ls13320. 17 nm - 2000 microns

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Blood Banking Capillary Electrophoresis Cell Analysis Centrifugation Genomics Lab Automation Lab Tools Particle Characterization Meeting and exceeding the standard for laser diffraction particle size analysis. LS 13 320 Particle Size Analyzer BR-9809B

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Dry powder or particles in aqueous /organic suspension- Truly Automodal: You don\'t need to know anything related to size / modalities prior to running sample.- Highest accuracy: Scattered data Cannot be manipulated to meet modality expectations. You get what what you have in there. 1 single answer every time.

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Page 1: LS13320. 17 nm -  2000 microns

Blood Banking

Capillary Electrophoresis

Cell Analysis

Centrifugation

Genomics

Lab Automation

Lab Tools

Particle Characterization

Meeting and exceeding the standard

for laser diffraction particle size analysis.

LS 13 320 Particle Size Analyzer

BR-9809B

Page 2: LS13320. 17 nm -  2000 microns

LS 13 320 Integrated smart solutions forlaser diffraction particle size analysis

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The LS 13 320 Series is the most versatile andsophisticated laser diffraction particle size analyzeravailable today. Using the Fraunhofer and Mie theoriesof light scattering, the LS 13 320 Series offers thehighest resolution, reproducibility and unsurpassedaccuracy. All this, so you can count on the resultsgenerated by the LS 13 320 Series. In fact, theLS 13 320 can measure unknown sample distributionswithout having the analyst guess the type of distributionmode to preprogram the instrument.

Depending on your applications and requirements, twooptions of optical benches are available: the single-wavelength system covering a size range from 0.4 µmto 2,000 µm and the flagship multi-wavelength systemincorporating Beckman Coulter’s Polarization IntensityDifferential Scattering (PIDS) technology coveringa size range from 0.017 µm to 2,000 µm.

Our latest generation of sample-handling modules hasbeen designed for flexibility and convenience, offeringvarying degrees of automation. To save operators valuabletime, all modules “auto-dock” in seconds and areautomatically configured and recognized by the opticalbench due to their “plug-and-play” capabilities. Tofacilitate meeting compliance requirements, all themodule functions are fully controlled via StandardOperating Methods (SOM’s) and Standard OperatingProcedures (SOP’s), making their operation simpleand ensuring that all instrument conditions and settingsremain constant for any given sample. If full automationis required, the Auto Prep Station is available withup to 30 samples for walk-away routines.

Equally at home in research and development, qualitycontrol and manufacturing, the LS 13 320 particlesize analyzer provides the analyst with a system thatis easy to use, producing fast and reliable results, yettechnically advanced for dry, aqueous and non-aqueoussamples to satisfy all your particle sizing needs.

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Presenting your results in a flexible way

The LS 13 320 software offers great flexibility whenpresenting your results. Whether for pharmaceutical,industrial, quality control, or research applications,the software will satisfy any requirements fordata presentation.

Efficient data management

The LS 13 320 software allows the customizationof data output and printed reports. Through the useof SOP’s or preference files, design the report thatbest fits your needs.

Power, flexibility and simplictiyare the driving force behind theLS 13 320 software.

Step 1Load yourSOM or SOP

Step 2Click StartSOM or SOP

Step 3Get results

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SOM & SOP Standardize your process withStandard Operating Procedures and Methods

Establishing the SOM is quick, simple and foolproof

With Standard Operating Methods and Procedures, youcan ensure your analyses are the same run after run.

The use of SOM’s and SOP’s guarantee consistency anduniformity of your results, regardless of the instrumentsettings, operators and locations.

Standard Operating Procedure (SOP)

Every element of the analysis from method set-upto the final printout can be implemented into a userdefinable Standard Operating Procedure (SOP).Just select an SOM and Preference file and savethem as an SOP. Then click “Start SOP” andyou’re on your way to consistent results.

Step 1Set up your SOM andsample description

Step 2Identify your sample

Step 3Set up your anlaysisparameters

Step 4Choose your opticalmodel

Step 5Save your SOM

Your solution toconsistent resultsand reports.

