Automatic Glove Leak Tester
AGLTS 2 is the brand new fully automatic GMP compliant glove integrity testing system for isolators and RABS in the pharmaceutical industry, developed referring to the Positive Pressure Decay Method which follows the international standard ISO 14644-7 Annex E.5.
A new generation device way beyond the mere execution of glove testing, supporting the operators and pharmaceutical companies in the management of all glove testing related operations.
The most substantial novelty concerns the definition of the time intervals within which the glove test must be performed, thus defining an aspect that until now was at the discretion of the manufacturer. This newly published revision fills precisely this gap, specifying that, as far as isolators are concerned, glove testing must be performed at defined intervals, at least at the beginning and end of each production batch.
The choice of the right glove integrity testing equipment is a key aspect within the manufacturing process. As it “demonstrated to be suitable for the task and criticality”, as the revised Annex 1 states, there are also some technical and usage characteristics that should not be underestimated, with reference to the new regulatory framework.
With the increase in the number of tests depending on production batches, it is even more crucial to avoid the risk of running into both false positives and false negatives as much as possible.
There is no doubt that speed during testing plays a key role in not slowing down the production cycle. But this is not the only parameter to be taken into account: instrument set-up times are also important and can play a key role in streamlining the procedure.
A final aspect not to be underestimated is the ergonomics and user-friendliness of the equipment. Certainly a user-friendly instrument will enable the operator to perform the required operations at best in the shortest possible time.
Maintenance is also crucial. Specifically cleaning. Since this is an instrument used almost exclusively in classified environments, it is advisable to evaluate this aspect as well, since an easy-to-clean instrument will take less time to be ready for use, thus saving time and resources.
Our solution is AGLTS 2, developed to answer to all operator needs and to the strictest requirements of the Annex 1.
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.
Aseptic Processing, Sales Director Asia-Pacific
(former 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.
Coordinateur Projets MSFP - Projects Director F&FD
AGLTS 2 features unique performances and characteristics that make it a cutting-edge system, responding to and anticipating the needs that the pharmaceutical industry will meet in the near future.
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.
Capacitive 10” color touch display for immediate access to all commands, even when wearing gloves, and optimal visualization of real-time data and reports.
The system can test any type of glove port available on the market, thanks to a customizable adapter.
On-board precision calibration and validation system, with no need for either additional devices or destructive tests performed on the glove.
New feature to provide the operator with a clear and prompt view of all the data and parameters of the gloves, both tested and yet to be tested; and the entire life cycle of the glove itself.
For an easy integration of the system into the customer’s Active Directory Domain.
1. 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.
2. 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.
3. 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.
+ 4 wireless charging stations for AGLTS 2
+ Blind Port stations
+ 1 internal compartment
The design was created taking into consideration:
+ height from the ground, for a better use of display while AGLTS 2 is placed on its station, as well as for moving the device
+ symmetry, which allows two operators to work simultaneously on the Mobile Dock
+ choice and shape of materials, aiming to ease the cleaning process of the surfaces
This option allows for the seals and the pneumatic circuit of AGLTS 2 to be checked, in order to guarantee their tightness during the test cycle. The Blind Port can be tailor-made to suit the different shapes and sizes of glove doors.