The Multisizer 4e, the latest COULTER COUNTER designed with the SMART and DPP technologies, offers highly accurate and reliable particle counting and sizing

Count and size particles and cells as small as 0.2 microns

Industries and Applications

The Coulter Principle has been used to characterize thousands of different industrial and biological particulate materials. There are over 6,000 bibliographic references using the Coulter Principle. Here we list a few examples:

Proven Technology

• More than half a century of experience counting and sizing particles and cells
• More than 6,000 documented references using the Coulter Principle and nine approved ASTM methods
• Technology defined by the International Standard ISO 13319 Accurate sizing, counting and high resolution technology preferred by the industry for particle counting and size distribution
• It provides size, based on direct measurement of a real parameter of a particle - its volume. Color or refractive index does not affect results
• Capable of counting and sizing particles at concentration levels not detected by other technologies
• Dynamic size measurement. Pulse time stamp allows size change measurement in real time

Superior Instrument Design

• Ease-of-use. Instrument operation is completely controlled from the computer. Intuitive software with wizards are ideal for beginners, while simple menus assist experienced operators
• Volumetric metering pump is compatible with both aqueous and organic fluids
• Extended dynamic range
• Environmentally friendly, mercury-free metering system
• Improved performance in dusty environments
• Sample management system using Smart Technology provides a great level of consistency for running the analyses
• EZAccess fluid management system
• Electronic aperture blockage detection
• Automatic startup user-selectable routine

Quality Assurance Friendly System

• User-defined Standard Operation Procedure
• Multiple security levels
• Software enables 21 CFR Part 11 compliance
• Powerful and flexible software allows the processing and presentation of data to fit all needs, including industrial applications, biological applications, academic applications, research and quality control
• Automated calibration and calibration verification ensures reliable results for both size and counts
• V-Check validation package offers a comprehensive solution for today’s quality assurance requirements
• Certification program to ensure instrument performance

Digital Pulse Processor

In a traditional counter, analog circuits are designed and constructed to perform a set number of functions in real time. The definition of “pulse” needs to be set in advance so that measurements can be made while particles travel through the aperture. Each pulse is analyzed; its parameters are stored, then “forgotten” - to be replaced by the next pulse arriving in the analyzer. This type of device undoubtedly operates at amazingly high speed, and for simple counting or sizing purposes, it is often adequate. However, for advanced applications of the Coulter Principle, digital technology has obvious advantages.

The proprietary technology of digital pulse processing (DPP) employed in the Multisizer™ 4e involves sampling analog signals at a rate of millions of times per second. The digital values come from an analog-to-digital converter (ADC), which receives the analog output from the signal amplifier. The accuracy and resolution of the digital values depend on the fidelity of the amplifier and the number of bit of the ADC. Differently from analog instruments that capture and report a single value for each pulse, e.g. the peak height, the DPP yields a stream of values with magnitudes that rise and fall as particles pass through the aperture. Instead of a single number, multiple parameters that describe the entire pulse are saved. The DPP affords maximum flexibility in analyzing the data.

The data no longer must be processed and compressed on the fly. Instead, the pulse data generated by each particle is stored and saved without loss of information. They can be “rerun” any number of times using different analysis parameters. Furthermore, the pulses can be re-examined at any time after analysis, using software alone without the need to change hardware. In analog systems the number of channels is set in a chosen range of size for each measurement.

This means that once the data has been obtained, the resolution is fixed. Increasing the resolution in a part of that size range can only be done by re-measuring the sample under a higher resolution setting. With the DPP, the data is always at a higher resolution. The grouping of data into channels is entirely for convenience or display. Channels are defined solely by the software algorithm and can be changed at any time - even after analysis. The ability to reanalyze the data in a narrower size range at a higher resolution is one of the most useful features of the DPP.

Smart Technology

The Smart Technology designed into the Multisizer™ 4e makes it the most reliable and easy-to-use Coulter Counter instrument on the market today. Its design ensures the repeatability and uniformity of analysis conditions for all samples and therefore ensures reliable results.

Regulatory Compliance with 21 CFR Part 11 enabled

The Electronic Records and Electronic Signatures Rule (21 CFR Part 11) was established by the FDA to define the requirements for submitting documentation in electronic form and the criteria for approved electronic signatures. This rule, in effect since August 20, 1997, does not stand in isolation; it defines the standards by which an organization can use electronic records to meet its record-keeping requirements. Organizations that choose to use electronic records must comply with 21 CFR Part 11. It is intended to improve an organization’s quality control while preserving the FDA’s charter to protect the public. Since analytical instrument systems like the Multisizer™4 generate electronic records, these systems must comply with the Electronic Records Rule. By selecting the 21 CFR Part 11 option in the software, the system automatically reconfigures to comply with these regulations. In addition to 21 CFR Part 11, the software offers other security levels you may customize to your individual needs.

User-Friendly and Intuitive Software

The Multisizer™ 4e software is easy to use for both beginners and experienced users alike. For beginners, the setup of test procedures and the reporting of the results are made simple through wizards included in the software. For experienced users, the Multisizer 4e software provides user-friendly dialog boxes with quick access to all settings. “Create Sample Specifications” is a new feature that allows users to set their desired specifications for a sample. Results out of specifications will be highlighted by the software. The software provides size and pulse data in numerous formats. A broad range of statistical parameters are automatically calculated by the Multisizer 4e software. All the results are presented in a customized report.

V-Check Program

The V-Check Program is a comprehensive package that covers appropriate aspects of a product’s life cycle, from instrument development to verification (e.g. SQ, DQ, IQ, and OQ). The V-Check Program contains the necessary documentation for instrument validation. It consists of a number of functional inter-linked components, which have been designed to give you assurance that the product is fit for its designed purpose and will deliver consistent performance. Where other instrument manufacturers leave off, Beckman Coulter and its V-Check Program assist with ongoing quality checks of the instrument - demonstrating the value of a manufacturer who not only understands your needs, but is also willing to develop a partnership for the future.

Features

• Increased dynamic range
• Increased resolution
• Proven technology
• Superior instrument design
• Quality assurance friendly
• Digital Pulse Processor (DPP)
• Dynamic size measurements
• Provides number, volume, mass and surface area size distributions in one measurement
• V-Check (IQ, OQ, PQ) instrument validation