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Size Trend

The Size Trend function is used to plot the statisticsof several sample runs on one graph or report.This can help you keep track of your specificprocess since the files can be updated as oftenas necessary.

Sieve Analysis

The Sieve Analysis functionallows you to view thedata obtained from yourLS 13 320 in a sieveformat if you need tocompare old sieve data.

Interpolation

The LS 13 320 software can be used to createsample reports that will arrange the data to conformto a set of user defined “size classes” through theSize Interpolation function.

Cum. <ASTM Volume %

999 0400 79.5164325 83.6407270 87.4781230 91.1161200 94.0814170 96.2735140 97.5502120 98.4782100 99.2856

80 99.808770 99.978660 99.999350 10045 10040 10035 10030 10025 10020 100

Software designedwith the user in mind.

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ISO 13 320 Meeting and exceedingthe standard

With the publication of the InternationalStandard ISO 13320, Particle size analysis —Laser diffraction methods, it becomes possiblefor users to evaluate statistics within a scientificframe of reference.

Accuracy

The response of the laser diffraction instrument isconsidered to meet this standard if the mean valueof the X50 coming from at least three independentmeasurements deviates less than 3% from the certifiedrange of values specified for the material, i.e. the meanvalue together with its standard deviation; the meanvalues for the X10 and X90 should deviate less than5% from the certified range of values.

Repeatability

The repeatability of characteristic particle sizes in sizedistributions should be as follows: for any chosencentral value of the distribution, e.g. the median size(X50), the coefficient of variation should be smaller than3%. Values at the sides of the distribution, e.g. X10

and X90, should have a coefficient of variation notexceeding 5%.

An average of 10 separate runs showing the spreadof results with error bars of one standard deviation.

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Accuracy

• Custom designed X-shaped detectorarray allows the most accuratemeasurement to be obtained for thecharacterization of the scatteringpattern, which ultimately leads tothe most accurate results possible

• The PIDS system delivers unrivaledaccuracy in the submicron regionby taking 36 detection measure-ments for this region alone. Noother comparable system offersthis degree of capability in thesubmicron region

Resolution & Sensitivity

• High number of log-spaced detectorsprovide a clear difference in scatteringpattern between size classes

• Continuous averaging amplificationcircuitry to increase signal-to-noiseratio

• No requirement to pre-select curvefitting routines as with other manu-facturers, meaning the user hasno need to have an understandingof the nature of the distributionprior to the analysis

• Full and complete invocation ofboth Fraunhofer and Mie theories,including the use of multi-wave-length modeling, ensures the usercan make most benefit of theavailable raw data

Repeatability

• The automatic alignment systemensures accurate angular calibrationof the laser with respect to theoptical path. The benefit of this isthat the scattered light from anyparticulates in the sample cell willfall on the correct detectors froman angular perspective, offeringreproducible results time after time

• High quality components throughoutthe LS 13 320 design

Resolution & Sensitivity

The resolution of the particle sizedistribution, i.e. capability to differ-entiate between different particlesizes, and the sensitivity for small(extra) amounts of particles ofcertain size are restricted by thefollowing factors:

• Number, position and geometryof the detector elements

• Signal to noise ratio

• Fine structure in the measuredscattering pattern

• Difference in scattering patternbetween size classes

• Actual size range of theparticulate material

• Adequacy of the optical model

• Smoothing applied in thedeconvolution procedure

How does the LS 13 320 comply?

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Security 21 CFR Part 11 andinstrument qualification process

Security

The LS 13 320 software comes with a configurable security system.The user can choose between 5 levels of security, from No securityto 21 CFR Part 11, the choice is yours. Choosing 21 CFR Part 11configures the software to be compliant to 21 CFR Part 11, the FDAregulation covering electronic signatures and records.

One click awayfrom compliance.

