GIT-SE01 is specially designed for testing the glove integrity of Isolator and RABS systems. The gloves integrity is crucial to prevent the isolator system from contamination. GIT-SE01 adopts the pressure decay method which conforms to the ISO14644-7 requirements.
| Power Supply: 220V / 50Hz | Power: 200W |
| Input Pressure: 2-6bar | Inflation Pressure: 500-2500Pa |
| Test Time: 5-8 min | Weight: 12.5 Kgs |
| Detectable Pore: 300μm | Pressure Resolution: 0.1Pa |
| Dimensions: 340X245X330mm | Detection Port Dia: Ø255mm 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. …”
