Sistema-MK AFM-NEO Dual-Cube Series Piezoelectric Ultrasonic Airflow Visualization System
The AFM-NEO Dual-Cube Piezoelectric Ultrasonic Fogger & Airflow Mapping System is designed for visual verification of airflow in top-tier aseptic pharmaceutical workshops (Class A/B cleanrooms), aseptic isolators, restricted access barrier systems (RABS), biosafety cabinets (BSC), and laminar flow benches (LAF). It is specifically designed to intuitively evaluate and confirm the integrity of unidirectional (laminar) flow, airflow direction, flow field disturbances, dead zones, external air intrusion, and pressure differential barrier effectiveness.
I. Compliance with laws and international standards
It fully complies with the US FDA guidelines for sterile drug manufacturing, cGMP, the European Pharmacopoeia, EU GMP Annex 1 (Annex to Sterile Drug Manufacturing), ISO 14644-3 Annex B7/B12 international standards for airflow visualization, as well as USP <797>, USP <800>, NSF 49 and CE/EMC standards.
II. Core Piezoelectric Technology and Real Neutral Buoyancy
The system uses medical-grade AISI 316L high-frequency piezoelectric transducers, using high-purity deionized water (DI water) or water for injection (WFI) as the medium. It generates uniform, high-density, ultrapure micromist of 1 to 3 µm through room temperature oscillation. It has true neutral buoyancy, with no thermal effects causing it to rise or condense and sink, and is 100% oil-free, non-toxic, and leaves no secondary residue. It evaporates naturally without wiping and will never damage the HEPA/ULPA filter.
III. Dual independent stepless control and full-form flow field accessories
It features dual independent 0–100% precise digital stepless control technology for airflow and fog volume, which can completely eliminate the zero exit momentum of the fog outlet, perfectly adapting to and capturing the weak laminar airflow velocity of 0.36 to 0.54 m/s in cleanrooms; it supports point source air guide tubes, straight-tube multi-hole smoke rakes and flat air curtain nozzles, and can be paired with long-distance wireless remote control modules and high-contrast LED Boost lighting systems to clearly capture fine airflow trajectories, turbulent diffusion and personnel interference dynamics against complex dark backgrounds or metallic reflective backgrounds.
IV. Sanitary Dual-Cube Chassis and Continuous Testing Efficiency
The entire unit adopts an AISI 316L/304 sanitary-grade dual-cube modular stainless steel frame with a smooth mirror surface, eliminating dead angles and reducing dust generation. It is highly resistant to vaporized hydrogen peroxide (VHP), isopropanol (IPA), and commonly used cleanroom chemical sterilizers. It exclusively supports "Filling on the fly" online non-stop water replenishment technology, providing continuous mist supply without disassembly, and fully meets the high efficiency and strict compliance requirements of the Dynamic Smoke Study.
Equipment Introduction
Piezoelectric Ultrasonic Fogging Technology
Ultramicron neutral buoyancy mist: Using a medical-grade AISI 316L high-frequency voltage transducer array, pure water (DI Water) or water for injection (WFI) is atomized into ultramicron mist of 1.0 to 3.0 µm, which has excellent neutral buoyancy and truly reflects weak laminar flow of 0.36 to 0.54 m/s (±20%) without false descent or settling.
Room temperature, no thermal effect mist generation: The entire process uses room temperature physical vibration to generate mist (Cold Mist), eliminating the thermal convection lift and buoyancy deviation of traditional heating-type smoke generation equipment, and providing a distortion-free flow field visualization.
Independent dual-channel flow control
Independent adjustment of fog density and air velocity: The panel is equipped with two sets of 0 to 100% independent stepless digital fine adjustment knobs, which can precisely control the fog density and air velocity respectively, and are suitable for various test scales from micro isolation devices to large-area cleanrooms.
Eliminating Exit Jet Momentum: Unique airflow mixing and energy dissipation technology allows the mist to gently escape at near-zero exit momentum, completely eliminating the disturbance and artificial vortex caused by traditional high-pressure jet momentum to unidirectional flow.
Dual-Cube Hygienic & VHP Resistant Design
Pharmaceutical-grade stainless steel protection: The entire body is made of AISI 316L / AISI 304 sanitary-grade stainless steel with a mirror-polished finish (Ra < 0.8 µm), eliminating grooves and dirt-trapping corners. It is fully resistant to VHP (vaporized hydrogen peroxide) sterilization, alcohol, IPA, and various powerful cleanroom disinfectants.
