NeuronBC Integtest V1.2 Integrity Tester
| Brand | NeuronBC |
|---|---|
| Origin | Beijing, China |
| Model | Integtest V1.2 |
| Power Supply | 100–240 VAC, 50 Hz, 120 W |
| Operating Pressure Range | 100–8000 mbar (max. 115 psi) |
| Bubble Point Accuracy | ±75 mbar |
| Diffusion Flow Accuracy | ±4% |
| Bubble Point Range | 590–6900 mbar |
| Diffusion Flow Rate Range | 1–180 mL/min |
| Environmental Operating Conditions | 5–40 °C, 10–80% RH |
| Dimensions (L×W×H₁×H₂) | 400 × 240 × 270 × 220 mm |
| Weight | 7.5 kg |
| Display | 3.2″ monochrome LCD |
| Data Storage | 20 test records |
| Language | Chinese only |
| Test Modes | Bubble point (fully automated), diffusion flow (semi-automated), pressure hold (manual setup) |
| Membrane Compatibility | Symmetric and asymmetric membranes |
| Filter Formats | Disc membranes (Φ25–300 mm), standard cartridges (2.5″–40″, 1–15 cores), capsule filters, mini-cartridges, flat-sheet filters, pleated cylindrical filters (≤20″, ≤3 cores), air/gas terminal filters |
| Installation Mode | Offline (benchtop) and online (with optional manifold interface) |
| Cleanroom Class Compatibility | ISO Class 5 (Grade B) and above |
| Compliance Context | Designed to support execution of ASTM F838-22, ISO 13408-2:2018, USP <1207>, EU GMP Annex 1 (2022), and Ph. Eur. 2.6.27 |
Overview
The NeuronBC Integtest V1.2 Integrity Tester is a benchtop-capable, regulatory-aligned instrument engineered for quantitative integrity verification of hydrophobic and hydrophilic microporous filters used in pharmaceutical aseptic processing. It operates on the physical principles of gas diffusion through wetted membrane pores under controlled differential pressure—enabling non-destructive assessment of pore structure continuity prior to or following sterilizing-grade filtration. The device implements standardized test protocols defined in major pharmacopoeial and quality guidance documents, including USP “Package Integrity Evaluation”, Ph. Eur. 2.6.27 “Bacterial Retention Testing of Filters”, ISO 13408-2:2018 “Aseptic processing of health care products — Part 2: Filtration”, and EU GMP Annex 1 (2022) requirements for filter validation and post-use integrity confirmation. Unlike destructive challenge testing, the Integtest V1.2 delivers rapid, repeatable pass/fail determinations without compromising filter sterility or process timelines.
Key Features
- Integrated system self-diagnostic routine validating gas supply stability, pressure transducer calibration status, and internal pneumatic circuit integrity prior to test initiation
- Dual-mode operation supporting both bubble point determination (for hydrophobic filters) and diffusion flow measurement (for hydrophilic and hydrophobic filters), with configurable upstream volume input for accurate flow normalization
- Real-time pressure ramping control with programmable dwell times and slope monitoring to ensure compliance with ISO 13408-2 step-pressure methodology
- Compact, modular chassis designed for Grade B cleanroom environments—constructed from corrosion-resistant anodized aluminum and medical-grade polymers with smooth, non-shedding surfaces
- Onboard thermal printer providing immediate hardcopy output of test parameters, raw data traces, pass/fail verdicts, operator ID, and timestamp—formatted to meet ALCOA+ documentation expectations
- Local data retention of up to 20 complete test reports with metadata (date/time, filter type, test mode, pressure setpoint, measured values), accessible via front-panel navigation
Sample Compatibility & Compliance
The Integtest V1.2 accommodates a broad spectrum of filter geometries and materials without mechanical adaptation: disc membranes (25–300 mm diameter), standard pleated cartridges (2.5″–40″ length, 1–15 core configurations), capsule filters, mini-cartridges, flat-sheet modules, and terminal air/gas filters. It supports both symmetric (e.g., polyethersulfone) and asymmetric (e.g., polyvinylidene fluoride) membrane architectures. All test procedures align with the methodological rigor required for GMP-regulated manufacturing environments. While the instrument itself does not carry CE marking or FDA 510(k) clearance, its operational logic and output structure are compatible with audit readiness for FDA 21 CFR Part 11 (when paired with validated electronic record workflows), EU Annex 1 traceability mandates, and ISO 9001/ISO 13485 quality system documentation.
Software & Data Management
The Integtest V1.2 operates via embedded firmware with no external PC dependency. Its user interface provides guided workflow navigation in Chinese only, minimizing cognitive load during routine QC execution. Test parameters—including upstream volume, target pressure, hold duration, and acceptance criteria—are entered manually and retained per session. Raw pressure vs. time and flow vs. time datasets are stored in non-volatile memory and printed verbatim. Though native USB or Ethernet connectivity is not provided, printed outputs include all elements necessary for manual inclusion in batch records or electronic batch master records (EBMR). For laboratories implementing paperless systems, scanned thermal printouts may be archived alongside associated SOPs and change control documentation to satisfy GLP/GMP data integrity requirements.
Applications
- Pre-use integrity testing of sterilizing-grade filters in biopharmaceutical buffer and media preparation suites
- Post-use integrity verification following aseptic drug product filtration, as mandated by EU GMP Annex 1 Section 8.112
- Qualification of compressed air and nitrogen filters in filling line environments
- Validation support for filter compatibility studies involving aggressive solvents or high-pH solutions
- Routine surveillance testing of HVAC terminal HEPA/ULPA filters in critical manufacturing zones
- Diffusion flow trending across multiple batches to detect gradual membrane fouling or housing seal degradation
FAQ
Does the Integtest V1.2 comply with USP Appendix 4 requirements for diffusion flow testing?
Yes—the instrument implements constant-pressure diffusion flow methodology with upstream volume normalization, consistent with USP Appendix 4 specifications for hydrophilic filter evaluation.
Can it perform pressure hold tests in fully automated mode?
No—pressure hold testing requires manual pressure stabilization and timed decay observation; the device supports this protocol only via operator-guided semi-automated timing and recording.
Is firmware upgrade capability available?
Firmware updates are performed exclusively by authorized NeuronBC service personnel using proprietary diagnostic hardware; no field-upgradable interface is provided.
What maintenance intervals are recommended for long-term accuracy?
Annual calibration of the integrated pressure transducer and leak-check validation of all pneumatic fittings are advised, per ISO/IEC 17025-aligned laboratory practice.
Does it support multi-language UI beyond Chinese?
No—the current firmware release supports Chinese language only; English or other language options are not implemented.
