PULUODY PLD-601-B Pharmacopoeia Insoluble Particle Analyzer
| Brand | PULUODY |
|---|---|
| Origin | Shaanxi, China (Manufactured in China) |
| Manufacturer Type | Direct Manufacturer |
| Model | PLD-601-B |
| Price | USD 29,500 (approx.) |
| Detection Principle | Light Obscuration (LO) |
| Calibration Standards | USP <788>, USP <789>, EP 2.9.19, JP 6.04, ChP 2015 Vol I Appendix IX R |
| Measurement Range | 0.03 µm – 3000 µm (configurable sub-ranges) |
| Channel Count | 1000 adjustable size channels |
| Sample Volume | 1 mL to unlimited (programmable) |
| Flow Accuracy | ±1% |
| Counting Accuracy | ±3% typical |
| Coincidence Limit | ≤3% at 40,000 particles/mL |
| Resolution | ≥95% (ChP 2015), <10% (USP <788>, ISO 21501-4, JJG 1061) |
| Viscosity Range | 0–99 mm²/s (pressurized up to 500 mm²/s) |
| Flow Rate | 5–150 mL/min (sampling), 5–500 mL/min (flushing) |
| Temperature Range | Fluid 0–80 °C |
| Data Storage | ≥20,000 test records (expandable via USB) |
| Compliance | FDA 21 CFR Part 11 ready (audit trail & electronic signature optional), GLP/GMP traceable operation |
Overview
The PULUODY PLD-601-B Pharmacopoeia Insoluble Particle Analyzer is a fully integrated, regulatory-compliant instrument engineered for quantitative detection and size-resolved enumeration of insoluble particulate matter in parenteral drug products, ophthalmic solutions, injectables, infusion sets, and pharmaceutical excipients. It operates on the internationally recognized light obscuration (LO) principle—where particles suspended in a liquid stream pass through a focused laser beam, generating transient reductions in transmitted light intensity proportional to particle cross-sectional area. This method is explicitly mandated by major pharmacopoeial standards including USP , USP , European Pharmacopoeia 2.9.19, Japanese Pharmacopoeia JP 6.04, and Chinese Pharmacopoeia 2015 Edition Vol. I Appendix IX R. The PLD-601-B features a seventh-generation dual-laser narrow-beam sensor optimized for high signal-to-noise ratio and minimal refractive index dependency, enabling robust performance across aqueous, oily, and low-conductivity formulations without dilution or filtration artifacts.
Key Features
- 1000-channel high-resolution particle sizing with user-definable binning (e.g., 4-, 8-, 16-, 32-, 64-, 128-, or full 1000-channel mode) for granular compliance reporting per USP/EP/ChP thresholds.
- Integrated precision piston pump and electromagnetic flow control system ensuring volumetric accuracy of ±1% and repeatable sample delivery from 1 mL to unlimited volume.
- Programmable pressure-assisted sampling (up to 500 mm²/s kinematic viscosity) with built-in vacuum/positive-pressure manifold for degassing viscous or volatile samples and minimizing bubble interference.
- Touchscreen-driven embedded operating system with real-time histogram display, automatic grade assignment per pharmacopoeial limits (e.g., ChP Grade A/B/C), and on-device thermal printing—no external PC required.
- RS232, RS485-to-USB, and LAN interfaces support LIMS integration, remote diagnostics, and 21 CFR Part 11-compliant data archiving with optional electronic signatures and audit trail modules.
- Factory-calibrated using NIST-traceable GBW reference materials; optional accredited calibration certificates available from Northwest National Metrology Testing Center (CNAS-accredited).
Sample Compatibility & Compliance
The PLD-601-B accommodates a broad range of pharmaceutical liquids: sterile water for injection (WFI), saline, dextrose solutions, lipid emulsions, monoclonal antibody formulations, suspensions, and polymer-based delivery vehicles. Its fluid path is constructed from chemically inert, non-shedding materials compliant with USP Class VI and ISO 10993 biocompatibility requirements. The instrument meets mechanical and electrical safety standards IEC 61010-1 and electromagnetic compatibility per IEC 61326-1. All measurement protocols align with validation requirements under ICH Q5A(R2), Q5C, and Annex 15: Qualification and Validation. Method suitability testing—including filter compatibility, carryover assessment, and system precision per USP —is supported via built-in validation templates and raw pulse-data export.
Software & Data Management
P6.4 Analysis Software (integrated or PC-deployable) provides full data governance functionality: time-stamped acquisition logs, user access controls, version-controlled SOP execution, and automated report generation in PDF or CSV formats. Raw pulse-height data is retained alongside processed counts, enabling retrospective re-binning or secondary analysis. The system supports multi-level user roles (Operator, Supervisor, Administrator) with password protection and session timeout. Audit trails record all parameter changes, result modifications, and calibration events—fully compliant with FDA 21 CFR Part 11 Subpart B when enabled. Data export conforms to ASTM E2500 and ISO/IEC 17025 documentation requirements for GLP and GMP environments.
Applications
- Final container testing of injectables per USP and ChP Appendix IX R.
- Filter integrity verification and extractables/leachables screening in single-use bioprocessing systems.
- Particulate load monitoring during filling line qualification and routine QC release testing.
- Compatibility studies between drug product and primary packaging (e.g., glass vials, rubber stoppers, plastic syringes).
- Stability-indicating assay for aggregation onset in protein therapeutics under accelerated stress conditions.
- Raw material qualification of excipients such as polysorbates, PEGs, and phospholipids.
FAQ
Does the PLD-601-B comply with USP and USP requirements for particle counting?
Yes—the instrument implements light obscuration detection with validated sensitivity down to 0.03 µm, configurable channel thresholds, and automated pass/fail grading against specified limits for both 10 µm and 25 µm particles.
Can it measure highly viscous or volatile samples?
Yes—via its dual-mode pressure/vacuum sampling system and temperature-controlled fluid path (0–80 °C), it supports samples up to 500 mm²/s viscosity and minimizes volatilization artifacts.
Is 21 CFR Part 11 compliance built-in or optional?
Core audit trail and electronic signature capabilities are software-configurable; full Part 11 readiness requires optional license activation and documented system validation per your internal SOPs.
What calibration standards does it support out-of-the-box?
Pre-loaded profiles include USP , EP 2.9.19, JP 6.04, ChP 2015, ISO 21501-4, and ISO 21510; additional pharmacopoeial or custom standards can be imported via XML configuration files.
How is traceability maintained for routine calibration?
Each unit ships with GBW-certified reference particles; annual recalibration is supported by CNAS-accredited Northwest National Metrology Testing Center, with full calibration reports traceable to SI units.
