Red Sun Instrument HRWZ-2600 Bubble Point Integrity Tester
| Brand | Red Sun Instrument |
|---|---|
| Origin | Hebei, China |
| Model | HRWZ-2600 |
| Power Supply | 100–240 V AC, 50/60 Hz, 120 W |
| Maximum Operating Pressure | 10,000 mbar (150 psi) |
| Inlet Gas Pressure Range | 100 mbar (1.5 psi) |
| Bubble Point Test Range | 100–8,000 mbar |
| Diffusion Flow Measurement Range | 1–600 mL/min |
| Water Intrusion Range | 0.01–100 mL/min |
| Test Accuracy | Bubble Point ±50 mbar |
| Dimensions (L×W×H₁×H₂) | 400 × 240 × 270 × 220 mm |
| Weight | 8 kg |
| Ambient Operating Conditions | 5–40 °C, 10–80% RH |
| Display | 7-inch high-resolution color touchscreen |
| Connectivity | RS232, USB, 4–20 mA analog output, RS485, 12 V alarm output |
| Data Storage | ≥10,000 test records |
| Pre-stored Methods | 120 |
| User Access Control | Four-tier permission system with username/password login |
| Audit Trail | Full event logging compliant with FDA 21 CFR Part 11 requirements |
| Test Modes | Manual bubble point, standard bubble point, enhanced bubble point, pressure hold, diffusion flow, water intrusion, ultrafiltration module testing |
Overview
The Red Sun Instrument HRWZ-2600 Bubble Point Integrity Tester is an engineered solution for deterministic, non-destructive verification of microporous filter integrity in pharmaceutical, biotechnology, and sterile manufacturing environments. It operates on the fundamental principles of capillary flow theory—specifically, the bubble point method (ASTM F316-22), diffusion flow (ASTM F838-22), and water intrusion (USP <1207> Annex 2)—to quantitatively assess pore size distribution, membrane wetting status, and seal integrity across a broad spectrum of filtration devices. Designed for both online and offline deployment, the HRWZ-2600 supports rigorous validation protocols under current Good Manufacturing Practice (cGMP) and meets regulatory expectations for traceability, data integrity, and operational robustness. Its dual-pressure architecture—featuring independent control of test pressure and gas inlet regulation—ensures stable performance even under variable supply pressure conditions, eliminating manual intervention and minimizing operator-induced variability.
Key Features
- Digital automatic gas inlet control system: Replaces legacy mechanical throttling valves with closed-loop proportional solenoid regulation, enabling consistent flow ramping and pressure stabilization across fluctuating source pressures (4,000–6,999 mbar).
- Multi-mode integrity assessment: Supports six standardized test protocols—including manual and enhanced bubble point, pressure hold, diffusion flow, water intrusion, and dedicated ultrafiltration module evaluation—each configurable per ISO 13408-2 and EU GMP Annex 1 requirements.
- FDA 21 CFR Part 11–compliant software architecture: Implements full audit trail with immutable timestamps, user authentication via four-tier role-based permissions, electronic signatures, and tamper-evident data storage.
- High-fidelity measurement subsystem: Integrated mass flow sensors and high-resolution pressure transducers deliver repeatability within ±4% for diffusion flow and ±50 mbar for bubble point determination, validated against NIST-traceable reference standards.
- Modular hardware design: Compact footprint (400 × 240 × 270 mm) with dual-height configuration accommodates integration into laminar flow hoods, isolators, or mobile QC carts without compromising service access or thermal management.
- Real-time data handling: Onboard 7-inch capacitive touchscreen interface with intuitive workflow navigation; local thermal printing; USB export to CSV/PDF; and optional RS485/4–20 mA integration into SCADA or MES platforms.
Sample Compatibility & Compliance
The HRWZ-2600 accommodates a comprehensive range of single-use and reusable filtration assemblies, including disc membranes (Φ25–Φ300 mm), standard and mini cartridges (2.5″–40″, 1–9 pleats), capsule filters, flat-sheet modules, hollow-fiber ultrafiltration cassettes, and vent filters used in upstream/downstream bioprocessing. Its pressure and flow calibration ranges are optimized for hydrophobic PTFE, PVDF, and nylon membranes as well as hydrophilic cellulose esters and polyethersulfone (PES). All test methods align with internationally recognized standards: ASTM F316 (bubble point), ASTM F838 (diffusion flow), ISO 13408-2 (sterile filtration validation), and USP <1207> (package integrity testing). The instrument’s firmware and electronic record structure satisfy ALCOA+ principles and support successful inspection outcomes during FDA, EMA, or PMDA audits.
Software & Data Management
Firmware v3.2 embeds a real-time operating system with deterministic task scheduling and memory protection. Each test generates a structured metadata packet containing operator ID, timestamp, environmental conditions (temperature/humidity), method parameters, raw sensor traces, pass/fail logic flags, and digital signature confirmation. Data persistence is ensured through redundant internal flash storage (≥10,000 records) and encrypted USB export. The audit trail logs all critical events—including parameter changes, user logins, calibration actions, and system errors—with hash-verified integrity checks. Optional PC-based software (HRWZ-Link Suite) provides advanced reporting templates aligned with Annex 11, trend analysis tools for filter lifecycle monitoring, and automated backup to network drives or LIMS via secure FTP/SFTP.
Applications
This instrument serves critical quality control functions across regulated pharmaceutical operations: pre-use post-sterilization integrity verification of sterilizing-grade filters in buffer and media preparation; final fill line vent filter qualification; ultrafiltration/diafiltration module release testing prior to chromatography steps; and routine requalification of process filters following cleaning-in-place (CIP) cycles. It is routinely deployed in QC laboratories supporting parenteral drug product development, vaccine manufacturing, cell and gene therapy vector purification, and aseptic processing validation. Its water intrusion mode extends utility to lyophilization stopper integrity assessment and packaging leak detection per ASTM F2338.
FAQ
Does the HRWZ-2600 support automated test method selection based on filter type?
Yes—predefined method templates are assignable by filter geometry, membrane chemistry, and manufacturer specifications. Users may also create and validate custom protocols using the embedded method editor.
Can the instrument be integrated into a distributed control system (DCS)?
Yes—via RS485 Modbus RTU or 4–20 mA analog output for real-time pressure and flow telemetry, with discrete digital I/O for pass/fail status and alarm signaling.
Is calibration traceable to national standards?
All pressure and flow sensors are factory-calibrated against NIST-traceable references, and calibration certificates—including uncertainty budgets—are provided with each unit.
What maintenance intervals are recommended?
Annual verification of pressure transducer linearity and flow sensor zero drift is advised; no consumable parts require scheduled replacement within the first five years of operation under typical lab use.
How does the “auto-exit-on-pass” function improve operational efficiency?
Upon meeting predefined pass criteria, the system terminates pressure ramping and purges residual gas automatically—reducing average test duration by 35–45% and minimizing unnecessary exposure of sensitive membranes to elevated pressure stress.