Online non-stop water replenishment technology: It adopts an atmospheric pressure liquid level replenishment framework (Filling on the Fly) to support real-time water replenishment during smoke generation testing without depressurization, process interruption or restart, ensuring that long-term dynamic flow field recording is completed in one go.
Residue-Free & HEPA/ULPA Safe Operation – Zero Loss Protection for Clean Media and Filters
Pure water medium, no wiping required: 100% pure water or WFI water for injection is used only. It is oil-free and glycol-free. The mist dissipates naturally without leaving any secondary residues. No cleaning or wiping is required after testing.
The filter is aseptic and environmentally friendly: Long-term testing has proven that microdroplets do not adhere, clog, or shorten the lifespan of HEPA/ULPA high-efficiency filters, making it suitable for core critical areas such as aseptic filling points, freeze dryer loading and unloading areas, and biosafety cabinets.
Modular Distribution & Barrier Adapters
Multi-channel flow expansion: standard/optional food-grade clean silicone hose, single-point micro probe, 300-1200 mm multi-hole smoke rakes and flat air curtain nozzles, evenly spreading a large area of blind-spot-free tracking line.
Airtight barrier penetration and long-distance remote control: Offers sanitary quick-release clamp (Tri-Clamp) flange kits and glove box penetration components to introduce mist without damaging isolators or RABS airtight environments; supports multi-channel long-distance wireless remote control, allowing precise operation through windows.
Regulatory Compliance & Validation Support
International Pharmacopoeia and Cleanliness Regulations: Fully compliant with ISO 14644-3:2019 (Annex B.7 / B.12), the latest revised version of EU GMP Annex 1 (with confirmed static and dynamic airflow field recording), FDA aseptic process guidelines, USP <797>/<800> and NSF 49 standards.
Complete IQ/OQ validation support: Original manufacturer's inspection report, Material Certificate 3.1, and complete installation and operation validation (IQ/OQ) folder are provided randomly to facilitate pharmaceutical companies to conduct rigorous audits and record keeping.
Product Features
Zero-impulse portable handheld smoke generator for rapid area inspection and leak detection.
Piezoelectric ultrasonic cooling technology
Suitable for pharmaceutical laboratories
Semiconductor cleanroom models
Ultra-pure liquid nitrogen, high-volume white smoke - specially designed for large cleanrooms
Designed by ISO Suites
Overall Specifications
Product Models : AFM-NEO Dual-Cube Series (AFM-NEO Standard / AFM-NEO Plus / AFM-NEO Max)
Manufacturer : SISTEMA Group (Germany)
Version Specification : Version 2.0 / 2025 Latest Technical Specifications
Product positioning and operating principles :
The advanced desktop/mobile Piezoelectric Ultrasonic Cleanroom Airflow Mapping System is designed for the sterile core areas of pharmaceutical manufacturing and the high-cleanliness environments of semiconductor manufacturing.
The core utilizes AISI 316L medical-grade stainless steel high-frequency voltage electric transducers , which use high-frequency ultrasonic cavitation to atomize pure water at room temperature into 1–3 µm ultrafine droplets. This completely eliminates the heating and temperature rise problems of traditional thermal atomization, generating pure white sterile micromist with true neutral buoyancy. This micromist flows naturally with a weak airflow (0.36–0.54 m/s), faithfully presenting laminar flow, unidirectional flow, and flow field boundaries.
Compliance with laws and standards :
Strictly conforms to ISO 14644-3 (Annex B7 Airflow direction confirmation / Annex B12 Airflow field visualization).
Strictly compliant with EU GMP Annex 1 (Sterile Pharmaceutical Manufacturing Annex – Dynamic Smoke Study / In-situ Airflow Pattern).
It complies with the U.S. FDA Aseptic Processing Guidelines.
It complies with USP <797> (aseptic preparation), USP <800> (handling of hazardous pharmaceuticals) and NSF 49 biosafety cabinet certification standards.
It complies with Federal Standard 209E cleanliness standards and EU CE/EMC safety standards.
Applicable environments and application areas :
Suitable environments: Grade A / Grade B sterile and cleanrooms, sterile filling and freeze dryer discharge areas, and high-cleanliness areas for semiconductor wafer manufacturing.
Applicable barrier systems: sterile isolators, open/closed access restriction barrier systems (oRABS / cRABS).
