Sistema-MK Fog Pistol EVO Series Handheld Airflow Visualization Fogger
The SISTEMA Fog Pistol EVO Handheld Neutral Buoyant Cleanroom Airflow Mapping Fog Pistol is designed for micro-confined spaces, critical process points, and sterile barrier systems. It is widely used for visual verification of unidirectional flow, turbulence, dead zones, and leaks in Class A/B cleanrooms, sterile isolators, restricted access barrier systems (RABS), biosafety cabinets (Class II Type A2/B2 BSC), laminar flow sampling/dispensing hoods (LAF hoods), and glove boxes.
I. Fully compliant with international aseptic process regulations and standards, including ISO 14644-3 (Annex B7 Airflow Direction / Annex B12 Airflow Field Visualization), EU GMP Annex 1 (Sterile Pharmaceutical Manufacturing Annex), US FDA Aseptic Processing Guidelines, USP <797>, USP <800>, NSF 49 Biosafety Cabinet Certification Standards, and Federal Standard 209E.
II. The core technology utilizes advanced hot wire thermal vaporization, combined with the patented "Zero Momentum Fog-to-Cloud Modulation" system, to instantly generate high-density, pure white (Paper White) oil-free ultrapure micro-mist with true neutral buoyancy. The mist flows with the air without being disturbed by thermal buoyancy rising or gravity sinking, completely and realistically restoring the physical trajectory of airflow.
III. Patented VISUFLUID medical-grade formula (ultra-pure deionized water > 75% + medical-grade triethylene glycol < 25%), 100% non-toxic and residue-free, harmless to HEPA/ULPA ultra-high efficiency filters, dissipates naturally after testing, and requires no cleaning or wiping.
IV. Anodized aerospace-grade aluminum alloy ergonomic gun body (corrosion resistant and resistant to IPA alcohol and conventional disinfectant wiping), the whole machine weighs only about 1 kg; equipped with an external high-energy rechargeable lithium battery handle, supporting continuous full-load operation for up to 60 minutes on a single charge, achieving ultimate mobility without the need for cables or external air sources.
Equipment Introduction
Meets the latest international aseptic standards and strict requirements.
Designed specifically to meet EU GMP Annex 1 Dynamic Smoke Study, FDA aseptic process inspection and ISO 14644-3 standards.
It is specifically used to verify the effectiveness of sterile barriers, turbulence during door opening, dynamic airflow during glove operation, exhaust-suction balance, and biosafety cabinet opening protection.
Neutral Buoyancy & Zero Momentum
The patented modulation cavity completely eliminates the initial velocity impulse of traditional jet-type smoke generators, allowing the micromist to be gently released in the form of a "zero initial velocity cloud" after leaving the nozzle, flowing completely with the environmental flow field.
It possesses true neutral buoyancy characteristics (density equivalent to that of sterile room air), will not sink prematurely due to its own weight, nor will it produce a false sense of buoyancy due to excessively high temperatures, faithfully presenting the true streamlines and vortices under laminar flow at a low wind speed of 0.36–0.54 m/s.
Pure and pollution-free formula, zero burden of cleaning verification (Zero Residue / Safe for HEPA)
It uses patented VISUFLUID medical-grade vaporizer, which is pure in ingredients and never uses oily bases or highly toxic glycerin derivatives.
After testing, it completely vaporizes and evaporates, leaving no oil film, stains, or chemical deposits on stainless steel surfaces, glass windows, or inside equipment, eliminating the need for time-consuming secondary cleaning and wiping (No wipe-down).
Authoritative testing has shown that all HEPA/ULPA filters pose no risk of chemical corrosion, clogging, or adhesion.
Modular dual-model configuration (EVO.1 Compact / EVO.2 Wide-angle Incremental)
Fog Pistol EVO.1 (part number FP-R01) : Standard configuration includes a 60 mm precision straight nozzle. The entire unit, including the battery, weighs only 974 g. It is suitable for laminar flow calibration in small spaces such as around syringe filling needles, inside glove boxes, and ultra-compact isolators.
