Sistema-MK Apollo Series Ultrapure LN2 Airflow Visualization System
The Apollo LN2 Ultrapure Liquid Nitrogen Fogger & Airflow Mapping System is designed for advanced aseptic pharmaceutical workshops (Class A/B cleanrooms), aseptic isolators, restricted access barrier systems (RABS), semiconductor wafer fabs' ultra-clean rooms, and advanced packaging flow field visualization verification. It is specifically designed to intuitively evaluate and confirm unidirectional flow (laminar flow) integrity, airflow direction, flow field disturbances, dead zones, external air intrusion, and pressure differential barrier effectiveness.
I. Fully compliant with US FDA guidelines for sterile pharmaceutical manufacturing, cGMP, European Pharmacopoeia, EU GMP Annex 1 (Annex to Sterile Pharmaceutical Manufacturing), ISO 14644-3 Annex B7/B12 international standards for airflow visualization, as well as USP <797>, USP <800>, NSF 49 and Federal Standard 209E standards.
II. The system uses advanced ultrapure liquid nitrogen (LN2) combined with water for injection (WFI) or high-purity deionized water (DI water), along with dual electric heating coils for precise heat exchange vaporization control technology, to instantly generate high-density, pure white smoke with a dry character. 100% of the particles are concentrated below 0.5 µm (particle distribution: <0.3 µm 28%, 0.3–0.5 µm 72%, >0.5 µm 0%). It is oil-free, non-toxic, and residue-free, and undergoes natural and complete vaporization and sublimation (no wipe-down), ensuring no damage to HEPA/ULPA filters.
III. The equipment features neutral buoyancy characteristics and an ultra-long projection distance (7 to 14 meters). It comes standard with a straight-tube multi-hole smoke rake, a T-shaped smoke rake, and a flat wide-width air curtain nozzle, enabling simulation of all types of flow fields, including point source, line source, and area source. It is equipped with a long-distance multi-functional wireless remote control (supporting constant speed, fine adjustment, and Flash pulsed light) and an optional LED Boost Gen2 high-contrast white/color matrix lighting system, which can clearly capture fine airflow trajectories, turbulent diffusion, and personnel operation dynamics in complex production environments.
IV. The entire machine is made of AISI 304/316 medical-grade stainless steel, meeting the standards for tolerating 6% vaporized hydrogen peroxide (VHP), sodium hypochlorite, and IPA sterilization. It exclusively supports "Filling on the fly" technology for continuous online water replenishment and Dewar bottle replacement, and operates safely at an extremely low pressure of 0.3 bar, fully meeting the high efficiency and strict compliance requirements of aseptic process fume study.
Equipment Introduction
Fully compliant with EU GMP Annex 1 and international aseptic regulations.
(Dedicated Airflow Verification for Sterile Pharmaceutical Environments)
Designed specifically for airflow visualization verification in Class A/B clean areas for sterile pharmaceutical manufacturing, isolators, RABS, aseptic filling lines, and high-specification cleanrooms for semiconductors.
Fully compliant with EU GMP Annex 1, FDA Aseptic Processing Guide, ISO 14644-3 (Annex B7/B12), USP <797>/<800> and WHO standards, and provides smoke pattern analysis certification that meets regulatory inspection standards.
High-purity pharmaceutical-grade fumes, non-toxic, residue-free, and environmentally friendly.
(High-Purity Pharma-Grade Fog: Non-Toxic, Residue-Free & Non-Contaminating)
By combining ultrapure liquid nitrogen (LN2) with deionized water/water for injection (DI/WFI Water), 100% of the smoke particles are concentrated below 0.5 µm (<0.3 µm accounts for 28%, 0.3–0.5 µm accounts for 72%).
It has a dry character, completely evaporates smoke without leaving water stains, oil films and particles, and is completely harmless to high-efficiency filters (HEPA/ULPA), production equipment and sterile environments, eliminating the need for cumbersome cleaning and wiping procedures.
High-contrast visual imaging technology makes airflow trajectories clearly discernible.
(High-Contrast Visual Imaging Technology for Clear Airflow Tracking)
With "Paper White Density" and neutral buoyancy, it can project a distance of 7 to 14 m and can remain suspended in the air for a long time against a bright background, clearly displaying the macroscopic flow field.
Equipped with a dedicated LED Boost Gen2 high-contrast auxiliary light source (cool white light or RGBWA color rendering light curtain array), it can accurately capture personnel dynamic operation disturbances, negative pressure leakage, vortices, and air stagnation dead zones.
Diverse flow guide accessories support multi-form flow field simulation
(Versatile Flow Delivery Accessories for Multi-Scenario Simulations)
Equipped with Ø 60 / Ø 80 mm corrosion-resistant guide pipe, 316L stainless steel multi-hole straight pipe / T-type smoke rake, flat air curtain nozzle (350 / 500 mm) and bidirectional manual butterfly valve diverter.
