Easy, Autonomous, 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.
AGLTS has been making the difference right from the start, and we at Tema Sinergie are proud to announce its first 100 installments all over the world.
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.
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 sento to a control station via TCP/IP-based wireless transmission protocol.
- fully automatic testing procedures
- customizable testing formulas, related to glove material, shape, and dimension
- safe recognition of the tested glove port by means RFID Technology
- wireless data transmission for both test data and glove port identification
- unlimited number of gloves tested simultaneously
- GMP compliance
- GAMP 5 & 21 CFR part 11 compliance
- operator friendly interface is available in different languages
- testing time up to 10 minutes, depending on both glove material and dimension
- low start-up costs
- saving manufacturing time in isolated filling lines, and RABS-technology
- avoiding operator mistakes
- detecting small holes in the gloves (≥ 100 µm)
- data evaluation can be done outside the classified environment
Customized solutions may include different numbers of testing units upon customer request.
Alternative configurations are also available (i.e. the control unit based on a touch screen all-in-one PC can be installed into an unclassified area, while testing units and charging stations can be located into the cleanroom).
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AGLTS is controlled by a 12.1" PC panel touchscreen, and by a dedicated Windows based software application for a fully automatic storage and report of the transmitted glove test data.
The equipment takes advantage of a VPN connection, a Virtual Private Network which allows a secure and private communication via Internet network.