Nuyin Integtest 6.0 Filter Integrity Tester
| Origin | Beijing, China |
|---|---|
| Manufacturer Type | Authorized Distributor |
| Origin Category | Domestic (China) |
| Model | 6.0 |
| Price | USD 11,800 (approx.) |
| Power Supply | 100–240 VAC, 50 Hz, 120 W |
| Operating Pressure Range | 100–10,000 mbar (14.5–145 psi) |
| Environmental Operating Conditions | 5–40 °C, 10–80% RH |
| Dimensions (mm) | 400 D × 240 W × 270 H₁ × 220 H₂ |
| Weight | 8 kg |
| Bubble Point Accuracy | ±50 mbar |
| Diffusion Flow Accuracy | ±4% |
| Water Intrusion Accuracy | ±0.01 mL |
| Net Volume Test Accuracy | ±4% |
| Bubble Point Range | 100–8,000 mbar |
| Diffusion Flow Range | 1–600 mL/min |
| Water Intrusion Range | 0.01–100 mL/min |
| Pre-stored Protocols | 80 |
| Audit Trail Events | 16+ logged parameters (user, timestamp, method, pressure, flow, pass/fail status, etc.) |
| Data Storage Capacity | >5,000 test records (unlimited with USB backup) |
| Display | 7" high-resolution color touchscreen |
| Interface Options | RS232, USB, optional industrial bus (e.g., Modbus TCP, Profibus DP) and analog I/O |
| Language Support | English & Chinese |
| Compliance | Fully aligned with USP <1207>, EP 2.6.27, ISO 13408-2, and FDA 21 CFR Part 11 requirements for electronic records and signatures |
Overview
The Nuyin Integtest 6.0 Filter Integrity Tester is a fully compliant, laboratory- and manufacturing-grade instrument engineered for deterministic, repeatable integrity verification of sterilizing-grade membrane filters and filtration systems used in biopharmaceutical, aseptic processing, and parenteral manufacturing environments. It operates on the fundamental physical principles of gas diffusion, capillary flow, and liquid displacement—enabling precise quantification of pore size distribution and defect detection via standardized methods including Forward Flow (Diffusion), Bubble Point, Pressure Hold (Pressure Decay), Water Intrusion, and Enhanced Bubble Point testing. Designed to meet the stringent data integrity and regulatory expectations of global pharmaceutical quality systems, the Integtest 6.0 implements hardware-enforced audit trail logging, role-based access control, and cryptographic electronic signature capability—ensuring full traceability from test initiation through final report generation.
Key Features
- Comprehensive method coverage: Supports all major regulatory-compliant integrity test types—Diffusion Flow, Bubble Point, Pressure Hold, Water Intrusion, and Enhanced Bubble Point—as defined in USP , EP 2.6.27, and ISO 13408-2.
- FDA 21 CFR Part 11 compliance architecture: Four-tier user permission levels, password-protected login, mandatory electronic signatures for critical actions (e.g., test start, result approval), and tamper-evident audit trail storage with time-stamped event sequencing.
- Robust audit trail system: Records ≥16 discrete operational events per test—including operator ID, timestamp, selected protocol, applied pressure, measured flow, temperature compensation, pass/fail determination, and instrument configuration—stored in non-volatile memory with chronological indexing and export capability.
- High-capacity protocol management: Stores up to 80 pre-configured test protocols with customizable parameters (test duration, pressure ramp rate, stabilization delay, pass criteria), enabling rapid deployment across diverse filter configurations without manual reconfiguration.
- Scalable physical testing capability: Accommodates filter assemblies up to 9-cartridge, 20-inch housings—supporting validation of complex multi-element sterile filtration trains commonly deployed in large-scale bioreactor harvest or buffer preparation lines.
- Flexible integration-ready interface suite: Standard RS232 and USB ports; optional industrial communication modules (Modbus TCP, Profibus DP, 4–20 mA analog outputs) facilitate seamless integration into SCADA, MES, or fully automated SIP/CIP control architectures.
Sample Compatibility & Compliance
The Integtest 6.0 validates integrity across symmetric and asymmetric membranes—including hydrophilic and hydrophobic variants—across disc formats (Φ25 mm to Φ300 mm), standard cartridges (2.5″ to 40″, 1–15 cores), capsule filters, mini-cartridges, flat-sheet filters, hollow-fiber ultrafiltration modules, and irregularly shaped process filters. It is routinely deployed for air/gas filter qualification in HVAC and compressed gas systems, as well as for integrity assurance of ultrafiltration columns in downstream purification workflows. All test algorithms and calibration routines are traceable to NIST-certified pressure and flow standards. The instrument’s firmware and software architecture comply with GMP Annex 1 (Grade A/B environments), EU GMP Annex 11, and FDA guidance on computerized system validation (CSV), supporting both prospective and retrospective validation protocols.
Software & Data Management
Data integrity is enforced at the firmware level: every test generates a self-contained, digitally signed record containing raw sensor data, interpolated curves (e.g., diffusion vs. time, pressure decay slope), metadata, and operator credentials. Historical records (>5,000 entries) reside in internal flash memory with automatic rollover and full USB mass-storage export—including CSV, PDF reports, and binary .dat files preserving original acquisition resolution. The embedded 7″ capacitive touchscreen provides intuitive navigation in either English or Chinese, with real-time graphing of pressure and flow dynamics during test execution. Optional PC software enables advanced trending analysis, statistical process control (SPC) charting, and automated report generation compliant with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).
Applications
- Pre-use post-sterilization integrity testing of sterilizing-grade filters in biomanufacturing suites.
- Final filter validation prior to aseptic filling operations under Grade A conditions.
- Periodic in-process integrity monitoring of vent filters in bioreactors and media tanks.
- Water intrusion testing of hydrophobic PTFE and PVDF filters used in compressed air and nitrogen systems.
- Diffusion flow qualification of ultrafiltration cassettes during TFF system setup and cleaning validation.
- Supporting regulatory submissions (e.g., IND, BLA, MAA) with auditable, Part 11–compliant test documentation packages.
FAQ
Does the Integtest 6.0 support electronic signatures per FDA 21 CFR Part 11?
Yes—the instrument implements role-based digital signing with unique user authentication, biometric-equivalent password enforcement, and immutable signature binding to each test record.
Can test data be exported in machine-readable format for LIMS integration?
Yes—USB export delivers timestamped CSV and binary data files compatible with common LIMS, ELN, and statistical analysis platforms.
Is calibration traceable to international standards?
All pressure and flow sensors are factory-calibrated against NIST-traceable reference standards, with calibration certificates provided upon request.
What environmental conditions are required for operation?
Ambient temperature: 5–40 °C; relative humidity: 10–80% non-condensing; no vibration or EMI sources within 1 m.
How is audit trail integrity protected against tampering?
Audit logs are written to write-once memory segments with cryptographic hash chaining; modification attempts trigger immediate system alert and log corruption flagging.
