Selection Guide for the German SISTEMA AFM-NEO Series Cleanroom Non-Contaminating Airflow Visualization Fog Generators

(Based on ISO 14644-3 Annex B7 and the latest original manufacturer catalog specifications, REV.01.2024)

Chapter 1: Product Technical Positioning and Compliance Core

A cleanroom is by no means a static space. It is a dynamic contamination-critical control area where personnel movement, material transfer, and machine operation occur frequently. To comply with the latest aseptic processing regulatory requirements, facilities must periodically use high-purity airflow visualization equipment (Airflow Mappers) for on-site airflow verification.

The AFM-NEO series developed by Germany’s SISTEMA-MK uses a patented, specially designed medical-grade AISI 316L stainless steel high-performance piezoelectric oscillation module and offers five core technical advantages:

1. Single pure medium, truly zero chemical residue

The entire system uses only deionized water (DI Water) or water for injection (WFI) as the fogging medium, with no oil, glycol, propylene glycol, glycerin, or any other organic additive. Non-volatile residue (NVR) testing is zero, effectively eliminating HEPA/ULPA filter clogging and chemical buildup on precision filling equipment such as ceramic pumps and analytical balances. Pharmaceutical manufacturers may directly apply for a Cleaning Validation Waiver.

2. Extreme neutral buoyancy and ideal micro-fog particle distribution

Under a water temperature of 7°C, the measured micro-fog particle distribution shows that as much as 92% of droplets are smaller than 5.0 microns (µm), exhibiting true neutral buoyancy with no gravitational settling and no thermal uplift:

• Less than 0.3 µm: 12%

• 0.3 µm to 0.5 µm: 36%

• 0.5 µm to 1.0 µm: 24%

• 1.0 µm to 5.0 µm: 20%

• Greater than 5.0 µm: only 8%

3. Flexible airflow and concentration control

The built-in low-disturbance fan supports stepless adjustment from 0 to 100%, combined with oscillation section switching (4-3-2-1 module segmentation) to achieve precise zero-momentum output. This fully matches laminar airflow velocity (0.36 to 0.45 m/s, ±20%) and prevents false turbulence caused by excessive jet force.

4. High compatibility with sterilization and disinfection

The entire structure and all contact materials are made of medical-grade AISI 316L stainless steel and can withstand wiping and disinfection with 6% hydrogen peroxide (H2O2), calcium hypochlorite solution (0.2 mL / 100 mL), or 70% isopropyl alcohol (IPA).

5. Online refilling and long service life

Optional “Refill on the Fly” functionality enables continuous refilling without stopping recording or opening containment barriers. The system is highly fault-tolerant, and the manufacturer provides a minimum 3-year warranty.

Chapter 2: International Standards and Application Scenarios

1. ISO 14644-3 cleanroom test methods

• Annex B7 Airflow visualization test: verifies the direction, uniformity, and distribution of static and dynamic airflow in cleanrooms.

• Annex B12 Airflow recovery/self-cleaning test: measures the time curve required for a cleanroom to recover from a dynamic contamination state to baseline cleanliness.

2. EU GMP Annex 1 (2022 revision)

• Clauses 4.21 and 4.22: unidirectional airflow systems (UDAF) must undergo airflow pattern visualization testing to prove that Grade A protection zones are not affected by backflow or shear disturbance from external air currents.

• Clauses 8.19 and 9.28: dynamic video recording is mandatory for worst-case human interventions, including jammed container removal, stopper replacement, broken bottle cleanup, and assembly operations, with full video archiving required.

3. USP 797 and USP 800

Used for dynamic airflow and laminar flow visualization verification in aseptic compounding facilities, primary engineering control (PEC) devices, glove boxes, and biosafety cabinets.

4. NSF 49 and EN 12469

Used to verify front-window air curtain integrity, opening protection performance, and airflow disturbance when personnel arms enter Class II A2/B2 biosafety cabinets.

5. Semiconductor process and differential pressure evaluation

Includes containment transfer verification for advanced wafer processing tools, tracking external air ingress paths, fine-tuning dynamic pressure balance in airlocks, and practical dynamic training for aseptic operators.

Chapter 3: Technical Evaluation of the Four Main Models

1. AFM40-DUAL (The Benchmark Flagship)

Positioning and features: Equipped with twin fog outlets, the highest fog output and widest coverage. Designed for large filling-line protective curtains, simultaneous dual-station visualization, and wide-span space verification.

• Piezoelectric oscillation module: 40 AISI 316L stainless steel oscillators

• Fog outlet: dual-port configuration

• Housing: AISI 316L medical-grade stainless steel

• Standard accessories: 2 fog rakes, 60 mm diameter × 650 mm length; 2 flexible 5 m fog hoses, 80 mm diameter

• Runtime per full fill: approx. 62 minutes (supports online refilling without stopping)

• Fog volume flow rate: 6.4 m³/min (226 cft/min)

• Water consumption: 866 mL/min

• Total fog output in a 60-minute cycle: 360 m³

• Effective visualization range: 7 to 10 m

• Dimensions: 60 × 32 × 29 cm

• Net weight: 19.4 kg

2. AFM35-NEO (The Power House)

Positioning and features: High-energy output and high-density fog, suitable for high-throughput Grade A filling stations, continuous intervention recording in oRABS, and long-distance fog delivery through extended tubing.

