NanoFlowSizer

The ONLY TRUE inline analyzer in the market today

The need for inline particle sizing

Nanotechnology, the design, synthesis, characterization and application of material and devices on the nanometre scale, is revolutionizing many technology and industry sectors: vaccines, medicine, energy, food, inks…

Physical, chemical and biological properties at the nanoscale are completely different from properties of bulk matter.

Current limitations

  • Batch rejection
  • Interruption of production process
  • No continuous manufacturing
  • Long time for analysis
  • Limited performance
  • Low control over production process

Lead to:  Economic losses due to lack of solutions!

No real solutions available…

Restrictions in nanoparticle analysis:

  • Low control over the production process
  • Interruption of the production flow every time conditions are changed
  • Need for laboratory analysis
  • Impossibility to carry out Continuous Manufacturing (24-hour)
  • Long time for analysis (10 min – hours)
  • Variations in product quality due to absence of full process control
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A unique nanoparticle sizer: the NanoFlowSizer


The importance of particle size monitoring

The capacity of nanoparticles to carry out their function is dependent on their size as well as size distribution, which are directly related to efficacy and safety (for patients in pharma applications).

Since the behaviour of particles at the nanoscale depend highly on these properties, their control is paramount to the entire development and manufacturing process of nanoparticle products.

Uncompromised monitoring

Pharma industry demands complete control over production processes of their high-quality products that need to comply with stringent regulations and demands, which costs $1 million/day1. They thus require sophisticated, highly efficient Process Analytic Technologies (PAT).

However, there is lack of such PAT solutions for monitoring particle size and size distribution in the nanoscale regime, hindering nanoparticle applications from reaching full potential.

Nanoparticles and its applications

Nanoparticles are natural and synthetic particles with a size in the 10-9 m range (1-1,000 nm). Due to their small size they have a large surface area in relation to their volume, conferring them special properties.
Nanoparticles are present in many of the items in our every-day life, such as transparent sunscreens or scratchproof glasses. Of special interest for the pharmaceutical industry, nanoparticles are used under different formulations, such as engineered drug delivery systems targeted to disease cells, reducing damage to healthy ones.

The InProcess-LSP solution

  • Reduction in analysis time >90%
  • Better process understanding promoting innovation
  • New possibilities to study particle size dynamics in real time
  • Reduction of production time with 1-3 days per batch
  • Significant reduction in batch rejection saving € 0.2- 2M per manufacturing event
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How this analyzer is different

NanoFlowSizer (NFS) is a new non-invasive nanoparticle size analyser developed by InProcess-LSP, the only one capable of carrying particle size and size distribution measurement for non-solid products inline, at the production flow, with no need to extract or treat a sample.

Results every 10 sec

With the NanoFlowSizer, nanoparticle sizing takes place within 10s, enabling continuous real-time in flow analysis.

Continuous, real-time nanoparticle size characterization

The NanoFlowSizer is a new innovative system for 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).

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We are extremely impressed by the system and the quality of the data!

Top 5 vaccine manufacturer

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Process monitoring

The result of this poor process control is uncertain product quality that leads to up to a 50% rejection rate in batch production for pharmaceutical companies. While also being able to carry out measurements offline, it is the NanoFlowSizer inline functionality that allows for complete control over the production process, an advantage highly demanded by pharmaceutical companies.

Save unnecessary costs

Having absolute control over the manufacturing conditions of nanoparticles leads to a reduction of batch rejection related to nanoparticle size measurements to 0. It simplifies the measurement process by eliminating the need for stopping production and the time-consuming and complicated sampling and sample treatment processes. As a result, the NanoFlowSizer can provide annual savings of as much as €3 million per produced drug.

“As inline instrument, the NanoFlowSizer is a powerful non-invasive Process Analytical Tool allowing close monitoring of particle size characteristics in your process in either development laboratories, pilot plants or commercial operations, without the need of sampling.”

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Average particle size and size distributions every 10 seconds

  • Continuous size characterization of nanoparticles during processing
  • Inline Process Analytical Tool
  • Non-invasive measurement
  • Real-time process feedback
  • Measurement of highly turbid materials
  • High speed measurement
  • Inline, online and offline operation
  • For very small (<<mL) to large sample volumes

Fast and real-time process control

What can the NanoFlowSizer mean for your process?

Excellent quality control

excellent-quality-nanoparticle-characterizationMeasuring particle size and distribution in real time allows process engineers to correct processing conditions immediately as opposed to having to discard entire defective batches after production.
Currently up to 50% of all batches produced during development and 15.8% during commercial manufacturing are rejected.

Outcome: significant batch rejection improvement.

Timely Analysis

fast-measurement-nanoparticle-sizingThe NanoFlowSizer offers significantly faster analysis time and no sample preparation time.
Particle size is measured every 10 sec and particle size distribution calculated within 1 min eliminating the quality control time delay giving instant feedback.

Outcome: reduction of required analysis time by >90% (primary market research).

Remote Measurement

turbid-solutions-nanoparticle-sizingThe device remotely measures concentrated turbid solutions eliminating the need to extract & dilute samples, preserving sample integrity and the sterility of the end product is assured.

Outcome: Safe products.

Promotes Innovation

process-efficiency-nanoparticle-sizingGreater process insight and control promotes efficiency and innovation as process engineers have better understanding and control over manufacturing dynamics.

Outcome: Valuable information for engineers.