Selection Guide for the German SISTEMA Apollo LN2 Series Ultra-Pure Liquid Nitrogen Smoke Generator
Selection Guide for the German SISTEMA Apollo LN2 Series Ultra-Pure Liquid Nitrogen Smoke Generator
(Compliant with ISO 14644-3 Annex B7/B12 and EU GMP Annex 1 dynamic airflow visualization and self-cleaning/recovery validation)
I. Introduction and International Regulatory Compliance
A sterile cleanroom is not a static environment; it is a dynamic critical process area where personnel, raw materials, and transfer equipment are in frequent motion. In response to international pharmaceutical regulatory standards, including EU GMP Annex 1 (2022 edition, Clauses 4.21, 4.22, 8.19, and 9.28), ISO 14644-3:2019 (Annex B.7 airflow visualization testing and Annex B.12 recovery capability verification), the U.S. FDA aseptic processing guidance, USP <797>/<800>, NSF 49, and Federal Standard 209E, cleanrooms and internal aseptic operation equipment must, during new construction, retrofits, process reconfiguration, or routine periodic requalification, provide high-level dynamic smoke study analysis and airflow recovery time video and data evidence.
The SISTEMA Apollo LN2 series smoke generator combines ultra-pure liquid nitrogen (LN2) with Water for Injection or deionized water (WFI / DI-Water), and through dual electric heating coil precision temperature-controlled vaporization technology, generates ultra-pure, residue-free smoke with both dry character and paper-white, ultra-high density. This system thoroughly overcomes the shortcomings of conventional piezoelectric ultrasonic foggers, including insufficient output, heavy dry-ice particles that settle too quickly, and chemical oil residue generated by heated-wire systems. It is specially designed for comprehensive dynamic airflow analysis in medium to extra-large spaces such as aseptic rooms, large filling lines, operating rooms, ISO suites, and semiconductor fabs.
II. Core Technical Features and Particle Distribution Characteristics
Ultra-clean dry character, zero chemical non-volatile residue (NVR = 0)
The system uses 100% liquid nitrogen and Water for Injection or deionized water, with absolutely no chemical oils, glycerin, or glycol surfactants added. It will not clog or corrode HEPA/ULPA filters. After testing, no wipe-down is required, significantly reducing time-consuming cleaning validation and wipe sampling procedures.
Extreme particle distribution (100% below 0.5 microns)
According to laser optical particle counter measurements, all smoke particles fall within the submicron range:
Below 0.3 microns: 28%
0.3 to 0.5 microns: 72%
Above 0.5 microns: 0%
No large droplets or heavy condensate above 0.5 microns are produced. This demonstrates excellent neutral buoyancy, with no self-settling and no adhesion to equipment surfaces, allowing extremely small turbulence and flow direction changes to be clearly visualized.
Stepless airflow adjustment and smoke temperature monitoring
A high-performance dust-free centrifugal blower is built in, supporting stepless airflow adjustment from 0 to 100%. The operator can freely control smoke temperature and nitrogen consumption speed from the control panel, ensuring the output momentum matches the ambient laminar flow speed exactly, such as Grade A standard airflow velocity of 0.36 to 0.45 m/s ±20% for isokinetic delivery.
Dual-outlet integrated and multi-point synchronous smoke generation
The unit is equipped with two standard 80 mm outlets, and with the factory splitter module can realize two-point, three-point, or four-point simultaneous curtain release from a single machine, eliminating airflow disturbance caused by moving equipment.
Online refilling of water and replacement of Dewar bottle without stopping operation (Media Filling On The Fly)
The system supports continuous addition of Water for Injection during testing without stopping, and the external LN2 Dewar bottle can be replaced online while the system is running, enabling uninterrupted dynamic intervention recording for several hours.
Chemical resistance and atmospheric-pressure safety design
The entire unit is built from corrosion-resistant stainless steel and cleanroom-grade engineering materials. It can withstand 6% hydrogen peroxide (H2O2), calcium hypochlorite solution (0.2 mL / 100 mL), or 70% isopropyl alcohol (IPA) surface disinfection. The operating pressure of the system is only 0.3 bar (43.5 psi), with triple overpressure exhaust safety valves for safe operation.
Modular redundancy and original manufacturer warranty
The system adopts a highly modular architecture with fault tolerance and redundancy. The German manufacturer provides a 3-year quality warranty.
III. Technical Specifications and Model Comparison for the Four Main Models
Model: AP35 (LN2)
Product positioning: Highly mobile and flexible model, suitable for medium-to-large cleanrooms and localized containment testing.
