Glove Integrity Tester for Isolators

The glove tester enables rapid and reliable detection of perforations using a traceable, reproducible method that complies with current regulations, in particular Annex 1 of GMP. The system can also be adapted to all shapes of glove rings.
Glove Integrity Tester for Isolators
Description of the EREA glove tester
Exclusive dual sensor technology
Operating principle

Documentation

Description of the EREA glove tester

The tester developed by EREA is:

  • Equipped with two sensors that detect pressure inside the glove
  • Integrated with a Siemens HMI interface for complete control
  • Designed to be lighter, with lower power consumption and longer battery life
  • Easy to use, with less mechanical complexity
  • Adaptable to different glove ring formats (round, oval, etc.)

Exclusive dual sensor technology

The EREA glove tester is controlled via the Siemens WinCC Unified system, a benchmark in the pharmaceutical industry. This interface offers complete and intuitive traceability, with: Automatic report generation, Alarm log available for consultation at any time, Secure audit trail to guarantee data integrity. A solution perfectly suited to demanding and regulated environments. Thanks to its intelligent design, the tester allows constant calibration with pressure sensors without any disassembly. It incorporates exclusive dual sensor technology:

  • The first sensor measures and regulates the pressure in the glove,
  • while the second continuously monitors the reliability of the first.

If a discrepancy is detected, a preventive alarm is triggered to alert the user to the need for calibration.

The EREA tester is WPA2 Enterprise compatible, a centralised authentication protocol ensuring that only authorised devices can connect to the Wi-Fi network. In addition, our Wi-Fi router is configured to be invisible to computers: it does not broadcast its name (SSID). An ultra-secure connection, only accessible to users with login details – effective protection against cyber attacks.

Operating principle

Thanks to its operating principle based on Hagen-Poiseuille’s law, the tester can simulate leaks equivalent to those generated by very small defects. For example, a calibrated 260 μm orifice used in testing is equivalent, in terms of leak rate, to a hole of around 113 microns in a glove. This means that the tester is sensitive enough to ultimately detect a hole of this size, thus ensuring a high level of micro-leak detection.

Once a year, secure and traceable calibration is carried out using a dedicated programme in the HMI and a test bench that reproduces the test conditions, enabling the accuracy of the pressure sensors to be checked and validated without dismantling, with the option of on-site intervention or return to EREA.

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