PULUODY PST-890SIS Automated Sample Introduction Insoluble Particle Detection System

Overview

The PULUODY PST-890SIS Automated Sample Introduction Insoluble Particle Detection System is a regulatory-compliant, light-blockage (light-obscuration) based instrument engineered for quantitative analysis of insoluble particulate matter in parenteral and ophthalmic pharmaceutical products, medical devices, and high-purity process liquids. It operates on the principle of single-particle optical sensing (SPOS), where particles suspended in a liquid stream pass through a focused laser beam, generating transient voltage pulses proportional to particle cross-sectional area. The dual-laser narrow-beam sensor—PULUODY’s proprietary 8th-generation optical architecture—enhances signal-to-noise ratio and minimizes refractive index dependency, enabling reliable detection across diverse formulations including lipid emulsions, viscous concentrates, lyophilized reconstitutes, and low-conductivity ultrapure water. Designed to meet stringent pharmacopeial requirements, the system delivers traceable, reproducible, and statistically robust particle counts per unit volume (e.g., particles ≥10 µm and ≥25 µm per mL), supporting quality control, filter validation, extractables/leachables assessment, and container-closure integrity evaluation.

Key Features

• 8th-generation dual-laser narrow-beam optical sensor with optimized beam geometry for improved sensitivity to sub-5 µm particles and reduced coincidence error
• Dual-precision fluidic control: integrated precision metering piston pump + ultra-stable electromagnetic flow regulation ensures volumetric accuracy <±1% and repeatability across variable viscosities and temperatures (0–80 °C)
• 1000-channel high-resolution pulse analysis (0.01 µm resolution increment), configurable into user-defined bin sets (4–128 channels) to align with pharmacopeial thresholds (e.g., USP , ChP 0903, EP 2.9.19)
• FDA 21 CFR Part 11-compliant software suite (V8.9) featuring five-tier role-based access control, electronic signatures, immutable audit trail, automatic data backup/recovery, and power-failure recovery
• Automated 36-position sample carousel with programmable rinse cycles, thermal equilibration hold, and barcode-assisted sample tracking
• Comprehensive calibration support: traceable to NIM Northwest Metrology Testing Center or Defense Science & Technology Commission Level-1 Particle Metrology Station No. 116 per JJG 1061, ISO 21501, or certified latex standards

Sample Compatibility & Compliance

The PST-890SIS accommodates a broad spectrum of regulated and industrial samples without manual dilution or filtration pre-treatment. Validated applications include intravenous fat emulsions, sterile powders (post-reconstitution), concentrated injectables, ophthalmic solutions, vaccines, Water for Injection (WFI), Purified Water (PW), pharmaceutical packaging components (e.g., stoppers, IV bags), and infusion sets per GB 8368. It supports filter challenge testing—including terminal sterilizing-grade filter efficiency verification (e.g., log reduction value assessment)—and quantifies residual particulates after filtration per ISO 13408-1 and ASTM F838. All operational protocols, data handling, and reporting conform to Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and ICH Q5A/Q5C frameworks. Full compliance documentation—including IQ/OQ/PQ templates, raw data export (CSV, PDF, XML), and electronic record retention—is provided for regulatory submissions and inspection readiness.

Software & Data Management

The V8.9 PC-based analytical platform integrates acquisition, visualization, statistical reporting, and long-term archiving within a single interface. Users define test methods via intuitive wizards—including particle size thresholds, sampling volume, flow rate, and rinse parameters—and save them as SOP-compliant templates. Real-time histograms, cumulative distributions, and batch trend charts are generated automatically. Data integrity safeguards include time-stamped operator logs, version-controlled method files, encrypted database storage, and exportable audit reports compliant with FDA 21 CFR Part 11 Annex 11 and EU GMP Annex 11. Raw pulse data (.dat) and processed results (.xlsx) are archived with SHA-256 hash verification. Optional LIMS connectivity (via ASTM E1384 or HL7) enables seamless integration into enterprise quality management systems.

Applications

• Pharmaceutical QC: Routine batch release testing of injectables per ChP 0903, USP , EP 2.9.19, and JP 17
• Medical device evaluation: Particulate shedding from syringes, IV tubing, connectors, and elastomeric stoppers per ISO 10993-12 and YBB 00272004-2015
• Water system monitoring: Solid contamination profiling in WFI, PW, and ultrapure water used in bioprocessing (ISO 21510, ASTM D6786)
• Semiconductor & electronics: Slurry cleanliness verification (CMP slurries), wafer rinse water, and photoresist carriers
• Specialty chemicals: Nanoparticle dispersion stability in inks, lubricants, and functional coatings
• Food & cosmetics: Quantitative microcontamination screening in sterile-filtered beverages and ophthalmic-grade cosmetics

FAQ

Does the PST-890SIS comply with FDA 21 CFR Part 11 requirements for electronic records and signatures?

Yes—the system implements full Part 11 functionality including role-based authentication, electronic signatures with biometric or token-based verification, time-stamped audit trails, and data immutability controls.
Can the instrument be validated for GMP environments?

Yes—comprehensive IQ/OQ/PQ documentation packages, traceable calibration certificates, and vendor-supported qualification services are available.
What is the minimum detectable particle size, and how is resolution verified?

The base configuration detects particles ≥1 µm; optional optics extend down to 0.03 µm. Resolution is verified per ISO 21501 using NIST-traceable polystyrene latex standards and confirmed by ≥95% counting efficiency at 5 µm per ChP 2020.
Is method transfer supported between different PST-890SIS units?

Yes—standardized sensor alignment protocols, identical firmware versions, and shared calibration reference materials ensure inter-instrument comparability across global sites.
How does the system handle highly viscous or protein-rich samples that may cause sensor fouling?

The dual-flow architecture isolates sample path from optical chamber; automated post-run cleaning cycles (up to 500 mL/min) with configurable solvent selection minimize carryover and maintain baseline stability over extended operation.