The Automatic Glove Leak Testing System (AGLTS) is the most advanced GMP compliant glove integrity system for isolators and RABs in the pharmaceutical industry, developed in compliance with the international standard ISO 14644-7 Annex E5.

Automatic Glove Leak Test System (AGLTS)

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.

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.

Customizable: The custom-designed glove port adaptor allows AGLTS to fit 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.

Performing: Fast and efficient, AGLTS detects holes down to 50 μm diameter in less than 8 minutes.

Compliant: FDA compliant (21 CFR part 11) and software GAMP 5 compliant

  • 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 8 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
  • 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

NORTH AMERICA

  • AAA, Millburn, USA
  • Pentec Health, Boothwyn, PA, USA
  • Celgene, Phoenix, AZ, USA
  • Pfizer, Andover, MA, USA

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

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

TESTIMONIALS

 

MARCO PREUS

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.”

MARCO PREUS, Product Manager - Isolation Technology IMA Life Division – IMA Pharma – IMA Group
PHILIPPE RIÈRE

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.”

PHILIPPE RIÈRE, Coordinateur Projets MSFP - Projects Director F&FD Sanofi Pasteur