AGLTS - The Automatic Glove Leak Test System

The most advanced GMP compliant glove integrity testing system for isolators and RABs in the pharmaceutical industry, developed in compliance with the international standard ISO 14644-7 Annex E5.

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  • Easy

    A user-friendly interface allows the operator to control the testing unit through basic and intuitive commands. Real time system status can be checked at all times by a supervisor thanks to the available control station.

  • AUTONOMOUS

    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.

  • WIRELESS

    Data can be sent to a control station via TCP/IP-based wireless transmission protocol.

  • CUSTOMIZABLE

    The custom-designed glove port adaptor allows AGLTS to fit every kind of glove ports. Including yours!

  • MODULAR

    From few to numerous gloves to be tested, AGLTS has it all. Integrated configurations of 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 for a smart and easy glove management.

  • PERFORMING

    Fast and efficient, AGLTS detects holes down to 50 um diameter in less than 10 minutes.

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    Testimonials

    Marco Preus

    Product Manager - Isolation Technology
    IMA Life Division – IMA Pharma – IMA Group

    "Nowadays, end users of aseptic filling lines are more conscious that glove leak testing is a fundamental procedure, in the direction of the Quality-by-Design approach. The Automatic Glove Leak Testing System (AGLTS) by Tema Sinergie is perfectly integrated into our aseptic filling line package, providing a reliable and easy-to-use solution to glove integrity testing."

    Philippe Rière

    Coordinateur Projets MSFP - Projects Director F&FD
    Sanofi Pasteur

    "Glove testing is a key element in our aseptic process operations. Unfortunately, we are most of the time chained with RABS / isolator suppliers: use of their own system without other possibilities neither flexibility between suppliers. That’s the reason why we were really interested at first sight to AGLTS from Tema Sinergie, as it is possible to adapt their equipment to our gloves with a format part. Wireless, flexibility (no compressed air required) were two other key parameters that lead us to try this equipment. Being one of the first user to choose AGLTS in 2014, we have been able to recommend some upgrades to improve the system, which are currently fully completed, but we are very pleased to use this type of system in our production units."

    References

    EUROPE
    Sanofi Pasteur, Marcy-l'Étoile, France
    SDN, Naples, Italy
    Fresenius Kabi, Isola della Scala, Italy
    GSK, Rosia-Sovicille, Italy
    Genzyme, Waterford, Ireland
    Patheon, Ferentino, Italy
    Alvotech Reykjavìk, Iceland
    Sanofi Pasteur, Val-de-Reuil, France
    Bristol-Myers Squibb, Anagni, Italy
    Patheon, Monza, Italy
    Kedrion, S. Antimo, Italy
    AstraZeneca, Sodertalje, Sweden
    Takeda, Singen, Germany
    Chiesi Farmaceutici, Parma, Italy
    Alexion, Athlone, Ireland
    AAA, Marseille, France
    Laboratorio Reig Jofre, Barcelona, Spain
    NORTH AMERICA
    AAA, Millburn, USA
    Pentec Health, Boothwyn, PA, USA
    Celgene, Phoenix, AZ, USA
    Pfizer, Andover, MA, USA

    CENTRAL & SOUTH AMERICA
    Libbs, San Paolo, Brasil
    Bio-Manguinhos, Rio de Janeiro, Brasil
    Novartis, San Paolo, Brasil

    ASIA
    Rohto, Mie, Japan
    Towa, Yamagata, Japan
    JCR, Hyogo, Japan
    DS Pharma Animal Health, Osaka, Japan
    Nihon Zoki, Hyogo, Japan
    Minopagen Pharmaceutical, Kanagawa, Japan
    Otsuka Pharmaceutical, Tokushima, Japan
    Pfizer, Aichi, Japan
    Bristol-Myers Squibb, Aichi, Japan
    Astellas Pharma Tech, Shizuoka, Japan
    Nipropharma, Akita, Japan
    Pfizer, Hangzhou, China

    EURASIA & MIDDLE EAST
    Abdi Ibrahim, Istanbul, Turkey
    Wockhardt, Dubai, United Arab Emirates
    Deva, Kartepe, Turkey
    Deva, Cerkezkoy, Turkey