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V-Check Program

The V-Check Program is a comprehensive package that coversappropriate aspects of a product’s life cycle, from instrumentdevelopment to verification (e.g. SQ, DQ, IQ, OQ). The V-CheckProgram contains the necessary documentation for instrumentvalidation. It consists of a number of functional inter-linkedcomponents, which have been designed to give you assurancethat the product is fit for its designed purpose and will deliverconsistent performance. Where other instrument manufacturersleave off, Beckman Coulter and its V-Check Program assistwith ongoing quality checks of the instrument – demonstratingthe value of a manufacturer who not only understands yourneeds, but is also willing to develop a partnership for the future.

Regulatory Compliance

The Electronic Records and ElectronicSignatures Rule (21 CFR Part 11)was established by the FDA to definethe requirements for submitting docu-mentation in electronic form and thecriteria for approved electronic signa-tures. This rule, which has been ineffect since August 20, 1997, doesnot stand in isolation; it defines thestandards by which an organizationcan use electronic records to meetits record-keeping requirements.Organizations that choose to useelectronic records must comply with21 CFR Part 11. It is intended toimprove an organization’s qualitycontrol while preserving the FDA’scharter to protect the public. Sinceanalytical instrument systems suchas the LS 13 320 generate electronic records, these systemsmust comply with the Electronic Records Rule. By selecting the21 CFR Part 11 option in the software, the system automaticallyreconfigures to comply with these regulations. In addition to the21 CFR Part 11, the software offers other security levels that maybe customized by the user.

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Operating Principles

The scattering of light is one of the most widely usedtechniques for measuring the size distribution of particles.

It is a fast and flexible technique that offers even thenovice user the chance to obtain high quality data.

The basis of the method is simple: a laser light sourceis used to illuminate particulates, usually contained

Beckman Coulter Firsts:• First company offering wide dynamic range without changing lenses

• First company with auto-alignment

• First company to utilize four wavelengths

• First and only company to incorporate scattering technology – PIDS

within a suitable sample cell. The light scattered by theparticles is then detected by silicon photo-detectors.

The intensity of light on each detector measured asa function of angle, is then subjected to mathematicalanalysis using a complex inversion matrix algorithm.The result is a particle size distribution displayed asvolume % in discrete size classes.

PIDS Detectors

High Angle Detectors

Low Angle Detectors

Mid Angle Detectors

Sample Chamber

Fourier Lens

Laser

MultipleWavelengthPIDS Wheel

PIDS Light Source

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PIDSPolarization Intensity Differential Scattering

Why use PIDS for sizing sub-micron particles ratherthan the standard forward low-angle scattering tech-nologies employed by other instrument manufacturers?Particles below a few microns in diameter have verysimilar light scattering patterns that are alike in bothshape and intensity. These physical properties makeit difficult to distinguish the differences between suchpatterns, which means inaccurate sizing with lowresolution, resulting in a high degree of uncertaintywhen resolving the actual particle size.

PIDS relies uponthe transversenature of light i.e.,that it consists ofa magnetic vectorand an electricvector at ninetydegrees to it. If forexample the elec-tric vector is ‘upand down’ thelight is said to bevertically polarized.When a sample is illuminated with a light of a givenpolarized wavelength, the oscillating electric fieldestablishes a dipole, or oscillation, of the electronsin the sample. These oscillations will be in the sameplane of polarization as the propagated light source.The oscillating dipoles in the particles radiate light inall directions except that of the irradiating light source.PIDS takes advantage of this phenomenon. Light atthree wavelengths (450 nm, 600 nm, and 900 nm)sequentially irradiates the sample, with first vertical andthen horizontal polarized light. The LS 13 320 measuresthe scattered light from the samples over a range ofangles. By analyzing the differences between thehorizontally and the vertically radiated light for eachwavelength, we gain information about the particle sizedistribution of the sample. It is important to rememberthat we are measuring the differences between thevertically and the horizontally polarized signals, andnot simply the values of a given polarization.The intensity vs. scattering angle information from thePIDS signals is then incorporated into the standardalgorithm from the intensity vs. scattering angle datafrom the laser light scattering to give a continuous sizedistribution.Another major benefit of acquiring PIDS data is that bysimple interpretation of the raw data we can quicklyconfirm whether small particles are genuinely presentor not, as large particles do not exhibit the differentialsignal shown by small particles.

