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.

  • Built-in, high-quality 5″  HMI touch panel

  • Powerful PLC—expand up to 2048 I/O points

  • Built-in COM ports: Ethernet, USB host & device

  • Add-on COM modules are available: CANbus, RS232, RS485.

  • 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.

© 2020 All rights reserved , A. Ravona Ltd.

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