• Piezoelectric oscillation module: 35 AISI 316L stainless steel oscillators

• Fog outlet: single-port configuration

• Housing: AISI 316L medical-grade stainless steel

• Standard accessories: 1 fog rake, 60 mm diameter × 650 mm length; 1 flexible 5 m fog hose, 80 mm diameter

• Runtime per full fill: approx. 72 minutes (supports online refilling without stopping)

• Fog volume flow rate: 5.0 m³/min (177 cft/min)

• Water consumption: 791 mL/min

• Total fog output in a 60-minute cycle: 300 m³

• Effective visualization range: 7 to 10 m

• Dimensions: 57 × 32 × 29 cm

• Net weight: 18.5 kg

3. AFM24-NEO (The Endurance Runner)

Positioning and features: Longest single-run endurance, up to 94 minutes, with low water consumption. Especially suitable for long-duration uninterrupted intervention recordings, space-limited filling stations, and biosafety cabinets.

• Piezoelectric oscillation module: 24 AISI 316L stainless steel oscillators

• Fog outlet: single-port configuration

• Housing: AISI 316L medical-grade stainless steel

• Standard accessories: 1 fog rake, 60 mm diameter × 650 mm length; 1 flexible 3 m fog hose, 80 mm diameter

• Runtime per full fill: approx. 94 minutes (supports online refilling without stopping)

• Fog volume flow rate: 3.5 m³/min (123.6 cft/min)

• Water consumption: 553.7 mL/min

• Total fog output in a 60-minute cycle: 210 m³

• Effective visualization range: 4 to 6 m

• Dimensions: 57 × 32 × 29 cm

• Net weight: 17.0 kg

4. AFM CUBE (The Entry-Level AFM)

Positioning and features: The smallest and lightest model, weighing only 12.4 kg. Easy for one person to carry between aseptic rooms. Designed for compact isolators, glove boxes, and small equipment inspections.

• Piezoelectric oscillation module: 20 AISI 316L stainless steel oscillators

• Fog outlet: single-port configuration

• Housing: AISI 316L medical-grade stainless steel

• Standard accessories: 1 fog rake, 60 mm diameter × 650 mm length; 1 flexible 3 m fog hose, 60 mm diameter

• Runtime per full fill: approx. 46 minutes (supports online refilling without stopping)

• Fog volume flow rate: 2.6 m³/min (92 cft/min)

• Water consumption: 402 mL/min

• Total fog output in a 60-minute cycle: 142 m³

• Effective visualization range: 4 to 6 m

• Dimensions: 35 × 32 × 29 cm

• Net weight: 12.4 kg

Chapter 4: Original Manufacturer Optional Accessories and Module Configuration

1. Stainless steel fog rake series

• FL650.60-STR: 60 mm diameter × 650 mm straight fog rake with directional fog outlets

• FL.1300.60-STR: 60 mm diameter × 1,300 mm straight fog rake with directional fog outlets

• FL.650.80-STR: 80 mm diameter × 650 mm straight fog rake with directional fog outlets

• FL.1300.80-STR: 80 mm diameter × 1,300 mm straight fog rake with directional fog outlets

• FL.1850.80-STR: 80 mm diameter × 1,850 mm extra-long straight fog rake with directional fog outlets

• FL.1350.80-T: 80 mm diameter × 1,300 mm T-type fog rake with directional fog outlets

2. Clean-grade fog hoses and adapters

• TUBE.3000.60-BS / TUBE.3000.80-BS: 3 m flexible hose with 60 mm or 80 mm end diameter

• TUBE.5000.80-BS: 5 m flexible hose with 80 mm end diameter

• EXT.TUBE.3000.60-BS / EXT.TUBE.3000.80-BS: extension hose, customizable in 1 m increments

• OUTLET.45° (80): 45-degree elbow hose, 80 mm diameter, for immediate angle correction at the outlet

• 80.60 RED: 80 mm to 60 mm reducer adapter without throttling valve

• TUBE.CON (80) / TUBE.CON (60): same-diameter quick-connect couplers

• THROTTLE.80: dedicated butterfly throttle valve installed at the end of the hose for stepless fog output adjustment from 0 to 100%

3. Special flat fog nozzles

• NOZ.350: 350 mm wide flat nozzle for rapid formation of a uniform airflow sheet

• NOZ.500: 500 mm wide flat nozzle with a special rectifying vane design, producing an extremely even and uniform thin fog curtain

4. Multi-point splitter system

• T-SPLITTER.80-STRD: standard T splitter, combining two FL.650.80-STR fog rakes into one 1,300 mm T-type rake

