FlowCam Nano is a flow imaging microscope for submicron particle imaging in biopharmaceutical and other materials applications. Its advanced optical imaging capabilities enable detection and morphological analysis of the smallest particles observable using light microscopy.

Detect submicron-sized particles including protein aggregates and small oligomers of drug delivery vehicles like LNPs and exosomes to proactively improve product stability and quality—even before larger particles are present.

• Detect early API aggregate formation and other forms of sample degradation that are prone to generating larger subvisible and visible particles
• Acquire high-resolution images to detect and identify submicron particle types to inform product development and monitor product quality
• Obtain size, morphology, and relative concentrations of particles that are too small to be detected by traditional Flow Imaging Microscopy
• Experience integrated, industry-leading VisualSpreadsheet software with the unique ability to image, classify, and characterize nanoparticles in real-time with an easy-to-use interface

USP <1788> introduces flow imaging as a technique to provide complementary morphology information and to overcome undercounting and undersizing challenges with the light obscuration method when measuring translucent particles such as proteins and other biological drugs.

Obtain light obscuration data to meet USP regulatory guidelines and verify your results with the highest quality images in FlowCam LO – all in a single instrument and single sample run.

• Perform both flow imaging and light obscuration measurements sequentially in the same instrument
• Obtain compendial particle sizing and counting according to USP <787> and <788>
• Acquire statistically significant results in less than a minute, with as little as 100 μL of sample
• Monitor and control particulates in your formulations

FlowCam Macro is the flow imaging microscope of choice for visible particles. Direct, image-based morphological measurements give you details not available with other particle analysis methods.

Monitor the sphericity of manufactured beads, the shape and structure of fibers, polymers, crystals, and powders, or achieve taxonomic identification of zooplankton with superior particle images and image analysis VisualSpreadsheet software.

• Perform automated flow imaging microscopy for visible particle analysis
• Perform quality control of food and beverage ingredients
• Ensure product quality for advanced materials applications
• Measure a broad scope of morphological parameters for cross-validation of data
• Recirculate sample volume to ensure that representative samples are measured

Particle Insight Raptor Portable Hardware Design

The Pi Raptor Portable was designed to serve as BOTH an at-line laboratory system as well as a field-based portable system. Numerous hardware updates have been made that benefit both types of users.

• System internally has a 5Ah Lithium LiFePO4 Deep Cycle Rechargeable Battery offering over 5 hours of operation while remaining low in weight. Battery charger is included. Higher capacity batteries can be installed upon request.
• Removable Microsoft Surface Pro tablet computer with touchscreen interface. Has internal battery and is also charged by on-board LiFePO4 battery. Using the latest version of Microsoft Windows ensures compatibility with other programs users may need to use for daily operation.
• Light weight portable rugged case weighing approximately 15lbs ( 7Kg ).
• Patent Pending features.

• Removable / disposable flow cell with small dead-volume can be interchanged with spare flow cell of the same channel depth or other flow cells with different path depths.M.
• New hardware features ensure flow cell always returns to proper location to ensure exact focal point is kept.

Flexible Fluid Design

The Pi Raptor Portable has been designed to offer sample suspension flexibility for the different needs of at-lab and remote users.

Disposable Syringes – For very small amounts of samples or if contamination is of concern, standard disposable syringes have always served as a good way to take samples. These medical syringes are sterile and inexpensive. Many industrial applications have used medical syringes as collection and storage devices. Now, the Pi Raptor Portable eliminates the need to re-suspend your captured sample and enables users to do an analysis directly from syringes. No mess, and when done, you still have your full sample complete, intact and without being contaminated where you can store for future use.

• Internal Pumping System – Just connect the two bypass tubes that use standard Luer fittings, and the Pi Raptor Portable software will control the internal pump.
• Using the internal pump allows users to connect to any external sampling source, including an available sample suspension vessel that allows for cleaning and rinsing between analysis.

As a portable system, the Pi Portable includes an accessory kit that is housed in a backpack style case. The many compartments are designed to carry specimen sample collection devices along with other safety items such as gloves, etc. Samples can be stored here for further analysis at-lab or can be analyzed in the field.

New Key Software Features

The Particle Insight Raptor Portable comes with numerous new software features that have been incorporated through the years.

