SISTEMA-MK
Brand Introduction
SITEMa-MK GmbH (SISTEMA Group) , headquartered in Germany, is a leading global manufacturer specializing in cleanroom airflow visualization systems (Smoke Study) and effective pollution control technologies.
With the comprehensive upgrading of sterility assurance requirements in international sterile pharmaceutical standards (especially the latest EU GMP Annex 1, FDA aseptic process guidelines, and ISO 14644-3), manufacturers must provide scientifically convincing dynamic and static airflow pattern imagery evidence in aseptic operating areas (Grade A/B), aseptic isolators, open/closed restricted access barrier systems (RABS), and advanced semiconductor manufacturing environments. Leveraging its advanced German engineering, SISTEMA has developed a comprehensive product matrix encompassing everything from handheld miniature smoke generators to large-scale ultra-high purity liquid nitrogen (LN2) smoke generation systems. This provides residue-free, high-contrast, and compliant airflow visualization solutions for aseptic pharmaceuticals, biotechnology, cell and gene therapy (CGT), high-end semiconductor wafer fabs, and professional efficacy consulting firms worldwide.
Core values
Strictly adheres to international aseptic and cleanliness regulations (Global Regulatory Compliance) :
Designed to meet stringent international standards such as EU GMP Annex 1 (Standard for the manufacture of sterile pharmaceuticals) , FDA Aseptic Processing Guidance , ISO 14644-3 Annex B7/B12 , USP <797> / <800> , NSF 49 and VDI 2083 , it provides complete compliance documentation for smoke study and flow pattern assessment.
Zero pollution and zero residue guarantee (Zero-Residue & Ultra-Pure Aerosol) :
Using pharmaceutical-grade ultrapure water (WFI/DI water) combined with high-purity liquid nitrogen, or a patented aseptic smoke-generating formula (VISUFLUID) that complies with regulations, the generated smoke particles are fine and uniform, leaving 100% zero residue after evaporation, with no chemical deposition and requiring no wipe-down. It does not cause any clogging or chemical damage to the HEPA/ULPA high-efficiency filter.
Excellent aerodynamics: Neutral buoyancy.
The smoke particle size is precisely controlled (100% concentrated below 0.5 µm), possessing high neutral buoyancy and patented "Zero Momentum Fog" technology. The smoke itself does not have the initial momentum to interfere with the airflow, and can 100% accurately reflect the laminar flow, turbulence, eddies, pressure differential penetration, and personnel operation interference in the clean room.
Chemically resistant, all-stainless steel robust structure (Pharma-Grade Engineering) :
The fuselage structure is made of high-grade medical-grade AISI 316L/304 stainless steel and aerospace-grade anodic aluminum oxide, which can withstand 6% hydrogen peroxide (H2O2), VHP vaporized hydrogen peroxide, isopropanol (IPA) and sodium hypochlorite disinfection and wiping. It is specially designed for strict aseptic environment and operation inside the isolator.
Modular human factors engineering and continuous operation (Filling on the Fly) :
The unique design supports continuous water replenishment/air source replacement during operation, significantly reducing downtime for large cleanroom assessments; the modular, detachable trolley and quick-release air guide accessories enable convenient single-person operation.
Product direction
SISTEMA's product line precisely covers everything from precise local micro-environment detection to large-scale airflow tracking across the entire plant:
1. Apollo Series: Ultrapure Liquid Nitrogen (LN2) Fume Generator (AP35 / AP50 / AP100 / AP150)
An industry-leading high-density ultrapure smoke generation system that utilizes high-purity liquid nitrogen (LN2) and ultrapure water (WFI/DI) combined with dual electric heating coils for precise temperature control and vaporization.
Paper White Density and Ultimate Purity :
The particle diameter is concentrated below 0.5 µm (< 0.3 µm accounts for 28%, 0.3 to 0.5 µm accounts for 72%, and > 0.5 µm accounts for 0%), producing a white fog with a dry character and extremely high contrast.
Powerful output and long-range shooting capability :
The smoke emission ranges from 8.0 to 24.0 m³/min , and the projection distance can reach 7 to 14 meters .
Main model configurations :
AP35 : 13.5 L water tank + 35 L Dewar bottle, smoke output 8.2 m³/min, continuous operation time approximately 47 minutes, integrated trolley design.
AP50 : 13.5 L water tank + 50/60 L Dewar bottle, smoke output 8.0 m³/min, approximately 60 minutes per run, dual-module independently detachable trolley.
