Pressure tester FIT-6.5

integritybubble pointflow

Overview

The FIT-6.5 filter integrity tester performs bubble point, diffusion flow, pressure-hold and ultrafiltration membrane tests for validation and routine QC in pharmaceutical, biotech and laboratory environments. It supports online and offline operation and provides secure authority management aligned with regulatory requirements.

Key features

• Multiple integrity methods: manual, basic and extensive bubble point, pressure holding, diffusion flow, water intrusion and ultrafiltration membrane test
• First domestic implementation for ultrafiltration system integrity testing
• Authority management with user/password, permission levels and electronic signature compliant with FDA 21 CFR Part 11
• Storage for 120 reservation solution sets and configurable test programs
• Rich connectivity: RS232/USB standard; customizable industrial bus and control ports for integration with automation and sterilization systems
• Built-in printer and USB export (including test curves)
• Optional accessories: 1D/2D barcode scanner, lithium battery

Technical specifications

• Model: FIT-6.5
• Power supply: 100–260 VAC, 50 Hz, 120 W
• Operation pressure: 100–10000 mbar (1.5–145 psi)
• Display: 7-inch color touch screen
• Dimensions (mm): 400 (Depth) × 240 (Width) × 272/222 (Heights)
• Weight: 8 kg
• Functions: manual/basic/extensive bubble point, pressure holding, diffusion flow, water intrusion, ultrafiltration membrane test
• Test accuracy: upstream volume ≤±4%; bubble point ≤±50 mbar; diffusion flow ≤±4%; water intrusion ≤±0.01 ml
• Test ranges: BP 100–8000 mbar; DF 1–600 ml/min; WI 0.01–100 ml/min
• Applicable filters: symmetric/asymmetric membranes, needle filters, filter bags, flat filters, cartridges (large volume), ultrafiltration membranes and columns, irregular filters
• Data & connectivity: RS232/USB; USB export including curves; signal outputs (4–20 mA, RS485, 12 V alarm)
• Storage: more than 15,000 historical records
• Work mode & language: online/offline; Chinese/English
• Protection & environment: front panel IP65; applicable environment: above D level

Applications

• Validation and routine quality control of sterile filtration and ultrafiltration systems in pharmaceutical and biotech production, pilot plants and QC laboratories
• Testing of filter cartridges, membranes, filter bags, ultrafiltration columns and custom filtration modules

Compliance & data handling

• User authentication, password management, electronic signature and configurable audit trail to meet FDA 21 CFR Part 11 requirements
• Built-in printer and USB export for GMP documentation; customizable logs and reporting