NeuronBC Integtest V8.0 FDA 21 CFR Part 11-Compliant 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) |
| Display | 10-inch true-color capacitive touchscreen |
| Environmental Operating Conditions | 5–40 °C, 10–80% RH |
| Enclosure Rating | IP54 |
| Dimensions | 480 × 300 × 190 mm |
| Weight | 12 kg |
| Compliance | CE certified, FDA 21 CFR Part 11 compliant, GMP-aligned audit trail & electronic signature support |
Overview
The NeuronBC Integtest V8.0 is a fully validated, regulatory-grade filter integrity testing instrument engineered for pharmaceutical and biotechnology manufacturing environments where data integrity, process compliance, and reproducible bubble point, diffusion, and pressure hold testing are mission-critical. It implements standardized physical principles—including gas diffusion measurement under constant differential pressure, bubble point determination via controlled upstream pressurization, and pressure decay analysis—to quantitatively assess the integrity of hydrophobic and hydrophilic membrane filters, cartridge filters, and capsule filters used in sterile filtration processes. Designed to meet the stringent requirements of cGMP, ISO 13408-2, ASTM F838-22, and USP , the system delivers traceable, auditable, and tamper-evident test execution—ensuring that every integrity test supports regulatory submissions and inspection readiness.
Key Features
- FDA 21 CFR Part 11–compliant architecture with role-based user authentication, four-tier permission hierarchy, and configurable electronic signatures—fully supporting ALCOA+ data governance principles
- Integrated audit trail logging all critical events: user logins, parameter modifications, test executions, result approvals, configuration changes, and firmware updates—with immutable timestamps and operator identifiers
- Real-time dual-curve and triple-curve visualization: simultaneous display and printout of pressure vs. time, diffusion flow vs. pressure, and pressure hold decay profiles
- High-precision pressure sensing subsystem with low-drift, compensated transducers (±0.1% FS accuracy), enabling reliable testing over extended gas pathways up to 100 m in length
- Self-diagnostic boot sequence verifying sensor calibration status, pneumatic valve response, touchscreen responsiveness, thermal printer functionality, and communication port integrity
- IP54-rated enclosure with Staubli-compatible quick-connect fittings, dust- and splash-resistant design optimized for cleanroom Grade B environments
- Embedded thermal printer with archival-grade output (legible >10 years under ambient storage), eliminating ink or toner contamination risks inherent in laser or inkjet systems
- Multi-language interface (English/Chinese) with switchable pressure units (mbar, kPa, psi, kgf/cm²) and context-sensitive help accessible directly from each test screen
Sample Compatibility & Compliance
The Integtest V8.0 supports integrity verification of all standard sterile-grade filter configurations: single- and multi-element cartridges, pleated membrane capsules, flat-sheet filters, and hollow-fiber modules—regardless of material (PVDF, PTFE, nylon, cellulose acetate, polyethersulfone). It accommodates both offline benchtop validation and online in-situ testing integrated into skid-mounted filtration systems. All test methods align with ISO 13408-2 Annex A, ASTM F838-22 (for bacterial challenge correlation), and EU GMP Annex 1 requirements for filter qualification and routine use monitoring. The system’s electronic records satisfy FDA expectations for data retention, retrievability, and long-term readability per 21 CFR Part 11 Subpart B, including full export capability for raw test data, metadata, configuration files, and audit logs via USB 2.0.
Software & Data Management
Running on a hardened, real-time Linux OS, the V8.0 firmware provides deterministic test sequencing, memory-resident data buffering during transient network outages, and encrypted local storage. Test protocols are stored as version-controlled XML templates, supporting IQ/OQ/PQ documentation packages out-of-the-box. Audit trail entries are cryptographically hashed and timestamped using an internal hardware RTC synchronized to UTC. Data exports include CSV-formatted raw sensor streams, PDF reports with embedded digital signatures, and structured JSON payloads for LIMS or MES integration. Optional OPC UA or Modbus TCP gateways enable seamless connectivity to SCADA and automated sterilization control systems—facilitating closed-loop validation of SIP (steam-in-place) and CIP (clean-in-place) cycles.
Applications
- Final sterile filtration validation for bulk drug substances and finished dosage forms (injectables, ophthalmics, vaccines)
- Pre-use post-sterilization (PUPSIT) integrity confirmation in aseptic processing lines
- Filter lifecycle monitoring across multiple production batches under change control
- Supporting regulatory filings (IND, NDA, MAA) with fully documented, inspectable electronic records
- Qualification of ultrafiltration/diafiltration systems in bioprocessing (e.g., mAb purification trains)
- Environmental monitoring filter verification in HVAC and water-for-injection distribution loops
FAQ
Does the Integtest V8.0 support both forward-flow and pressure-rise diffusion testing?
Yes—it implements ASTM F3157-compliant forward-flow methodology and also supports pressure-rise mode for low-diffusion-rate membranes, with automatic switching based on measured flow thresholds.
Can audit trail data be exported in a format compatible with eDMS systems?
All audit logs are exportable as time-stamped, digitally signed CSV or XML files—structured to align with common enterprise document management schema (e.g., ISO 15489, ICH M5).
