A self-contained device that leak-tests the gloves of aseptic isolators, containment isolators and RABS — automatically, with traceable, report-ready results.
Gloves are usually the primary source of leaks in an isolator. They are the contact point between the operator and the process, and a pinhole in a glove is too small for a whole-isolator leak test to detect. EU GMP Annex 1 and cGMP both point to the need for a dedicated glove integrity testing system.
Controlled pressure decay on each glove, with sensitivity to holes of roughly 50–100 µm.
Automatic test procedures with immediate alerts on failure and consistent, repeatable results.
Live glove status during the test and reports covering test parameters, performance and any leaks detected.
Settings adapt to different glove types, sizes and materials; works with non-Ravona glove ports too.
Single-glove recognition by RFID, so every glove has its own test history.
Active Directory integration for user access control, built-in report generation and PDF export; data transfer by SD card, USB or Wi-Fi.
Designed for 21 CFR Part 11, FDA, ISO and cGMP requirements. The IGT series is supplied with a complete documentation and validation package, plus Factory Acceptance Test (FAT) and Site Acceptance Test (SAT).
Ravona is a manufacturer of isolators, R.A.B.S and glove integrity testers. Product information and images are provided by Ravona (aravona.com) and used with their permission. Specifications may vary by configuration; contact us for current details.
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