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The Elzone II 5390 TheThe Elzone Elzone II II 5390 5390 Particle Count and Size Analyzer Elzone II Overview of Basic Theory • Operates using the Electrical Sensing Zone (ESZ) Principle, also known as the Coulter Principle. • First commercially available Elzone system was introduced in 1963. • Fully compliant to the ISO 13319 Standard - Determination of Particle Size Distributions- Electrical Sensing Zone Method, as well as numerous ASTM methods. • Technology has been standardized for use in automated blood cell counters as well as a characterization method for many biological and industrial products. • Thousands of references for the use of various Electrical Sensing Zone models documented. • The highest resolution technology available for particle counting and sizing. Elzone II Overview of Basic Theory • Individual Particle Size and Concentration are Measured. Not calculated. • Particle size is represented as the equivalent spherical volume diameter. • Operation is not affected bycolor of sample or refractive indexes (as is when using other analytical methods). • Capable of performing count and size of very low concentration samples if necessary. • Particle concentration is determined using an accurate metering device. • Dynamic size measurements are made in real time. • Capable of performing analyses with samples suspended in an aqueous buffer solution or hazardous diluents. Elzone II Overview of Basic Theory • Particles suspended in an electrolyte solution are drawn through a small aperture. Across the aperture a voltage is applied. This creates the “sensing zone.” • Particles passing through the aperture displace a volume of electrolytic solution equal to the particle’s own volume. • Displaced electrolyte causes a change in resistance across the aperture resulting in a voltage pulse. • Pulse intensity is proportional to the particle volume. Elzone II Overview of Basic Theory – Sensing Zone and Pulse Generation Sensing Zone 11 10 9 8 4 5 6 7 3 • As particles approach and pass through 2 the Electrical Sensing Zone, a pulse is 1 generated. • The pulse information is used to count and Particle entering size particles. the Sensing Zone • Individual pulse data is stored as a fingerprint enabling users to extract additional information about their sample. Unique fingerprint of each particle is 1 2 3 4 5 6 7 8 9 10 11 captured. Elzone II Features and Benefits • All functions are controlled through user friendly software. • Automatic calibration routine with unique Calibration Verification feature. • Ability to create, store and recall standard Analysis Conditions. • Validation program available (IQ, OQ). • 21 CFR part 11 software option. • Digital Pulse Capturing with graphical reporting feature. • Volume metering system is mercury-free and maintenance-free. • New system to fit aperture tubes eliminates the use of grease. • Automatic blockage detection and clearing. • Counts and sizes particles suspended in either organic or inorganic electrolyte. • Analyzes materials with mixed optical properties, densities and shapes. • Higher resolution than other sizing methods. • Detailed reporting system with report overlays to compare analyses. • Statistical Process Control features included. • Automatic start-up, analysis, and shut-down routines. • Compatible with Elzone II, Elzone I and competitive orifice tubes as well as historical data files. • Up to two instruments can be operated per computer. Elzone II Features and Benefits – Orifice Tubes • A large selection of orifice tubes are available to accommodate a wide range of sample sizes. • Each tube is carefully tested using standard samples of monodispersed polymer spheres to verify it produces distortion-free measurements. • The effective range of particle sizes a typical orifice can measure is from 2% to 60% of its orifice diameter. • To ensure accuracy, orifice tube calibration is performed with 4 NIST traceable standards of different sizes. Calibration data is stored and can be compared to the recommended recoverable Standard sizes available values. 19 76 190 30 95 300 • Users can blend (merge) data obtained from 48 150 380 multiple orifice tubes to report a continuous distribution for overlapping segments of a broad range of particle sizes. Elzone II Features and Benefits - Digital Pulse Capturing • The Elzone has the capabilityof capturing all particle pulse data and storing it for reprocessing. • Data can be recalled and reanalyzed in a narrower range. • In addition to this, the Elzone has the capabilityof reporting Pulse Length information AND reporting Pulse Length Vs. Particle Size information. Elzone II Features and Benefits - Pulse Length Reporting • Pulse Length Reporting enables the analysis of duration (in microseconds) that particles take to pass through the electrical