Pharmaceutical Grade Six-Channel Air Particle Counter with 100 L/min Flow Rate for Cleanroom Environmental Monitoring

Pharmaceutical Grade Six-Channel Air Particle Counter Y09-PH100

Y09-PH100 Pharmaceutical Grade Six-Channel Air Particle Counter for Drug Manufacturing

The Y09-PH100 Pharmaceutical Grade Six-Channel Air Particle Counter is specifically engineered for the demanding environmental monitoring requirements of pharmaceutical drug manufacturing facilities. From active pharmaceutical ingredient (API) synthesis suites to finished dosage form production areas, this instrument provides the comprehensive particle monitoring capabilities that quality assurance departments, regulatory affairs teams, and production managers rely upon to maintain validated state conditions. The Y09-PH100 combines high-sensitivity 0.3 micrometer particle detection with pharmaceutical-grade documentation features, making it an essential tool for facilities operating under FDA, EMA, PMDA, and other global regulatory frameworks.

Designed with pharmaceutical manufacturing workflows in mind, the Y09-PH100 features materials and construction specifically selected for cleanroom compatibility. The instrument housing is manufactured from VHP (vaporized hydrogen peroxide) and H2O2 resistant materials that withstand repeated exposure to common pharmaceutical cleanroom decontamination agents without degradation. The isokinetic stainless steel sampling probe maintains sample representativeness in unidirectional airflow environments typical of pharmaceutical Grade A/B cleanroom zones. An intuitive touchscreen interface presents GMP-critical information including real-time particle counts, classification status against user-selected cleanroom grades, alert and action limit status, and sampling protocol progress, enabling operators to maintain situational awareness throughout environmental monitoring sessions.

• Pharmaceutical Cleanroom Optimized Materials: Instrument housing constructed from VHP and H2O2 resistant polymers that maintain structural integrity and surface finish after repeated exposure to pharmaceutical cleanroom decontamination agents. All external surfaces feature smooth, crevice-free design that facilitates effective cleaning and minimizes particle generation from the instrument itself.
• Isokinetic Sampling System: The stainless steel isokinetic sampling probe ensures that the air sample entering the instrument accurately represents the particle concentration of the surrounding cleanroom environment in unidirectional airflow conditions, eliminating the sampling bias that can occur with non-isokinetic probes in laminar flow cleanroom zones typical of pharmaceutical Grade A and B areas.
• Comprehensive GMP Environmental Monitoring Support: Pre-configured sampling protocols aligned with pharmaceutical environmental monitoring program requirements for both routine monitoring and intensive process simulation (media fill) assessments. The instrument supports programmable sampling grids with configurable location labels, enabling efficient execution of established monitoring plans with automatic data organization.
• Configurable Alert and Action Thresholds: User-definable particle concentration thresholds for each cleanroom grade and particle size channel, with graduated alert levels supporting pharmaceutical quality system integration. When particle counts approach or exceed defined limits, the instrument provides immediate visual and audible notification to enable timely investigation and corrective action.
• Pharmaceutical Documentation Package: Automated generation of comprehensive environmental monitoring reports in PDF format with complete metadata including date, time, location, operator identification, particle counts per channel, classification status, alert threshold status, and instrument calibration information. Reports are formatted for direct inclusion in batch release documentation and regulatory submission packages.

The Y09-PH100 serves pharmaceutical manufacturing operations across the full spectrum of production environments and facility scales. In aseptic filling operations for injectable products, the instrument provides the Grade A (ISO Class 5) environmental monitoring data required to demonstrate ongoing control of the critical filling zone during production operations and the Grade B surrounding area monitoring that completes the aseptic processing environmental picture. Oral solid dosage form manufacturers utilize the Y09-PH100 for controlled production area monitoring to verify continued compliance with area classification requirements.

Sterile API manufacturers employ the instrument for process area environmental monitoring and HVAC system performance trending to support continued process verification programs mandated by modern GMP regulations. Biotechnology and cell therapy production facilities rely on the Y09-PH100 for cleanroom monitoring in both open and closed processing environments. Contract manufacturing organizations benefit from the instrument's multi-grade monitoring capability when supporting diverse client requirements across multiple production suites. Quality control microbiology laboratories utilize the instrument for environmental monitoring in sterility testing, endotoxin testing, and microbial limits testing areas to support laboratory quality system requirements and regulatory inspection preparedness.

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.