Product Introduction
This Filter Integrity Tester runs on self‑optimized Linux, supporting on‑line/off‑line tests and ultrafiltration system verification. It features a 10‑inch touchscreen, IP54 rating, 1000 pre‑saved protocols and full audit trail complying with 21 CFR Part 11. Equipped with thermal printer and rich interfaces, it holds CE certification for pharmaceutical applications.
Product feature
- Powerful functions covering all existing standard test methods for filter integrity.
- Equipped with a 10‑inch true‑color touch screen, delivering user‑friendly HMI for simple, fast and reliable operation.
- Supports both off‑line and on‑line testing. High‑accuracy pressure sensors with lower tolerance bands are deployed to improve instrument measurement precision.
- Automatic self‑diagnosis function. Multiple internal performances are self‑checked upon power‑on, and faults will be reported promptly once detected.
- The first domestic instrument enabling integrity testing for ultra-filtration systems; capable of testing ultra-filtration cassettes and hollow‑fiber cartridges (adapters to be provided by user).
- Scientific privilege management design with password login, hierarchical permission control and electronic signature. Electronic records comply with 21 CFR Part 11; calibration conforms to 21 CFR 820.72. Multi‑level user access rights are configurable to guarantee data integrity. Comprehensive audit‑trail function supports manual and electronic signatures.
- Up to 1000 pre‑saved test protocols are available to accommodate various filter cartridge types and diverse on‑site test conditions for simpler and smarter instrument operation.
- USB data export supported. Raw test data, source data and configuration data can all be exported to fully meet data‑integrity requirements.
- Integrated thermal printer eliminates risks of particle and ink contamination. Printouts can remain legible for more than 10 years under proper storage conditions.
- Custom external interfaces are available upon request to facilitate customer‑side automatic control and management.
- Bilingual operation interface for Chinese and English.
- Free switching among multiple pressure units (mbar, kPa, psi, kgf/cm²).
- This instrument has EU CE certification.
Product Parameter
| parameter | Specification |
| Power Supply | 110~250VAC, 50HZ,120W |
| Operation Pressure | 100~10000 mbar(150psi) |
| Unit | Mbar,kPa,psi,kgf/cm² |
| Operation Condition | Ambient Temperature: +5℃~+40℃；Relative Humidity: 10~80% |
| Dimension (mm) | 480(Depth)×300(Width)×190(Height) |
| Function | Manual Bubble Point Test、Basic Bubble Point Test、Combined BP+DF、 Pressure Holding Test、Diffusion Flow Test、Water Intrusion Test;Ultrafiltration Membrane Test |
| Test Accuracy | Net Volume Test： ±4%； Bubble Point Test： ±50mbar; Diffusion Flow Test： ±4%； Water Intrusion Test： ±0.01ml |
| Test Scope | Bubble Point Test： 100~8000mbar； Diffusion Flow Test： 1~1000ml/min； Water Intrusion Test： 0.01~100ml/min |
| Applied Range | Symmetric and asymmetric membrane test、 Needle filters、 Capsule filters、 Flat filters、 Cartridge filters (within12 cores and 20 inches)、 Ultrafiltration membrane packages、 Ultrafiltration columns、 Various irregular filters. |
| Audit Trail | Audit trail records can exportable and irreversible. |
| Access Management | User Name and Password to Login,4 Authority Grades, compliance with the FDA 21 CFR PART 11. |
| Program | 1000 / Sets |
| Audit trail record storage | ≥5 Years storage |
| Anti‑backflow (liquid) device | Customization |
| Number of users | 1000 / Set |
| Operating System | Linux System |
| Operation Interface | Chinese and English bilingual operation interface |
| Dustand Splash Level | IP54,Front is IP65 |
| Print Function | Built‑in Printer and support PC connection. |
| Historical Record | 300,000 sets records storage (Unlimited storage export via USB). |
| Records Copy | Support USB disk to export (include test curve). |
| Display Screen | High definition 10‑inch,color touch screen. |
| Serial Connection | RS232 Serial Port, USB Interface; Wireless Connection Supported. |
| Language | Chinese/English/Russian/Spanish |
| Work Mode | Online/Offline |
| Applicable Environment | Above D level |
| Signal Output | (4‑20) mA、RS485、12V Alarm Output /Customizable Communication Protocol (Optional) |
| Weight | 10KG |
Application：
