Red Sun Instrument HRYQ-2600 Online Filter Integrity Tester

Overview

The Red Sun Instrument HRYQ-2600 Online Filter Integrity Tester is an engineered solution for non-destructive, quantitative assessment of membrane filter integrity in pharmaceutical, biotechnology, and sterile manufacturing environments. It operates primarily on the pressure hold (diffusion flow) principle — a scientifically validated method recognized by regulatory authorities including FDA, EMA, and WHO for pre-use and post-use validation of sterilizing-grade filters. During testing, the upstream side of a fully wetted hydrophobic or hydrophilic membrane is pressurized with inert gas (typically nitrogen or compressed air) to a defined test pressure — typically set at 80% of the theoretical bubble point — and isolated as a sealed gas volume. Under this sub-bubble-point condition, molecular diffusion of gas through the saturated capillary network generates a measurable, time-dependent pressure decay. This decay rate, when normalized to upstream volume and atmospheric pressure, yields the diffusion flow value (mL/min), which correlates directly with pore structure integrity and potential defects. The instrument also supports complementary methods including standard and enhanced bubble point, water intrusion (for hydrophobic filters), and manual bubble point — ensuring full alignment with USP <1207>, ISO 13408-2, and ASTM F838-22.

Key Features

• Multi-method integrity testing platform compliant with current pharmacopeial standards and GMP requirements
• Industrial-grade dual-core processor enabling deterministic real-time control, stable execution of complex test sequences, and elimination of OS-level instability
• High-resolution color touchscreen interface supporting multilingual input (English, Chinese, numeric, symbolic) for comprehensive test annotation and traceability
• Advanced digital pressure sensing architecture delivering ±1.0 mbar sensitivity and ±60 mbar bubble point repeatability across the 500–6900 mbar test range
• Configurable test library supporting up to 120 pre-stored protocols, each with user-defined pressure setpoints, hold times, pass/fail thresholds, and data export preferences
• Integrated electronic signature and role-based user management (administrator, operator, reviewer) meeting FDA 21 CFR Part 11 and EU Annex 11 audit trail requirements
• Robust mechanical design with compact footprint (500 × 200 × 180 mm) optimized for integration into cleanroom utility panels or mobile validation carts

Sample Compatibility & Compliance

The HRYQ-2600 is validated for use with a broad spectrum of filter configurations, including cartridge, capsule, disc, and housing-integrated membranes composed of polyethersulfone (PES), polyvinylidene fluoride (PVDF), nylon, mixed cellulose ester (MCE), and polytetrafluoroethylene (PTFE). It accommodates both hydrophilic and hydrophobic membranes after appropriate wetting (e.g., water for hydrophilic; isopropyl alcohol/water for hydrophobic). All test algorithms adhere to the physical principles outlined in ISO 13408-2:2021 and USP Chapter <1207.1>, and support documentation required for regulatory submissions, process validation (IQ/OQ/PQ), and routine QC release testing. The system meets electromagnetic compatibility (EMC) requirements per IEC 61326-1 and electrical safety standards per IEC 61010-1.

Software & Data Management

The embedded firmware provides full GLP/GMP-compliant data handling, including timestamped raw pressure vs. time curves, calculated diffusion flow values, bubble point endpoints, and pass/fail determinations with configurable tolerance windows. All data are stored internally with immutable audit trails, including operator ID, parameter changes, test start/stop events, and system error logs. Standard communication interfaces include RS-232 and USB host/device ports; optional industrial fieldbus modules (Modbus RTU/TCP, Profibus DP) enable seamless integration into SCADA and MES platforms. The optional PC-based companion software supports automated report generation (PDF/CSV), trend analysis across multiple batches, and secure remote configuration via encrypted TLS channels.

Applications

• Pre-sterilization integrity verification of final-fill filters in aseptic processing lines
• Post-use integrity confirmation following steam-in-place (SIP) or chemical sanitization cycles
• Validation of filtration systems during process qualification and technology transfer
• Root cause analysis of filter performance deviations using comparative diffusion flow kinetics
• Supporting risk-based quality assurance strategies under ICH Q5A(R2) and Q9 frameworks
• Integration into continuous manufacturing workflows requiring real-time filter status monitoring

FAQ

What regulatory standards does the HRYQ-2600 comply with?

It supports testing protocols aligned with USP <1207>, ISO 13408-2, ASTM F838-22, and EU GMP Annex 1 requirements for filter integrity testing.
Can the instrument be integrated into a PLC-controlled manufacturing line?

Yes — via optional Modbus RTU/TCP or Profibus DP modules, enabling bidirectional command exchange and real-time status reporting.
Is calibration traceable to national standards?

All pressure sensors are factory-calibrated against NIST-traceable reference standards, with calibration certificates provided upon request.
Does the system support electronic signatures for 21 CFR Part 11 compliance?

Yes — it implements role-based access control, audit logging, and cryptographic signing of critical test records.
What wetting fluids are compatible with the water intrusion test method?

For hydrophobic membranes, certified IPA/water mixtures (e.g., 60/40 v/v) are recommended; for hydrophilic filters, purified water or WFI is used.