AGLTS

The Automatic Glove Leak Testing System

A SMART GUARDIAN FOR YOUR BARRIER ISOLATION TECHNOLOGY

It’s advanced. It’s Automatic. It’s above everything you have used so far.

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.

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Testimonials

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

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

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. 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 μm diameter in less than 8 minutes.

WIRELESS

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

DATA MANAGEMENT

A touchscreen PC Supervisor equipped with a dedicated Windows based software application (WinAGLTS) is available for storage and report of the transmitted data. AGLTS can also be upgraded with iFix / Historian Data Management Software (DMS) from GE Digital available upon specific request.

100+

AGLTS installed around the World

OTHER KEY FEATURES

  • 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 docking station made of SS304 (configurations for 4, 5, 6 and 8 testing units available)
  • Custom deisgned docking station made of SS304 available upon specific request
  • Low start-up costs

BENEFITS

  • Saving production time in isolated filling 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

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 (Novartis Group), Marseille, France
Laboratorio Reig Jofre, Barcelona, Spain
Cyclopharma, Clermond Ferrand, France
M2i, Dublin, Ireland
Pfizer, San Sebastian de Los Reyes, Madrid
AAA (Novartis Group), Murcia, Spain
AAA (Novartis Group), Saragoza, Spain
Universitaetsspital, Basel, Switzerland
Pharmathen, Pallini, Greece

NORTH AMERICA

AAA (Novartis Group), Millburn, USA
Pentec Health, Boothwyn, PA, USA
Celgene, Phoenix, AZ, USA
Pfizer, Andover, MA, USA
Revance, Newark, CA, USA

 

CENTRAL & SOUTH AMERICA

Libbs, San Paolo, Brasil
Bio-Manguinhos, Rio de Janeiro, Brasil
Novartis, San Paolo, Brasil

 

OCEANIA

Phebra, Lane Cove West, Australia
Royal Brisbane & Women’s Hospital, Brisbane, Australia
SAHMRI, Adelaide, Australia

 

EURASIA & MIDDLE EAST

Abdi Ibrahim, Istanbul, Turkey
Wockhardt, Dubai, United Arab Emirates
Deva, Kartepe, Turkey
Deva, Cerkezkoy, Turkey
Mustafa Nevzat İlaç, Istanbul, Turkey

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
Bharat Serum, Maharashtra, India
Chun Fo Dispensary Ltd., Hong Kong
Chonnam National University Hwasun Hospital, Jeonnam, South Korea
Teva Takeda Yakuhin Ltd, Koka City, Japan
Toyobo, Tokyo, Japan
Shionogi & CO. LTD, Kanegasaki, Japan
Teva Takeda Pharma,Gifu, Japan
Kyowa Hakko Kirin, Gumma, Japan
Nipropharma,Mie, Japan
Toyobo, Shiga, Japan
Nippon Medical & Chemical Instruments, Osaka, Japan
Ayumi Pharmaceutical, Tamagawa, Japan

© 2020 TEMA SINERGIE S.p.A
Fiscal Code n. 00970310397
Business Register of Ravenna n. 00970310397  |  R.E.A. 111877
Capital Stock € 2.000.000,00 paid-up