PULUODY PLD-601-D Disposable Ureteral Access Sheath Particulate Analyzer

Overview

The PULUODY PLD-601-D Disposable Ureteral Access Sheath Particulate Analyzer is a high-resolution, regulatory-compliant liquid-borne particle counter engineered for rigorous quality control in pharmaceutical manufacturing, medical device validation, and advanced materials R&D. Designed specifically to assess particulate contamination in single-use urological instrumentation—including ureteral access sheaths—the instrument employs light extinction (light blockage) detection principle per ISO 21501-4 and USP . Its 8th-generation dual-laser narrow-beam sensor delivers exceptional signal-to-noise ratio and minimizes optical diffraction artifacts across the full 0.01 µm to 450 µm measurement range. Unlike generic particle counters, the PLD-601-D integrates application-specific fluidics architecture optimized for low-volume, high-sensitivity analysis of rinse extracts from sterile medical devices—ensuring representative sampling of residual microcontaminants post-sterilization or during functional testing.

Key Features

• 8th-generation dual-laser narrow-beam optical sensor with real-time pulse height analysis for improved sizing fidelity and reduced coincidence error
• Dual-mode flow control: precision metering piston pump (±1% volumetric accuracy) coupled with ultra-fast electromagnetic flow regulation for stable, programmable sample delivery (5–150 mL/min)
• 1000 fully customizable size channels enabling granular compliance mapping against >510 global pharmacopoeial and industrial standards
• V8.9 Particulate Analysis Software Suite with embedded touchscreen interface and optional PC-based operation—supporting multi-language UI (English/Chinese), method templates, and automated report generation
• FDA 21 CFR Part 11-compliant architecture: role-based 5-tier user permissions, immutable audit trail, electronic signatures, automatic data backup/recovery, and power-loss recovery
• Thermally stabilized fluid path accommodating samples from 0 °C to 80 °C—critical for evaluating temperature-sensitive biologics and polymer-based device extracts
• Integrated cleaning protocol with adjustable rinse flow (5–500 mL/min) and programmable cycle sequencing to prevent carryover between high-risk samples

Sample Compatibility & Compliance

The PLD-601-D is validated for direct analysis of extractables and leachables from disposable urological devices, including ureteral access sheaths, guidewires, and associated packaging components. It supports standardized test protocols per YBB00272004-2015 (Chinese Pharmacopoeia packaging material particulate testing), GB 8368 (infusion equipment), and ISO 11171 (calibration standard). The system meets GLP/GMP data integrity requirements for QC laboratories operating under FDA, EMA, PMDA, and NMPA oversight. All software-generated reports include timestamped metadata, operator ID, instrument calibration status, and raw pulse data—fully traceable for regulatory inspection. Third-party metrological verification is supported by CNAS-accredited labs, including the Northwest National Metrology Center and the Defense Science & Technology Commission Particle Metrology Station No. 116.

Software & Data Management

The V8.9 software platform provides full lifecycle data governance: method creation, instrument calibration logging, batch-level result aggregation, statistical process control (SPC) charting, and PDF/CSV export with digital signature embedding. Audit trails record every user action—including parameter changes, data deletions, and report approvals—with hash-verified immutability. Data backups are encrypted and stored locally or on network drives; restoration preserves original timestamps and relational integrity. The system supports integration with LIMS via ASTM E1384-compliant interfaces and allows custom scripting for automated pass/fail evaluation against configurable limits per USP Table 1 or ISO 4406 class codes.

Applications

• Pharmaceuticals: Quantification of insoluble particles in injectables (solution, lyophilized, concentrated), ophthalmic solutions, vaccines, WFI, and container-closure system extracts
• Medical Devices: Filter efficiency testing of terminal IV filters, particulate shedding assessment from ureteral sheaths, catheters, and silicone tubing per ISO 10993-12
• Water & Semiconductors: Solid contaminant profiling in ultrapure water (UPW), CMP slurries, wafer rinse effluents, and electronic-grade solvents
• Advanced Materials: Nanoparticle dispersion stability in inks, lubricants, functional coatings, and nanocomposites
• Industrial Hygiene: Cleanroom fluid monitoring, hydraulic fluid cleanliness per NAS 1638, and turbine oil particulate load tracking

FAQ

Does the PLD-601-D comply with FDA 21 CFR Part 11 for electronic records and signatures?

Yes. The system implements full Part 11 controls including role-based access, audit trail with tamper-evident logs, electronic signatures tied to identity verification, and data backup/recovery protocols.
Can the instrument be calibrated to ISO 21501-4 and USP simultaneously?

Yes. The dual-laser sensor and 1000-channel architecture allow concurrent calibration using NIST-traceable latex standards per ISO 21501-4 while maintaining alignment with USP counting thresholds and sizing bins.
Is validation support available for IQ/OQ/PQ documentation?

Yes. PULUODY provides URS-aligned validation templates, DQ documentation, and on-site or remote OQ/PQ execution support through certified partners accredited by CNAS and ISO/IEC 17025.
What sample volume is required for a compliant test per ChP 0903?

The system supports minimum injection volumes as low as 1 mL with precision metering—fully compatible with ChP 0903 requirements for small-volume parenterals and device rinse extracts.
How does the system handle particle coincidence at high concentrations?

Coincidence correction algorithms are applied in real time, with verified performance ≤5% error at 1000 particles/mL—validated per ISO 21501-4 Annex C and documented in the instrument’s Type Evaluation Report.