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GIT-MINI02
The GIT-MINI02 is designed to test the integrity of isolator/RABS system sleeves, gloves, or integrated gloves. It features an intelligent, all-in-one control and display system, and can be connected to test ports compatible with isolator access points.
It operates in positive pressure mode, requiring no manual intervention from the operator. The display screen automatically shows the test results throughout the process, allowing for direct assessment of the gloves’ sealing integrity.
| Inflation Pressure: 500Pa~2500Pa | Test Time: 3-8min |
| Smallest Detectable Hole: 100μm | Continuous Working Time: ≥4 hours |
| Net Weight: ≈2.5Kgs | Battery: 12V Lithium battery |
| Pressure Display Resolution: 0.1Pa | Charging Time: 4h |
| Input Pressure: >0.2MPa | Dimensions: 260mmx280mmx125mm |
| Storage Data: 10,000 groups | Detection Port Dia: Φ255mm or customized |
ISO14644-7 Annex E.5
“The pressure decay tests described are only a few of many tests that can be used for glove testing and are intended to illustrate glove leak test procedures.”
EU GMP Annex 1 (2022) 4.21
“For isolators, leak testing of the glove system should be performed using a methodology demonstrated to be suitable for the task and criticality. The testing should be performed at defined intervals. ”
“For RABS… Gloves should be visually examined with each use, and integrity testing should be performed at periodic intervals.”
FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing (2004) Appendix 1
“…Physical integrity tests should also be performed routinely. A breach in glove integrity can be of serious consequence. …”
