Junray ZR-1640 Stainless Steel Portable Airborne Particle Counter with Triple-Level User Management and Audit Trail

Overview

The Junray ZR-1640 Stainless Steel Portable Airborne Particle Counter is an optically calibrated, high-flow laser scattering instrument engineered for quantitative measurement of airborne particulate contamination in controlled environments. It operates on the principle of single-particle light scattering—where aerosol particles pass through a focused laser beam, generating scattered light pulses proportional to particle size—and converts these signals into real-time concentration data across six user-selectable size channels (0.3, 0.5, 1.0, 3.0, 5.0, and 10.0 µm). Designed specifically for ISO Class 3–8 cleanrooms and GxP-regulated facilities, the ZR-1640 delivers metrologically traceable performance aligned with ISO 21501-4:2018, ISO 14644-1/2, GB/T 16292-2010, and JJF 1190-2008. Its stainless steel housing ensures chemical resistance and mechanical durability in pharmaceutical manufacturing, biotech labs, and medical device cleanroom validation workflows.

Key Features

• Stable 28.3 L/min volumetric flow rate maintained by integrated high-precision centrifugal blower with active feedback control (±2% flow accuracy)
• Six-channel simultaneous particle counting with configurable accumulation, zone-based counting, and selectable display modes (particles/m³ or total count)
• Onboard HEPA exhaust filtration (≥99.99% @ 0.3 µm) ensuring operator safety and ambient air protection
• Self-cleaning cycle completed in <10 minutes; external HEPA filter module enables rapid field maintenance without internal disassembly
• 7-inch capacitive touchscreen with bilingual UI (English/Chinese), intuitive icon-driven navigation, and graphical real-time trend visualization
• Integrated environmental sensors for concurrent logging of temperature (±0.5°C), relative humidity (±3% RH), and barometric pressure (±0.5 kPa)
• Rechargeable lithium-ion battery supporting ≥9 hours of continuous sampling under nominal load
• Standard isokinetic sampling probe and adjustable tripod included for compliant spatial sampling per ISO 14644-1 Annex B

Sample Compatibility & Compliance

The ZR-1640 is validated for use in non-hazardous, non-explosive indoor air environments—including sterile processing areas, isolators, laminar flow hoods, and HVAC ducts—where particle concentrations range from 1 to 10⁶ particles/m³. It meets the optical calibration and sizing accuracy requirements specified in ISO 21501-4:2018 (light scattering airborne particle counters) and JIS B 9921:2010. For regulated applications, its triple-level user management system (Administrator / Supervisor / Operator) enforces role-based access control, while the embedded audit trail logs all critical events—including user login/logout, parameter changes, calibration actions, data export, and print commands—with immutable timestamps and operator IDs. This architecture supports compliance with FDA 21 CFR Part 11 (electronic records/signatures), EU Annex 11, and GMP/GLP data integrity principles.

Software & Data Management

• Internal storage retains ≥10,000 sample records with full metadata (location ID, sampling duration, environmental conditions, operator ID)
• USB mass storage mode enables direct export of CSV-formatted datasets compatible with Excel, JMP, and statistical process control (SPC) platforms
• Optional PC software provides UCL (Upper Confidence Limit) calculation per ISO 14644-1:2015 Annex D, automatic classification reporting, and deviation flagging against preloaded standards (e.g., ISO, EU GMP, USP , Chinese GMP)
• All print outputs—including real-time snapshots and summary reports—are fully customizable: users define displayed parameters, header/footer content, and unit formatting
• Support for predefined room templates allows automatic derivation of minimum sample volume, number of sampling locations, and required sampling duration based on ISO 14644-1 Class and area dimensions

Applications

The ZR-1640 serves as a primary verification tool in cleanroom commissioning, routine monitoring, and periodic requalification. It is routinely deployed for: (1) ISO 14644-1 classification and monitoring of pharmaceutical manufacturing suites; (2) filter integrity testing and leak detection of HEPA/ULPA systems; (3) environmental monitoring in aseptic processing lines per USP and PDA TR13; (4) validation of biosafety cabinets (BSCs) and laminar airflow workstations per NSF/ANSI 49; (5) particulate challenge testing of respirators and surgical masks per ISO 16900 series; and (6) QA/QC of cleanroom garments and wiping materials. Its portability and battery operation make it suitable for mobile audits across multi-site GMP facilities.

FAQ

Does the ZR-1640 comply with FDA 21 CFR Part 11 requirements?
Yes—the built-in audit trail captures all data-altering activities with time-stamped, operator-identified entries, and the triple-tier user authentication prevents unauthorized configuration changes. Electronic records are stored in non-erasable format and support export for long-term archival.

Can the instrument automatically calculate sampling parameters per ISO 14644-1?
Yes—users input room class, area, and height; the system computes minimum sample volume, required number of sampling points, and total sampling duration in accordance with ISO 14644-1:2015 Annex D algorithms.

What is the calibration traceability path for this instrument?
Factory calibration is performed using NIST-traceable PSL (polystyrene latex) reference particles per ISO 21501-4. Certificate of Calibration includes uncertainty budgets and is supplied with each unit.

Is external power required during operation?
No—the integrated lithium-ion battery supports uninterrupted sampling for up to 9 hours. AC adapter is provided for charging and optional continuous operation.

How is data integrity ensured during USB export?
Data exported via USB retains original timestamps, operator IDs, and unmodified raw counts. No post-export recalculations or filtering are applied—ensuring full auditability from acquisition to analysis.