Benefit fromthe increasedsensitivity andperformance –real data meansreal results.

Large particles scatter light strongly at low anglesand with readily detectable maxima and minima in thescattering pattern. This means that detectors placedat low angles relative to the optical path and withsufficient angular resolution can detect these maximaand minima. Conversely small particles scatter lightweakly and without any discernible maxima andminima until extremely high angles of measurement arereached. This makes the detection and the resolutionof the scattering pattern difficult.Manufacturers have adopted different solutions toovercome these limitations with varying degrees ofsuccess. Most efforts have focused on the measurementof back-scattered light. While such strategies help theyare not complete solutions. For this reason BeckmanCoulter developed the PIDS system, allowing for the firsttime a complete solution to the problem of sub-micronsizing. The technology employed in PIDS is elegantyet simple and takes advantage of the Mie theory oflight scattering.

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USA, Brea, CA (1) 800 742 2345, (1) 714 993 5321 Email [email protected] all other countries and specific phone numbers for your local distributor, please visit:www.CoulterCounter.com/contactB2009-10614-LC-5K www.beckmancoulter.com © 2009 Beckman Coulter, Inc. PAR-PRINTED IN U.S.A.

LS 13 320 SpecificationsTechnology Low angle forward light scattering

with optional PIDS (PolarizationIntensity Differential Scattering)technology. Full implementationof both Fraunhofer and Mie theoriesof light scattering

Particle Size Range 0.017 µm - 2000 µm

Power Consumption ≤ 6 amps @ 90 – 125 VAC≤ 3 amps @ 220 – 240 VAC

Dimensions 10 in depth (25.4 cm)39.6 in width (100.7 cm)17 in height (44.5 cm)

Weight 71.5 lbs (32.5 kg)

Typical Analysis Time 15 - 90 sec

Illuminating Sources Diffraction: Solid State (780 nm)PIDS: Tungsten lamp with highquality band-pass filters (450,600 and 900 nm)

Humidity 0 - 90% without condensation

Temperature Range 10 - 40°C

Sample Modules Micro Liquid Module (MLM)Tornado Dry Powder System (DPS)Aqueous Liquid Module (ALM)Universal Liquid Module (ULM)Auto Prep Station (APS)

Operating System Windows 98, NT, 2000, XP, Vista

Visit our online store at:www.beckmancoulter.com/eStore

For more information on our Particle Characterization products,please visit us at www.CoulterCounter.com

Beckman Coulter, the stylized logo and COULTER COUNTER are registered trademarksof Beckman Coulter, Inc. LS is a trademark of Beckman Coulter, Inc.Windows is a registered trademark of Microsoft Corporation in the United States and other countries.

Aqueous Liquid Module (ALM)

• For samples requiring suspension inaqueous systems

• Auto rinsing, auto filling and auto dilutionfor maximum speed and throughput

• Sample sonication for the ultimatedispersion control

• When coupled to the Auto Prep Stationoffers full automation

Micro Liquid Module (MLM)

• Use when only small quantities ofsample are available

• Small amounts (12 mL) of volumerequired, particularly useful forhazardous dispersants as waste isminimized

• For use with both organic solventsand aqueous systems, giving the usermaximum flexibility

Tornado Dry Powder System (DPS)

• Measures entire sample as required bythe ISO 13 320 standard

• No sample preparation needed

• Fully automatic walk-away operation

• User-selectable vacuum pressure formaximum dispersion control

Universal Liquid Module (ULM)

• Fully automatic, with auto dilution, autofilling and auto rinsing for the ultimateease of use

• Analyzes samples suspended in aqueousas well as non-aqueous diluents formaximum flexibility

• Hazardous waste is contained in amonitored vessel to avoid spillage andprovide safe operation

• A variable speed pump allows for totaldispersion control of your sample, fromdelicate emulsions to heavy particulates

Sample Modules