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NP-M1 Pilot-Scale Nanoparticle Generator

Nanoparticle Generator for Pilot Scale

A modular pilot-scale platform for LNPs, polymeric nanoparticles and emulsions: three-channel liquid path, non-contact flow feedback, optional liquid heating and in-line dilution, software compliant with 21 CFR Part 11 — carrying laboratory formulations smoothly toward volume production.

0–500 mL/min flow rateRT–80 °C liquid heating±1% flow accuracy21 CFR Part 11
NP-M1 Pilot-Scale Nanoparticle Generator
Overview Five Systems Mixing Chips Specifications Applications FAQ
NP-M1 Pilot-Scale Nanoparticle Generator
Overview

Built for Scale-Up, Engineered for Compliance

NP-M1 is a pilot-scale nano-formulation preparation platform supporting continuous production of LNPs, polymeric nanoparticles, emulsions and more. Its modular design allows flexible configuration of liquid heating, flow feedback, in-line dilution and automatic pre/post waste switching; the software has a built-in audit trail that meets 21 CFR Part 11, with non-standard customization available.

  • Flow rate range 0–500 mL/min; tubing hold-up volume < 15 mL
  • Sample temperature control: ambient to 80 °C (optional heating module)
  • High-pressure plunger pumps with ruby valve cores stay stable under high pressure
  • 316L stainless liquid path — removable, replaceable, cleanable, cGMP-ready
Advantages

Three Core Advantages

Multi-Chip, Multi-Function

Houses two chips with multi-stage serial mixing; supports LNPs, PLGA nanoparticles, liposomes and exosome loading. Chips are quick to swap and clean for an efficient, clean workflow.

Full Software Control

Modules can run independently or as a coordinated line with live visualization of synthesis progress and instrument status. Three-tier permissions, password protection, e-signatures and audit trail ensure compliance and data integrity.

Easy to Clean & Maintain

Ruby-valve high-pressure plunger pumps perform stably under load; the 316L stainless liquid path can be replaced, disassembled and cleaned as a whole — meeting cGMP cleaning-validation requirements.

Integrated Systems

Five Integrated Systems for Stable, Efficient LNP Output

01

Liquid Delivery Control System

Three independent delivery channels support continuous feeding with ±1% flow accuracy:

  • High-pressure channel 1: 0–200 mL/min, max. working pressure 10 MPa
  • High-pressure channel 2: 0–300 mL/min, max. working pressure 10 MPa
  • Ambient-pressure channel: 0–2000 mL/min
02

Flow Measurement System

Dual non-contact mass flow meters (0–20 kg/h and 0–30 kg/h) monitor in real time, with ample range margin for high-density liquids to keep measurement accuracy consistent.

03

Optional Heating System

Sample inlets, tubing and chip heated together from ambient to 80 °C with ±2 °C accuracy, meeting the temperature requirements of various nanoparticle syntheses.

04

Pre/Post Waste Switching System

Real-time response and fast switching; a carefully designed flow path eliminates any risk of waste backflow, ensuring product purity and stability.

05

Optional Mixing Chips

Three standardized chip designs — Vortex, impinging jet (T-mix) and split-and-recombine (SAR) — in 316L stainless steel or Hastelloy, with custom metal chips available on request.

Customization Services

Non-standard customization supported: channel configuration, heating modules, in-line dilution units and more can be combined to your process. An advanced chip design and manufacturing team provides end-to-end support for special flow structures.

Mixing Chips

Mixing Chip Family

Three standardized mixing architectures plus fully custom flow paths, covering every mixing need from process development to pilot production.

Impinging Jet Chip (T-mix)

Outstanding at production scale: simple structure, low flow resistance and high flow capacity — the preferred design of leading vaccine companies and nanoparticle plants. Multiple channel widths tailor to different flow requirements.

Vortex Chip

A newer architecture with 2–4 liquid inlets. Matches T-mix at low flows; at higher flows it delivers smaller particle size and lower PDI. Also widely used for PLGA nanoparticles and liposomes.

