Professional Filter Integrity Tester | FDA-Compliant Solutions for Pharma & Biotech
Short Description:
Automated filter integrity testing systems with 0.1μm resolution. Validated per ASTM F838 & EU GMP Annex 1 requirements.
FDA-Approved Filter Integrity Testing Solutions
Ensure 100% compliance in critical filtration processes with our AI-powered filter testers:
✔ Pharmaceutical Grade
Validated for sterile filtration (0.22μm/0.45μm filters)
Full 21 CFR Part 11 compliance with electronic signatures
✔ Multi-Industry Ready
Semiconductor UPW systems
Food & beverage sterile filtration
Vaccine production lines
✔ Smart Automation
Auto-calibration with NIST-traceable standards
4-hour continuous testing capacity
FDA 21 CFR Part 11 compliant
CE marked (2014/68/EU)
ISO 9001:2015 certified manufacturing
◎ Parameters
| Power Supply | 100–240 VAC, 50HZ, 120W Spare battery（Operational） |
| 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) × 210(Height1) |
| Function | Manual Bubble point Test；Basic Bubble Point Test；Extensive Bubble Point Test； Pressure Holding Test；Diffusion FLow Test；Water Immersion Test；Ultrafitration Membrane Test |
| Test Accuracy | Upstream Volume Test：± 4%；Bubble Point Test：± 50mbar ； Diffusion Flow Test：± 4% ；Water Immersion：± 0.01ml |
| Test Scope | BP：100-8000mbar DF：1-900ml/min WI：0.01-100ml/min |
| Applied Range | Symmetric and asymmetric membrane test, needle filters, capsule filters, flat filters, cartridge filters (within 12 cores and 20 inches), ultrafiltration membrane packages, ultrafiltration columns, various irregular filters |
| Audit Trial | Audit trail records can exportable and ireeversible |
| Authority Management | User Name and Password to Login ,4 Authority Grades，meeting the FDA 21CFR PART 11requirements |
| Reservation Solution(programs) | 1000sets |
| Audit trail record storage | ≥5 years storage |
| Anti-backflow(liquid) device | Customization |
| Number of users | 1000sets |
| Operating System | Linux system |
| Operation Interface | Chinese and English bilingual operation interface |
| Dust and splash level | IP54 |
| Print Function | Built-in printer，can control on PC；choose subject |
| Historical Record | 300000 sets records storage |
| Records Copy | Support USB disk to export （include test curve）； |
| Display Screen | High definition 10 inch ,color touch screen; |
| Serial Connection | RS232/USB/Support wireless connection; |
| Language | Chinese/English |
| Work Mode | Online/Offline |
| Applicable Environment | Above D level |
| Weight | 10KG |
