Acona A7000 APS Optical Particle Counter (SPOS)
| Brand | Acona |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | OEM Manufacturer |
| Product Category | Domestic |
| Model | Acona A7000 APS |
| Instrument Type | Optical Particle Counter (Light Obscuration / SPOS) |
| Detection Principle | Single Particle Optical Sensing (SPOS) with Dual-Mode Extinction + Scattering |
| Dynamic Range | 0.5–400 µm |
| Resolution | 1024 channels, down to 0.01 µm bin width |
| Sensitivity | ≤10 ppt (particles per trillion) for ≥0.8 µm |
| Max Sample Concentration | 10¹¹ particles/mL (with integrated two-step auto-dilution) |
| Regulatory Compliance | 21 CFR Part 11, USP <729>, Chinese Pharmacopoeia 2020 Edition |
| Software | Audit-trail enabled, role-based access control, electronic signature, LIMS-compatible |
Overview
The Acona A7000 APS is a high-precision optical particle counter engineered for quantitative, high-resolution particle size distribution (PSD) analysis using Single Particle Optical Sensing (SPOS) technology. Unlike ensemble-averaging techniques such as laser diffraction or dynamic light scattering, the A7000 APS operates on a true “one-particle-at-a-time” principle—measuring extinction (light blockage) and scattering signals simultaneously from individual particles suspended in liquid media. This dual-mode detection architecture enables robust discrimination across a wide dynamic range—from submicron contaminants to large aggregates—while maintaining trace-level sensitivity and metrological traceability. The system is purpose-built for applications demanding regulatory-grade data integrity, including pharmaceutical parenteral quality control, semiconductor slurry monitoring, and advanced material dispersion stability assessment.
Key Features
- Two-Step Automatic Dilution System: Patented hardware-integrated dilution module enables direct analysis of undiluted samples up to 10¹¹ particles/mL. Eliminates manual dilution variability, reduces operator-induced error, and ensures reproducible concentration recovery via real-time dilution factor compensation.
- Dual-Physics SPOS Detection (LE400 Sensor): Combines light obscuration (LO) and light scattering (LS) within a single flow cell. Optimizes signal-to-noise ratio for both small particles (100 µm), delivering high-fidelity volumetric and number-based PSDs.
- Ultra-High Spectral Resolution: 1024-channel data acquisition with 0.01 µm bin resolution enables unambiguous separation of closely spaced populations—e.g., resolving distinct peaks for 0.8 µm, 2.0 µm, and 5.0 µm reference standards without peak merging or artifact generation.
- Sub-ppb-Level Large Particle Counting (LPC) Sensitivity: Capable of detecting particles ≥0.8 µm at concentrations as low as 10 ppt (parts per trillion). Demonstrates >6000× higher sensitivity for tail-end large particles compared to conventional laser diffraction methods—critical for CMP slurry qualification and fat emulsion safety assessment.
- Regulatory-Ready Software Architecture: Fully compliant with 21 CFR Part 11 requirements, supporting electronic signatures, granular user permission tiers, immutable audit trails, automated database backup, and seamless LIMS integration.
Sample Compatibility & Compliance
The A7000 APS accommodates aqueous and non-aqueous suspensions—including high-viscosity formulations (e.g., lipid emulsions, CMP slurries, photoresists)—via adjustable flow rate and pressure-controlled syringe pump delivery. It supports ISO 21501-4, USP (for fat emulsion PFAT5 calculation), and Chinese Pharmacopoeia 2020 Edition Chapter 0903. All calibration protocols follow NIST-traceable PSL and silica reference materials. The instrument meets GLP/GMP environmental controls when operated in validated laboratory settings and supports IQ/OQ/PQ documentation packages for regulated facilities.
Software & Data Management
Acona’s APS Control Suite provides full lifecycle data governance: role-based login (administrator, analyst, reviewer), timestamped action logging (test execution, calibration, report export), and tamper-proof audit trail export in CSV or PDF. Reports include automatic Pass/Fail evaluation against configurable limits (e.g., USP PFAT5 threshold), raw channel histograms, cumulative distributions, and statistical summaries (D10, D50, D90, span). Data encryption, scheduled backups, and ODBC-compliant database schema ensure compatibility with enterprise LIMS and ELN systems. Electronic signature workflows adhere to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).
Applications
- Pharmaceutical Quality Control: Quantitative monitoring of subvisible particles in injectables; automated PFAT5 computation per USP ; stability-indicating trend analysis of lipid emulsions and liposomal drug products.
- Semiconductor Manufacturing: In-process monitoring of CMP slurry degradation; detection of >2 µm particles during recirculation; formulation screening of abrasive suspensions under varying pH/ionic strength conditions.
- Advanced Materials R&D: Characterization of protein aggregates, inkjet ink dispersions, photoresist contaminants, and nanoparticle suspensions where number-weighted distributions are essential for performance prediction.
- Academic & Industrial Research: Method development for high-concentration colloidal systems; validation of filtration efficiency; investigation of shear-induced aggregation kinetics.
FAQ
What is the maximum sample concentration the A7000 APS can analyze without manual dilution?
The system handles undiluted samples up to 10¹¹ particles/mL using its integrated two-step auto-dilution module.
Does the A7000 APS comply with 21 CFR Part 11 for electronic records and signatures?
Yes—the software includes full audit trail functionality, role-based access control, electronic signature capture, and data immutability features required for FDA-regulated environments.
Can the instrument differentiate between particle types (e.g., silicone oil vs. cellulose) based on optical signals?
No—it reports size and count only. Material identification requires complementary techniques such as Raman microspectroscopy or SEM-EDS.
Is calibration traceable to national standards?
All calibrations use NIST-traceable polystyrene latex (PSL) and silica reference particles certified per ISO 21501-4 Annex B.
What maintenance is required for routine operation?
Daily cleaning of the flow cell and tubing with recommended solvents; quarterly verification of dilution accuracy and sensor baseline stability; annual performance qualification per manufacturer protocol.
