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Annex 1
EU GMP Guidelines
AGLTS 2
Automatic Glove Leak Test System
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- Fast and Reliable Tests
- Built-in Calibration
- Glove Lifecycle Management
- Maximum flexibility
AGLTS 2 is the new automated system for testing the integrity of gloves installed on isolators and RABS in the pharmaceutical industry. Compliant with EU GMP requirements, it is based on the positive pressure decay method, in accordance with the international standard ISO 14644-7, Annex E.5.
Used in the following contexts:
In-house
Designed and Manufactured by Tema Sinergie
Reducing false positives and false negatives
As the number of tests increases in line with production batches, it becomes even more critical to minimize the risk of both false positives and false negatives as much as possible.
Easy maintenance, maximum efficiency
Since this device is used in classified environments, a tool that is easy to clean will take less time to be ready for use again, resulting in savings in both time and resources.
Reduce system test and setup times
Speed during the testing phase plays a crucial role. But it is not the only factor to consider: the instrument's setup time is also important to avoid slowing down production.
Ergonomics, ease of use, and speed
One aspect that should not be underestimated is ergonomics and ease of use. A user-friendly tool will enable the operator to perform the required tasks as effectively as possible in the shortest amount of time.
Features
AGLTS 2 was designed to make the glove testing procedure compliant with ISO 14644-7 Annex E.5 (“Pressure Change Method”) as simple and straightforward as possible. It offers performance features that make it a state-of-the-art glove box testing system, capable of meeting the needs the pharmaceutical industry will face in the coming years.
Glove Life Cycle Management
A new feature that provides an overview of all data related to tested gloves, gloves to be tested, and the entire lifecycle of the glove itself.
Wi-Fi Wireless Connection
Wireless connection for data transmission via a dedicated router (AGLTSnet) or the customer's Wi-Fi network.
iAGLTS Remote Supervision System
iAGLTS – iFIX-based Remote Control Unit for data archiving, management, and real-time report viewing.
PDF Report Generation
Direct creation of reports in PDF format, in compliance with the provisions of 21 CFR Part 11.
Features
Video Camera
Additional Features
Power Button
Features
10-inch Color Touch Screen
A simple and functional interface that provides immediate access to all controls—even while wearing gloves—and optimal display of real-time data and reports.
Features
Embedded PC
The system features a built-in PC that allows data to be managed directly from the system interface, offering maximum flexibility of use.
Features
Customizable Glove Holder
The system can test any type of glove port available on the market thanks to a customizable adapter.
Features
Desk Dock
Battery recharge via wireless inductive system, via its dedicated charging station.
Features
Ergonomic
The system's ergonomic design is intended to minimize any downtime and speed up the necessary testing procedures. The materials are easy to clean and compatible with sanitizing agents and bio-decontamination processes.
Performance
AGLTS 2 offers performance that makes it a state-of-the-art glove box testing system, capable of anticipating and meeting the needs the pharmaceutical industry will face in the coming years.
Specifically with regard to EU GMP Annex 1, AGLTS 2 features an on-board calibration and validation system designed to enhance reliability and minimize any potential false results.
Specifically with regard to EU GMP Annex 1, AGLTS 2 features an on-board calibration and validation system designed to enhance reliability and minimize any potential false results.
It can quickly perform a complete glove test, according to the glove material, size, and parameters inserted in the test formula.
On-board precision calibration and validation system, with no need for either additional devices or destructive tests performed on the glove.
Long lasting lithium battery. A full charge covers the whole daily activity without interruptions or pauses for recharging.
It can detect holes of minimal dimensions with maximum precision, thanks to an extremely precise and high-performance proprietary algorithm.
Testimonials
Marco Preus
Aseptic Processing, Sales Director for Asia-Pacific
(former Product Manager – Isolation Technology)
IMA Life Division – IMA Pharma – IMA Group
"Today, end users of aseptic filling lines are increasingly aware that glove leak testing is a fundamental procedure in line with the Quality-by-Design approach. The Automatic Glove Leak Testing System (AGLTS) by Tema Sinergie is seamlessly integrated into our aseptic filling line package, providing a reliable and user-friendly solution for glove integrity testing."
Testimonials
Philippe Rière
MSFP Projects Coordinator, F&FD Projects Director
Sanofi Pasteur.
"Glove testing is a key element in our aseptic process operations. Unfortunately, we are usually tied to RABS/isolator suppliers: we have to use their own systems without any other options or flexibility among suppliers. That’s why we were immediately interested in AGLTS from Tema Sinergie—because their equipment can be adapted to our gloves with a custom part. Wireless operation and flexibility (no compressed air required) were two other key factors that led us to try this equipment. As one of the first users to adopt AGLTS in 2014, we were able to suggest some upgrades to improve the system—which have now been fully implemented—and we are very pleased to use this type of system in our production facilities."
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Accessories
Mobile Dock
A solution designed to organize, charge, use, and move up to four AGLTS 2 devices simultaneously.
It features four wireless charging stations, an internal compartment, and two customizable Blind Ports for testing the seals and the pneumatic circuit.
Easy to Use AGLTS 2.
Practical and comfortable handling.
Effective cleaning.
Two operators working simultaneously.
accessories
Calibration Chamber
The calibration chamber is designed to test and calibrate the AGLTS 2 under controlled conditions, ensuring the accuracy and reliability of measurements.
This solution allows for periodic inspections and functional tests to be performed in a simple, fast, and repeatable manner.
Beyond Glove Testing
AGLTS 2: The factors that guided the development of a next-generation device that goes beyond simply performing glove tests, supporting operators and pharmaceutical companies in the comprehensive management of all related activities.
01
The experience gained on a worldwide leading system
AGLTS 2 is the evolution of the previous version of the automatic glove testing system developed by Tema Sinergie, from which it inherits features, know-how and stability.
The development starts from the engineering experience, gained on the hundreds of units presently still active and used in several production sites.
02
The attention to the new needs of the pharmaceutical industry
AGLTS 2 is definitely more than just an upgrade. It was developed with a particular attention to the new needs of the pharmaceutical industry within the scenario designed by Annex 1.
AGLTS 2 also features unique performances and characteristics responding to and anticipating the needs that the phgarmaceutical industry will meet in the near future.
03
New generation device way beyond glove testing
The outcome is a new generation device way beyond the mere execution of glove testing, or supporting operators and pharmaceutical companies in the management of all glove testing related operations.
All of this in full compliance with the most relevant regulations on the subject: Annex 1, EU Guidelines, GMP, ISO 14644 7 Annex E.5, Gamp5, FDA CFR 21 part 11.
Developed from the satisfaction of around 200 companies worldwide.
80 Companies in 16 Countries:
Belgium (1), Cyprus (1), France (16), Germany (4), Greece (1), Iceland (1), Ireland (4), Italy (26), Poland (5), Russia (2), Romania (1), Spain (10), Sweden (1), Switzerland (5), UK (1), Ukraine (1)
10 Companies in 4 Countries:
Emirates (1), Israel (3), Saudi Arabia (2), Turkey (4)
52 Companies in 10 Countries:
Bangladesh (1), China (4), Hong Kong (1), India (6), Indonesia (3), Japan (30), Singapore (1), South Korea (3), Taiwan (1), Thailand (2)
35 Companies in 4 Countries:
Canada (2), United States of America (21), Mexico (2), Brazil (10)
5 Companies in 1 Country:
Australia (5)
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