Glove Integrity Tester

Designed for testing the glove integrity of Isolator and RABS systems.

Introduction

Features

Specifications

Compliance

Applications

Inquiry

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.

Testing the integrity of complete port, sleeve and glove assembly

The gloves and sleeves should be tested before / after use according to the regulations

Gloves & sleeves leak test for aseptic isolators and RABS

Features

In-situ testing without removal of the gloves.
Fully automated compliance with cGMP.
Made of stainless steel suitable for use in clean room.
With built-in pump.
Built-in printer for real-time printing.
Comply with 21CFR part 11 requirements.
Follow the ISO14644-7 standard.

Specifications

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

Compliance

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. …”