SAR & Custom Chips

The standardized SAR chip suits gentle stepwise mixing; for special designs and processes, our chip team provides full-custom flow path services.

Chip specifications
Chip typeMaterialMax. flow rateMax. pressure
Impinging jet (T-mix)316L stainless steel (or Hastelloy)200 / 300 / 400 mL/min10 MPa
Vortex316L stainless steel (or Hastelloy)500 mL/min10 MPa
Custom316L stainless steel (or Hastelloy)On request10 MPa
Specifications

Specifications

Process specifications
Flow rate range0 – 500 mL/min
Tubing hold-up volume< 15 mL (dual high-pressure plunger pumps + vortex chip, typical configuration, excluding external tubing)
Sample temperature controlAmbient – 80 °C (optional heating module, ±2 °C accuracy)
Chip architecturesImpinging jet (T-mix), vortex, split-and-recombine (SAR)
Chip material316L stainless steel or Hastelloy
Tubing material316L stainless steel
Liquid path & instrument specifications
Channel configuration2 high-pressure lines + 1 ambient-pressure line
High-pressure channel flowChannel 1: 0–200 mL/min; Channel 2: 0–300 mL/min (±1% accuracy, max. working pressure 10 MPa)
Ambient channel flow0 – 2000 mL/min
Flow meters2 non-contact mass flow meters (0–20 kg/h; 0–30 kg/h)
ControlExternal PC control (with audit trail, 21 CFR Part 11 compliant)
Environment4 – 40 °C; humidity < 90%
Power220 V ± 5%, 50 Hz, 10 A (transformer on request)
Dimensions (L×W×H)62 × 75 × 107 cm
Applications

Applications

LNP Pilot Production

Process scale-up and pilot batches of mRNA vaccine and nucleic acid drug LNPs, with parameters consistent with the benchtop platforms.

Polymeric NP Production

Pilot preparation of biodegradable polymer nanoparticles such as PLGA, generating process data for clinical translation.

Cosmetic Nanoparticles & Emulsions

Continuous pilot production of active-ingredient nanocarriers and emulsion systems, improving uniformity and efficiency.

NP-M1 five integrated systems
Workflow

A Complete Closed Loop of Continuous Production

From continuous feeding and real-time flow feedback through multi-stage mixing, in-line dilution and automatic waste switching, NP-M1 organizes pilot production into one stable line — every step recorded by software to satisfy audit and traceability requirements.

  • Continuous feeding matched to batch production rhythms
  • Live visualization of synthesis progress and instrument status
  • Free switching between independent module control and whole-line management
FAQ

FAQ

Will particle size change when scaling lab formulations up to NP-M1?
NP-M1 shares the same microfluidic mixing principle and chip design as the benchtop platforms, with an identical TFR/FRR parameter system. Multiple channel widths of the T-mix and vortex chips maintain consistent mixing hydrodynamics during scale-up. The vortex chip can even deliver smaller particle size and lower PDI at high flow rates.
How does the software meet regulatory compliance?
The software is designed and developed per 21 CFR Part 11, with built-in three-tier user permissions, password protection, electronic signatures and audit trail — every operation is logged to satisfy data-integrity requirements in regulated environments.
How does the system meet cGMP cleaning requirements?
The delivery path uses 316L stainless tubing that can be replaced, disassembled and cleaned; high-pressure plunger pumps use ruby valve cores, pressure-stable and durable. The whole liquid path design supports cGMP cleaning validation.
What customizations are available?
NP-M1 supports non-standard customization: channel count and ranges, heating modules, in-line dilution units and waste-switching logic can be combined to your process; our chip team also builds fully custom flow structures.
What are the maximum flow rate and pressure?
The vortex chip reaches 500 mL/min; impinging jet chips come in 200/300/400 mL/min variants; high-pressure channels are rated to 10 MPa.
What are the site requirements?
Footprint 62 × 75 × 107 cm, 220 V ± 5% / 50 Hz / 10 A supply (transformer on request); ambient 4–40 °C, humidity < 90%.
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