Integrity tester FIT-8.0

bubble pointflowmicro flow

Features

• Comprehensive support for all common filter integrity test methods
• Optimized Linux-based control system for stability and reliability
• Streamlined test procedures to reduce total test time
• 10-inch true-color touchscreen with intuitive HMI for fast, reliable operation
• High-accuracy pressure sensors to support online and offline testing and improve measurement precision
• Automatic multi-function self-test at power-on with fault reporting
• Pioneering domestic implementation of ultrafiltration system integrity testing
• Secure user management: password login, user roles, electronic signature compliant with GMP and FDA 21 CFR Part 11; multi-level access control and manual or electronic signatures
• Built-in audit trail meeting data integrity requirements
• Up to 1000 pre-stored program sets to cover multiple filter types and test conditions
• Display and print of diffusion flow–pressure curve; supports three-curve output
• Optimized air intake control for faster, stable pressurization

Additional features and functions

• USB export of raw test data, source and configuration files; single-test PDF export
• Expandable communications and network interfaces; optional wireless connectivity
• Instrument enclosure optimized to IP54 (overall) and IP65 front; quick connectors to prevent incorrect inlet/outlet connections
• Queryable and exportable test records and audit trails
• High-precision sensors and algorithms allow gas line extension up to 100 m for accurate upstream volume testing in the field
• Built-in thermal printer to avoid contamination and preserve long-term legibility under appropriate conditions
• Customizable external interfaces for automated control and system integration
• Chinese/English bilingual interface
• Multiple pressure units selectable (mbar, kPa, psi, kgf/cm2)
• Support for 1000 user accounts and four user levels with flexible authority configuration
• Capable of testing most filter cartridges up to 12-core, 20-inch to improve workflow efficiency
• Rich data interfaces: standard RS232 and USB; optional industrial buses and analog control ports for intelligent upgrades (e.g., online full automation with bioburden control systems)
• Independent R&D team available for custom solutions and technical support for filtration system design

Specifications (table view)
Model | FIT-8.0
Power Supply | 100–240 VAC, 50 Hz, 120 W; spare battery (optional)
Operation Pressure | 100–10,000 mbar (150 psi)
Unit | mbar, kPa, psi, kgf/cm2
Operation Condition | Ambient Temperature: +5°C ~ +40°C; Relative Humidity: 10–80%
Dimension (mm) | 480 (Depth) × 300 (Width) × 210 (Height)
Function | Manual Bubble Point Test; Basic Bubble Point Test; Extensive Bubble Point Test; Pressure Holding Test; Diffusion Flow Test; Water Immersion Test; Ultrafiltration Membrane Test
Test Accuracy | Upstream Volume Test: ±4%; Bubble Point Test: ±50 mbar; Diffusion Flow Test: ±4%; Water Immersion: ±0.01 ml
Test Scope | Bubble Point: 100–8000 mbar; Diffusion Flow: 1–900 ml/min; Water Immersion: 0.01–100 ml/min
Applied Range | Symmetric and asymmetric membranes; needle, capsule, flat and cartridge filters (up to 12 cores, 20 inches); ultrafiltration packages and columns; irregular filters
Audit Trail | Exportable and irreversible audit trail; storage ≥ 5 years; 32 event logs, exportable and immutable
Authority Management | Username/password login; four authority levels; meets FDA 21 CFR Part 11 requirements
Reservation Programs | 1000 sets
Historical Records | Storage for ~300,000 test records
Records Export | USB export including test curves; single-test PDF export
Display Screen | High-definition 10-inch color touchscreen
Serial Connection | RS232/USB; supports wireless connection
Language | Chinese/English bilingual
Work Mode | Online/Offline
Applicable Environment | Grade B or above
Battery | Customizable
Weight | 10 kg

Technical specifications

• Model: FIT-8.0
• Power supply: 100–240 VAC, 50 Hz, 120 W; optional backup battery
• Operation pressure range: 100–10,000 mbar (up to 150 psi)
• Units supported: mbar, kPa, psi, kgf/cm2
• Operating conditions: +5°C to +40°C; relative humidity 10–80%
• Dimensions (mm): 480 (Depth) × 300 (Width) × 210 (Height)
• Supported tests: manual/basic/extended bubble point, pressure hold, diffusion flow, water immersion, ultrafiltration membrane test
• Test accuracy: upstream volume ±4%; bubble point ±50 mbar; diffusion flow ±4%; water immersion ±0.01 ml
• Test ranges: BP 100–8000 mbar; DF 1–900 ml/min; WI 0.01–100 ml/min
• Applicable filters: symmetric/asymmetric membranes, needle/capsule/flat/cartridge (≤12 cores, 20 in), ultrafiltration packages and columns, irregular filters
• Audit trail: exportable, irreversible; storage ≥ 5 years; comprehensive event logs
• User & authority management: username/password, up to 1000 users, 4-level authority, FDA 21 CFR Part 11 compliant
• Pre-stored programs: 1000 sets
• Historical record capacity: ~300,000 sets
• Data export: USB including test curves; single-test PDF output
• Printer: built-in thermal printer; PC control supported
• Display: 10-inch high-definition color touchscreen
• Connectivity: RS232, USB; optional wireless and customizable industrial buses
• Languages: Chinese and English
• Protection rating: IP54 overall, front IP65
• Weight: 10 kg