Junray ZR-2052 Airborne Microbial Sampler

Overview

The Junray ZR-2052 Airborne Microbial Sampler is a single-stage, multi-orifice impactor designed for quantitative collection of viable airborne microorganisms in controlled and critical environments. It operates on the Anderson-type inertial impaction principle, with a calibrated jet velocity of 10.8 m/s at the orifice exit—optimized to efficiently deposit particles ≥1 μm aerodynamic diameter onto standard agar-based culture media. This physical separation mechanism ensures high collection efficiency for culturable bacteria and fungi while minimizing shear-induced microbial inactivation. The instrument maintains isokinetic sampling at 0.4 m/s, matching typical unidirectional airflow velocities in ISO Class 5–8 cleanrooms (per ISO 14644-1), thereby reducing particle resuspension and spatial bias during sampling. Its design conforms to core regulatory frameworks governing environmental monitoring in life sciences facilities, including ISO 14698-1 & -2 (Biocontamination Control), USP (Microbiological Control and Monitoring of Aseptic Processing Environments), and EU GMP Annex 1 (2022) requirements for viable particle enumeration.

Key Features

• High-stability mass flow control system with real-time electronic flow compensation, maintaining ±2.5% accuracy across variable backpressure conditions encountered during agar media drying or filter loading.
• Dual-mode sampling operation: programmable time-based or volume-based acquisition, enabling compliance with both GB/T 16293-2010 (pharmaceutical cleanroom testing) and GB/T 39990-2021 (bioaerosol sampler technical specifications).
• Interchangeable Petri dish holder accommodating either Ø90 mm or Ø100 mm standard culture plates, with mechanical centering and vertical alignment assurance to minimize edge effects and ensure uniform impaction distribution.
• Integrated HEPA-filtered exhaust system (≥99.99% @ 0.3 µm) prevents cross-contamination between sampling cycles and safeguards ambient environment integrity.
• Rechargeable lithium-ion battery pack supporting continuous operation >8 hours at 100 L/min; rapid-charge capability (<2.5 h full recharge) minimizes downtime in high-throughput QC laboratories.
• Configurable multi-cycle sampling protocol: users may define up to 99 sequential runs with independent delay intervals, inter-run pauses, and cumulative volume tracking—essential for mapping spatial-temporal bioburden gradients in large-scale manufacturing suites.

Sample Compatibility & Compliance

The ZR-2052 supports both ambient air and compressed gas (e.g., medical air, nitrogen, CO₂) sampling when used with optional inline pressure regulators and moisture traps. All wetted components contacting sampled gas streams are constructed from autoclavable, non-reactive stainless steel and food-grade polymers compliant with USP Class VI and ISO 10993-5 cytotoxicity standards. Device validation documentation includes traceable calibration certificates aligned with JJF (Jiangsu) 188–2017 (Calibration Specification for Airborne Microbial Samplers) and supports IQ/OQ/PQ execution per GAMP 5 guidelines. Data integrity meets ALCOA+ principles, with full audit trail generation for all parameter changes, start/stop events, and error logs.

Software & Data Management

Embedded firmware features role-based access control (RBAC) with three-tier user hierarchy (Operator, Supervisor, Administrator), enforcing password complexity, session timeout, and forced re-authentication for critical actions. All sampling metadata—including date/time stamps, flow rate history, total sampled volume, ambient temperature/humidity readings, and operator ID—are encrypted and stored locally in non-volatile memory (≥10,000 records). Optional PC-based software provides CSV export, statistical trend analysis (e.g., colony-forming units per cubic meter vs. location/time), and automated report generation compliant with FDA 21 CFR Part 11 requirements (electronic signatures, audit trails, data immutability).

Applications

• Environmental monitoring (EM) programs in sterile pharmaceutical manufacturing (Grade A–D zones per EU GMP Annex 1).
• Compressed gas system qualification per ISO 8573-7 and PDA Technical Report No. 29.
• Healthcare facility infection control assessments, including operating theatres, isolation rooms, and HVAC ductwork verification.
• Food and beverage production line hygiene validation under HACCP and BRCGS standards.
• National public health surveillance networks requiring field-deployable, battery-operated bioaerosol samplers meeting GB 50591-2010 and WHO Air Quality Guidelines.

FAQ

What is the minimum detectable particle size for viable microorganism capture?
The ZR-2052 achieves ≥90% collection efficiency for particles ≥1.0 µm aerodynamic diameter under nominal 100 L/min flow, as verified by monodisperse polystyrene latex (PSL) aerosol challenge testing per ISO 21501-4.
Can the device be used for compressed gas sampling without modification?
No—compressed gas sampling requires an optional pressure-reduction module and desiccant trap to prevent condensation-induced agar cracking and flow instability; these accessories are validated for use up to 1.0 MPa inlet pressure.
Is the internal battery certified for air transport?
Yes—the 14.8 V / 4.4 Ah Li-ion battery complies with IATA Packing Instruction 965 Section II and carries UN3481 certification for safe shipment by air.
Does the software support 21 CFR Part 11 compliance out-of-the-box?
Yes—when deployed with the optional desktop application and networked authentication server, the system satisfies electronic record/electronic signature (ER/ES) requirements, including mandatory audit trail review, change control, and retention for ≥2 years.
How frequently must the flow sensor be recalibrated?
Annual recalibration against a NIST-traceable primary standard (e.g., dry calibrator or bubble meter) is recommended; interim verification using a secondary reference flowmeter is advised before each critical EM campaign.