It can flexibly switch between various test scenarios such as "point source injection" (to assess equipment boundary or glove box leakage), "line source flow" (to assess unidirectional laminar flow uniformity and enveloping transmission), and "area source barrier" (to assess air gates and differential pressure barriers).
Precision smoke volume adjustment and remote wireless control
(Precision Fog Volume Control & Remote Wireless Operation)
It provides a wide range of smoke output from 8.0 to 24.0 m³/min and supports "Filling on the fly" non-stop online water replenishment and Dewar bottle rotation technology to avoid smoke momentum interfering with the real airflow.
It supports long-distance, multi-functional wireless remote control (on/off, flash pulse, and fine-tuning of airflow), allowing operators to control it remotely from outside the isolation zone, minimizing the interference of personnel activities on the flow field.
Product Features
Ultra-pure, pollution-free "paper-white" dry fog and submicron-sized particles
With its high smoke output and long battery life, it is specially designed for large-area cleanrooms.
Non-stop water replenishment and bottle replacement, and a pharmaceutical-grade, durable, disinfection-resistant body.
Overall Specifications
Product Series: Apollo LN2 Series Ultrapure Liquid Nitrogen Cleanroom Foggers / Airflow Mappers
Applicable models: AP35 LN2, AP50 LN2, AP100 LN2, AP150 LN2
Manufacturer: SISTEMA Group (Germany)
Technical version: Brochure 02.2025 (2025 latest technical release version)
Product positioning and operating principles:
Smoke Study is an ultrapure airflow visualization testing system specifically designed for high-end cleanrooms in the semiconductor industry, Class A/B aseptic filling areas in pharmaceutical plants, isolators, restricted access barrier systems (RABS), and biosafety cabinets.
Combining ultrapure liquid nitrogen (LN2) and ultrapure water (WFI / DI Water), along with a built-in dual electric heating coil precision heat exchange vaporization control technology, it instantly generates ultrapure sterile smoke with high-density pure white (Paper White Density) and dry characteristics.
By using micro-positive pressure dynamics, pure white micro-mist is precisely projected into the flow field to be tested, realistically presenting the laminar flow direction, dead zone turbulence, equipment surface turbulence, pressure differential boundary shielding effect, and dynamic interference from aseptic operators in the sterile room.
Compliance with laws and standards:
Strictly compliant with ISO 14644-3 Annex B7 (Airflow Direction Test) and Annex B12 (Airflow Visualization Test).
It fully complies with the latest revised EU GMP Annex 1 (A/B level dynamic airflow visual assessment requirements for sterile pharmaceutical manufacturing).
It complies with the FDA Aseptic Processing Guide.
It meets USP <797> (Aseptic Preparation Environment), USP <800> (Hazardous Pharmaceuticals Handling Facility) and NSF 49 Biosafety Cabinet Testing Standards.
It complies with Federal Standard 209E cleanroom standards.
All contact materials and the casing meet cGMP and GLP hygienic design standards; they can withstand disinfection and cleaning with 6% H₂O₂ vaporized hydrogen peroxide (VHP), sodium hypochlorite, and 70% isopropanol (IPA).
Physical properties and particle distribution of fog:
Particle diameter distribution: 100% of the particle size is concentrated in the ultra-fine particle range below 0.5 µm (<0.3 µm accounts for 28%, 0.3–0.5 µm accounts for 72%, and >0.5 µm accounts for 0%).
Buoyancy characteristics: Neutral buoyancy, it floats completely along the actual airflow trajectory, does not sink prematurely due to gravity, and has no excess momentum to disturb the real flow field.
Cleanliness and residue: 100% oil-free, non-toxic, and free of organic chemical residues. It naturally and completely vaporizes and sublimates after testing, requiring no complicated cleaning or wiping (No wipe-down), and will not damage the HEPA/ULPA filter.
Smoke projection distance: 7 to 14 meters (7–10 m for AP35; 10–14 m for AP50/AP100/AP150).
Core technologies and operational features:
Non-stop online replenishment technology (Filling on the fly): Supports online replenishment of water or replacement of liquid nitrogen Dewar bottles during operation without the need to shut down and wait for cooling, greatly improving the efficiency of large cleanrooms and continuous verification.
Safe operation at atmospheric and low pressure: The system operates at a pressure of only 0.3 bar (43.5 psi), eliminating the restrictions and safety concerns associated with high-pressure vessel operation regulations.
Multifunctional long-distance wireless remote control: Features remote on/off, stepless fine-tuning of airflow, smoke concentration adjustment, and Flash pulse frequency smoke generation function to prevent personnel from interfering with the Class A flow field when entering or leaving.