Fog Pistol EVO.2 (part number FP-R02) : Standard configuration includes a 160 mm airflow nozzle, significantly increasing smoke output by 30%, with a total weight of only 1,040 g. It is suitable for airflow mapping in biosafety cabinet air curtains, large workbenches, and aseptic transfer windows.
Rapid injection vial and ultra-long battery life
The reservoir uses a 60 mL medical-grade Luer-Lock quick-release syringe structure, which only takes a few seconds to replace the fuming liquid; it has extremely low liquid consumption per minute (about 1.0 mL/min), and a single full syringe can continuously generate fumes for up to 60 minutes.
An optional 1L bulk bottle is available, which can support up to 16 hours of cumulative smoke emission testing.
Highly mobile wireless operation and hygienic chemical-resistant body
The handle and gun body are machined from anodized aerospace-grade aluminum alloy, with no exposed screws or dead corners, and are completely resistant to IPA (isopropyl alcohol) wiping and disinfection.
Equipped with a quick-swap 15V / 3,200 mAh (48 Wh) high-energy lithium-ion battery handle, and comes standard with a 115/230V universal smart fast charger (fully charged in about 60 minutes), eliminating the risks of tangled wires and cross-regional pollution.
A comprehensive range of cleanroom flow field sampling and flow guiding accessories.
We offer autoclavable Fog Curtains/Rakes: 300 mm (3 holes), 600 mm (6 holes), 900 mm (9 holes) and T-type Fog Curtains (650 mm+), which can quickly create wide air curtains.
Optional features include ±30° joint ball joints, 300/600/900 mm rigid extension rods, clean-grade low-temperature resistant silicone hoses (1/2/4/6 m), glove box flange penetration connectors, micro-leakage detection needle tip components, and heavy-duty stainless steel air curtain lifting legs up to 3 meters long.
It comes standard with a high-strength professional anti-collision carrying case that is dustproof and waterproof, with pre-cut precision shock-absorbing foam inside, making it easy to store safely and move between various clean workshops.
Product Features
Patented zero impulse and neutral buoyancy
Pharmaceutical-grade high-purity medium with 100% zero residue
Lightweight handheld wireless design and isolator-friendly
Overall Specifications
Product Model : Fog Pistol EVO (includes two configurations: EVO.1 and EVO.2)
Manufacturer : SISTEMA Group (Germany)
Version Specification : Version 2.0 / 2025 Latest Technical Specifications
Product positioning and operating principles :
The ultra-lightweight handheld neutral buoyant cleanroom airflow mapping fog pistol is designed for micro-confined spaces, critical process sites, and sterile barrier systems.
Employing hot wire thermal vaporization technology combined with the patented "Zero Momentum Fog-to-Cloud Modulation" system, it eliminates the initial jet velocity impulse and gently releases the mist in the form of a zero-initial-velocity cloud. This produces a pure white, high-density mist with true neutral buoyancy, which truly flows with the air without being disturbed by thermal buoyancy rising or gravity sinking.
Compliance with laws and standards :
Strictly conforms to ISO 14644-3 (Annex B7 Airflow Direction Confirmation / Annex B12 Airflow Field Visualization).
Complies with EU GMP Annex 1 (Sterile Pharmaceutical Manufacturing Annex – Dynamic Smoke Study).
It complies with the U.S. FDA Aseptic Processing Guidelines.
It complies with USP <797> (aseptic preparation), USP <800> (handling of hazardous drugs) and NSF 49 biosafety cabinet certification standards.
It complies with Federal Standard 209E cleanroom testing specifications and EU CE/EMC safety standards.
Applicable environments and application areas :
Suitable environments: Grade A / Grade B sterile cleanrooms, sterile filling lines, semiconductor high-cleanliness areas.
Applicable barrier equipment: Isolators, Restricted Access Barrier Systems (RABS), Laminar Flow Hoods.
Applicable biosafety equipment: Class II (Type A2 / B2) biosafety cabinets (BSC) and glove boxes.
Core test items: verification of parallelism between unidirectional flow and laminar flow, detection of vortices and dead zones, evaluation of disturbances during door/glove operation, pressure differential balancing of air gates, and tracking of seal leakage.
Atomization characteristics and aerodynamics :
Buoyancy characteristics: True neutral buoyancy (the buoyancy is exactly the same as the air density in the sterile room, it will neither sink nor float on its own).