Applicable equipment: Laminar flow hoods (LAF Hoods), Class II (Type A2 / B2) biosafety cabinets (BSC), and pass-boxes/airlocks for personnel and materials.
Core test items: verification of parallelism between unidirectional and laminar flow, evaluation of overflow and turbulence at the operating opening, interference of dynamic operating flow field in the glove box, and detection of dead air return and particulate retention areas.
Micromist Characteristics and Aerodynamics :
Particle size: 1.0 to 3.0 µm uniform particle distribution (high purity ultrasonic cooling mist).
Buoyancy characteristics: True neutral buoyancy, consistent with the air density of the sterile room, with no thermal buoyancy rising or gravity sinking effect.
Cleanliness and Residue: 100% oil-free, non-toxic, chemical-free, and residue-free. It naturally vaporizes and disappears after testing, requiring no wiping .
Filter compatibility: Effectively evaluated to be completely harmless to HEPA and ULPA filter media, without causing surface pore clogging or chemical degradation.
Fume-generating medium and liquid addition technology :
Suitable media: High purity deionized water (DI water) or water for injection (WFI, water for injection), without any fuming agents or glycerol/diol media.
Online water replenishment technology: Supports "Filling on the fly" technology , which allows for direct water replenishment during smoke generation without interrupting smoke generation tests or turning off the power, ensuring long-term verification of continuity.
Water consumption: Adjusted by setting the mist volume, approximately 300 to 1,200 mL/h (extremely high liquid conversion efficiency).
Control system and operation functions :
Independent dual-channel stepless regulation:
Independent airflow control : 0–100% digital/knob stepless adjustment, precisely matching laminar flow velocity (0.36–0.54 m/s), eliminating initial outlet velocity.
Independent Fog Volume Control : 0–100% digital/rotary stepless adjustment, allowing for fine-tuning of fog density at any time to meet the needs of video recording optical contrast.
Intelligent liquid level monitoring: Built-in electronic low liquid level automatic sensing and dry burning protection warning to ensure transducer life.
Dual-directional operating interface: The main panel features intuitive function switches and supports long-distance multi-functional wireless remote control , allowing operators to remotely control opening, closing, and fine-tuning from outside the sterile area/barrier.
Airframe structure and material properties :
Design structure: Dual-Cube (modular geometric structure) highly stable body with excellent ergonomic balance and ease of handling.
Machine material: The entire machine is made of AISI 316L / AISI 304 medical-grade mirror stainless steel (all internal parts in contact with pure water are 316L), with a surface roughness Ra < 0.8 µm.
Sterilization resistance: Fully resistant to VHP (Vaporized Hydrogen Peroxide) sterilization cycles, IPA (Isopropyl Alcohol) wiping disinfection, and various conventional cleanroom disinfectants.
Cleanliness Protection: IP-rated protective panel, flat and seamless design throughout the body, preventing any particle accumulation or cross-contamination.
Optional accessories and expansion modules :
Clean-grade Fog Curtains/Rakes: Available in lengths of 300 mm, 600 mm, 900 mm, and 1200 mm, featuring a uniform microporous array and supporting autoclavable high-temperature and high-pressure sterilization of all materials.
Flat Curtain Nozzles: Wide and uniform airflow design, specially designed for visibility of biosafety cabinet working openings and air curtains.
Clean drainage hose: Medical-grade flexible and flexural silicone hose (various diameters, lengths of 2 m, 3 m, 5 m or custom extensions).
Extended rigid bar and through joint: Carbon fiber/stainless steel extension handle, Tri-Clamp sanitary flange sealing through kit for isolators.
LED Boost Gen2 Contrast Illumination Module: Cool white high-lumen array lamps or multi-channel optical supplement system, significantly enhances image contrast in Smoke Study high-speed photography.
Telescopic lifting tripod: Stainless steel heavy-duty telescopic bipod (span and height up to 3–4 m), supporting high-altitude laminar flow ports or equipment top positioning tests.
Industrial-grade protective transport case: High-rigidity heavy-duty waterproof and shockproof engineering plastic hand-held case with custom-made one-piece molded antistatic and shockproof foam inside.
Documentation and validation support :
Comes with a factory QC certificate, a material certificate (Material Certificate 3.1), and an operating manual as standard.
A complete set of original manufacturer verification documents fully compliant with cGMP / GLP specifications, including DQ (Design Qualification), IQ (Installation Qualification), and OQ (Operational Qualification) standard test documents.