Glove Integrity Tester Manufacturer & Supplier
Wireless pressure-decay glove integrity testing for isolators, RABS and glove boxes — detect leaks down to 100 µm, electronic records for ≥5 years.
Overview
Manufacturer & U.S. supplier. MedIntegrity designs and builds the glove integrity tester in its own factory — 28 patented products, 15 years in pharmaceutical testing equipment.
Where Glove Integrity Tester Is Used
Isolators & RABS
Glove integrity verification for the barrier systems that protect people and product — pre-production, post-production and each critical phase, consistent with EU GMP Annex 1 and quality risk management.
Aseptic line routines
Routine, repeatable glove inspection on production lines — the pattern Sunny Pharmaceutical runs in Egypt with the WGT-1000 Online for routine aseptic-line glove inspection.
Suite-wide standardization
When a site deploys across multiple isolators, a single tested instrument family keeps the method, the limits and the record format identical everywhere — BeiGene USA operates twenty WGT-1200 units for exactly this reason.
Going Deeper
Integrity Assurance for Isolators & RABS
Barrier systems such as isolators and RABs protect people and products in pharmaceutical production. Gloves — only tenths of a millimetre thick — are the most crucial interface in these sealed units. A thorough and regular inspection of glove integrity is vital.
EU GMP Annex 1 & PIC/S
EU GMP Annex 1 states that glove integrity testing is fundamental for pre- and post-production qualification in aseptic processes; gloves must be checked before and after production and during each critical phase, consistent with quality risk management. The WGT series is built for that cadence: a test you can run at every phase without re-rigging the barrier system.
Wireless Testing, 100 µm Detection
The WGT series uses pressure decay with a rechargeable battery and wireless operation — designed for isolator and RABS environments where cabling is a contamination risk. Minimum detectable hole: 100 µm. The record is electronic and sized for five years or more, so the history of every glove check is available when the question comes.
WGT-1000 vs WGT-1200
Both models deliver wireless pressure-decay testing with 100 µm minimum detection and long-term electronic records; the WGT-1000 Online is deployed on routine aseptic-line glove inspection — Sunny Pharmaceutical in Egypt runs it as its routine check — while the WGT-1200 is the model biopharma suites standardize on: BeiGene USA operates twenty units for isolator and RABS glove verification. We will confirm the right model for your barrier configuration and test cadence.
Why wireless at the barrier
A cable run from an external instrument into an isolator is a penetration the contamination control strategy has to manage. Wireless operation removes that penetration from the test step entirely: the operator connects the glove, runs the decay test, and the result is recorded — no tether through the glove port, no extra validation burden on the barrier system.
Frequently Asked Questions
What is the minimum detectable hole size?
100 µm, on both WGT models. That sensitivity is what makes the test a meaningful integrity check rather than a coarse one.
Why wireless instead of a cabled instrument?
A cable from an external instrument into an isolator or RABS is a penetration the contamination control strategy has to manage. The WGT series is battery-powered and wireless — no tether through the glove port, no extra validation burden on the barrier system.
How long are the electronic records kept?
The WGT series is designed for electronic records of five years or more, so the history of glove checks is available for trend analysis and audit long after the production run it belongs to.
Which model — WGT-1000 or WGT-1200?
Both deliver wireless pressure-decay testing with 100 µm minimum detection and long-term electronic records. The WGT-1000 Online is the model deployed for routine aseptic-line inspection, and the WGT-1200 is the model biopharma suites standardize on across isolators and RABs. We will confirm the right fit for your barrier configuration and test cadence.
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