• Y-SPLITTER.80-STRD: standard Y splitter, evenly dividing one air source into two outputs, with short connecting tubes

• Y-SPLITTER.80-THROTTLE: advanced Y splitter with independent manual butterfly valves on both output branches for separate 0–100% adjustment, solving fog balance issues between test points with different resistance

• QUAD (1 in 4 out): high-throughput 1-to-4 splitter manifold supporting four-point simultaneous fogging, available only for AFM40-NEO and AFM40-DUAL

5. Dedicated contrast lighting system

LED.BOOST-GEN2 dual-light source set

• Light source 1: 360 high-brightness cool white LEDs (0.5 W SMD 2835), providing strong lateral light penetration and visualization

• Light source 2: Vector Pixel Bar professional color-rendering strip light (18 × 15 W emitters, RGBWA five-in-one mixing, 45-degree beam angle, supports 10/28/90/100 DMX dimming channels), specifically designed to eliminate reflections from mirror-finish AISI 316L stainless steel

6. Control, stands, carts, and protective accessories

• RC.AFM.AD: multifunction long-range wireless remote control supporting power on/off, Switch & Flash stroboscopic visualization, airflow adjustment, and 4-3-2-1 module switching

• WR.PS: universal power supply module, 100–240V wide input, 50/60Hz

• IQ/OQ: standard German manufacturer qualification documentation package

• LF.AFM: dedicated lifting-free mobile cart with steering handle and ultra-quiet dust-free casters

• TRIPOD-L/F: heavy-duty dual-stand set with stainless steel clamps and straps; both height and horizontal span can reach up to 4 m

• TRIPOD-900 / 1200 / 1500: dedicated stands for 900 mm, 1200 mm, and 1500 mm laminar-flow workbenches, with top fixation clips and silicone straps

• BOX.AFM-NEO / DUAL / CUBE: European-style high-rigidity protective transport case with telescopic pull handle, heavy-duty shock-absorbing foam, and wheels

Chapter 5: Application-Based Model Selection

Scenario 1: Compact aseptic isolator, biosafety cabinet, or glove box

Core challenge: Very limited enclosed space with high-precision balances and drive components inside; oily residue is strictly forbidden.

Recommended model: AFM CUBE

Reason: At only 12.4 kg and with a compact footprint, it is easy to carry. The fog output of 2.6 m³/min is moderate and will not over-whiten the vision field in a confined space. Combined with a Ø60 mm hose and a wall-through flange, testing can be completed quickly.

Scenario 2: Medium-sized filling equipment and long-duration worst-case simulation (continuous recording for 60 to 90 minutes)

Core challenge: Simulate multiple continuous human interventions, such as repeated jam removal, material changeover, and cleaning, without interrupting video recording or stopping due to lack of water.

Recommended model: AFM24-NEO

Reason: It provides up to 94 minutes of single-run endurance with low water consumption, allowing the full worst-case dynamic process to be recorded without frequent refilling and avoiding deficiencies during inspection.

Scenario 3: Standard Grade A filling lines, oRABS, and long-span airflow paths

Core challenge: Barriers extend several meters, and fog must be delivered through long tubing to specific workstations, where piping resistance is significant.

Recommended model: AFM35-NEO

Reason: With a fog output of 5.0 m³/min and an effective range of 7 to 10 m, it can overcome the pressure loss caused by long tubing while maintaining fog density and initial micro-fog momentum balance.

Scenario 4: Multi-station parallel fogging, large-span protective curtains, or four-point split verification

Core challenge: A large protective air curtain must be verified simultaneously, or visualization is needed at multiple filling needles or star-wheel positions at the same time.

Recommended model: AFM40-DUAL

Reason: With dual independent fog outlets and 40 high-efficiency piezoelectric modules, it provides a powerful output of 6.4 m³/min and can be paired with Y splitters, QUAD four-way splitters, and dual fog rakes to achieve uniform simultaneous multi-point fogging.

Chapter 6: International Reference Customers

The German SISTEMA AFM series is widely adopted by multinational pharmaceutical, biotechnology, medical device, and semiconductor leaders:

• Top global pharmaceutical groups: Pfizer, Novartis, Roche / Genentech, Merck / MSD, AstraZeneca, GlaxoSmithKline (GSK), Sanofi, Eli Lilly, Takeda, Boehringer Ingelheim, AbbVie / Allergan, Amgen, Novo Nordisk, Bayer, Sandoz, Teva, Grifols, Baxter, CSL Behring, Patheon

• CDMO and leading aseptic filling equipment brands: Lonza, Catalent, Sartorius, Getinge, OPTIMA Pharma

• High-end semiconductor and technology giants: ASML, Lam Research, Microsoft, OSRAM

Professional Consultation and Online Sample Test Planning

You are 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 regulatory response and equipment selection solution tailored to your laboratory:

• Official website: www.dissolution.com.tw

• Product section: Airflow Monitoring

• Technical hotline: 04-2241-1607