Tianhe GWF-RS Optical Particle Counter for Insoluble Microparticle Analysis

Overview

The Tianhe GWF-RS Optical Particle Counter is a regulatory-grade, light obscuration (LO)-based instrument engineered for quantitative detection and size-resolved enumeration of insoluble microparticles in parenteral pharmaceutical products. Designed in strict alignment with pharmacopoeial requirements—including the forthcoming Chinese Pharmacopoeia (ChP) 2025, United States Pharmacopeia (USP) chapters and , and ISO 21510—the GWF-RS delivers traceable, reproducible particle counts across the 1–500 µm range. Its measurement principle relies on calibrated laser beam interruption: as particles suspended in liquid flow through a precision-engineered sensing zone, each event generates a pulse proportional to cross-sectional area, enabling real-time classification into up to 64 user-defined size channels (with 0.1 µm resolution). The system supports both volumetric and concentration-based reporting, with full compliance traceability embedded at firmware level.

Key Features

• Pharmacopoeia-compliant optical detection architecture validated per ChP 2025, USP /, and ISO 21510 protocols
• Dedicated fat emulsion injection testing mode with optimized fluid dynamics and signal processing for high-viscosity, light-scattering matrices
• Stable 650 nm laser source with real-time optical energy compensation—ensuring consistent sensitivity across colorless, amber, or lightly tinted solutions
• Chemically inert fluidic path constructed from imported 316L stainless steel and PTFE—compatible with organic solvents, lipid-based vehicles, and mildly acidic/alkaline formulations
• Motorized Z-axis sample stage with programmable height adjustment—enabling direct aspiration from irregularly shaped vials, IV bags, and syringes without adapter dependency
• Embedded high-throughput processor supporting >10,000 independent counting events/sec and real-time histogram generation
• Automated NIST-traceable calibration routine with onboard reference standards; eliminates manual alignment drift and inter-operator variability
• FDA 21 CFR Part 11–compliant software stack featuring electronic signatures, immutable audit trail, role-based permissions (admin/operator/auditor), and ALCOA+ data integrity architecture

Sample Compatibility & Compliance

The GWF-RS accommodates a broad spectrum of parenteral dosage forms: sterile aqueous injections, lyophilized powders (post-reconstitution), fat emulsions (e.g., Intralipid®-type formulations), ophthalmic solutions, and infusion set extracts. Its wide dynamic concentration range (up to 18,000 particles/mL) and adjustable flow rate (5–80 mL/min) allow robust analysis of low-volume (0.2 mL) and high-volume (1000 mL) samples with ±0.5% volumetric accuracy. All hardware and firmware components meet Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) infrastructure expectations. Regulatory documentation—including IQ/OQ/PQ templates, validation protocols, and raw data export logs—is provided to support global marketing authorization applications and inspection readiness.

Software & Data Management

Running on a certified Android-based embedded OS, the GWF-RS interface provides intuitive touch navigation, multilingual support (English/Chinese), and context-aware workflow guidance. The integrated relational database stores ≥100,000 test records with metadata (operator ID, timestamp, method version, environmental conditions). Statistical functions include batch trending, pass/fail flagging against pharmacopoeial limits, RSD calculation (validated at <1.5% for ≥1000 particles/mL), and customizable report generation (PDF/CSV). Data export occurs via USB mass storage or RS232 serial link; no proprietary drivers required. Audit trail entries record every critical action—including parameter modification, calibration execution, result deletion, and user login—with cryptographic timestamping and non-erasable storage.

Applications

• Final container testing of injectables per ChP 2025 Section 0903 and USP
• Quality control of intravenous fat emulsions under ChP 2025 and Ministry of Health Drug Standard requirements
• Extractables and leachables assessment of infusion sets, filters, and stoppers
• Stability-indicating particle monitoring during accelerated and real-time shelf-life studies
• Raw material particulate screening for excipients used in sterile manufacturing
• Supporting regulatory submissions requiring ISO 21510–aligned instrumentation qualification

FAQ

Does the GWF-RS comply with FDA 21 CFR Part 11 requirements for electronic records and signatures?

Yes. The system implements full Part 11 functionality including role-based access control, electronic signatures with biometric or password authentication, time-stamped audit trails, and data immutability safeguards.
Can it analyze highly viscous or opaque emulsions without dilution?

Yes—its dedicated fat emulsion mode adjusts sampling pressure, dwell time, and signal gain to maintain counting fidelity in turbid, high-refractive-index media.
Is calibration traceable to national metrology institutes?

Calibration uses NIST-traceable polystyrene latex (PSL) reference particles; certificate of calibration includes uncertainty budget and traceability chain documentation.
What is the minimum detectable particle size and resolution capability?

The instrument resolves particles from 1.0 µm with 0.1 µm channel increment granularity and >95% sizing resolution (per ISO 21510 Annex B).
How is data integrity ensured during power loss or unexpected shutdown?

All measurements are written to non-volatile flash memory in real time; incomplete runs are flagged but preserved for forensic review and resumption.