Red Sun HR-WZX2600 Diffusion Flow Filter Integrity Tester

Overview

The Red Sun HR-WZX2600 Diffusion Flow Filter Integrity Tester is an engineered solution for quantitative, non-destructive integrity verification of hydrophobic and hydrophilic membrane filters used in pharmaceutical aseptic processing. It operates on the principle of diffusion flow measurement—quantifying the rate of gas permeation through a fully wetted, pressure-stabilized filter under controlled upstream pressure. This method is grounded in Fick’s law of diffusion and validated per ASTM F838-22 (“Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration”) and aligned with USP <1207> “Packaging–Integrity Evaluation of Sterile Products”. Unlike bubble point or water intrusion tests—which are qualitative or semi-quantitative—the HR-WZX2600 delivers traceable, repeatable diffusion flow values (mL/min) that correlate directly with pore size distribution, membrane wettability, and system geometry. Its design supports both pre-use, post-sterilization (PUPSIT) and post-use integrity testing in bioprocessing, final fill, and buffer filtration applications.

Key Features

• Automated diffusion flow calculation using real-time pressure decay monitoring and integrated upstream volume calibration
• Programmable upper-limit alarm for diffusion flow thresholds—enabling pass/fail logic per user-defined SOPs
• Circulating fluid delivery architecture (vs. traditional single-pass systems), minimizing stagnant zones and supporting turbulent flow conditions (Re > 4,000) in associated wetting circuits
• Intelligent liquid-level detection to prevent air entrainment during wetting cycles—critical for reproducible membrane saturation
• Modular interface for integration with TOC analyzers via auto-sampler coordination, enabling unattended multi-sample batch testing
• Environmental resilience: operational range 15–30 °C; relative humidity ≤70% non-condensing; designed for ISO Class 7/8 cleanroom-adjacent environments

Sample Compatibility & Compliance

The HR-WZX2600 accommodates flat-sheet membranes (e.g., PTFE, PVDF, nylon, PES) and cartridge filters (lengths up to 30″, diameters up to 6″) across nominal pore sizes from 0.1 µm to 0.45 µm. Wetting protocols support purified water (for hydrophilic media), isopropanol or ethanol (for hydrophobic media), and process-specific fluids—provided compatibility data are supplied by the filter manufacturer per ISO 13408-2 Annex A. All test parameters—including pressure ramp rate, stabilization dwell time, and diffusion duration—are configurable to meet site-specific validation requirements. The instrument’s firmware logs all critical events with timestamps and operator IDs, satisfying ALCOA+ principles and enabling audit readiness for FDA 21 CFR Part 11-compliant environments when paired with validated electronic signature software.

Software & Data Management

The embedded control software provides guided workflow navigation—from wetting sequence initiation to final report generation. Raw pressure vs. time datasets are stored in CSV format with metadata (test ID, date/time, operator, filter lot, upstream volume, temperature). Exported files retain full traceability for statistical process control (SPC) analysis, including trend charts for diffusion flow stability over consecutive batches. Audit trail functionality records all parameter modifications, user logins, and report exports—supporting GLP/GMP documentation standards. Optional Ethernet or USB export enables direct import into LIMS or electronic batch record (EBR) systems without manual transcription.

Applications

• Pre-sterilization and post-sterilization integrity testing of vent filters in bioreactor and tank systems
• Final sterile filtration validation for parenteral drug products per EU Annex 1 Section 8.122
• Supporting risk-based filter qualification per ICH Q5A(R2) and PDA TR26
• Monitoring filter performance degradation during extended-use campaigns (e.g., continuous buffer filtration)
• Root cause analysis of unexpected microbial breakthrough incidents via historical diffusion flow trending
• Training and qualification of QC personnel in ASTM F838-compliant methodology

FAQ

What is the minimum required upstream volume for accurate diffusion flow calculation?
The instrument requires precise input of upstream volume (V, in mL), which must include filter housing void volume, tubing dead volume, and sensor chamber volume. Accuracy depends on volumetric calibration—not absolute minimum size—but typical configurations range from 5 mL (small disc filters) to 250 mL (large cartridges).
Can the HR-WZX2600 perform water intrusion tests?
No. The HR-WZX2600 is purpose-built for diffusion flow and pressure decay methods only. Water intrusion testing requires separate high-pressure capability (>5 bar) and specialized hydrostatic sensors not present in this platform.
Is temperature compensation applied during testing?
Yes. An integrated NTC thermistor monitors ambient temperature near the pressure transducer, and the software applies empirically derived correction factors to diffusion flow values per ISO 13408-2 Clause 7.3.2.
How does the circulating wetting system improve microbial control?
By maintaining Reynolds numbers >4,000 in wetting lines, the system suppresses laminar boundary layers at pipe walls—reducing biofilm nucleation sites and enhancing cleaning-in-place (CIP) efficacy in connected fluid circuits.
Does the instrument support 21 CFR Part 11 compliance out-of-the-box?
The hardware and firmware provide foundational controls (audit trail, electronic signatures, role-based access); however, full Part 11 compliance requires site-specific validation of the entire software environment—including network configuration, backup protocols, and digital certificate management.