HJ ZJSJ-008 Compressed Air Sampler
| Brand | HJ |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Manufacturer |
| Model | ZJSJ-008 |
| Flow Rates | 28.3 L/min, 50 L/min, 100 L/min |
| Flow Accuracy | ±5% |
| Operating Pressure Range | 0.1–1.0 MPa (30–150 psi) |
| Particle Size Cut-off | ≥0.3 µm |
| Microbial Sampling Mode | Viable airborne microorganism collection at 50 L/min and 100 L/min |
| Operating Temperature | 0–35 °C |
| Operating Relative Humidity | 0–35% RH |
| Gas Compatibility | Nitrogen, Argon, Helium |
| Noise Level | <50 dB(A) |
| Housing Material | SUS304 stainless steel |
| Dimensions (L×W×H) | 150 × 300 × 200 mm |
| Weight | 3.3 kg |
Overview
The HJ ZJSJ-008 Compressed Air Sampler is a precision-engineered instrument designed to meet the stringent compressed air quality verification requirements of current Good Manufacturing Practice (cGMP), ISO 8573-1:2010 (Class 0–4 for particles, water, and oil), and EU GMP Annex 1 (2022). It operates on the principle of isokinetic sampling with internal flow-controlled aspiration, enabling simultaneous quantitative assessment of both particulate contamination (≥0.3 µm) and viable airborne microorganisms in compressed air systems used across pharmaceutical, biotechnology, medical device, and sterile manufacturing facilities. Unlike conventional dilution-based or bypass-type samplers, the ZJSJ-008 directs 100% of the incoming gas stream through the sampling stage—ensuring no sample loss and maximal collection efficiency for low-abundance bioburden. Its pressure-tolerant architecture (0.1–1.0 MPa) allows direct inline integration into compressed air distribution networks without external regulators or pressure-reduction stages.
Key Features
- Triple-flow configuration: selectable fixed flow rates of 28.3 L/min (for ISO 8573 particle counting alignment), 50 L/min, and 100 L/min (validated for pharmacopeial microbial recovery per USP & EP methods)
- True 100% gas utilization: zero bypass design eliminates sample splitting, maximizing colony-forming unit (CFU) recovery sensitivity
- SUS304 stainless steel housing: corrosion-resistant, non-shedding, and compliant with cleanroom-compatible material requirements (ISO 14644-1 Class 5–8 environments)
- Front-panel mechanical flow regulation: intuitive, tool-free adjustment with tactile feedback; no software dependency for basic operation
- Low acoustic signature (<50 dB[A] at 1 m): suitable for use in QC laboratories, isolators, and controlled manufacturing suites without ambient noise interference
- Multi-gas compatibility: validated for use with nitrogen, argon, and helium—critical for inert gas line monitoring in aseptic processing
- Modular inlet interface: standardized 1/4″ NPT or Swagelok®-compatible ports facilitate rapid connection to compressed air manifolds and validation test rigs
Sample Compatibility & Compliance
The ZJSJ-008 supports standard microbiological collection media including 90 mm contact plates, 55 mm Petri dishes, and membrane filtration cassettes (e.g., 47 mm mixed cellulose ester). Its aerodynamic design ensures laminar, non-turbulent airflow across agar surfaces—minimizing droplet impaction artifacts and preserving microbial viability. The instrument complies with ISO 14698-1:2003 (Biocontamination control) and aligns with the sampling strategy guidance in PDA Technical Report No. 75 (Sterile Product Manufacturing). For regulatory submissions, it supports audit-ready documentation: all operational parameters (flow rate, duration, pressure, ambient T/RH) are manually recorded per batch log—fully compatible with paper-based GLP/GMP recordkeeping and electronic data capture (EDC) workflows.
Software & Data Management
The ZJSJ-008 is a hardware-only, firmware-free platform—intentionally omitting embedded software to eliminate cybersecurity vulnerabilities, reduce validation burden (no 21 CFR Part 11 compliance required), and ensure long-term operational stability. All calibration, maintenance, and usage records are maintained externally via facility-controlled LIMS or paper-based SOPs. Optional traceable calibration certificates (NIST-traceable flowmeter verification) and annual performance qualification (PQ) protocols are available upon request. The absence of digital interfaces also ensures immunity to electromagnetic interference (EMI) in high-voltage manufacturing areas.
Applications
- Compressed air system qualification (IQ/OQ/PQ) per ISO 8573-1 and EU GMP Annex 1
- Routine environmental monitoring (EM) of Grade A/B cleanrooms and RABS isolators
- Validation of sterile filtration integrity and compressed air dryer performance
- Microbial challenge testing during aseptic process simulation (media fill studies)
- Investigation of bioburden excursions in final product packaging lines using nitrogen purge systems
- Pharmaceutical water-for-injection (WFI) system compressed air overlay monitoring
FAQ
Is the ZJSJ-008 suitable for ISO 14644-1 Class 5 cleanroom use?
Yes—the SUS304 construction, low particulate shedding, and sub-50 dB noise output meet physical and operational requirements for Grade A/B environments.
Does it require electrical power or compressed air as the driving force?
It operates passively using the pressure energy of the sampled gas stream; no external power source is needed.
Can it be used with glycerol-based or selective agars (e.g., Sabouraud Dextrose Agar)?
Yes—its laminar flow profile and low shear stress preserve viability of yeasts, molds, and bacteria across standard microbiological media.
What is the recommended calibration frequency?
Per ISO/IEC 17025, flow verification should be performed prior to each qualification campaign and annually for routine use; certificate of calibration is provided with each unit.
Is it compatible with automated colony counters?
Yes—standard 90 mm Petri dishes collected using the ZJSJ-008 are fully compatible with FDA-cleared digital colony enumeration platforms (e.g., ProtoCOL, ScanStation).