Release characteristics: Zero momentum mist release, no jet impact, faithfully reflects the flow field at a low wind speed of 0.36 to 0.54 m/s.
Residue and cleanliness: 100% oil-free, non-toxic, and leaves no secondary residue. It evaporates naturally after testing and requires no wiping.
Filter compatibility: Evaluated as completely safe and harmless to HEPA and ULPA ultra-high efficiency air filters, without causing chemical corrosion or pore clogging.
Fume-generating liquid consumables and storage systems :
Special consumable formula: VISUFLUID medical grade special smoke generator (pure water > 75%, triethylene glycol < 25%).
Storage tank design: 60 mL medical-grade quick-release Luer-Lock Syringe Reservoir.
Consumption rate: Approximately 1.0 mL/min. Extremely low liquid consumption.
Continuous smoke generation time: A full 60 mL reservoir can generate smoke continuously at full load for up to 60 minutes; the optional 1 L bulk bottle can support a cumulative operation of approximately 16 hours.
Model specifications and performance comparison :
EVO.1 (Part No. FP-R01) :
Nozzle specifications: Standard configuration includes a 60 mm rigid precision straight nozzle.
Body weight: The entire device, including the battery, weighs only 974 g.
Applicable scenarios: airflow tracking in extremely confined and precise spaces such as syringe filling points, glove box interiors, and miniature isolators.
EVO.2 (Part No. FP-R02) :
Nozzle specifications: Standard configuration includes a 160 mm straight nozzle.
Body weight: 1,040 g including battery.
Mist output efficiency: 30% higher than EVO.1.
Applicable scenarios: wide-area airflow mapping such as open air curtains for biosafety cabinets, large clean benches, and transfer windows.
Power supply and battery systems :
Power source: External quick-release high-performance lithium-ion battery handle (Li-ion Battery Pack).
Battery specifications: Rated 15 V / Capacity 3,200 mAh (48 Wh).
Battery life: A single battery can operate continuously for 60 minutes under 100% full load and smoke generation conditions.
Charging specifications: Standard configuration includes a smart fast charger, universal wide voltage 115/230 V AC, 50/60 Hz; charging time is approximately 60 minutes.
Airframe structure and material properties :
Shell material: Anodized aerospace aluminum alloy, with sanitary-grade, seamless machining throughout.
Chemical resistance: The surface is highly resistant to IPA (isopropyl alcohol) wiping disinfection and common cleanroom disinfectants.
Body dimensions: Approximately 275 × 227.5 mm (length × height, excluding external accessories).
Optional accessories and expansion modules :
Clean-grade Fog Curtains/Rakes: 300 mm (3 holes), 600 mm (6 holes), 900 mm (9 holes) and T-type multi-hole rakes (650 mm+), all materials support autoclavable sterilization.
Multi-angle joint ball joint: ±30° universal swivel adapter, supporting flexible fine-tuning at any angle.
Rigid extension hardbars: 300 mm, 600 mm, 900 mm Lightweight carbon fiber/stainless steel extensions to prevent personnel limbs from entering the damaging laminar flow.
Isolator Penetration Kit: Sanitary Tri-Clamp sanitary flange and sealed penetration connector, supporting remote fume injection from outside the enclosure.
Micro-leakage kit: A special fine probe for precise leak detection of filter strips, door seams, and sealing rings.
Clean drainage hose: Medical-grade flexible silicone hose (lengths of 1 m, 2 m, 4 m, and 6 m are available).
Lifting tripod system: 500 mm / 750 mm / 1000 mm stainless steel columns or heavy-duty telescopic lifting tripods up to 3 m.
Multi-unit synchronous module: Multiple EVO units are linked and synchronized to control the system, supporting multi-point synchronous smoke emission assessment in large sterile clean rooms.
Documentation and validation support :
Original manufacturer's quality control certificate and original manufacturer's operating manual are included.
Standard configuration includes a dedicated shock-resistant and protective carrying case (lined with one-piece molded shockproof foam).
Complete original manufacturer IQ (Installation Qualification) and OQ (Operation Qualification) verification documents conforming to GMP standards can be provided.