Smoke outlet configuration: Dual outlets (2 x 80 mm)
Water tank capacity: 13.5 liters (WFI / DI-Water)
Double-wall vacuum Dewar capacity: 35-liter stainless steel double-wall vacuum Dewar
Heating module: Dual heating coils
Cart structure: Stainless-steel semicircular detachable protective cart with 4 high-rigidity anti-static casters
Smoke output: 8.2 m³/min (290 cfm)
Water consumption: 866 mL/min
Continuous operation per fill: approx. 47 minutes
Total smoke output per 60-minute cycle: 492 m³
Effective visual projection range: 7 to 10 m
Dimensions: L 134 cm × W 59 cm × H 88 cm
Standard accessories: 1 straight smoke rake, 80 mm diameter × 650 mm length; 1 airflow hose, 80 mm diameter × 5 m length
Vacuum-sealed anti-loss technology: Standard, with built-in low-liquid warning
Operating pressure: Atmospheric micro-pressure system (0.3 bar / 43.5 psi)
Power supply: Single-phase 100–240V AC, 47–63 Hz universal voltage
Model: AP50 (LN2)
Product positioning: High-capacity continuous operation model, suitable for large aseptic filling lines and recovery time validation.
Smoke outlet configuration: Dual outlets (2 x 80 mm)
Water tank capacity: 13.5 liters (WFI / DI-Water)
Double-wall vacuum Dewar capacity: 50–60 liters
Heating module: Dual heating coils
Cart structure: Split dual-module cart for the controller and Dewar bottle, each with 4 casters, 8 casters total, separable for independent movement
Smoke output: 8.0 m³/min
Water consumption: 866 mL/min
Continuous operation per fill: approx. 60 minutes
Total smoke output per 60-minute cycle: 840 m³
Effective visual projection range: 10 to 14 m
Dimensions: L 134 cm × W 59 cm × H 127 cm
Standard accessories: 2 straight smoke rakes, 80 mm diameter × 650 mm length; 2 airflow hoses, 80 mm diameter × 5 m length
Vacuum-sealed anti-loss technology: Standard, significantly suppressing natural LN2 evaporation in standby mode
Operating pressure: Atmospheric micro-pressure system (0.3 bar / 43.5 psi)
Power supply: Single-phase 100–240V AC, 47–63 Hz universal voltage
Model: AP100 (LN2)
Product positioning: Ultra-high smoke output, long-duration model, suitable for continuous unattended dynamic validation and large-space pressure differential analysis.
Smoke outlet configuration: Dual outlets (2 x 80 mm)
Water tank capacity: 13.5 liters (WFI / DI-Water)
Double-wall vacuum Dewar capacity: 100 liters
Heating module: Dual heating coils
Cart structure: Split dual-module cart for controller and Dewar bottle, with 8 anti-static casters total
Smoke output: 16.0 m³/min
Water consumption: 866 mL/min
Continuous operation per fill: approx. 120 minutes (2 hours)
Total smoke output per 60-minute cycle: 840 m³
Effective visual projection range: 10 to 14 m
Dimensions: L 134 cm × W 59 cm × H 127 cm
Standard accessories: 2 straight smoke rakes, 80 mm diameter × 650 mm length; 2 airflow hoses, 80 mm diameter × 5 m length
Vacuum-sealed anti-loss technology: Standard
Operating pressure: Atmospheric micro-pressure system (0.3 bar / 43.5 psi)
Power supply: Single-phase 100–240V AC, 47–63 Hz universal voltage
Model: AP150 (LN2)
Product positioning: Flagship maximum-output model, suitable for very large-span facilities, semiconductor fabs, and multi-zone airflow leakage tracking.
Smoke outlet configuration: Dual outlets (2 x 80 mm)
Water tank capacity: 13.5 liters (WFI / DI-Water)
Double-wall vacuum Dewar capacity: 150 liters
Heating module: Dual heating coils
Cart structure: Split dual-module cart for controller and Dewar bottle, with 8 anti-static casters total
Smoke output: 24.0 m³/min
Water consumption: 866 mL/min
Continuous operation per fill: approx. 180 minutes (3 hours)
Total smoke output per 60-minute cycle: 840 m³
Effective visual projection range: 10 to 14 m
Dimensions: L 157 cm × W 59 cm × H 127 cm
Standard accessories: 2 straight smoke rakes, 80 mm diameter × 650 mm length; 2 airflow hoses, 80 mm diameter × 5 m length
Vacuum-sealed anti-loss technology: Standard
Operating pressure: Atmospheric micro-pressure system (0.3 bar / 43.5 psi)
Power supply: Single-phase 100–240V AC, 47–63 Hz universal voltage
IV. Test Scenarios and Model Selection Recommendations
Scenario 1: Small to medium aseptic compounding room, airflow verification around a single filling machine
Recommended model: AP35 (LN2)
Reason: The total equipment height is only 88 cm, making it highly flexible for entering and exiting various cleanroom buffer rooms and airlocks. A single fill provides 47 minutes of stable smoke generation, enough to fully record airflow unidirectionality during operator interventions, tool transfer, and hand movements.
Scenario 2: Standard high-speed aseptic filling and packaging line, ISO 14644-3 Annex B12 recovery capability test
Recommended model: AP50 (LN2)
Reason: The split cart design facilitates deployment in narrow machine spaces. With 60 minutes of smoke generation and 8 m³/min output, the dual outlets can simultaneously form curtains on both sides of the machine. The high-contrast paper-white smoke accurately quantifies recovery time in seconds.
