introduction The GIT-WLAN02 is designed for in-situ leak testing of gloves installed on isolators and RABS. It performs automatic pressure-decay tests, logs results and stores data wirelessly on a PC with database support. The device supports routine integrity verification in compliance with relevant industry guidance.
Features - In-situ testing without sleeve/glove removal to avoid process disruption.
- Compact, portable design for easy handling in cleanroom environments.
- Quick-switch test ports for multiple glove types and sizes.
- Microcontroller control with color LCD for clear status and results.
- Built-in air pump; no external compressed air required.
- Replaceable 12V lithium battery for immediate swap-out.
- Up to 8 hours standby and ≥4 hours continuous working time.
- Wireless connection (WIFI) to monitoring and data-acquisition systems.
- RFID-based automatic glove identification.
- Upper-level control and data acquisition software for centralized observation and operation.
- Ultra-fast inflation system with airtight adapter compatible with standard and custom glove flanges.
- Configured for pre- and post-use integrity testing of sleeves/gloves in RABS and isolator systems.
- Clean operation and user interface aligned with GMP requirements.
- Design supports IOQ and PQ activities.
Compliance & standardsComplies with ISO 14644-7 Annex E.5; EU GMP Annex 1 (2022) section 4.21 guidance on glove leak testing intervals and methodology; aligns with FDA guidance for routine physical integrity testing of aseptically processed sterile products.
ApplicationsIntended for glove/sleeve integrity testing on isolators and RABS in pharmaceutical and biotechnology aseptic manufacturing, food safety control, and high-risk industrial protection contexts.
Technical specifications - Inflation pressure: 500–2500 Pa
- Test time: 3–6 min
- Pressure display resolution: 0.1 Pa
- Smallest detectable hole: 100 μm
- Net weight: ≈ 3 kg
- Dimensions: Ø280 mm × 150 mm
- Battery: 12 V lithium battery (replaceable)
- Power: ≤ 20 W
- Continuous working time: ≥ 4 hours
- Standby time: up to 8 hours
- Communication: WIFI