Intelligent liquid level and temperature safety protection: Built-in low water level dry burning protection, over-temperature cut-off, vacuum insulation standby heat preservation and anti-loss, and overload automatic pressure relief device.
Technical parameters comparison of each model:
AP35 LN2:
Dewar flask capacity: 35 L (high vacuum double-walled stainless steel dewar flask)
Water tank capacity: 13.5 L
Smoke emission: 8.2 m³/min (290 cft/min)
Total smoke generation over 60 minutes: 492 m³
Smoke generation time per full load: approximately 47 minutes
Liquid nitrogen consumption density: 866 mL/min
Export configuration: Dual Ø 80 mm quick-release smoke outlets
Trolley type: Integrated semi-circular stainless steel anti-static mobile trolley (4-wheel configuration)
Body dimensions (W × D × H): 1340 × 590 × 880 mm
AP50 LN2:
Dewar flask capacity: 50 L / 60 L
Water tank capacity: 13.5 L
Smoke emission: 8.0 m³/min
Total smoke generation over 60 minutes: 840 m³
Smoke generation time per full load: approximately 60 minutes
Liquid nitrogen consumption density: 866 mL/min
Export configuration: Dual Ø 80 mm quick-release smoke outlets
Trolley type: Dual-module separate independent trolley (4 wheels for the main control unit + 4 wheels for the Dewar bottle, a total of 8 ultra-quiet dust-free wheels)
Body dimensions (W × D × H): 1340 × 590 × 1270 mm
AP100 LN2:
Dewar flask capacity: 100 L
Water tank capacity: 13.5 L
Smoke emission: 16.0 m³/min
Total smoke generation over 60 minutes: 840 m³
Smoke generation time per full load: approximately 120 minutes
Liquid nitrogen consumption density: 866 mL/min
Export configuration: Dual Ø 80 mm quick-release smoke outlets
Trolley type: Dual-module detachable independent trolley (8-wheel configuration)
Body dimensions (W × D × H): 1340 × 590 × 1270 mm
AP150 LN2:
Dewar flask capacity: 150 L
Water tank capacity: 13.5 L
Smoke emission: 24.0 m³/min
Total smoke generation over 60 minutes: 840 m³
Smoke generation time per full load: approximately 180 minutes
Liquid nitrogen consumption density: 866 mL/min
Export configuration: Dual Ø 80 mm quick-release smoke outlets
Trolley type: Dual-module detachable independent trolley (8-wheel configuration)
Body dimensions (W × D × H): 1570 × 590 × 1270 mm
Structural materials and electrical requirements:
Body and shell material: AISI 304 / 316 medical-grade stainless steel, with electrolytic polishing and fine hairline finish (Ra < 0.8 µm).
Roller system: Medical-grade dust-free antistatic, conductive, wear-resistant, and silent wheels with independent pedal steering lock and brake positioning mechanism.
Electrical specifications: 100–240 VAC, 47–63 Hz globally compatible adaptive wide voltage, with CE/EMC certification.
Optional accessories and flow expansion modules:
Fog Rakes: Straight tube type (Ø 60 / Ø 80 mm, length 650 / 1300 / 1850 mm), T-type uniform diversion rake (Ø 80 × 1300 mm).
Wide-width air curtain nozzles: 350 mm / 500 mm flat air curtain nozzles (specifically for verification of air gates and laminar flow surface barriers).
Clean flow hose: Ø 60 mm / Ø 80 mm food and pharmaceutical grade low-temperature resistant corrugated hose (standard 5 m, 3 m or extended hose section optional), 45° angle elbow, 80/60 mm reducing adapter.
Diversion and control valves: T-type/Y-type bidirectional diversion manifolds, independent manual precision butterfly valves, and throttling control valves.
LED Boost Gen2 Visual Contrast Lighting Module:
Cool white high contrast module (360 0.5W SMD 2835 high lumen LEDs).
RGBWA Professional Color Rendering Lighting Kit (18 × 15W, 45° projection angle, supports DMX control, can switch between green and amber light for high-definition recording and background contrast imaging).
Installation and support kit: 4-meter heavy-duty telescopic air curtain lifting tripod, laminar flow workbench/isolation dedicated suspension telescopic fixing bracket (900 / 1200 / 1500 mm).
Valid documentation and standard supply:
Apollo AP main unit and dedicated stainless steel trolley system
Standard double-walled vacuum-insulated stainless steel Dewar flask
Standard configuration includes a smoke rake tube assembly and a 5-meter guide hose.
Long-distance multi-functional wireless remote control
European standard pallet-grade heavy-duty protective transport box (high-rigidity composite protective box or shockproof solid wood box)
Complete IQ/OQ/DQ/QC validation folders, Certificate of Conformity (CoC), material test certificates, and operation and maintenance manuals.