Digital leak tester FIT-4.0

pressureflowfor the pharmaceutical industry

Product overview
FIT series integrity testers are designed to verify the integrity of sterilizing filters and filter assemblies in accordance with FDA, pharmacopoeia and GMP requirements. The FIT-4.0 is a fully automated integrity tester that performs bubble-point, diffusion-flow, enhanced bubble-point and water-based (WH) tests for hydrophobic filters. The instrument supports multiple test modes to cover different validation needs in pharmaceutical and medical device production.

Main features

• Electronic signature and user classification to record operator responsibility and reduce the risk of incorrect operation.
• Real-time display of test data and curves for continuous monitoring of the test sequence.
• Automatic print function for immediate output of test parameters and results.
• Water-based (WH) test option for hydrophobic filters using purified water instead of IPA or ethanol to avoid trace solvent contamination.
• Onboard storage of up to 500 test records with associated graphical curves.

Specifications

• Model (SKU): FIT-4.0
• Tests supported: bubble-point, diffusion-flow, enhanced bubble-point, water-based (WH) for hydrophobic filters
• Power: 100–240 VAC, 50/60 Hz, 110 W
• Maximum working pressure: 9999 mbar
• Minimum working pressure: 1000 mbar
• Test pressure range: 500–6900 mbar
• Test accuracy: Diffusion (D) ±4%; Bubble point (BP) ±50 mbar; V of WH ±4%; Upstream volume ±4%
• Dimensions (L × D × H): 400 × 380 × 335 mm
• Working conditions: Temperature 20 °C ±15 °C; Relative humidity 45% ±35%
• Memory: 500 test records with graphic curves
• Display: 5.7″ TFT (monocular)
• I/O: RS232
• Menu languages: Chinese or English
• Checklist print: input parameters, output data and results in Chinese
• Test times (indicative): Upstream volume test: 5 min ±2 min; Quick D test: 10 min ±2 min; Base BP test: 15 min ±2 min; Enhanced test: 20 min ±2 min; WH: 30 min ±2 min