Sirius Insight Particle Size and Shape Analyzer

Size Matters

Particle size is a key physical property for many materialswhich has an important impact on product and processperformance. For pharmaceuticals, the particle size of theactive pharmaceutical ingredient and excipients can affectbioavailability, stability and the ability to process andmanufacture a product. Particle size is often a criticalquality attribute controlled by a compound specification. The measurement of particle size can be a significantanalytical challenge during drug development to ensurethat results are meaningful and enable the effective controlof product and process. The analytical approach taken mustensure suitable dispersion of the sample and utilise aneffective measurement technique to deliver an accurateand reproducible particle size distribution.

Sirius Insight

The new Sirius Insight is an innovative particle sizeanalyzer which makes particle size measurements easier,more meaningful and robust. The instrument utilises twomeasurement methods: Laser Obscuration Time (LOT) anddigital video imaging. This dual channel approach enablesthe measurement of particle size using the LOT techniqueand provides a large number of particle shape parametersthrough dynamic image analysis. The LOT methodpossesses many advantages as a sizing technique:

• LOT is independent of optical properties andmakes no assumptions about the particlesbeing measured (e.g. shape or refractiveindex). This makes it very suitable for makingaccurate size measurements on samples whichare either single compounds or mixtures ofcompounds such as drug-excipient blends.

• It is not a volume based measurement, so itcan be used effectively for polydispersedsamples and samples with minor size fractions.

• LOT is a time-domain measurement, making itsuitable for solids concentrationmeasurements.

• Dual channel detection gives high informationcontent: the video channel enables thedetermination of a number of particle shapeparameters. This powerful feature enablesmaterial behaviour to be correlated withparticle properties other than size.

Flexible

Effective sample dispersion is critical to making validparticle size measurements. The Sirius Insight offers amodular design with nine different dispersion cells tooptimise the dispersion process for your sample.

These include: small volume stirred cells, a flow throughcell, a slide cell (which enables the determination of particlesize of suspended solids in ointments for example), and aheated cell. These are easily interchangeable. It’s anapplication driven approach that accommodates particlesin liquids, emulsions, dry powders, fibres, heated liquids andaerosols.

Capable

Particle Size using Laser Obscuration Time

The laser channel determines particle size by analysing theinteraction of the laser beam with the particles in themeasurement zone. The laser is focussed into a narrowspot which is rotated by a wedge prism so that the beamdescribes a narrow circular path in the sample zone.

When the laser beam interacts with a particle in its path, aphoto diode detects the duration of the temporaryinterruption of the laser beam by the particle. The time ofobscuration is directly related to the chord length of theparticle that interacted with the laser beam; larger particlesgive longer obscuration duration than smaller particles. Theresults can be presented in volume and number sizedistributions. This technology gives access to the directmeasurement of particle size; it is not inferred fromanother property which requires a mathematical model toderive particle size.

PS distribution: LOT measurement provides high resolution particle size distributionswhich can be presented as number or volume distributions.

Particle Imaging using Dynamic Image Analysis

The addition of a second measurement channel enables awealth of particle shape data to be acquired through digitalvideo microscopy. Images can be acquired on the sameparticle population measured by the laser channel. Theseare processed to provide up to 40 shape parameters.Detailed object information is available for all particles

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Ta TbTime

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Tc Td Te Tf

Scanning Laser

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LOT measurement principle: This principle enables the laser beam to interact with avery large number of particles. Accurate particle size measurements are assured by peakprofile analysis to ensure that only oncentre and in-focus interactions are recorded.

Laser ChannelA - He-Ne Laser TubeB - Wedge PrismC - Wedge Prism AssemblyD - Photodiode DetectorE - LensF - Collimator LensG - Sample

Laser DataAquisition Card

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LOT measurement principle: The LOT measurement is mounted on an optical benchwhich accommodates a number of different dispersion systems.

detected. Image analysis is particularly valuable fordetermining the size of non-spherical particles and givesthe opportunity to understand how particle propertiesimpact the performance of the product and the process.

Image DataAquisition Card

SynchronizationSignal

Optional Lenses for CIS-100

CW for F.O.V. 430µ : Range 2 - 150µDW for F.O.V. 1400µ : Range 10 - 600µEW for F.O.V. 5400µ : Range 20 - 3600µ

G - SampleH - FlashI - CameraJ - Lens

Video Channel

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Digital Image Analysis: The video analysis channel collects digital images used forvisualisation during laser measurements, capturing images, recording movies anddynamic shape analysis.

Compact

The Sirius Insight makes the best use of your laboratoryspace. With a small footprint of 665(W) x 280(D) x 183(H) itcan be easily accommodated in most laboratories.

Compliant

The Sirius Insight is available with 21CFR Part 11 compliantsoftware making it suitable for regulatory pharmaceuticalapplications.

Support

You are not on your own. When you purchase a SiriusInsight you will have access to Sirius’ expert applicationschemist and engineering support.

Try It

There are many techniques available for particle sizeanalysis but you will find that the LOT sizing technique willgive you a different insight into your particles.

Sirius Analytical Ltd.Riverside, Unit 12, Forest Row Business Park, Forest Row, East Sussex, RH18 5DW, UK

Telephone: +44 (0) 1342 820720Fax: +44 (0) 1342 820725Email: sirius@sirius-analytical.comweb: www.sirius-analytical.com

Measured parameters: Particle size, shape and concentration

Particle size range: 0.1 – 3600 mm

Concentration range: Up to 109 particles/cm3 (for 1 mm particles)

Particle presentation phases: Liquid suspension, airborne, on a surface

Modular measurement cells:Liquids, emulsions and opaque liquids, dry powders, fibres,magnetic particles, heated liquids and aerosols

Laser: 2mW HeNe, 632.8 nm, silicon PIN photodiode detector

Laser resolution: 0.33% of full scale up to 0.2 mm

Video camera:High resolution B&W CCD camera, PAL 768x572 pixels, NTSC640x840 pixels

Illumination:Synchronised strobe light, adjustable intensity and duration,flash rate up to 30 frames/second

Software:Windows XP operating system, automatic reporting, FDA 21CFR Pt 11 compliant

ISO compliancy: Compliant to a number of ISO-methods

System dimensions and weight: 665mm (W) x 280mm (D) x 183mm (H), 14Kg

Required services: Electricity, 100-130V, 205-240V, 50/60Hz, 100VA

Accessories:Automatic liquid flow controller, powder dispenser, powderfeeder, temperature controller, aerosol controller

Technical Specification

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