I. Product Positioning and Core Technical Principles

In modern pharmaceutical aseptic rooms, advanced semiconductor wafer fabs, biosafety cabinets (BSCs), and isolators (Isolator/oRABS), personnel and material movement, equipment modifications, and airflow disturbances can easily cause cross-contamination. According to ISO 14644-3 Annex B7, cleanroom operators must periodically provide validation evidence of in-situ airflow mapping.

The AFM FOG PISTOL EVO.1 and EVO.2 handheld fog guns developed by Germany’s SISTEMA-MK are specially designed for high-cleanliness critical environments and feature extremely lightweight construction and pure fog characteristics:

• Unique Zero Momentum Fog to Cloud Modulation:

  Fog is emitted without forward jet momentum. After leaving the nozzle, it quickly transforms into a cloud that drifts with the micro-airflow, completely eliminating pseudo-flow interference caused by the instrument’s initial velocity and revealing the true micro-airflow pattern.

• Neutral Buoyant & Paper White Fog:

  The fog has the same density as the surrounding air, with no thermal rise or settling. It provides very high optical contrast and an extremely long suspension time (Long Standing Fog).

• Non-toxic, non-hazardous, residue-free, no wipe-down required (Sterile Media VISUFLUID & Hot Wire Technology):

  Uses hot-wire vaporization technology together with the sterile dedicated medium VISUFLUID (>75% deionized injection water + <25% triethylene glycol compound). The fogging process is clean, colorless, odorless, non-adsorptive, and leaves zero residue. No wipe-down is required after testing, and it will not damage HEPA/ULPA filters.

• Extremely lightweight and ergonomic:

  The housing is made of anodized aluminum alloy with silver/black/cyan finish. The EVO.1 weighs only 974 g, and the EVO.2 only 1,040 g. With a body size of just 27.5 × 22.75 cm, it can be deployed rapidly after very short setup time.

• Modular scalability and synchronized operation:

  Supports parallel synchronized control of two or more units, making it suitable for anything from single-point leak tracing to airflow evaluation across medium-sized laminar flow benches.

II. Applicable International Standards and Test Scenarios

• ISO 14644-3 Annex B7: cleanroom in-situ airflow visualization tests

• ISO 14644-3 Annex B12: airflow recovery tests

• EU GMP Annex 1 (2022): dynamic interventions and airflow protection validation in bottle-opening / capping areas

• USP <797> & USP <800>: in-situ airflow direction analysis in aseptic compounding rooms and hazardous drug compounding areas

• NSF 49 / EN 12469: verification of inflow and vertical laminar protection in Class II biosafety cabinets

• SEMI Guidelines / Federal Standard 209E: protection testing for semiconductor wafer transfer equipment (FOUP/EFEM)

• Containment transport studies and equipment placement airflow optimization

• Cleanroom leakage tracking, air infiltration path tracking, and pressure balancing adjustment

• Aseptic gowning, glove box operations, and dynamic operator training

III. Detailed Comparison of the Two Main Models (EVO.1 vs. EVO.2)

Item 1: Original Manufacturer Part Number

• EVO.1: FP-R01 EVO.1

• EVO.2: FP-R02 EVO.2

Item 2: Fog Output Capacity

• EVO.1: baseline fog output (100%)

• EVO.2: 30% higher fog output (+30%), suitable for denser fog and wider coverage testing

Item 3: Main Nozzle Specification

• EVO.1: 60 mm standard nozzle tube, for narrow spaces and point-to-point tracing

• EVO.2: 160 mm extended nozzle tube, with better diffusion and rectification effect

Item 4: Net Weight

• EVO.1: 974 g

• EVO.2: 1,040 g

Item 5: Dimensions

Both models are approximately 27.5 × 22.75 cm and include a flat-bottom standing design for upright placement on a workbench.

Item 6: Fluid Reservoir Capacity and Runtime

• Reservoir: 60 mL syringe-type detachable cartridge with medical-grade Luer-Lock interface

• Consumption: approx. ±1 mL/min

• Runtime: continuous fogging for 60 minutes per full fill, with very high consumable efficiency

Item 7: Power and Charging System

• Battery module: rechargeable lithium battery (15V / 3,200 mAh, 48 Wh), CE certified

• Charger: dual-voltage fast charger (115V / 230V), fully charges in 60 minutes and supports alternating use of two battery sets

Item 8: Standard Package Contents

• Main unit (EVO.1 with 60 mm nozzle; EVO.2 with 160 mm nozzle)

• 1 dedicated lithium battery module

• 1 fast charger

• 2 × 60 mL cartridges

• 1 injection syringe set

• Dedicated connecting tubing

Item 9: Best Application Environments

• EVO.1: glove boxes, micro-isolators, pass boxes, weighing enclosures, precision point leak detection, and exhaust airflow balancing

• EVO.2: Class II biosafety cabinets (BSC A2/B2), small/medium laminar airflow benches (LAF Bench), filling-line bottle-opening areas, and dynamic hand-intervention assessment