Scenario 3: Large biopharmaceutical aseptic corridors, large RABS and isolator integrated systems, requiring 2 hours of continuous testing
Recommended model: AP100 (LN2)
Reason: Equipped with a 100-liter Dewar and 16.0 m³/min ultra-high smoke output, it can operate continuously for up to 2 hours per fill, eliminating the need for mid-test refilling. It is ideal for full-process airflow evaluation in dynamic batch production.
Scenario 4: Very large semiconductor fabs, large operating rooms, cross-facility pressure equalization and containment leakage testing
Recommended model: AP150 (LN2)
Reason: With top-tier output of 24.0 m³/min and up to 3 hours of runtime, the strong gas generation capability can establish a large, high-contrast visual flow field within minutes, rapidly identifying cross-zone negative-pressure leaks and dead-zone vortices.
V. Original Accessories and Optical System Configuration
Cleanroom-grade smoke rakes (Fog Rakes)
FL650.60-STR: Straight smoke rake, 60 mm diameter × 650 mm
FL.1300.60-STR: Straight smoke rake, 60 mm diameter × 1300 mm
FL.650.80-STR: Straight smoke rake, 80 mm diameter × 650 mm
FL.1300.80-STR: Straight smoke rake, 80 mm diameter × 1300 mm
FL.1850.80-STR: Extra-long straight smoke rake, 80 mm diameter × 1850 mm
FL.1350.80-T: T-shaped symmetric dual-direction smoke rake, 80 mm diameter × 1300 mm
Clean hoses and quick-release connector set
TUBE.3000.60-BS and TUBE.5000.60-BS: 3 m and 5 m clean airflow hoses, 60 mm diameter, with quick-release flange
TUBE.3000.80-BS and TUBE.5000.80-BS: 3 m and 5 m clean airflow hoses, 80 mm diameter, with quick-release flange
EXT.TUBE extension module: Custom extension pipe segments added in 1 m increments
OUTLET.45° (80): 80 mm, 45-degree outlet elbow for directional airflow in special spaces
Adjustment valves, flat curtain nozzles, and splitters
THROTTLE.60 and THROTTLE.80: Manual throttling valves for 60 mm and 80 mm tubing, supporting 0–100% output fine adjustment
80.60 RED: 80 mm to 60 mm reducing connector
TUBE.CON (60) and TUBE.CON (80): Straight quick-connect coupling adapters
NOZ.350 and NOZ.500: 350 mm and 500 mm wide flat-curtain nozzles with flow straightening vanes
T-SPLITTER.80-STRD: 80 mm T-type symmetric splitter
Y-SPLITTER.80-STRD: 80 mm Y-type dual splitter
Y-SPLITTER.80-THROTTLE: 80 mm Y-type dual splitter with independently adjustable butterfly valves at both outlets
QUAD: 1-in / 4-out four-way splitter
Optical contrast lighting and remote wireless control system
LED.BOOST-GEN2 airflow contrast lighting kit
First light source: 360 pieces of 0.5W SMD 2835 cool-white high-intensity matrix LEDs
Second light source: 18 pieces of 15W high-CRI RGBWA mixed-light bars, 45-degree projection angle, DMX signal control supported
RC.AFM.AD intelligent long-range wireless remote controller
Supports remote on/off, flash-pulse smoke output, airflow increase/decrease, and multi-zone control.
Support stands and protective transport cases
TRIPOD-L/F dual-lift tripod kit: with stainless-steel fixed base, height up to 4 m and span up to 4 m, for suspending extra-large curtain systems
TRIPOD-900 / 1200 / 1500: Stainless-steel dual-column stands with fixed heights of 900, 1200, and 1500 mm
BOX.AP35 and BOX.AP50: European pallet-grade high-rigidity synthetic protective transport cases
BOX.AP100 and BOX.AP150: European pallet-grade heavy-duty wooden shockproof transport cases
IQ/OQ validation folder: Original manufacturer’s complete Installation Qualification (IQ) and Operational Qualification (OQ) technical acceptance documentation
VI. International References and Customer Adoption
The German SISTEMA product line has been highly recognized by major international pharmaceutical, biotechnology, medical engineering, and high-end semiconductor manufacturers, and is standard equipment for responding to inspections by the U.S. FDA, the EU EMA, and regulatory authorities in various countries:
Multinational pharmaceutical and biotechnology companies
Pfizer, Novartis, Roche, Merck Serono, AstraZeneca (AZ), GSK, Sanofi, Eli Lilly, Takeda, Boehringer Ingelheim, AbbVie, Amgen, Novo Nordisk, Bayer, Sandoz, Teva, Alcon, Allergan, Baxter, Grifols, CSL Behring, Patheon, Lonza, and Catalent.
Aseptic equipment integration and cleanroom engineering companies
Sartorius, Getinge, OPTIMA Pharma, Trescal, and ENGIE.
Advanced semiconductor and precision optoelectronics manufacturers
ASML, Lam Research, Microsoft, and OSRAM Semiconductor.
Professional Consultation and Online Sample Test Planning
Welcome to click the link below to visit DS official website, or fill out the online consultation form. Our professional technical consultants will help plan a customized regulatory response and equipment selection solution for your laboratory:
Official website: www.dissolution.com.tw
Product section: Airflow Monitoring and Visualization
Technical consultation hotline: 04-2241-1607