Tianhe GWF-8JD Insoluble Particle Analyzer
| Brand | Tianhe |
|---|---|
| Origin | Tianjin, China |
| Manufacturer Type | Authorized Distributor |
| Regional Classification | Domestic (PRC) |
| Model | GWF-8JD |
| Pricing | Upon Request |
Overview
The Tianhe GWF-8JD Insoluble Particle Analyzer is a precision optical particle counter engineered for quantitative analysis of subvisible particulate matter in parenteral pharmaceuticals and medical devices. It operates on the principle of light obscuration (also known as single-particle optical sensing, SPOS), where particles suspended in a liquid medium pass through a precisely defined laser beam, causing transient attenuation of transmitted light proportional to their cross-sectional area. This signal is converted into equivalent spherical diameter and counted in real time across user-defined size channels. Designed to meet stringent regulatory requirements—including the 2025 edition of the Chinese Pharmacopoeia (ChP), United States Pharmacopeia (USP and ), and GB 8368 for infusion devices—the instrument delivers traceable, reproducible results essential for quality control laboratories operating under GMP, GLP, and ISO/IEC 17025 frameworks.
Key Features
- High-stability 650 nm semiconductor laser source with dynamic light-energy compensation circuitry, enabling accurate detection across colorless, colored, and turbid transparent liquids without signal drift.
- High-pressure precision syringe pump sampling system with programmable volume (0.2–1000 mL, ±0.1 mL accuracy) and flow rate (2–100 mL/min), optimized for viscous formulations including oil-based injectables and liposomal suspensions.
- Chemically inert fluidic path constructed from imported 316L stainless steel and PTFE—compatible with organic solvents, ethanol/water mixtures, and aggressive excipients.
- 16-user-configurable detection channels with resolution down to 0.1 µm; supports customizable binning schemes spanning 1–500 µm, compliant with ChP, USP, and ISO 21501-4 calibration protocols.
- Motor-driven, frictionless impeller stirrer (0–2000 rpm) with programmable rotation profile—ensures homogeneous particle suspension in vials, ampoules, and infusion bags while eliminating mechanical shedding artifacts.
- Integrated pharmacopeial workflow modules: dedicated assay sequences for small-volume injections (e.g., 1–10 mL ampoules), automatic conversion to particles per container, and batch-level reporting aligned with ChP Annex X and USP Section 4.2.
Sample Compatibility & Compliance
The GWF-8JD accommodates a broad range of sample types: sterile aqueous solutions, lyophilized reconstitutes, lipid emulsions, polymeric nanosuspensions, and infusion set extracts. Its hardware and software architecture are validated for compliance with FDA 21 CFR Part 11 (electronic records/signatures), EU Annex 11 (computerized systems), and ISO 13485 for medical device testing. Built-in calibration routines support multi-point verification using NIST-traceable polystyrene latex (PSL) standards (e.g., 3.0, 5.0, 10.0, 25.0 µm); automatic channel gain adjustment and volumetric calibration ensure long-term measurement stability across varying ambient pressure conditions—including high-altitude laboratory environments.
Software & Data Management
The embedded Android-based OS features a 10.1-inch capacitive touchscreen with full Chinese/English bilingual interface and predictive Chinese character input. Real-time data visualization includes multi-channel histograms, cumulative/differential counts, and trend overlays. All test parameters, raw counts, calibration logs, and audit trails are stored locally with timestamped metadata. Data export options include CSV, PDF reports (with embedded chromatogram-style particle distribution plots), and RS-232 serial output for integration into LIMS or MES platforms. The system supports 21 CFR Part 11-compliant user access levels (Operator, Supervisor, Administrator), electronic signatures, and immutable audit trail generation—including all parameter changes, calibration events, and report approvals.
Applications
- Final container testing of injectables per ChP Vol. IV, USP , and EP 2.9.19.
- Extractables and leachables assessment of IV sets, syringes, and stoppers per GB 8368 and ISO 8536-4.
- Stability-indicating monitoring of protein therapeutics and mRNA-LNP formulations during accelerated and real-time studies.
- Raw material qualification of excipients (e.g., polysorbate 80, phospholipids) where subvisible particle load impacts formulation integrity.
- Process validation support for filtration steps, filling line qualification, and environmental monitoring of Grade A cleanrooms.
FAQ
Does the GWF-8JD comply with USP for routine QC testing?
Yes—it meets all hardware, calibration, and procedural requirements specified in USP , including mandatory use of calibrated reference standards, volumetric accuracy verification, and channel resolution validation.
Can it analyze samples containing ethanol or isopropanol?
Yes—the 316L/PTFE wetted path ensures chemical compatibility with alcohols, acetone, DMSO, and other common organic solvents used in pharmaceutical processing.
Is remote data retrieval supported?
While the unit lacks native Ethernet/Wi-Fi, RS-232 output enables bidirectional communication with external PCs running validated data acquisition software for centralized database ingestion.
What is the minimum detectable particle size and its associated uncertainty?
The system achieves nominal sizing resolution at 0.1 µm per ISO 21501-4; actual lower detection limit depends on sample matrix clarity and background noise—typical practical LOD is ~0.3 µm in water with RSD <1.5% (n ≥ 10) for ≥1000 particles/mL suspensions.
How is instrument qualification performed?
IQ/OQ/PQ protocols are provided, covering installation checks, operational verification (including flow rate accuracy, channel linearity, counting efficiency), and performance qualification using certified reference materials per ISO 21501-4 Annex B.