IV. Original Accessories and Expansion Module Guide (Ordering Part Numbers)

Multi-port fog rakes and articulated joints

• FP.RAKE-S (300): 300 mm stainless steel fog rake with 3 uniform fog outlets, autoclavable

• FP.RAKE-M (600): 600 mm stainless steel fog rake with 6 uniform fog outlets, suitable for 2- to 3-foot benches, autoclavable

• FP.RAKE-L (900): 900 mm stainless steel fog rake with 9 uniform fog outlets, suitable for laminar benches over 4 feet, autoclavable

• FP.BALLJOINT: ±30° multi-directional rotating ball joint for fine adjustment of fog rake projection angle, with anti-tip triangular support base

• T-FP.RAKE: T-type adapter for extending T-type wide fog rakes of 650 mm or longer

Extension pipes and dedicated micro-leak detection kit

• FP-EXT.300 / 600 / 900: stainless steel extension pipe sections in lengths of 300 mm / 600 mm / 900 mm, useful for directing fog to ceiling HEPA outlets, top return ducts, or elevated piping

• FP.LEAKTEST: micro-leak detection kit with a nozzle module for fine smoke strands; releases ultra-low-flow, high-contrast delicate smoke filaments for HEPA frame gasket inspection, flange sealing checks, and enclosure leak tracing, fully replacing conventional chemically corrosive or residue-producing smoke chemicals

Vertical stainless-steel stands for laminar benches

• FP-TRIPOD-500: 100% medical-grade stainless-steel stand, 500 mm high, with adjustable fixing clamp, autoclavable

• FP-TRIPOD-750: 100% medical-grade stainless-steel stand, 750 mm high, autoclavable

• FP-TRIPOD-1000: 100% medical-grade stainless-steel stand, 1,000 mm high, autoclavable

• FP.HOLDER/TRIPOD: silicone quick-release mounting base for the fog pistol, with a 3 m floor-standing lift tripod, suitable for room airflow and background airflow evaluation

Remote control, hoses, and dedicated consumables

• FP.RC: plug-in wireless transmitter and remote controller for fogging control outside isolators or through the protective window of a bench

• FP.HOSE-S / M / L / XL: clean-grade flexible silicone hoses, lengths of 1 m, 2 m, 4 m, and 6 m respectively, with quick-release adapters

• FP.FLUID-1L: 1-liter sterile dedicated fogging fluid (>75% DI-water mixture), providing up to 16 hours of cumulative fogging time, residue-free and no wipe-down required

• FB.BOX: custom double-layer shock-absorbing protective transport case with laser-engraved foam insert, capable of holding the main unit, accessories, and consumables

• FP.BC-2 / FP.BAT-2: spare fast charger (full charge in 60 minutes) and spare 15V / 3,200 mAh lithium battery module

• FP.FILL-KIT: spare refilling syringe kit, including 60 mL cartridge, 60 mL filling syringe, Luer-Lock adapter, and connection tubing

• FP.4OP: dedicated replacement nozzle tip set (blue, 4 pieces per set), universal for fog rakes and leak testing kits

V. Recommended Configurations for Common Scenarios

Aseptic isolator / glove box / pass box airflow visualization

Recommended model: FP-R01 EVO.1Recommended accessories: FP.RC wireless remote + FP.HOSE-S (1 m) silicone hose + FP.RAKE-S (300 mm) fog rake Technical benefit: Fog can be guided through the glove port or quick-release flange, and operators can trigger fog remotely from outside. The zero-momentum fog does not disturb micro-pressure differentials, and the chamber requires no wipe-down after testing.

Class II biosafety cabinet (BSC) / laminar airflow sampling hood (LAF)

Recommended model: FP-R02 EVO.2Recommended accessories: FP-TRIPOD-500 stainless-steel stand + FP.RAKE-M (600 mm) fog rake + FP.BALLJOINT rotating joint Technical benefit: Creates a uniform wide fog curtain, fully verifies the front-window inflow barrier and vertical laminar airflow over the work surface, and accurately captures boundary overflow or vortices.

HEPA / ULPA filter sealing and piping flange micro-leak detection

Recommended model: FP-R01 EVO.1Recommended accessories: FP.LEAKTEST leak detection kit + FP-EXT.600 extension rod Technical benefit: Releases ultra-fine fog filaments to precisely locate leaks at frame edges and ceiling seams. It will not damage the filter and poses no chemical residue risk.

Dynamic operator intervention validation in aseptic filling lines

Recommended model: FP-R02 EVO.2Recommended accessories: FP.HOLDER/TRIPOD (3 m tripod) + FP.HOSE-M (2 m) hose + FP.RAKE-L (900 mm) fog rake Technical benefit: Fog can be generated in real time during worst-case interventions such as bottle removal, needle replacement, or sampling, clearly recording whether the operator’s hand motions compromise the aseptic barrier.

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 inquiry form. Our professional technical consultants will help you plan a regulatory response and equipment selection solution tailored to your laboratory:

• Official website: www.dissolution.com.tw

• Product section: Airflow Monitoring and Visualization

• Technical hotline: 04-2241-1607