NeuronBC IntegTest V8.0 Integrity Tester for Pharmaceutical Filtration Systems
| Brand | NeuronBC |
|---|---|
| Origin | Beijing, China |
| Model | V8.0 |
| Power Supply | 100–240 VAC, 50 Hz, 120 W |
| Operating Pressure Range | 100–10,000 mbar (max. 145 psi) |
| Environmental Operating Conditions | 5–40 °C, 10–80% RH |
| Display | 10-inch true-color touchscreen |
| Enclosure Rating | IP54 |
| Dimensions | 480 × 300 × 190 mm |
| Weight | 12 kg |
| Compliance | CE certified, FDA 21 CFR Part 11 compliant, GMP-aligned |
| Data Interface | RS232, USB, configurable industrial bus & wireless options (optional) |
| Maximum Test Configuration | 12-cartridge, 20-inch filter housing |
| Sensor Accuracy | High-precision pressure transducers with <±0.5% FS deviation |
| Audit Trail | Built-in, time-stamped, immutable event logging with user attribution |
| Language Support | English / Chinese |
| Pressure Units | mbar, kPa, psi, kgf/cm² |
| User Management | Four-tier role-based access control with customizable permissions and electronic signature support |
Overview
The NeuronBC IntegTest V8.0 is a fully integrated, GMP-compliant integrity tester engineered for deterministic validation of liquid and gas filtration systems across biopharmaceutical manufacturing, sterile processing, and upstream/downstream purification workflows. It operates on the fundamental physical principles of bubble point, diffusive flow (forward flow), and pressure hold testing—methods standardized in ASTM F838, ISO 13408-2, and USP <1207>. Unlike legacy instruments relying on proprietary real-time operating systems, the V8.0 implements a hardened, vendor-optimized Linux kernel to ensure deterministic process timing, memory stability, and long-term firmware maintainability. Its architecture supports both offline benchtop verification and online integration into automated skid-mounted or cleanroom-distributed filtration systems—enabling seamless alignment with Process Analytical Technology (PAT) frameworks and continuous monitoring strategies.
Key Features
- Triple-test methodology support: Bubble Point, Diffusive Flow, and Pressure Hold—with automatic method selection based on filter type, membrane chemistry, and wetting fluid parameters.
- 10-inch capacitive touchscreen interface with intuitive workflow navigation, context-sensitive prompts, and real-time graphical display of pressure vs. time, diffusion rate vs. pressure, and hold curve dynamics.
- High-fidelity pressure sensing: Dual calibrated transducers (low-range: 0–2,000 mbar; high-range: 0–10,000 mbar) delivering <±0.5% full-scale accuracy and thermal drift compensation across the operational temperature range.
- Extended pneumatic path capability: Optimized gas flow control enables reliable testing over tubing runs up to 100 meters—critical for large-scale bioreactor train or multi-vessel system validation without signal attenuation or delay artifacts.
- IP54-rated enclosure with Staubli-compatible quick-connect fittings, minimizing cross-contamination risk and eliminating misconnection errors during routine filter housing swaps.
- Built-in thermal printer with archival-grade media—capable of retaining legible printouts for ≥10 years under ambient storage conditions, satisfying long-term record retention requirements per ALCOA+ principles.
Sample Compatibility & Compliance
The IntegTest V8.0 validates hydrophilic and hydrophobic membranes—including PVDF, PES, nylon, PTFE, and cellulose esters—across single-use and stainless-steel housings up to 20 inches in length and 12 parallel cartridges. It accommodates standard pharmaceutical wetting fluids (e.g., water, isopropyl alcohol, ethanol/water blends) and supports custom wetting parameter tables for non-standard solvents. The instrument meets EU CE marking requirements under Directive 2014/30/EU (EMC) and 2014/35/EU (LVD). Its software architecture and data handling protocols are designed to satisfy FDA 21 CFR Part 11, Annex 11, and ICH GCP/GMP expectations for electronic records and signatures—including mandatory audit trail generation, user authentication, role-based permissions, and immutable log export (CSV/XML).
Software & Data Management
Firmware v8.0 introduces a modular, event-driven software architecture with embedded SQLite database for local storage of test results, configuration profiles, and audit events. All user actions—including login/logout, parameter edits, test initiation, result approval, and report export—are timestamped, digitally signed, and stored with full traceability. Data export supports USB mass storage mode: raw sensor streams (100 Hz sampling), processed test reports (PDF), configuration snapshots (JSON), and complete audit logs (CSV)—all cryptographically hashed to prevent post-hoc tampering. Optional network modules enable OPC UA or Modbus TCP integration for centralized SCADA/MES connectivity, while optional Wi-Fi/4G modules support remote diagnostics and secure cloud-based backup (TLS 1.2+).
Applications
- Pre-use post-sterilization integrity verification of sterilizing-grade filters in aseptic filling lines.
- Validation of tangential flow filtration (TFF) cassettes and hollow-fiber modules in bioprocessing.
- Post-use integrity assessment of virus removal filters following monoclonal antibody harvest.
- Periodic requalification of compressed air and nitrogen distribution systems per ISO 8573-1 Class 1 compliance.
- Supporting PQ protocol execution for single-use bioreactors and fluid management systems.
- Integration into automated SIP/CIP cycles via programmable digital I/O or industrial Ethernet interfaces.
FAQ
Does the IntegTest V8.0 support IQ/OQ/PQ documentation packages?
Yes—comprehensive qualification templates (including test scripts, acceptance criteria, and evidence mapping) are provided as part of the standard delivery package, aligned with ASTM E2500 and ISPE GAMP 5.
Can the instrument be validated for use in regulated environments requiring 21 CFR Part 11 compliance?
Yes—the system includes preconfigured electronic signature workflows, audit trail review tools, and password-protected user roles (Administrator, Supervisor, Operator, Viewer), all validated during factory release testing.
Is remote firmware update supported?
Firmware updates require authenticated USB media import; over-the-air updates are disabled by default to preserve regulatory stability—custom secure OTA can be enabled under controlled change control procedures.
What is the maximum allowable upstream volume for pressure hold testing?
The algorithm dynamically compensates for system compressibility; validated performance extends to total upstream volumes ≤ 50 L when using the high-accuracy transducer pair and optimized gas flow control.
Are calibration certificates traceable to national standards included?
Yes—each unit ships with a UKAS-accredited (or NIST-traceable) pressure transducer calibration certificate, valid for 12 months from date of shipment.