• New Time series chart feature. This feature allows the evaluation of behavior from particles suspended in a solution by plotting results of pre-selected measures and statistics from a collection of run files, over a period under the same conditions and settings. The charts created for each combination of parameters reflect the behavior of particles and can be used in different applications and processes like dissolution and crystallization in pharmaceutical industries.

• Correlation Plot Enhanced Features… More tools that help customers use scattergram charts to further identify and study particles and particle populations in more detail.

• Many added functions to sample overlays enabling customers to compare and identify all or portions of sample distributions. For example, if one sample or lot has a greater amount of agglomerates than another, you can now see exactly by how much and view those select agglomerates.

• New Sieve Comparison features offering more ways to view and correlate results to Sieves.

As a new generation of the traditional Particle Insight instrument, the new features are:

• 
  Improved optics. All components related to image capture (camera and Lens) have been noticeably improved, including easier magnification configuration. Higher speed data transfer rate improves real-time analysis.
• Improved images. Higher resolution and image capture for better edge definition.

• Improved accuracy. Better accuracy and ability to differentiate minor differences in particle shape down to one micron.
• Improved resolution. USB 3 high resolution digital camera with up to 5 MPs resolution and higher speed data transfer rate and capable of taking up to 127 frames per second rated, captures live images of thousands of particles.

• Improved fluidics. The oscillating pumps have been replaced with stronger peristaltic pumps that use a chemical resistant tubing. Also, the peristaltic pumps are less prone to maintenance issues.
• Improved plumbing.Pi Sentinel PRO has a Chemical resistant tubing to maintain compatibility for organic solvents.
• Improved Sample Cell assembly. The Quartz sample cell has been implemented with quick connectors (body and insert) to facilitate easy removal for cleaning purposes, replacement or just change the size of the cell for another size.

• Improved thumbnail features. When viewing particle thumbnails, the left-mouse button will display all the shape measurement values for that selected thumbnail, the right-mouse button will allow the user to eliminate that specific particle from the database and statistics. Useful when, for example, a single air bubble is not wanted in the database.

• Improved correlation plot features. Correlation Plot now, able to view thumbnails directly from correlation plot area of interest.

• New perimeter measure. A second Circularity measure was developed called “Perimeter Circularity” to assist customers with existing FPIA systems who have data using this different Circularity measure.

• New 3 digits resolution. Circularity and ALL other fraction measures have data reported with 3-decimal place accuracy. A requirement for transition from FPIA data to Pi Sentinel PRO data.

• New instrument Certification program. IO / OQ Certification and Validation program using NIST traceable standards.

• New Data Integrity compliance. The Certification program complies to new Data Integrity FDA Guidance document.

• New computing platform. Included with every system is an All-in-One computer with touch screen, allowing the customer more interaction with the software features.

• New software interface. The software user interface has been changed to reduce the clutter of options presented to the user. The user still has all the options of the old Pi, they are just accessed differently.

Particles are suspended homogeneously in a carrier liquid. They pass through a thin flow cell in the optical path. Light is transmitted through the flow cell, thus projecting silhouettes of the particles onto a high-resolution camera sensor. The high frame rate and high resolution of the camera combined with a high-speed host computer enables the characterization of thousands of particles per second in real-time. This technique is ideal for applications where shape, not just diameter, is critical information for predicting raw material performance.

As a result of the improvements, the benefits are:

• Higher speed data transfer rate, up to 127 frames per second rated digital camera with up to 5 MPs resolution, captures live images of thousands of particles.
• Over 30 shape parameters are recorded, including circularity, ellipticity, opacity, mean diameter, smoothness, aspect ratio, fiber length and many more.
• All analysed particles have thumbnail images saved for post-run viewing and shape analysis, both in grey scale and binary views.
• Ability to compare different analyses via histogram overlays for all analysed shape parameters.
• Scatter plot correlates two shape measurements and can be utilized as a process quality control criterion as an at-line application within unit operations.
• Unique and powerful software permits the use to simplify data processing to a pass/fail reporting or choose to extend data analysis to a full suite of post processing image and shape analysis reports.

