Junray ZR-1630 Stainless Steel Portable Airborne Particle Counter (28.3 L/min)

Overview

The Junray ZR-1630 Stainless Steel Portable Airborne Particle Counter is an optically calibrated, high-stability 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 and generate scattered light pulses proportional to their size. These pulses are classified into six discrete channels (0.3, 0.5, 1.0, 3.0, 5.0, and 10.0 µm), enabling simultaneous real-time enumeration and size-resolved concentration reporting in particles per cubic meter (or per cubic foot). With a certified volumetric flow rate of 28.3 L/min (1 ft³/min), the ZR-1630 meets the fundamental sampling requirement for ISO 14644-1 Class 5–8 cleanroom certification and aligns with international calibration protocols defined in ISO 21501-4:2018 and JIS B 9921:2010. Its stainless steel enclosure ensures mechanical durability, chemical resistance, and compatibility with stringent decontamination procedures required in pharmaceutical manufacturing and biotechnology labs.

Key Features

• Optimized optical sensing module with temperature-stabilized laser diode and low-noise photodetector array for consistent pulse discrimination across all six size channels.
• Integrated high-precision mass flow controller and brushless DC fan delivering stable 28.3 L/min airflow with ≤ ±2% deviation under variable backpressure conditions.
• Onboard HEPA (H14) exhaust filtration system ensuring operator safety and preventing cross-contamination during repeated sampling cycles.
• Self-cleaning time < 10 minutes—validated per ISO 21501-4 Annex C—minimizing downtime between sequential measurements in multi-point cleanroom mapping.
• 7-inch capacitive touchscreen interface with bilingual (English/Chinese) firmware, graphical real-time particle histogram, and intuitive navigation for field technicians and QA personnel.
• Embedded environmental sensors (temperature, RH, barometric pressure) automatically timestamped and logged alongside particle data to support ISO 14644-2 environmental correlation analysis.
• Three-tier user access control (Operator, Supervisor, Administrator) with full audit trail per FDA 21 CFR Part 11 and EU Annex 11 requirements—including login history, parameter changes, and report generation events.

Sample Compatibility & Compliance

The ZR-1630 is validated for use in non-hazardous, non-explosive ambient air sampling only. It is not rated for corrosive, oily, or high-humidity (>95% RH) environments without external conditioning. The instrument complies with national and international standards governing cleanroom monitoring and particle counter performance verification: ISO 14644-1 (cleanroom classification), ISO 21501-4:2018 (calibration and metrological traceability), GB/T 16292-2010 (pharmaceutical clean area testing), JJF 1190-2008 (national calibration specification), and JIS B 9921:2010 (Japanese industrial standard). Its UCL (Upper Confidence Limit) calculation engine supports automatic statistical evaluation per ISO 14644-1 Annex D, accommodating up to 10 sampling locations per defined cleanroom zone. All firmware and calibration routines are documented for GLP/GMP audit readiness.

Software & Data Management

Data acquisition, storage, and reporting are managed via embedded firmware with dual export pathways: direct thermal printing (optional) and USB mass-storage mode. Raw datasets include timestamped particle counts per channel, environmental parameters, flow rate, battery status, and user ID. Files are saved in CSV format for seamless integration with LIMS, ELN, or statistical process control platforms. The instrument supports pre-configured room templates—including ISO class, area dimensions, and sampling point layout—enabling automated UCL computation and pass/fail determination against selected standards (e.g., ISO 14644-1 Table 1 or EU GMP Annex 1). Audit logs are immutable and retain full metadata, satisfying regulatory expectations for data integrity under 21 CFR Part 11 and EU Annex 11.

Applications

• Cleanroom qualification and routine monitoring in pharmaceutical manufacturing facilities (Grade A–D environments per EU GMP Annex 1).
• HEPA/ULPA filter integrity testing and efficiency validation per ISO 14644-3 and IEST-RP-CC001.
• Aseptic processing line environmental monitoring (ISO 14644-2 surveillance requirements).
• Biological safety cabinet and laminar flow hood certification (NSF/ANSI 49, EN 12469).
• Medical device packaging cleanroom compliance verification (ISO 13485, ISO 14644-1).
• Research laboratory air quality assessment in nanotechnology, semiconductor R&D, and vaccine development suites.

FAQ

What is the minimum detectable particle size and how is sizing accuracy verified?
The ZR-1630 detects particles ≥0.3 µm using light scattering intensity calibration traceable to NIST-traceable PSL standards. Sizing accuracy is verified per ISO 21501-4:2018 Annex B using monodisperse latex spheres.
Does the instrument support remote data transmission or network connectivity?
No Ethernet or Wi-Fi interface is integrated; data transfer is limited to USB mass storage and optional thermal printing to maintain electromagnetic compatibility and regulatory compliance in GMP environments.
Can the ZR-1630 be used for outdoor or industrial stack monitoring?
No—it is designed exclusively for indoor, low-concentration clean environments (typically < 35,000,000 particles/m³ at 0.5 µm). High-concentration or oily aerosols may saturate the sensor or contaminate the optics.
Is the internal battery replaceable by the end user?
The Li-ion battery is field-replaceable using manufacturer-supplied service kits; replacement requires recalibration of flow and optical alignment per JJF 1190-2008.
How frequently must the instrument be calibrated?
Annual calibration is recommended per ISO 21501-4 and JJF 1190-2008; interim verification using reference aerosols is advised before critical cleanroom certifications.