NeuronBC Integtest V8.0 Filter Integrity Tester
| Brand | NeuronBC |
|---|---|
| Origin | Beijing, China |
| Model | V8.0 |
| Power Supply | 100–240 VAC, 50 Hz, 120 W |
| Operating Pressure Range | 100–10,000 mbar (145 psi) |
| Environmental Operating Conditions | 5–40 °C, 10–80% RH |
| Display | 10-inch true-color touchscreen |
| Enclosure Rating | IP54 |
| Weight | 12 kg |
| Dimensions (L×W×H) | 480 × 300 × 190 mm |
| Compliance | CE certified, compliant with EU GMP Annex 1, USP <1207>, EP 5.1.1, FDA 21 CFR Part 11, ISO 13408-2 |
Overview
The NeuronBC Integtest V8.0 Filter Integrity Tester is a fully integrated, regulatory-compliant instrument engineered for deterministic integrity verification of sterilizing-grade and ultrafiltration membranes and filter assemblies used in pharmaceutical, biotechnology, and aseptic manufacturing environments. It operates on the fundamental physical principles of bubble point, diffusive flow (forward flow), and pressure hold testing—methods explicitly referenced in USP , European Pharmacopoeia Chapter 5.1.1, and ISO 13408-2. Unlike generic pressure test systems, the V8.0 implements calibrated gas diffusion measurement and real-time pressure decay modeling using thermally compensated, high-stability pressure transducers with traceable NIST-equivalent calibration. Its architecture supports both offline benchtop validation and online integration into skid-mounted or cleanroom-embedded filtration systems, enabling seamless execution of pre-use post-sterilization (PUPSIT) and post-use integrity testing protocols required under EU GMP Annex 1.
Key Features
- Multi-method integrity testing platform supporting bubble point, diffusive flow, and pressure hold—each executed per pharmacopeial algorithmic logic and configurable pass/fail criteria.
- Real-time triple-curve visualization: simultaneous display and printout of pressure vs. time, diffusion flow vs. pressure, and pressure decay rate vs. time—enabling root-cause analysis of non-conformance events.
- Embedded Linux-based control system with deterministic real-time scheduling, ensuring consistent test timing, data sampling resolution (≤100 ms), and deterministic I/O response—critical for audit-ready reproducibility.
- IP54-rated enclosure with Staubli-compatible quick-connect fluidic interfaces, minimizing connection errors and supporting operation in classified B-grade environments.
- Integrated thermal printer with pigment-based media, delivering archival-quality hardcopy reports with ≥10-year legibility—free from solvent, oil, or particulate contamination risks associated with inkjet or laser systems.
- Extended pneumatic path capability: validated performance up to 100 m tubing length with upstream volume compensation algorithms, eliminating false rejections due to system compliance artifacts.
- Four-tier user management with role-based permissions, electronic signatures, and mandatory password policies—fully aligned with FDA 21 CFR Part 11 requirements for electronic records and signatures.
Sample Compatibility & Compliance
The Integtest V8.0 accommodates a comprehensive range of pharmaceutical-grade filtration configurations: disc membranes (Φ25 mm to 300 mm), standard cartridges (2.5″ to 40″, 1–15 elements), capsule filters, mini-cartridges, vent filters, and ultrafiltration modules. It validates integrity across hydrophilic (e.g., PVDF, PES) and hydrophobic (e.g., PTFE, PP) membrane chemistries. All test methods are implemented in strict accordance with USP Annexes A–C, EP 5.1.1, and ISO 13408-2. The system includes built-in self-diagnostics covering pressure sensor linearity, valve actuation timing, leak integrity of internal manifolds, and touchscreen responsiveness—executed automatically at power-on and available on-demand. Full CE marking confirms conformity with the EU Medical Device Regulation (MDR) 2017/745 essential requirements for safety and performance.
Software & Data Management
Firmware version V8.0 incorporates an audit-trail subsystem that captures timestamped records of all critical user actions—including method selection, parameter modification, test initiation/abort, result approval/rejection, user login/logout, and configuration changes. Audit logs are immutable, digitally signed, and exportable in CSV or PDF format via USB 2.0 port. Raw sensor data (pressure, temperature, flow), intermediate calculation variables, and final test reports—including annotated curve plots—are stored in a structured binary archive with SHA-256 hash integrity verification. Optional RS232, analog 4–20 mA, and Modbus TCP interfaces support integration into MES, SCADA, or automated sterilization control systems. All data exports retain full traceability to original acquisition context, satisfying ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) principles.
Applications
- Pre-use post-sterilization integrity testing (PUPSIT) of sterilizing filters in bioreactor harvest lines.
- Final filter validation prior to aseptic filling in vial or syringe manufacturing suites.
- Integrity verification of compressed air and nitrogen distribution filters in Grade A/B environments.
- Ultrafiltration/diafiltration system qualification during process development and tech transfer.
- Supporting regulatory submissions with fully documented, reproducible test evidence meeting EMA, FDA, and PMDA expectations.
- In-process monitoring of filter performance degradation during extended-use campaigns (e.g., viral clearance studies).
FAQ
Does the Integtest V8.0 support both hydrophilic and hydrophobic membrane testing?
Yes—it executes bubble point, diffusive flow, and pressure hold tests on all common pharmaceutical membrane types, including PVDF, PES, nylon, PTFE, and polypropylene, with method-specific wetting and equilibration guidance embedded in the software.
Can test data be exported in a format compatible with LIMS or ELN systems?
Yes—raw data, reports, and audit logs export via USB in CSV, XML, and PDF formats, all retaining full metadata, digital signatures, and hash-verified integrity.
Is the instrument qualified for use in Grade A cleanrooms?
While the unit itself is rated IP54 for B-grade environments, it is routinely deployed in Grade A zones via remote operation and integrated pneumatic routing; full cleanroom compatibility requires site-specific risk assessment per ISO 14644-1.
What validation documentation is provided with the system?
Factory-issued IQ/OQ protocols, calibration certificates traceable to national standards, software verification summary (SVS), and 21 CFR Part 11 implementation report are included in the delivery package.
How does the V8.0 handle large-volume upstream systems (e.g., >10 L) during pressure hold testing?
The firmware applies dynamic upstream volume compensation using real-time temperature-corrected compressibility models, maintaining ±0.5% pressure stability over 30-minute holds—even with 100 m tubing runs and variable vessel volumes.