Not all particles are round. In fact, very few are in real life. particle with ECA circleLaser diffraction performs an indirect measurements of size. What this means is that what is being measured in laser diffraction is NOT the actual size of the particle but rather the diffracted angular light intensity that is scattered as a function of size. As a result, this method as well as many others used in industry, assume that particles are spherical in nature when reporting size information. The calculations rendered are based on what is known as Equivalent Spherical Diameter. If the particles being measured are, in fact, round in nature, this would be an accurate way of checking the size, however if they are not round, and most are not, then assuming they are round when looking at statistical results may lead the operator to believe that the particles will perform one way when in fact they will perform differently. For example, if a particle that is measured is assumed to be 100microns in diameter and this calculation is made assuming the particle is spherical, the operator may assume that the flow and mixing of these particles would be well dispersed and uniform in nature. However if the actual shape of the particle is far from being spherical in nature, then the performance of these particles would be drastically different. Particle sub-components may separate during transport and not blend well.

Image Analysis performs a direct measurement of the particle. Unlike Laser Diffraction and other indirect measurement techniques, Image Analysis will take measurements of images of the actual particle. By doing this, calculations can be made to render many different measures about a particle. In the similar case shown above, the 100micron diameter particle, assuming it is round in nature, would have up to 30 additional small particlesmeasurements calculated. This gives the user much more confidence to make correct assumptions of how their particles will perform.

Data can be compared using the Particle Insight instrument software or by comparing printed reports.

As a new generation of the traditional Particle Insight instrument, the new features are:

• 
  Improved optics. All components related to image capture (camera and Lens) have been noticeably improved, including easier magnification configuration. Higher speed data transfer rate improves real-time analysis.
• Improved images. Higher resolution and image capture for better edge definition.

• Improved accuracy. Better accuracy and ability to differentiate minor differences in particle shape down to one micron.
• Improved resolution. USB 3 high resolution digital camera with up to 5 MPs resolution and higher speed data transfer rate and capable of taking up to 127 frames per second rated, captures live images of thousands of particles.

• Improved fluidics. The oscillating pumps have been replaced with stronger peristaltic pumps that use a chemical resistant tubing. Also, the peristaltic pumps are less prone to maintenance issues.
• Improved plumbing.Pi Sentinel PRO has a Chemical resistant tubing to maintain compatibility for organic solvents.
• Improved Sample Cell assembly. The Quartz sample cell has been implemented with quick connectors (body and insert) to facilitate easy removal for cleaning purposes, replacement or just change the size of the cell for another size.

• Improved thumbnail features. When viewing particle thumbnails, the left-mouse button will display all the shape measurement values for that selected thumbnail, the right-mouse button will allow the user to eliminate that specific particle from the database and statistics. Useful when, for example, a single air bubble is not wanted in the database.

• Improved correlation plot features. Correlation Plot now, able to view thumbnails directly from correlation plot area of interest.

• New perimeter measure. A second Circularity measure was developed called “Perimeter Circularity” to assist customers with existing FPIA systems who have data using this different Circularity measure.

• New 3 digits resolution. Circularity and ALL other fraction measures have data reported with 3-decimal place accuracy. A requirement for transition from FPIA data to Pi Sentinel PRO data.

• New instrument Certification program. IO / OQ Certification and Validation program using NIST traceable standards.

• New Data Integrity compliance. The Certification program complies to new Data Integrity FDA Guidance document.

• New computing platform. Included with every system is an All-in-One computer with touch screen, allowing the customer more interaction with the software features.

• New software interface. The software user interface has been changed to reduce the clutter of options presented to the user. The user still has all the options of the old Pi, they are just accessed differently.

Dynamic Image Analysis

Particles are suspended homogeneously in a carrier liquid. They pass through a thin flow cell in the optical path. Light is transmitted through the flow cell, thus projecting silhouettes of the particles onto a high-resolution camera sensor. The high frame rate and high resolution of the camera combined with a high-speed host computer enables the characterization of thousands of particles per second in real-time. This technique is ideal for applications where shape, not just diameter, is critical information for predicting raw material performance.

As a result of the improvements, the benefits are:

• Higher speed data transfer rate, up to 127 frames per second rated digital camera with up to 5 MPs resolution, captures live images of thousands of particles.
• Over 30 shape parameters are recorded, including circularity, ellipticity, opacity, mean diameter, smoothness, aspect ratio, fiber length and many more.
• All analysed particles have thumbnail images saved for post-run viewing and shape analysis, both in grey scale and binary views.
• Ability to compare different analyses via histogram overlays for all analysed shape parameters.
• Scatter plot correlates two shape measurements and can be utilized as a process quality control criterion as an at-line application within unit operations.
• Unique and powerful software permits the use to simplify data processing to a pass/fail reporting or choose to extend data analysis to a full suite of post processing image and shape analysis reports.