Optional Heating ModuleAn optional heating function is available to support a wider range of application scenarios and accommodate the synthesis of various types of nanoparticles.
Versatile Chips andMultifunctional ApplicationsEach unit can accommodate two chips and supports multiple mixing models to enable multistage mixing. It is suitable for the preparation of lipid nanoparticles (LNPs), PLGA nanoparticles, liposomes, and exosome drug loading. The chips are easy to remove, clean, and replace, ensuring a clean and efficient workflow.
Software ControlThe system allows independent control of each module or parallel management of the entire process. It provides real-time visualization of synthesis progress and instrument status, ensuring full operational transparency. The software integrates advanced features such as three-tier user access control, password protection, electronic signatures, and audit trails to ensure operational compliance and data security.
Easy to Clean and MaintainThe high-pressure plunger pump uses a ruby valve core, ensuring stable performance even under high-pressure conditions.The liquid delivery pathway is constructed with 316L stainless-steel tubing, which can be replaced, removed, or cleaned as needed, fully meeting cGMP requirements.
The pilot-scale nanoparticle generator (NP-M1) is a pilot-grade platform designed for the manufacturing of lipid nanoparticles (LNPs), polymer nanoparticles, emulsions, and other nano-formulations. The NP-M1 supports non-standard customization and provides essential functions for continuous nanoparticle preparation. With flexible optional modules, it can achieve liquid line heating, flow-rate feedback, online dilution, and automatic switching of pre- and post- waste streams.The NP-M1 simplifies the workflow while ensuring product stability. The software also includes an audit trail function and complies with 21 CFR Part 11 requirements.
preparation flow rate range
filling volume
sample temperature
0 ~ 500 mL/min[1]
＜15mL [1]
4 ~ 80 ℃ [1]
***Modular system design with flexible configuration options
***Designed and manufactured in accordance with the requirements and regulations of 21 CFR Part 11.
Advantages
Optional Heating Module
An optional heating function is available to support a wider range of application scenarios and accommodate the synthesis of various types of nanoparticles.
Versatile Chips and Multifunctional Applications
Each unit can accommodate two chips and supports multiple mixing models to enable multistage mixing. It is suitable for the preparation of lipid nanoparticles (LNPs), PLGA nanoparticles, liposomes, and exosome drug loading. The chips are easy to remove, clean, and replace, ensuring a clean and efficient workflow.
Software Control
The system allows independent control of each module or parallel management of the entire process. It provides real-time visualization of synthesis progress and instrument status, ensuring full operational transparency.The software integrates advanced features such as three-tier user access control, password protection,electronic signatures, and audit trails to ensure operational compliance and data security.
Easy to Clean and Maintain
The high-pressure plunger pump uses a ruby valve core, ensuring stable performance even under high-pressure conditions. The liquid delivery pathway is constructed with 316L stainless-steel tubing, which can be replaced, removed, or cleaned as needed, fully meeting cGMP requirements.
Note: [1]: Typical values for a configuration with two high-pressure piston pumps and a vortex mixing chip, without external
Five Integrated Systems for Stable and Efficient LNP Production
Liquid Control System
Each controlled separately:Three independent liquid delivery channels.Comprises 2 high-pressure delivery channels and 1 atmospheric-pressure channel.
Supporting continuous feeding:Flow-rate accuracy of ±1%.
High-pressure Channel 1:0–200 mL/min, maximum operating pressure 10 MPa.
High-pressure Channel 2:0–300 mL/min, maximum operating pressure 10 MPa.
Atmospheric-pressure Channel: 0–2000 mL/min.
Flow MeasurementSystem
Coriolis flow meters × 2
Measurement range: 0–800 mL/min.
Measurement accuracy: ≤ 0.3% of full scale.
Optional HeatingSystem
Sample inlet, tubing, and chips can be heated simultaneously to meet temperature requirements from ambient to 80 °C, with a heating accuracy of ±2 °C.
Pre/Post WasteSwitching System
Provides real-time response and rapid switching, with a well-designed fluidic path that eliminates the risk of waste backflow.
Optional LiquidMixers (Chips)
Available materials: 316L stainless steel and Hastelloy.
FluidicLab offers three standardized chip designs for liquid mixing:
– Vortex mixing
– Impinging jet mixing
– Split-and-recombine (SAR) mixing
Custom metal chips are also available upon request.
Nanoparticle Preparation Chips
Impinging Jet Mixing Chip (T-mix)
The T-mix chip demonstrates excellent performance in scale-up production, offering advantages such as simple fabrication, low flow esistance, and a high upper limit for flow rates. These features have made it the preferred design for many leading vaccine manufacturers and nanoparticle production facilities. FluidicLab provides T-mix chips with various channel widths and can customize them to meet different flow-rate requirements under diverse production conditions.
Vortex Mixing Chip (Vortex)
As a novel mixing architecture, the Vortex chip supports two to four liquid inlets. In typical LNP formulation processes, the Vortex chip can achieve mixing performance comparable to a T-mix chip at relatively low flow rates, producing particles with similar sizes. When the flow rate increases, the Vortex chip yields significantly smaller particle sizes with a lower PDI. This chip is also widely applicable for the preparation of various nanoparticle formulations, including polymeric nanoparticles (e.g., PLGA) and liposomes.
Customized Chips
Our advanced chip design and manufacturing teams provide full support for customized flow-channel structures,tailored to unique design and process requirements.
Applications
Pilot-scale productionof LNPs
Production ofpolymeric nanoparticles(e.g., PLGA nanoparticles)
Synthesis ofcosmetic nanoparticlesand emulsions
Parameter
Nanoparticle Generator for Pilot Scale
Technical Specifications
Environmental Requirements
Temperature: 4–40 °C; Humidity: <90%
Power Requirements
Voltage: 220 V ±5%, 50 Hz, 10 A （A transformer is available upon request）
