Tianhe GWF-8JDS Insoluble Particle Analyzer
| Brand | Tianhe |
|---|---|
| Origin | Tianjin, China |
| Manufacturer Type | Authorized Distributor |
| Product Category | Domestic |
| Model | GWF-8JDS |
| Pricing | Upon Request |
Overview
The Tianhe GWF-8JDS Insoluble Particle Analyzer is a fully compliant, laboratory-grade optical light-blockage (light obscuration) particle counter engineered for quantitative analysis of non-viable, insoluble particulate matter in parenteral pharmaceuticals and medical devices. It operates on the principle of single-particle optical sensing (SPOS), where particles suspended in a liquid medium pass through a precisely defined detection zone illuminated by a high-stability laser source. Each particle causes a transient reduction in transmitted light intensity proportional to its cross-sectional area, enabling precise sizing and counting across a calibrated dynamic range. Designed specifically for regulatory compliance in sterile drug product release testing, the GWF-8JDS meets the instrumental performance and procedural requirements of the Chinese Pharmacopoeia (ChP) 2020 Edition (General Chapter 0903), United States Pharmacopeia (USP) and , ISO 21501-4:2018, and GB 8368–2018 for infusion sets. Its architecture supports both routine QC batch release and method validation workflows under GLP and GMP environments.
Key Features
- High-fidelity laser-based optical detection system with real-time energy compensation circuitry, ensuring consistent sensitivity across colorless, amber, or lightly tinted transparent solutions—including oil-based and organic solvent formulations.
- Programmable high-pressure syringe pump sampling module with selectable syringe volumes (1 mL, 2.5 mL, 5 mL, 10 mL, 25 mL) and adjustable flow rates (2–100 mL/min), enabling accurate volumetric delivery for viscous or low-volume samples such as small-volume parenterals (SVPs).
- 16-user-configurable particle size channels, with resolution down to 0.1 µm; supports cumulative, differential, and histogram-based counting modes for flexible data interpretation.
- Detection path components—including flow cell slit and fluidic tubing—constructed from electropolished ASTM F138-grade 316L stainless steel and PTFE, ensuring chemical compatibility with aggressive solvents, ethanol/water mixtures, and lipid emulsions.
- Non-contact, variable-speed paddle stirrer with ceramic bearings, minimizing mechanical shedding and maintaining homogeneous particle suspension without introducing extraneous artifacts.
- Integrated calibration management system with preloaded traceable calibration curves aligned to ChP, USP, and ISO 21501-4 reference standards; automatic channel and volume verification routines ensure long-term metrological integrity.
Sample Compatibility & Compliance
The GWF-8JDS accommodates a broad spectrum of sample types relevant to pharmaceutical quality control: aqueous injectables (e.g., saline, dextrose), lyophilized reconstituted powders, lipid emulsions, ophthalmic solutions, and infusion set extracts. Its validated operating range covers sample volumes from 0.2 mL to 1000 mL (±0.5% volumetric accuracy), supporting both standard 10 mL and SVP-specific protocols (e.g., 1 mL ampoules). All hardware and software functions are designed to fulfill data integrity requirements per FDA 21 CFR Part 11, EU Annex 11, and WHO TRS 992 Annex 5. Audit trail functionality logs all user actions, parameter changes, calibration events, and result exports with immutable timestamps.
Software & Data Management
The embedded Linux-based control interface features a 10.1-inch capacitive touchscreen with full Unicode support, enabling direct Chinese/English bilingual input for sample IDs, batch numbers, and operator credentials. Preloaded databases include ChP-listed injectable drug names and common medical device categories (e.g., IV sets, filters, stopcocks), reducing manual entry errors. Data storage includes local encrypted SSD retention (≥100,000 test records), USB export (CSV/PDF), and optional network integration via Ethernet for LIMS connectivity. Role-based access control implements four-tier privilege levels (Administrator, Supervisor, Analyst, Viewer), with automated backup scheduling and point-in-time recovery.
Applications
- Final container testing of injectables per ChP 0903 and USP
- Filter validation and extractables/leachables assessment of plastic packaging and infusion systems
- Stability-indicating monitoring of protein therapeutics and nanosuspensions
- QC release testing of prefilled syringes, autoinjectors, and blow-fill-seal containers
- Method suitability studies for new formulations containing surfactants or co-solvents
- Supporting ICH Q5C stability protocols requiring particulate trend analysis over time
FAQ
Does the GWF-8JDS comply with USP and for subvisible particle testing?
Yes — it satisfies all instrumental performance qualification (IPQ) criteria including resolution, accuracy, precision, and limit of quantitation as specified in USP Annexes, supported by built-in calibration verification routines.
Can it analyze samples containing organic solvents such as ethanol or acetone?
Yes — the wetted path uses chemically inert 316L SS and PTFE, validated for compatibility with solvents up to 100% concentration under controlled flow conditions.
Is audit trail functionality enabled by default?
Yes — all critical system events (login/logout, test execution, calibration, report generation) are recorded with tamper-evident timestamps and user attribution, meeting ALCOA+ principles.
What is the smallest detectable particle size, and how is resolution verified?
The instrument achieves 0.1 µm lower detection limit with >95% channel resolution, verified using NIST-traceable polystyrene latex (PSL) standards per ISO 21501-4 procedures.
Does the system support 21 CFR Part 11-compliant electronic signatures?
Yes — role-based digital signature enforcement is available for report approval, calibration confirmation, and method modification, with configurable signature policies and certificate integration options.