sensing zone. • This feature enables users to separate discrete population changes (i.e. spheres may pass through faster than cylindrical particles generating a distinctly different Pulse Length fingerprint). • As seen below, the sample consisted of two distinct shapes of particles. Elzone II Features and Benefits - Pulse Length vs. Particle Size • Pulse Length Vs Particle Size Reporting enables a 3 Dimensional view (Particle Count Vs. Particle Diameter Vs. Particle Duration. An Industry First. • This enables users to further analyze their sample population in detail. • For example, Toner particles tend to agglomerate. This feature would enable users to detect the agglomerated toner over the duration of the analysis. Elzone II Features and Benefits - Auto Calibration • Calibration of the Elzone is Automatic (simple and quick). • Unlike competitive systems, the calibration is performed with 4 different standards to ensure accuracy across the range of the aperture. • Calibration information is stored in software with tube diameter and serial number. • Calibration can be based upon mean, median or mode of standard. • Software stores table of entered standards with specifications, tolerance, and lot number enabling users to perform verification activities without the need for paper assay sheets. Elzone II Features and Benefits – Multi-point Calibration • Due to the nature of the Electrical Sensing Zone method, it is likely that the calibrationof anorifice tube is not linear throughout the dynamic range. • To ensure linear accuracy, the Elzone multi-point calibration is performed. • This multi-point calibration offers redundancy and assurance of accuracy. Elzone II Features and Benefits – Analysis Conditions • The Elzone enables the creation of Analysis Conditions. • Analysis Conditions guarantee the consistency and uniformity of analysis. • Specific Analysis Conditions can be created for any number of samples and canbe recalled byan operator as needed. Elzone II Features and Benefits – 21 CFR Part 11 • The Elzone is fullycompliant to 21 CFR Part 11 Electronic Signatures and Records requirement set forth by the FDA. Elzone II Features and Benefits – Suspension Modules The Elzone brings flexibility when it comes to particle suspension. All options are software selectable and part of the Analysis Conditions feature. This is industry exclusive. Sample Stirrer Motor with Glass suspension rod. • Standard with the Elzone II • Selectable speed and direction. • Can also be manually controlled from software. Hydropulser • Use with fragile particles and with low sample volumes. • Sample is agitated using pulsating suction action. Elzone II Features and Benefits – Aperture Viewing System A first in the industry, the Elzone camera enables users to: • View particle activity in the orifice • Detect blockages in the orifice • Check the orifice for particle build-up • Capture Pictures in Digital format for future reference • Zoom, and Pan the image of the aperture Elzone II Features and Benefits – Sample Platform The Elzone Sample Platform allows for operator ease of use and functionality. • Manually raised by operator • Smooth, easy operation • Position detected by software • Warning given if platform not raised at start of analysis Elzone II compliance with ASTM Standards • Test Method F577- 03 Standard Test Method for Particle Size Measurement of Dry Toners • Test Method E1772-95 Standard Test Method for Particle Size Distribution of Chromatography Media by Electric Sensing Zone Technique. • Test Method D4438-85 (1997) Standard Test Method for Particle Size Distribution of Catalytic Material by Electronic Counting. • Test Method F662-86 (1992) Standard Test Method for Measurement of Particle Count and Size Distribution in Batch Samples for Filter Evaluation Using an Electrical Resistance Particle Counter. • Practice F660-83 (1993) Standard Practice for Comparing Particle Size in the Use of Alternative Types of Particle Counters • Test Method C690-86 (1997) Standard Test Method for Particle Size Distribution of Alumina or Quartz by Electric Sensing Zone Technique. Micromeritics Laboratory Services Micromeritics Analytical Services • Contract laboratory services • cGMP compliant • FDA registered • DEA certified • Data consultations • Priority analysis available • Cooperation with other labs for additional analysis techniques Micromeritics Corporate Overview Over Four Decades of Growth and Innovation Particle size, surface area, pore size, material density, and active surface area are characteristics that are crucial to the understanding of a variety of materials. This knowledge is essential in the development of products, the efficient utilization of raw materials, and the understanding of many natural phenomena. Pharmacology, cosmetics,
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