PULUODY PLD-601jc Intelligent Particle Counter
| Brand | PULUODY |
|---|---|
| Model | PLD-601jc |
| Origin | Shaanxi, China |
| Sensor Technology | 8th-generation dual-laser narrow-beam particle detection |
| Flow Control | Precision metering piston pump + ultra-precise electromagnetic flow control |
| Detection Range | 1–450 µm (optional: 0.03–3000 µm) |
| Resolution | 1000 user-definable channels down to 0.01 µm |
| Accuracy | ±5% typical (per ChP 2015/2020) |
| Counting Threshold | Customizable channel thresholds from 1–100 µm or 4–70 µm (c), including 0.1 µm (c) mode |
| Sample Flow Rate | 5–150 mL/min |
| Rinse Flow Rate | 5–500 mL/min |
| Fluid Temperature Range | 0–80 °C |
| Ambient Operating Temperature | 0–50 °C |
| Compliance | FDA 21 CFR Part 11 (audit trail, electronic signature, role-based 5-level access), GLP/GMP-ready |
| Calibration Standards | JJG1061, ISO 21501, NIST-traceable latex spheres |
| Software | PULUODY V8.9 Analysis Suite (PC & embedded touchscreen) |
| Regulatory Alignment | USP <788>, <789>, <797> |
Overview
The PULUODY PLD-601jc Intelligent Particle Counter is a high-fidelity, regulatory-compliant liquid particle analyzer engineered for quantitative microcontamination assessment in critical life science and industrial applications. It operates on the principle of light obscuration (LO), also known as the optical blockage or resistive pulse method, enhanced by an 8th-generation dual-laser narrow-beam sensor architecture. This configuration delivers superior signal-to-noise ratio, minimized coincidence error, and extended dynamic range across submicron to coarse particulate regimes. The instrument is purpose-built for compliance-driven environments—pharmaceutical manufacturing, biologics QC labs, medical device validation, semiconductor process water monitoring, and advanced material R&D—where trace-level particle enumeration must meet stringent pharmacopoeial, ISO, and military-grade cleanliness specifications.
Key Features
- Dual-laser narrow-beam optical detection system with real-time signal discrimination, enabling reliable sizing and counting of particles from 0.01 µm to 450 µm (with optional extended range up to 3000 µm)
- Two-stage precision fluidic control: a calibrated metering piston pump for volumetric accuracy (<±1%) and an ultra-stable electromagnetic flow regulator for consistent laminar sample delivery
- 1000-channel high-resolution analysis engine, supporting fully customizable binning schemes—including fixed-width, logarithmic, or pharmacopoeia-mandated thresholds (e.g., USP 10/25 µm, EP 10.0 2/5/10/25 µm)
- FDA 21 CFR Part 11-compliant software suite (V8.9) with full audit trail, electronic signatures, five-tier user permission management, automated data backup/recovery, and power-fail resilience
- Integrated color touchscreen interface with bilingual (English/Chinese) operation, complemented by optional wireless keyboard/mouse support for lab-wide deployment flexibility
- Thermally stabilized fluid path accommodating samples from 0 °C to 80 °C, ensuring measurement integrity for temperature-sensitive formulations such as vaccines and ophthalmic solutions
Sample Compatibility & Compliance
The PLD-601jc is validated for direct analysis of parenteral dosage forms—including sterile injectables (solution, lyophilized powder, concentrated solution), intravenous raw materials, ophthalmic preparations, vaccines, and Water for Injection (WFI). It supports filtration efficiency testing of terminal sterilizing filters (e.g., 0.22 µm PVDF membranes) and quantifies removal rates per ISO 13408-2 and USP . The system meets all major global regulatory frameworks: Chinese Pharmacopoeia (ChP) 2015 & 2020 Section 0903, United States Pharmacopeia (USP) Chapters , , and , European Pharmacopoeia (Ph. Eur.) 10.0 and 9.0, British Pharmacopoeia (BP) 2019, Japanese Pharmacopoeia (JP) 17, and WHO International Pharmacopoeia IV. It further complies with ISO 4406 (fluid cleanliness), ISO 11171 (calibration standard), NAS 1638 (aerospace fluids), and MIL-STD-1246D (spacecraft contamination control).
Software & Data Management
PULUODY V8.9 Analysis Software provides a unified platform for instrument control, method development, real-time visualization, statistical reporting, and long-term data governance. All analytical sessions are timestamped and logged with operator ID, parameter settings, calibration history, and raw pulse data. Audit trails record every user action—including method edits, result approvals, and report exports—with immutable hashing. Electronic signatures conform to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate) and support 21 CFR Part 11 Subpart B requirements. Data export formats include CSV, PDF, XML, and LIMS-compatible ASTM E1382-compliant structured files. Optional integration with enterprise LIMS or MES systems is supported via secure RESTful API.
Applications
- Pharmaceutical Quality Control: Routine particulate testing of injectables per ChP 0903, USP , and Ph. Eur. 10.0; extractables/leachables screening of primary packaging (glass vials, rubber stoppers, plastic syringes) per YBB00272004-2015
- Biotherapeutics & Vaccines: Subvisible particle characterization in monoclonal antibodies, mRNA-LNPs, and viral vector suspensions; stability-indicating assays under ICH Q5C guidelines
- Medical Devices: Particulate shedding evaluation of infusion sets, IV tubing, and dialysis membranes per GB 8368 and ISO 8536-4
- High-Purity Water Systems: Monitoring of ultrapure water (UPW) in semiconductor fabs (SEMI F63), pharmaceutical WFI loops (ASTM D5127), and clean steam condensate
- Advanced Materials: Slurry particle distribution analysis in CMP processes, nanoparticle dispersion homogeneity in battery electrolytes, and contaminant profiling in photoresists and inkjet inks
FAQ
Does the PLD-601jc comply with FDA 21 CFR Part 11 for electronic records and signatures?
Yes. The V8.9 software implements full Part 11 functionality—including role-based access control, electronic audit trails, digital signature capture, and data integrity safeguards aligned with Annex 11 and GAMP5 best practices.
Can the instrument be calibrated to ISO 21501-4 and JJG1061 standards?
Yes. Calibration is performed using NIST-traceable polystyrene latex (PSL) reference particles or certified ISO 21501-4 calibration kits. Traceability documentation is provided upon request and aligns with requirements of national metrology institutes including China’s Northwest National Metrology Center.
Is it possible to define custom particle size channels beyond pharmacopoeial defaults?
Yes. Users may configure up to 1000 independent size bins with arbitrary lower/upper thresholds, logarithmic spacing, or hybrid schemes—enabling method development for novel therapeutics, nanomaterials, or proprietary cleanliness specifications.
What maintenance intervals and service support does PULUODY provide?
The instrument includes a 12-month comprehensive service agreement (“Sunshine Customer Service”), 24/7 remote diagnostics, and guaranteed response within 100 working days for data interpretation and method validation consulting. Third-party calibration and ISO/IEC 17025-compliant verification are available through authorized metrology partners.