AP100 : 13.5 L water tank + 100 L Dewar bottle, smoke output 16.0 m³/min, approximately 120 minutes of operation per cycle, dual-module independently detachable trolley.
AP150 : 13.5 L water tank + 150 L Dewar bottle, smoke output 24.0 m³/min, approximately 180 minutes of operation per run, dual-module independently detachable trolley.
High security and uninterrupted replenishment :
Operating at atmospheric pressure (0.3 bar / 43.5 psi), it features intelligent level and vacuum-sealed standby monitoring, and supports online continuous water replenishment and Dewar bottle replacement via Filling on the Fly .
2. EVO Series: Handheld Mini Smoke Generators (EVO.1 / FP-R01 and EVO.2 / FP-R02)
An ultra-lightweight handheld system designed specifically for biosafety cabinets (BSCs), laminar flow hoods (LAFs), sterile isolators, and confined spaces:
Extreme lightweight and ergonomics :
The entire unit is made of aerospace-grade anodized aluminum. The EVO.1 weighs only 974 g (60 mm nozzle) and the EVO.2 weighs only 1,040 g (30% increase in smoke output, 160 mm nozzle).
Patented hot wire vaporization and zero-momentum diffusion :
Utilizing Hot Wire Technology and the patented Zero Momentum Fog to Cloud Modulation technology, the smoke output is transformed into a uniform cloud, without generating propulsion jet interference flow patterns.
Aseptic patented formulation medium (VISUFLUID) :
Using a high-purity patented solution of DI water (>75%) and triethylene glycol (<25%), the 60 mL syringe reservoir can continuously generate fumes for about 60 minutes; it can also be expanded to a 1 L continuous feeding module to achieve up to 16 hours of operation.
Wireless lithium battery powered :
It has a built-in 15V / 3,200 mAh high-performance lithium battery, which can run under full load for up to 60 minutes and supports 60-minute fast charging.
3. Professional airflow visualization and guidance accessories (Lighting)
High-contrast auxiliary light source (LED Boost Gen2) :
The high-contrast cool white light (360 0.5W SMD 2835 LEDs) and multi-band RGBWA LEDs (18 x 15W, 45° angle illumination, DMX signal control support) developed specifically for high-speed photography and image accuracy enable smoke to appear in front of the lens with extremely high clarity.
Multi-functional smoke generator and manifolds :
Straight smoke rake (Ø 60/80 mm, length 650 to 1850 mm) and T-type smoke rake, flat narrow-slit nozzle (350/500 mm), Y/T splitter (with optional precision double independent butterfly valve), air curtain lifting double stand (height/width can be expanded to 4 meters).
Wireless remote control and system integration :
Supports long-distance multi-channel wireless remote control (on/off, pulse flash, airflow adjustment and zone control), allowing testing personnel to conduct remote controlled testing outside the isolation area.
Brand advantages
SISTEMA's ultrapure liquid nitrogen fumes, the preferred brand for EU and US GMP factory inspections , possess extremely high physical whiteness and uniformity. During the Dynamic Smoke Pattern Test, it can clearly display the actual airflow direction of aseptic gowning, glove box operations, high-speed filling and plugging, and freeze dryer feeding and discharging in front of HD/4K cameras, fully meeting the stringent requirements of factory inspectors for "flow pattern clarity and no blind spot recording".
HEPA/ULPA Filters and Products Zero-Risk Commitment : Unlike traditional fume-generating equipment that may leave oily deposits or glycerin viscous residues, the SISTEMA system has been verified by an authoritative third-party laboratory to ensure that the fumes evaporate into pure water vapor and nitrogen, or completely decompose through volatilization, guaranteeing zero toxicity and zero chemical contamination to expensive sterile environments and end products.
Covering all scenarios from micro-stations in R&D to large-scale workshops : The product matrix spans from the lightweight and portable handheld EVO series to the Apollo AP150 with a super-large gas production capacity of up to 24 m³/min. Whether it is micro differential pressure testing of sterile isolators within 1 cubic meter or overall differential pressure balance assessment of automated sterile filling workshops of thousands of cubic meters, it can handle it all with ease.
Complete validation documentation support (IQ/OQ Documentation) : All equipment series comes with a complete original manufacturer validation documentation package that complies with GAMP 5 and cGMP standards (including material compatibility certificate, particulate analysis report, factory test report and IQ/OQ agreement), which greatly reduces the regulatory compliance burden on pharmaceutical companies during equipment implementation and validation.
