Overview
The PBL-GT Glove Tester is an innovative system that ensures the highest standards of safety and performance in pharmaceutical applications. With precise pressure decay testing and customizable protocols, it detects even the smallest leaks, ensuring consistent results and enhanced operational efficiency.
Precision in Pressure Decay Testing
The PBL-GT employs the industry-standard pressure decay test, ensuring consistent, reliable results.
It is designed for both online and offline glove testing, and introduces a new approach by pre-stretching each glove multiple times before testing begins.
This guarantees that all gloves are tested under identical conditions, regardless of previous use, significantly enhancing the reproducibility of test results.
Customizable Testing for Optimal Accuracy
With the PBL-GT, the glove system is subjected to a specified test pressure, precisely monitored by a calibrated sensor.
This feature ensures that the correct parameters are applied to each glove type, preventing undetected damage that could occur with incorrect pressure settings.
The system’s high sensitivity allows it to detect even the smallest leaks, as minute as a few micrometers.
Reliable, Repeatable Results
Once the target pressure is reached, it is carefully measured over a set period. If any leaks are present, the pressure decreases, and the system immediately detects the issue.
Depending on the glove’s material and thickness, testing durations range from 10 to 20 minutes.
This precise, repeatable process is ideal for routine glove testing, ensuring maximum safety and reliability.
Compliant with Industry Standards (Annex 1)
Aligned with Draft Annex 1 guidelines, the PBL-GT ensures the integrity of barrier systems through rigorous glove and isolator leak testing.
Testing is recommended at defined intervals-at minimum, before and after each batch—with visual inspections following any interventions that may impact system integrity.
Test procedure
- Automatic glove inflation
- Stabilization
- Integrity testing using the pressure decay method
- Detection of micro-leaks as small as 30 microns
- Automated glove holder identification
- Simultaneous management of multiple tests
Characteristics
· Annex 1 Compliant
· CFR21 Part 11 Compliant
· Server-Client-Solution
· Active Directory Integration
· OPC UA/ SCADA
More features
· Multiple testing of gloves
· Audit Trail
· GAMP 5
· Batch reports
Key Features
· PBL-GT (Glove Tester) can be integrated in the machine door or in stand-alone version
· Fast and reliable Pressure decay method Detects glove holes down to 30 microns
· Automated identification and detection of glove port
· Simultaneous tests of all gloves with overall process time in less than 20 minutes
More features
· Customizable access levels and easy and reliable data management
· Easy and user-friendly operation via machine HMI
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