NeuronBC Integtest V4.0 Filter Integrity Tester

Overview

The NeuronBC Integtest V4.0 Filter Integrity Tester is a fully automated, regulatory-compliant instrument engineered for quantitative integrity verification of hydrophilic and hydrophobic membrane filters used across pharmaceutical, biotechnology, and sterile manufacturing processes. It implements three primary ASTM- and ISO-aligned test methods—diffusive flow (ASTM F838), pressure hold (bubble point), and water intrusion (ISO 15717)—to validate pore structure integrity prior to and after filtration operations. Unlike empirical pass/fail systems, the V4.0 performs real-time net volume measurement during pressurization, correcting for system compressibility and temperature-induced gas expansion to deliver traceable, repeatable results aligned with FDA Guidance for Industry on Sterile Filtration (2022) and EU Annex 1 (2022). Its dual-pressure architecture enables precise control over ramp rates and stabilization thresholds, minimizing mechanical stress on filter media while maintaining compliance with USP and ISO 13408-2 requirements for non-destructive integrity assessment.

Key Features

• Fully automated gas delivery system with programmable ramp rate and pressure-hold profiling—eliminates operator-dependent variability in pressure application.
• Real-time net volume calibration: measures actual gas displacement during pressurization to correct for system compressibility, improving bubble point repeatability to ±50 mbar and diffusive flow accuracy to ±4%.
• Integrated water intrusion module—the first commercially deployed implementation of ISO 15717 methodology in mainland China—enabling validated integrity testing of hydrophobic PTFE, PVDF, and polypropylene filters without pre-wetting solvents.
• 5.7″ monochrome TFT LCD with adjustable backlight ensures legibility under cleanroom lighting conditions (ISO Class B ambient); supports both English and Chinese UI navigation.
• Onboard thermal micro-printer provides immediate hardcopy output compliant with ALCOA+ data integrity principles; all reports include timestamp, operator ID, filter ID, test parameters, and raw curve data.
• RS232 serial interface enables bidirectional communication with LIMS or MES platforms; supports CSV export of full test datasets including pressure vs. time and flow vs. time profiles.

Sample Compatibility & Compliance

The Integtest V4.0 accommodates a broad range of single- and multi-element configurations, including syringe filters (13–25 mm), capsule filters (10–100 cm²), flat-sheet membranes (up to 100 × 100 mm), and cylindrical cartridges (≤3 elements, ≤20 inches). It supports both symmetric (e.g., cellulose acetate) and asymmetric (e.g., PVDF, nylon) architectures. All test modes comply with current Good Manufacturing Practice (cGMP) expectations for audit readiness: electronic records meet FDA 21 CFR Part 11 requirements via configurable user authentication, electronic signatures, and immutable audit trails. The device has been validated per IQ/OQ protocols against ICH Q5A and ISO 13408-2 for use in viral clearance validation studies and final sterile filtration release testing.

Software & Data Management

Firmware v4.2 includes embedded data governance logic: each test record stores metadata (date/time, operator ID, filter lot, test mode, pressure setpoint, dwell time), raw sensor outputs (pressure, flow, temperature), and calculated pass/fail status per USP acceptance criteria. Up to 500 complete test histories are retained onboard with cyclic overwrite protection. Data export via RS232 supports GLP/GMP-aligned reporting formats—including PDF summaries and ASCII-delimited time-series logs—for integration into electronic quality management systems (eQMS). Optional PC-based software (IntegView Pro) provides advanced curve fitting, statistical trend analysis, and deviation alerting based on historical control limits.

Applications

• Pre-use integrity verification of sterilizing-grade filters in bioprocess fluid paths (e.g., harvest, buffer, formulation).
• Post-use integrity confirmation following terminal sterilization or cleaning-in-place (CIP) cycles.
• Validation of filter performance across multiple batches in QC release testing per pharmacopoeial standards (USP, EP, JP).
• Water intrusion testing of hydrophobic vent filters in compressed air and nitrogen systems—critical for ISO 8573-1 Class 0 compressed gas certification.
• Diffusive flow quantification for low-flux filters where bubble point exceeds practical operating pressure limits.
• Supporting regulatory submissions requiring documented evidence of filter robustness under process-relevant differential pressures.

FAQ

Does the Integtest V4.0 support 21 CFR Part 11 compliance?

Yes—when operated with configured user roles, electronic signatures, and audit-trail enabled firmware, it satisfies electronic record and signature requirements for regulated environments.
Can it test multi-cartridge housings simultaneously?

No—it evaluates one filter assembly per test cycle; multi-element housings require sequential testing per element with appropriate isolation valving.
Is calibration traceable to national standards?

Yes—pressure transducers are factory-calibrated against NIST-traceable references; users may perform field verification using certified deadweight testers.
What maintenance is required for long-term reliability?

Annual verification of leak integrity, pressure sensor linearity, and printer ribbon replacement; no consumables beyond standard O-rings and filter fittings.
How does water intrusion differ from traditional bubble point testing?

Water intrusion applies controlled pressure to dry hydrophobic membranes, measuring forced water penetration as volumetric flow—avoiding solvent use and enabling testing of vent filters unsuitable for wetting agents.