Isolation Technology

Automatic Glove Leak Testing System – AGLTS

| PRODUCT MANUFACTURER: TEMA SINERGIE

Product Description

One of the most advanced cGMP compliant glove integrity system for isolators and RABs in the pharmaceutical industry today, developed in compliance with the international standard ISO 14644-7 Annex E5.
AGLTS requires no external compressed air piping or power supply cables: all the essential pneumatic equipment and a durable Lithium battery are integrated into the testing device. A user-friendly interface allows the operator to run the testing unit through basic and intuitive commands. Real time system status can be always checked by a supervisor.

Main Features and Benefits

  • 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 within 8 minutes, depending on both glove material and dimension
  • Standard ergonomic stainless steel docking station (configurations for 4, 5, 6 and 8 testing units available)
  • Saving production time in isolated filling lines, stand-alone isolator systems, and RABS Technology
  • Avoiding operator mistakes
  • Detecting small holes in the gloves (≥ 100 µm)
  • Data consulting can be done outside the classified environment
  • 21 CFR part 11 compliant

Additional Video

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    Additional Product Model Imagery

    Installed AGLTS

    AGLTS

    AGLTS in operation

    AGLTS loading and data station

    Installed AGLTS_2

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