0.3μm High Sensitivity Air Particle Counter with ISO 21501-4 Compliance and NIST Traceable Calibration for Cleanroom Monitoring

0.3μm High Sensitivity Air Particle Counter Y09-03S

Y09-03S 0.3μm High Sensitivity Air Particle Counter for Precision Cleanroom Classification

The Y09-03S 0.3μm High Sensitivity Air Particle Counter represents the pinnacle of sub-micron particle detection technology for demanding cleanroom classification and monitoring applications. Engineered around a precision long-life laser diode sensor with optimized optical collection efficiency, the Y09-03S achieves reliable 0.3 micrometer particle detection with 50 percent counting efficiency in full compliance with ISO 21501-4 calibration standards. This level of sensitivity is essential for ISO Class 5 (Class 100) and higher cleanliness classifications where 0.3μm and 0.5μm particle counts are the primary determinants of cleanroom performance status. The instrument provides definitive measurement data that cleanroom managers and quality assurance professionals can rely upon for certification decisions, regulatory compliance documentation, and trend-based environmental quality management programs.

Beyond basic particle counting, the Y09-03S incorporates sophisticated analysis capabilities that transform raw count data into actionable cleanroom intelligence. The onboard classification engine automatically evaluates measurement results against user-selected standards including ISO 14644-1:2015 for all cleanliness classes, EU GMP Annex 1 for Grades A through D, and FS 209E for historical reference. Complete statistical analysis including upper confidence limit (UCL) calculations at 95 percent confidence level, mean particle concentration determination, and pass/fail classification determination is performed automatically and presented in clear, auditor-ready report formats. The instrument stores complete sampling protocols as configurable recipes, enabling one-touch execution of standardized monitoring procedures across multiple operators and shifts.

• 0.3μm Minimum Detection Sensitivity: Precision-engineered laser diode sensor achieves reliable 0.3 micrometer particle detection meeting ISO 21501-4 calibration requirements for counting efficiency, size resolution, and false count rate. This detection threshold enables accurate classification of ISO Class 5 (Class 100) cleanrooms and provides the sensitivity margin needed for monitoring controlled environments where early detection of contamination trends is critical.
• NIST Traceable Calibration: Every Y09-03S instrument is individually calibrated against NIST-traceable particle size standards using monodisperse polystyrene latex (PSL) spheres across the full measurement range. The calibration certificate documents counting efficiency, size resolution, and flow rate accuracy with complete measurement uncertainty analysis, providing the documentation trail required for pharmaceutical regulatory inspections and ISO 17025 accredited laboratory operations.
• Advanced Signal Processing: The onboard digital signal processor continuously analyzes detector pulse height distributions in real time, discriminating true particle events from electronic noise with exceptional accuracy. Proprietary pulse analysis algorithms maintain consistent size discrimination even at high particle concentrations, while automatic baseline correction compensates for detector drift during extended continuous monitoring sessions.
• Comprehensive Cleanroom Classification Engine: Pre-loaded with complete algorithms for ISO 14644-1:2015, EU GMP Annex 1, FS 209E, and China GB/T 25915 standards, the classification engine automatically performs all required statistical calculations including 95 percent UCL determination and generates formatted classification reports that can be directly submitted as part of facility certification documentation packages.
• High-Capacity Recipe Memory: The instrument stores up to 200 user-defined sampling recipes, each specifying complete measurement parameters including sample volume, sample time, number of cycles, delay between samples, location labels, alarm thresholds per channel, and target classification standard. This recipe-based approach standardizes monitoring procedures across facilities and ensures consistent data quality across long-term monitoring programs.

The Y09-03S 0.3μm High Sensitivity Air Particle Counter is specifically designed for applications requiring the highest level of sub-micron particle detection sensitivity. In pharmaceutical aseptic processing environments, it provides 0.3μm and 0.5μm particle count data essential for demonstrating compliance with EU GMP Annex 1 Grade A and Grade B area requirements during both at-rest and in-operation monitoring states. The instrument supports comprehensive environmental monitoring including routine viable and non-viable particle monitoring, process simulation environmental assessment, and HVAC system performance verification in critical pharmaceutical manufacturing zones.

In semiconductor wafer fabrication facilities, the Y09-03S enables precise monitoring of ISO Class 1-3 cleanroom environments where 0.3μm particle counts are the primary metric for contamination control in advanced photolithography and EUV lithography areas. Medical device manufacturers utilize the instrument for ISO Class 5-8 cleanroom monitoring in implantable device assembly, sterile barrier packaging, and terminal sterilization validation. Biotechnology laboratories employ the Y09-03S for biosafety cabinet certification, cell culture laboratory environmental monitoring, and gene therapy production facility qualification. The instrument also supports optical component manufacturing, aerospace cleanroom certification, and precision bearing assembly applications worldwide.

Each Sujing air particle counter is carefully packaged in a durable export-grade carton with high-density foam inserts ensuring maximum protection during international shipping. Standard packaging includes the main instrument unit, isokinetic sampling probe, power adapter with charging cable, zero-count filter, thermal printer paper roll, USB communication cable, PC software installation media, calibration certificate, comprehensive user manual, and protective carrying case. All shipments undergo thorough pre-dispatch inspection including functional testing across all six particle channels, zero-count verification, flow rate calibration check, and communication interface testing.

Sujing Instrument maintains an ISO 9001:2015 certified quality management system with complete traceability from raw material sourcing through final product delivery. Each instrument undergoes rigorous quality assurance testing including 24-hour burn-in, multi-point calibration verification, and full functional validation before release. We provide comprehensive after-sales support including a 12-month standard warranty, lifetime technical consultation, remote diagnostic assistance, and optional on-site calibration with maintenance services performed by factory-trained technicians. Our global service network covers over 60 countries worldwide.

For regulated industries requiring formal cleanroom compliance documentation, we provide complete qualification and validation support packages including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols upon request. Our application engineering team is available to assist with custom configurations and specialized monitoring solutions.