NeuronBC Integtest V6.5 Filter Integrity Tester
| Brand | NeuronBC |
|---|---|
| Origin | Beijing, China |
| Manufacturer Type | Authorized Distributor |
| Country of Origin | China |
| Model | Integtest V6.5 |
| Price | USD 11,200 (approx.) |
| Power Supply | 100–240 VAC, 50 Hz, 120 W |
| Operating Pressure Range | 100–10,000 mbar (14.5–145 psi) |
| Temperature Range | +5 °C to +40 °C |
| Relative Humidity | 10–80 % RH |
| Dimensions (L×W×H) | 400 × 240 × 270 mm (main unit), +220 mm (height with display stand) |
| Weight | 8 kg |
| Bubble Point Accuracy | ±50 mbar |
| Diffusive Flow Accuracy | ±4 % |
| Water Intrusion Accuracy | ±0.01 mL |
| Net Volume Measurement Accuracy | ±4 % |
| Bubble Point Range | 100–8,000 mbar |
| Diffusive Flow Range | 1–600 mL/min |
| Water Intrusion Range | 0.01–100 mL/min |
| Pre-stored Protocols | 80 |
| Audit Trail Events | 16+ traceable parameters (user, timestamp, method, pressure ramp, pass/fail status, etc.) |
| Data Storage | >5,000 test records (unlimited with USB backup) |
| Display | 7" high-resolution color touchscreen |
| Interface | RS232, USB, optional industrial bus modules (e.g., Modbus RTU/TCP, Profibus DP, analog 4–20 mA output) |
| Language Support | English & Chinese |
| Compliance | Fully aligned with FDA 21 CFR Part 11 (electronic signatures, role-based access control, audit trail, data immutability) and supports GLP/GMP validation protocols |
Overview
The NeuronBC Integtest V6.5 is a fully integrated, regulatory-compliant filter integrity tester engineered for pharmaceutical, biotechnology, and sterile manufacturing environments. It implements standardized physical test principles—including bubble point, diffusive flow (forward flow), pressure hold (decay), water intrusion, and enhanced bubble point—to verify the structural integrity of hydrophobic and hydrophilic membrane filters across diverse configurations. The instrument operates on the fundamental principle that intact microporous membranes retain gas under controlled pressure until the critical bubble point is reached; deviations in gas flow or pressure decay directly correlate with defect size and distribution. Designed for both offline benchtop verification and online integration into automated sterilization-in-place (SIP) and clean-in-place (CIP) systems, the V6.5 delivers deterministic, repeatable results traceable to ISO 13408-2, ASTM F838-22, and USP guidance.
Key Features
- Comprehensive test methodology coverage: manual and automated bubble point, enhanced bubble point, pressure hold, diffusive flow, water intrusion, and ultrafiltration (UF) membrane package testing—validated for symmetric and asymmetric membranes.
- Regulatory-grade software architecture compliant with FDA 21 CFR Part 11: four-tier user permission hierarchy, encrypted electronic signatures, mandatory password policy, and immutable audit trail recording 16+ event parameters per test (e.g., operator ID, timestamp, test method, applied pressure profile, result status, calibration state).
- High-throughput capability: supports integrity testing of multi-cartridge assemblies up to 9-core, 20-inch filter housings—reducing batch release cycle time without compromising measurement fidelity.
- Modular hardware interface design: standard RS232 and USB ports; optional field-configurable industrial communication modules (Modbus RTU/TCP, Profibus DP, 4–20 mA analog output) enable seamless integration into SCADA, MES, and fully automated SIP control systems.
- Intuitive human-machine interface: 7-inch capacitive color touchscreen with dual-language support (English/Chinese), real-time graphical pressure vs. time curves, and context-sensitive soft keys for rapid protocol navigation.
- Robust data governance: onboard micro-printer for immediate hardcopy reports; >5,000 test records stored internally; full dataset export (including raw pressure-time curves) via USB flash drive with CSV and PDF report generation.
Sample Compatibility & Compliance
The Integtest V6.5 accommodates a broad spectrum of filtration devices used in aseptic processing and purification workflows: syringe filters, capsule filters, flat-sheet membranes, cartridge filters (single- and multi-core), pleated cylindrical housings (≤20 inch length, ≤9 cores), hollow-fiber UF modules, and custom-shaped membranes. Its pressure control system (100–10,000 mbar) and calibrated flow sensors ensure accurate detection of defects down to sub-micron levels across hydrophilic (e.g., PVDF, PES, nylon) and hydrophobic (e.g., PTFE, PP) media. All firmware and software components are validated per GAMP 5 guidelines and support IQ/OQ/PQ documentation packages. The system meets ISO 9001:2015 quality management requirements and aligns with EU Annex 1 (2022), WHO TRS 986, and PIC/S PI 036-3 expectations for data integrity in sterile product manufacturing.
Software & Data Management
Firmware v3.2.x incorporates a deterministic real-time operating system (RTOS) ensuring deterministic execution timing for pressure ramping, flow sampling, and pass/fail logic evaluation. Test data—including raw sensor timestamps, pressure setpoints, measured flow rates, and calculated integral values—is written to non-volatile memory immediately upon acquisition. Audit trail entries are cryptographically sealed and cannot be edited or deleted. Electronic signatures require dual authentication (username/password + role-specific approval token) for critical actions such as protocol modification or result override. Data export supports CSV (for LIMS ingestion) and PDF/A-1b (archival-compliant) formats, both embeddable with digital signatures and hash verification metadata. Optional cloud-sync module enables secure TLS 1.3–encrypted remote data forwarding to centralized validation servers.
Applications
- Pre-use post-sterilization integrity verification of vent filters, process filters, and final fill filters in bioreactor trains and buffer preparation systems.
- Post-use integrity confirmation of tangential flow filtration (TFF) cassettes and hollow-fiber modules in monoclonal antibody and vaccine purification suites.
- Validation of water-for-injection (WFI) and pure steam distribution loop filters per USP and EC Guide to Good Manufacturing Practice Annex 1.
- Supporting risk-based filter qualification per ISO 13408-2, including worst-case challenge studies using Brevundimonas diminuta for 0.22 µm-rated filters.
- Integration into automated SIP sequences where pressure hold tests trigger cascade logic for steam valve actuation and temperature ramp validation.
FAQ
Does the Integtest V6.5 support IQ/OQ protocol templates for GMP validation?
Yes—NeuronBC provides vendor-qualified IQ/OQ documentation packages compliant with ASTM E2500 and ISPE Baseline Guide Vol. 5, including installation checklists, operational boundary verification matrices, and electronic record integrity test scripts.
Can the instrument perform water intrusion testing on hydrophobic PTFE filters?
Yes—the V6.5 includes dedicated water intrusion mode with programmable wetting pressure ramp, dwell time, and volumetric displacement measurement calibrated to ±0.01 mL accuracy.
Is remote firmware update supported over USB or network?
Firmware updates are performed exclusively via authenticated USB drive with SHA-256 signature verification; network-based updates are disabled by default to maintain air-gap security in regulated environments.
What is the maximum allowable test duration for pressure hold tests?
The system supports configurable hold durations from 10 seconds to 24 hours, with real-time drift compensation algorithms to correct for ambient temperature-induced pressure fluctuations.
How does the system handle multi-cartridge testing with differential flow paths?
The V6.5 employs dynamic pressure balancing and sequential isolation valves to isolate individual cartridges within a multi-core housing, enabling independent integrity assessment without cross-contamination or shared-path interference.
