PSS AccuSizer 780 FX-Nano High-Concentration Particle Counter
| Brand | Particle Sizing Systems (PSS) |
|---|---|
| Origin | USA |
| Manufacturer Type | Authorized Distributor |
| Product Category | Imported Instrument |
| Model | AccuSizer 780 FX-Nano |
| Dispersion Method | Wet Dispersion |
| Instrument Type | Online Laser-Based Particle Counter |
| Measurement Range | 0.15 µm – 400 µm and 2 µm – 5000 µm |
| Repeatability | >99% |
| Measurement Time | 1–10 min |
| Detection Principle | Single Particle Optical Sensing (SPOS) with Light Obscuration |
| Particle Counting Accuracy | ≤10% |
| Size Accuracy | ≤2% |
| Sensitivity | ≤10 ppt (particles per trillion) |
| Dilution System | Automated Two-Step Dynamic Dilution Module |
| Flow Rate (Dilution) | 60–180 mL/min |
| Software Options | Windows-based Standard or 21 CFR Part 11 Compliant Version |
| Power Supply | 100–120 VAC, 60 Hz or 220–240 VAC, 50 Hz |
| Dimensions (Counter Unit) | 20 × 45 × 20 cm |
| Dimensions (Dilution Unit) | 25 × 45 × 56 cm |
| Weight | ~30 kg |
| Solvent Compatibility | Aqueous and most organic solvents |
| Sample Volume Options | 0.5–5 mL |
| Regulatory Compliance | Supports GLP/GMP workflows with audit trail, electronic signatures, and data integrity controls per FDA 21 CFR Part 11 |
Overview
The PSS AccuSizer 780 FX-Nano High-Concentration Particle Counter is an advanced, modular laser-based particle characterization system engineered for high-fidelity detection and quantification of individual particles in concentrated dispersions. Unlike ensemble-averaging techniques such as dynamic light scattering (DLS) or traditional laser diffraction, the FX-Nano employs Single Particle Optical Sensing (SPOS) — a light obscuration method where each particle traversing a precisely defined optical sensing zone generates a discrete voltage pulse proportional to its cross-sectional area. This principle enables true number-weighted size distribution analysis, delivering statistically robust particle counts and size resolution down to 150 nm, even in samples exceeding 107 particles/mL. Its dual-range capability (0.15 µm–400 µm and 2 µm–5000 µm) accommodates both submicron aggregates and coarse contaminants within a single platform. The instrument’s architecture is purpose-built for applications demanding trace-level large-particle detection — particularly where regulatory compliance, process consistency, and stability assessment are critical.
Key Features
- True single-particle counting via calibrated light obscuration (SPOS), eliminating ensemble averaging artifacts and inter-particle interference.
- Integrated two-step automated dilution module enabling direct analysis of highly concentrated slurries (up to 107 particles/mL) without manual preparation or operator variability.
- Dual optical sensor configuration supporting extended dynamic range: high-sensitivity submicron detection (0.15 µm threshold) and macro-particle quantification up to 5000 µm.
- Repeatability >99% across repeated measurements under identical conditions, validated per ISO 22412 and ASTM E2494 standards.
- Full system automation: one-click operation from sample loading, dynamic dilution, measurement, to post-run system flush and priming.
- Modular design allows field-upgradable sensors, pump modules, and software packages to match evolving analytical requirements.
- Robust fluidic architecture with pressure-controlled flow (50–80 PSI), compatible with aqueous buffers, alcohols, hydrocarbons, and polar aprotic solvents.
Sample Compatibility & Compliance
The FX-Nano is routinely deployed in environments requiring strict adherence to quality assurance frameworks. It supports sample matrices including protein therapeutics (e.g., monoclonal antibodies, viral vectors), CMP slurries, nanomaterial suspensions, inkjet formulations, and parenteral drug products. Its measurement methodology aligns with USP , , and for particulate matter testing, while the optional 21 CFR Part 11-compliant software package provides full audit trail logging, role-based access control, electronic signatures, and immutable data storage — essential for FDA-regulated manufacturing and QC labs operating under cGMP. All calibration protocols follow NIST-traceable reference standards, and system suitability tests (SST) are programmable and reportable within the software environment.
Software & Data Management
The instrument operates on a Windows-based platform with intuitive graphical interface and configurable workflow templates. Raw pulse data is captured at >1 MHz sampling rate, enabling high-resolution histogram binning and real-time statistical validation. Software features include automatic threshold optimization, multi-modal peak deconvolution, differential and cumulative distribution plots, and customizable reporting (PDF, CSV, XML). Data export supports LIMS integration via ODBC and HL7 protocols. For regulated environments, the Part 11 version enforces user authentication, session locking, change history tracking, and digital signature binding for all critical actions — satisfying ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).
Applications
- Pharmaceutical Development & QC: Quantification of subvisible particles (>0.15 µm) in biologics, liposomes, vaccines, and sterile injectables; monitoring aggregation kinetics during formulation stress studies.
- Semiconductor Manufacturing: Monitoring CMP slurry cleanliness, detecting abrasive agglomerates and metallic contaminants impacting wafer yield.
- Advanced Materials: Characterizing nanoparticle dispersion stability in conductive inks, battery slurries, and catalyst suspensions.
- Food & Cosmetics: Assessing ingredient uniformity, emulsion breakdown, and foreign particulate contamination in final products.
- Filtration Validation: Challenge testing of sterilizing-grade filters using standardized particle suspensions per ISO 4022 and ASTM F838.
FAQ
How does SPOS differ from laser diffraction or DLS in detecting large particles?
SPOS detects and sizes each particle individually, offering superior sensitivity to low-abundance large particles (e.g., outliers >5 µm) that are statistically masked in ensemble methods. Independent validation shows SPOS is 1,500–25,000× more sensitive to tail-end particles than DLS or acoustic spectroscopy.
Can the FX-Nano analyze undiluted high-concentration samples?
Yes — its integrated two-step dynamic dilution module automatically adjusts sample concentration in real time to maintain optimal particle flux (<10,000 particles/sec) through the sensor, ensuring accuracy without manual intervention.
Is method transfer possible between different AccuSizer 780 configurations?
Yes — standardized sensor geometry, pulse processing algorithms, and calibration protocols ensure consistent results across FX-Nano, APS, and standard 780 platforms, facilitating lab-to-lab comparability and regulatory submission support.
What maintenance is required for long-term operational reliability?
Routine maintenance includes quarterly optical alignment verification, annual sensor calibration using NIST-traceable latex standards, and periodic replacement of fluidic tubing and filters — all documented in the onboard maintenance log.
Does the system support IQ/OQ/PQ qualification documentation?
Yes — comprehensive vendor-supplied qualification protocols (including test scripts, acceptance criteria, and blank templates) are provided for installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) per GAMP 5 guidelines.
