Red Sun HR-W2400 Filter Integrity Tester with Full Audit Trail Compliance
| Brand | Red Sun Instrument |
|---|---|
| Origin | Hebei, China |
| Manufacturer Type | Authorized Distributor |
| Origin Category | Domestic (China) |
| Model | HR-W2400 |
| Pressure Range | 200–5000 Pa (adjustable) |
| Test Duration | 1–10 min (adjustable) |
| Pressure Resolution | 1 Pa |
| Acoustic Noise Level | ≤50 dB(A) |
| Operating Mode | Continuous |
| Bubble Point Accuracy | ±10 mbar |
| Diffusion Flow Resolution | 0.1 mL/min |
| Water Intrusion Flow Resolution | 0.01 mL/min |
| System Sensitivity | ±1.0 mbar |
| Max Test Pressure | 9999 mbar |
| Min Supply Pressure | 100 mbar |
| Gas Supply Requirement | Clean, dry air or nitrogen (4000–6999 mbar) |
| Power Supply | 100–240 V AC, 50/60 Hz, 100 W |
| IP Rating | IP54 |
| Data Storage Capacity | 10,000 test records |
| Display | 10-inch full-color TFT touchscreen |
| Communication Interfaces | RS232, USB, optional industrial bus (e.g., Modbus RTU), wireless module |
| Printer Options | Built-in thermal or dot-matrix printer |
| User Management | Up to 9-level permission hierarchy with electronic signature support |
| Audit Trail | Time-stamped, immutable event log (user login/logout, parameter changes, test execution, result modification, calibration, system errors) |
| Compliance | Fully aligned with FDA 21 CFR Part 11, EU Annex 11, and ISO 13485 |
Overview
The Red Sun HR-W2400 Filter Integrity Tester is a fully automated, regulatory-compliant instrument engineered for deterministic, non-destructive integrity verification of hydrophilic and hydrophobic membrane filters used in pharmaceutical, biotechnology, and sterile manufacturing processes. It implements three standardized physical test methods—Pressure Hold (Diffusion), Bubble Point, and Water Intrusion—each grounded in fundamental gas diffusion kinetics and capillary flow theory. The system operates on the principle that intact membranes resist gas passage below their intrinsic bubble point pressure; deviations in pressure decay over time directly correlate to pore size distribution and defect presence. Unlike empirical or estimated-pressure instruments, the HR-W2400 delivers traceable, metrologically rigorous measurements via closed-loop pressure control calibrated to ±1.0 mbar accuracy, enabling precise validation of filter performance across diverse configurations—from single 10-inch cartridges to multi-cartridge assemblies up to 12 × 20-inch housings.
Key Features
- True audit trail architecture: Immutable, time-stamped digital log recording all user actions—including login/logout, parameter edits, test initiation/abortion, result approvals, calibration events, and system faults—with operator ID, timestamp, and contextual metadata.
- Multi-tiered electronic signature framework compliant with FDA 21 CFR Part 11 and EU Annex 11: Supports role-based authentication, password policies, and configurable signature requirements for critical operations.
- High-fidelity pressure control: Integrated high-stability Honeywell piezoresistive sensors and adaptive PID algorithms ensure pressure regulation within ±1 mbar of setpoint during Water Intrusion tests—eliminating error-prone estimation protocols used by legacy systems.
- Intelligent test sequencing: Automatic selection and execution of optimal test method (Bubble Point, Diffusion, or Water Intrusion) based on filter type, wetting fluid, and process history—no manual mode switching required.
- Ruggedized industrial design: IP54-rated enclosure with quick-connect pneumatic fittings, dust- and splash-resistant construction, and extended 100-meter gas line capability for large-volume upstream systems.
- Embedded real-time diagnostics: Comprehensive self-test at power-on covering sensor linearity, valve actuation, pressure transducer zero drift, and communication port functionality—with immediate visual and audible fault alerts.
- Scalable data management: Local storage of ≥10,000 complete test records (including raw pressure/time curves, environmental metadata, and operator annotations); exportable via USB in CSV, PDF, or XML formats with embedded digital signatures.
Sample Compatibility & Compliance
The HR-W2400 accommodates flat-sheet, cartridge, capsule, and housing-mounted filters across all common pharmaceutical membrane chemistries—including polyethersulfone (PES), polyvinylidene fluoride (PVDF), nylon, mixed cellulose ester (MCE), and polytetrafluoroethylene (PTFE). It supports both aqueous (e.g., water, buffer) and non-aqueous (e.g., IPA, ethanol) wetting fluids for Bubble Point and Diffusion testing, and certified water for Water Intrusion testing per ASTM F838-22. All test methodologies align with USP <1207>, ISO 15189, and PDA Technical Report No. 26. The device’s firmware and hardware architecture are validated per ICH Q9/Q10 principles and documented to satisfy GMP Annex 15 requirements for computerized system validation (CSV).
Software & Data Management
Running a deterministic real-time OS, the HR-W2400’s 10-inch capacitive touchscreen interface provides intuitive workflow navigation with WYSIWYG test configuration, live pressure curve visualization, and dynamic pass/fail decision logic based on configurable acceptance criteria. All data—including raw sensor outputs, derived metrics (e.g., diffusion rate, bubble point threshold), and audit logs—are cryptographically hashed and stored in a tamper-evident database. Export packages include full traceability: test ID, operator credentials, instrument calibration status, environmental conditions (temperature/humidity), and version-controlled firmware build numbers. Optional network integration enables secure TLS-encrypted data transfer to LIMS or MES platforms via RESTful API or OPC UA.
Applications
- Final filter validation prior to sterile drug product filling
- In-process integrity verification of vent filters in bioreactor and purification skids
- Post-sterilization (SIP) integrity confirmation of TFF cassettes and depth filters
- Qualification of pre-filters and final filters in parenteral manufacturing lines
- Supporting regulatory submissions (IND, NDA, BLA) with ALCOA+ compliant data packages
- Periodic requalification of filtration trains under ongoing process verification (OPV) programs
FAQ
Does the HR-W2400 comply with FDA 21 CFR Part 11 requirements for electronic records and signatures?
Yes. It implements role-based access control, audit trail immutability, electronic signature enforcement for critical actions, and secure data export—all validated per Part 11 Annex A guidance.
Can the instrument perform Water Intrusion testing on hydrophobic filters without manual pressure adjustment?
Yes. Its closed-loop pressure control automatically ramps to and maintains the exact target pressure (e.g., 2500 mbar ±1 mbar) without estimation or operator intervention.
What is the maximum upstream volume the system can accurately test?
Up to 100 liters, enabled by optimized gas dynamics modeling and low-drift sensor architecture—validated per ASTM F3154-18 Annex A.
Is the audit trail exportable in a reviewable format for regulatory inspections?
Yes. Audit logs export as time-ordered, digitally signed PDF or CSV files containing full event context, user identity, and cryptographic hash verification.
Does the system support integration with enterprise quality management systems (QMS)?
Yes. Standard RS232 and USB interfaces are included; optional Modbus TCP, EtherNet/IP, or MQTT modules enable bidirectional integration with TrackWise, MasterControl, or Veeva QMS.
