Glove integrity tester GIT-SE01

for laboratory isolatorsfor the pharmaceutical industryRABS

Product introduction
GIT-SE01 is designed for in-situ testing of glove integrity on isolators and RABS. The device uses a pressure-decay method in accordance with ISO14644-7 to detect leaks in glove, sleeve and port assemblies, supporting routine and periodic integrity verification in aseptic environments.

Key capabilities

• In-situ testing without glove removal.
• Automated test sequences compatible with cGMP workflows.
• Stainless steel construction suitable for cleanroom use.
• Integrated vacuum/pump unit.
• Built-in thermal printer for real-time records.
• Electronic records functionality compatible with 21 CFR Part 11.
• Test method aligned with ISO14644-7.

Scope / What it tests

• Integrity testing of complete port, sleeve and glove assemblies.
• Leak detection for gloves and sleeves used in aseptic isolators and RABS.
• Intended for pre- and post-use testing as required by applicable regulations.

Compliance
The GIT-SE01 implements pressure-decay testing consistent with ISO14644-7 Annex E.5 and supports recommendations from regulatory guidance including EU GMP Annex 1 (2022) clause 4.21 and FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing (2004) Appendix 1. The device supports routine physical integrity tests and periodic verification as recommended by these standards.

Applications

• Pharmaceutical and biotechnology aseptic production
• Food industry safety control
• High-risk industrial protection

Technical specifications

• Power supply: 220 V / 50 Hz
• Power: 200 W
• Input pressure: 2–6 bar
• Inflation/test pressure: 500–2,500 Pa
• Typical test time: 5–8 min
• Weight: 12.5 kg
• Detectable pore size: 300 μm
• Pressure resolution: 0.1 Pa
• Dimensions: 340 × 245 × 330 mm
• Detection port diameter: Ø255 mm (customizable)