The NanoFlowSizer from InProcess-LSP is a new innovative analyzer, designed to perform continuous, real-time nanoparticle size characterization of colloidal systems, nanosuspensions, nanoemulsions and other dispersed nanoproducts directly in manufacturing processes (inline) or in a laboratory setting (offline). Measurements can be performed without requiring sample extraction, dilution or treatment. It is a one-of-a-kind technology to perform this function.
Results every 10 seconds
The NanoFlowSizer enables users to make rapid nanoparticle size characterization in less than 10 seconds, allowing continuous, real-time in-flow analysis.
How the NanoParticle Analyzer differs
All commercial particle size analyzers need sampling during or after production and, in most cases, requiring treatment or dilution of the sample. Subsequently, offline testing is done in a laboratory environment. The outcome of this type of process (quality) control could cause unreliable product quality, which potentially might result in up to 50% rejection rates in batch production (based on data from the pharmaceutical sector).
Total production process control in real-time
In addition to performing measurements offline, the NanoFlowSizer inline functionality enables faster development and full control across and during the entire manufacturing process. This major benefit of using Process Analytical Technologies (PAT) to monitor and control the quality of medicines and drug carriers is increasingly demanded by pharmaceutical companies. PAT and inline nanoparticle size measurement has currently become even more urgent because of the increased activities and urgencies in vaccine development and manufacturing for Covid-19.
Savings up to 2 million
Having absolute control over the manufacturing conditions of nanoparticles leads to a reduction of batch rejection to zero in relation to nanoparticle size measurements. It simplifies and increases the total manufacturing time through the elimination of the need for production stops and complicated and time-consuming sampling and sample treatment processes. According to the pharmaceutical sector, savings per event are usually sub millions up to several million Euros, which demonstrates a substantial added value for the business.
Experts in Process Analytical Technology
With extensive scientific knowledge and experience in Process Analytical Technology, InProcess-LSP is able to assure adequate performance and optimal alignment with customer objectives. Our NanoFlowSizer solution concept includes full set-up and monitoring at any stage of implementation at the customer's site. At InProcess-LSP, the goal is to provide customers with total solutions that address their particular problems and requirements for PAT. The NanoFlowSizer evolves from the fulfillment of an unmet need in the pharma and other sectors where sizing of nanoparticles is important (fe. food, inks, cosmetics and chemicals markets). Developing answers to key challenges in PAT is a core element in InProcess-LSP’s activity in these markets.
| NanoFlowSizer functionalities |
Needs covered |
| Inline, online, atline and offline |
Versatility |
Complete control over the production process and product quality:
- Batch rejection related to particle size reduced - saving up to €2 million per event
- 24-hour production possible: increasing revenues
|
| Non-invasive |
Suitable for sterile processes No need for sampling or sample treatment (no expensive time-consuming laboratory testing): €600-700K per drug saved annually, incl. increased productivity |
Particle size information
within seconds (10 s) |
Real-time Continuous measurements |
| 10 – 1,000 nm range |
Highly-concentrated products |
NanoFlowSizer : The System
The NFS comprises three key elements: 1. Base Unit: With the light source and spectrometer 2. Probe Unit: Interferometer and sensor 3. XsperGo software: Instrument control and calculations of particle size characteristics
Image Credit: InProcess-LSP
Low coherence light moves from the light source to the optical unit via a fiber connection. Light is subsequently directed to the nanosuspension and dispersed by the nanoparticles in a pattern sensed by the sensor and the interferometer provided in the optical unit. The scatter patterns acquired are then processed via our patented XsperGo software (set up in the PC linked to the NanoFlowSizer), which comprises data treatment algorithms, offering nanoparticle size and size distribution to regulate product and process quality.
NanoFlowSizer modules (above) and configurations (below). Image Credit: InProcess-LSP
The NanoFlowSizer is a versatile modular system delivering various functionalities based on the module used:
- Offline: Outside the production area (laboratory) - sampling necessary
- At-line: Static measurements performed in proximity to the manufacturing process - sampling necessary
- Online: A sampling loop connects to the production flow
- Inline: In the continuous production flow (instant and realtime non-invasive measurements, without the need for sampling and sample treatment)
With the modular design, users can configure all functionalities as listed above. The non-invasive measurement process requires only 10 seconds for nanoparticle size and particle size distribution. Real-time process feedback data, which is crucial for superior quality control of all production processes, is enabled by the continuous analysis mode.
The NanoFlowSizer goes beyond innovation in Nanoparticle size analysis.
A number of methods are available to establish the size of nanoparticles:
- Static light scattering or laser diffraction establishes particle size from the quantified variation in the intensity of scattered light as a function of the scattering angle.
- Nanoparticle tracking analysis aims a laser beam through a chamber that holds suspended particles. These particles scatter the laser, enabling them to be visualized and examined.
- Dynamic light scattering (DLS) quantifies particle motion (Brownian motion) from variations in the intensity of the scattered light. Particle size can then be deduced from the movement of particles.
The majority of nanoparticle size analyzers available in the market are based on DLS technology. Existing DLS systems technically cannot perform inline measurements. A large number of vendors in particle size instrumentation provide offline DLS systems.
Why can NanoFlowSizer Carry Out Inline Analysis?
Spatially Resolved Dynamic Light Scattering
The main innovation in the NFS is that it uses Spatially Resolved Dynamic Light Scattering (SR-DLS) based on Fourier Domain Low-Coherence Interferometry (FD-LCI). FD-LCI Light scattering data is acquired from particles at different depths in the sample.
The exclusive depth-resolved light scattering information is paramount and holds data on both particle size and process flow properties. The patented algorithm of InProcess-LSP’s XsperGo software can extract the applicable data continuously, offering size characterization every 10 seconds.
Summary
When opting for the offline functionality, the NanoFlowSizer provides better performance than existing particle sizers for extremely turbid and concentrated samples thus preventing the need for sample preparations.
As the only true inline nanoparticle size analyzer, the NanoFlowSizer is the sole system currently available on the market. It provides all the benefits related to inline analysis functionality. Since sampling is not required before analysis, risks such as contamination and failures associated with sampling and testing are reduced considerably.
Moreover, constant monitoring of process flows is now feasible since inline measurements require just 10 seconds, giving instant performance and quality feedback and full control of the production process. Consequently, the NanoFlowSizer allows non-invasive process control and decreases batch-rejections associated with particle size analysis.