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Beckman Coulter

    LS™ 13 320 MW

     

    The LS 13 320 MW offers an easy to use system, producing fast and reliable particle size analysis results for dry, aqueous and non-aqueous samples by utilizing polarization intensity differential scattering (PIDS) technology and the Tornado dry powder dispersing system. 

    The LS 13 320 MW Utilizes Unique Patented Systems

    The LS 13 320 MW particle size analyzer is one of the most capable and sophisticated particle size analyzers available on the commercial market today. In fact, many of the sub-systems are unique, e.g. the Beckman Coulter exclusive, polarization intensity differential scattering (PIDS) technology and the patented Tornado dry powder dispersing system. The LS 13 320 MW uses reverse Fourier optics incorporated in a patented fiber optic spatial filter system and a binocular lens system. This enables the LS 13 320 MW to optimize light scattering measurement across the widest dynamic range, from 0.017µm to 2000 µm, in a single scan with no extrapolation.

    The LS 13 320 MW Delivers Excellent Data Reproducibility

    Reproducibility is one of the most important factors in laser diffraction particle size analysis. Tighter product specs allow manufacturers of bulk and particulate materials to have a higher quality product. And while the industry standard for reproducibility is 2%-4% under ideal conditions, the LS 13 320 MW, typically, has better than 1% reproducibility.

    Standard Operating Procedures and Methods (SOP's & SOM's)

    The easy creation of SOP's allows the standardization of analysis methods and the reporting of results. The use of SOP's guarantee consistency and uniformity regardless of the number of applications, operators, instruments and locations involved and ensure your analyses are the same run after run by using the advanced SOP routine. Every element of the analysis from method set-up to the final printout can be locked into a user definable SOP. The SOM covers all those aspects of the analysis relating to the instrument settings. These files can be e-mailed to other users ensuring conformance and harmony regardless of location.

    Software Security and 21 CFR Part 11 enabled Regulatory Compliance

    The LS 13 320 MW comes with a configurable security system. The user can choose between 4 levels of security. From No security to High security, the choice is yours. Choosing High Security configures the software to be compliant to 21 CFR Part 11, the FDA regulation covering electronic signatures and records.

    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, which has been 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 such as the LS 13 320 MW 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 that may be customized by the user.

    You can simply pick the 21 CFR 11 button to ensure the correct options are chosen; as we say, you're one click away from compliance.

    V-Check Program

    The V-Check program is a comprehensive package that addresses all appropriate aspects of a product's life cycle, from instrument development to ongoing performance verification (SQ, DQ, IQ, OQ and PQ). The V-Check program contains all the necessary documentation for instrument validation. This documentation is required to show auditors and investigators proof of proper instrument validation. It consists of a number of functional inter-linked components, which have been designed to give the user assurance that the product is fit for the purpose that it has been designed for and will perform on a consistent basis for these tasks. Where other instrument manufacturers leave off, Beckman Coulter and its V-Check program assist with ongoing quality checks of the instrument (PQ). This proves that it is important to consider products from a manufacturer who not only understands your needs, but is also willing to develop a partnership for the future.

    Modules
    LS 13 320 SW Aqueous Liquid Module Aqueous Liquid Module (ALM)LS 13 320 SW Micro Volume Module Micro Liquid Module (MLM)
    LS 13 320 SW Tornado Dry Powder System Tornado Dry Powder System (DPS)LS 13 320 Universal Liquid Module Universal Liquid Module (ULM)

    Features

    • Particle size measurement range from 0.017µm to 2000µm
    • One of the highest submicron resolutions, using the Polarization Intensity Differential Scattering (PIDS) technology
    • Tornado dry powder dispersing system
    • Fiber optic spatial filter system
    • 'Auto Dock' - Unique module change system
    • Change between wet and dry to wet again in less than a minute
    • User friendly software and advanced software security features
    • Easy to follow Standard Operating Methods (SOM's)
    • Multi-component Standard Operating Procedures (SOP's)
    • Certification Program to ensure instrument performance
    • V-Check (IQ, OQ, PQ) instrument validation