GMP Compliant Six-Channel Air Particle Counter for Pharmaceutical Cleanroom Monitoring

GMP Compliant Six-Channel Air Particle Counter Y09-GMP100

Y09-GMP100 GMP Compliant Six-Channel Air Particle Counter for Pharmaceutical Cleanrooms

The Y09-GMP100 GMP Compliant Six-Channel Air Particle Counter is purpose-built for the pharmaceutical industry, delivering the comprehensive regulatory compliance features that quality assurance professionals and regulatory auditors demand. Engineered to meet the stringent requirements of EU GMP Annex 1 for manufacture of sterile medicinal products and FDA 21 CFR Part 11 for electronic records and electronic signatures, the Y09-GMP100 provides a complete environmental monitoring solution that stands up to the most rigorous regulatory scrutiny. Every aspect of the instrument, from data acquisition through report generation, has been designed with pharmaceutical quality system integration as the primary design objective.

The instrument incorporates a full electronic audit trail that automatically records all user actions, data modifications, and system events with tamper-evident timestamps and user identification. Multi-level password-protected user access control ensures that only authorized personnel can perform configuration changes, initiate sampling protocols, or modify stored data. All particle count data is stored in an ALCOA+ compliant format that ensures data is Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available throughout the required retention period. The Y09-GMP100 generates pharmaceutical-grade reports in PDF format with complete metadata, digital signature support, and direct compatibility with regulatory submission documentation packages.

• Full EU GMP Annex 1 Compliance: Pre-configured with Grade A through D classification algorithms, automated UCL calculations per GMP statistical requirements, and complete sampling protocols aligned with pharmaceutical environmental monitoring program expectations. The instrument supports both at-rest and in-operation monitoring states with automatic classification determination and alert threshold management.
• FDA 21 CFR Part 11 Electronic Records: Complete implementation of FDA requirements for electronic records including secure user authentication with unique user IDs and encrypted passwords, comprehensive audit trail logging of all data creation, modification, and deletion events, authority checks ensuring only authorized individuals can access and modify system functions, and device checks validating data input accuracy.
• ALCOA+ Data Integrity Architecture: All measurement data is stored in an immutable format that preserves original records, prevents unauthorized modification, and maintains complete traceability throughout the data lifecycle. The ALCOA+ framework ensures data meets pharmaceutical regulatory expectations for Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available characteristics.
• Automated Environmental Monitoring Reports: One-touch generation of pharmaceutical-grade monitoring reports in PDF format with complete sample metadata, particle count data for all six channels, classification status determination, alert threshold status, graphical trend displays, and digital signature fields. Reports are formatted for direct inclusion in regulatory submission packages.
• Configurable Alert and Action Limits: User-definable alert and action thresholds for each particle size channel and cleanroom grade, with automatic notification when counts approach or exceed specified limits. The alert system supports pharmaceutical quality system integration with escalation protocols and corrective action tracking.

The Y09-GMP100 serves pharmaceutical manufacturing facilities of all scales, from large-scale sterile production operations to specialized compounding pharmacies and biotechnology process development laboratories. In aseptic filling operations, the instrument provides critical environmental monitoring data for Grade A (ISO Class 5) filling zones and Grade B surrounding areas, supporting both routine monitoring programs and process simulation (media fill) environmental assessments. Sterile API manufacturing facilities utilize the Y09-GMP100 for controlled production area monitoring and HVAC system performance verification to maintain validated state conditions.

Quality control microbiology laboratories employ the instrument for cleanroom monitoring in sterility testing suites, endotoxin testing areas, and microbial limits testing facilities. Contract manufacturing organizations (CMOs) benefit from the comprehensive regulatory compliance features when serving multiple pharmaceutical clients with varying documentation requirements. The instrument also supports hospital pharmacy sterile compounding operations requiring compliance with USP 797 and USP 800 standards, cell and gene therapy production facilities, and active pharmaceutical ingredient (API) manufacturing operations. Regulatory affairs professionals value the complete audit trail and automated report generation capabilities that streamline inspection readiness and regulatory submission preparation.

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.