Why glove tester?
Isolator / Glove Box integrity is an absolute necessity to guarantee an aseptic safe working chamber.
Standard leak tests can be verified with a test on the entire isolator, but the leak test on the full chamber volume is not sensitive enough to detect a pinhole leak in one of the gloves.
Some known facts:
• Gloves are the biggest and most vulnerable elastic consumable
the component in an isolator or R.A.B.S.
• Gloves are the most exposed part to punctures or cuts because they are the contact point between the operator hands and process tools.
• Since the gloves are more likely to be changed frequently, the possibility of incorrect installation can cause leak problems.
• Statistically, gloves are the first source of leaks problems inside an isolator
Ravona Glove tester.
Highlights:
A battery-powered glove tester Enables leak testing on gloves installed on isolators or RABS where a strict separation between the isolated area and the external environment is required. The system performs pressure decay integrity tests that comply with the requirements of ISO 14644-7-2004 Annex E.5.
Being an experienced manufacturer of Isolator /Glovebox and a role player in the pharmaceutical industry, Ravona Pharma turned to the engineering and development department in order to produce a reliable, sophisticated and user-friendly device, Specifically: an integrity Glove Tester.
Once understanding the demands from such a device, the search for the appropriate components took place with the goal of "Synergy" between the components.
The results are quite remarkable, a fairly compact, easy to use integrated wireless, self-contained glove integrity tester.
Features:
* Built-in rechargeable Samsung 9,000 mA 25.2 V supplied with charger*
* Incorporated Unitronics PLC/HMI :
Superbly compact, 5″ Pro is highly compact controllers, where the PLC, HMI,
and I/Os are built into a single unit and in a range of built-in I/O configurations.
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Built-in, high-quality 5″ HMI touch panel
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Powerful PLC—expand up to 2048 I/O points
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Built-in COM ports: Ethernet, USB host & device
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Add-on COM modules are available: CANbus, RS232, RS485.
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Complying with FDA - 21 CFR part 11 Electronic Records & Signatures
* installed miniature valves and check valves
* Built-in pressure transducer.
* employing a miniature high-pressure compressor.
* Specially developed software to allow easy operation and measuring results
complying with:
Positive-pressure glove-leak tester guidelines EN ISO14644−7:2004 Annex E.5
Compatibility
Ravona-Pharma Glove integrity tester can work with any size glove port.
Just send a drawing of the glove port in your RABS, Isolator/Glove-Box, we will match our insert to your glove port.
Parameters can be changed in all test parameters using the HMI.
The control system has WiFi capability to drive a verity of WiFi Printers.