High Precision Solutions for Cleanliness Analysis

Determining precise measurements of particle contamination is imperative in both the manufacturing and pharmaceutical industries, as the potential damage that can result from this contamination can harmfully effect both the machinery and efficacy of pharmaceutical products.

To resolve this dilemma, Clemex offers customers the PSFilter, which has been specifically designed to analyze particle contamination by measuring the presence of these unwanted particles that are found on membrane filters, wafers, tape lifts or gel packs. Following particle analysis, the Clemex PSFilter provides users with statistically significant and reproducible data through the use of its image analysis technology.

The types of analytical procedures that can be performed by the Clemex PSFilter include, but are not limited to:

  • Microparticles or micro-organisms filtered through a liquid
  • Witness plates that have retained airborne particles in cleanrooms
  • Evaluate tape lifts for the presence of unwanted particles or fungal spores present in the surrounding environment
  • Evaluation of Gel-Paks used in the aeronautics industry

Product Features

  • Rapid analysis procedure
    • The PSFilter produces a large number of images, classifies particulates and generates an easily reproducible report in only a few minutes
    • All data results can be used for documentation and presentation purposes
  • Provides detailed results on particle sizes
    • Macroscopic results: > 5 microns
    • Microscopic results: > 0.5 microns
  • High-resolution USB II Camera
  • Intuitive interface
  • Robust report
  • Installation and training on the system can be provided in the lab
  • Conforms to various international standards, of which include:
    • USP 788
    • ISO 4406 & 4407
    • ISO 1 6232
    • IEST STD CC1246D
    • Additional customization available as needed by the user
  • Provides combined data on a single sheet
    • Provides important information on a wide range of particle sizes
    • When multiple particle types are present, the PSFilter scans samples twice; initially at a higher magnification and then at a lower magnification to combine the results from both analyses on a single data sheet.
  • Wide range of particle types are detected with varying characteristics including:
    • Size
    • Morphology
    • Color
    • Elevation
    • Composition
  • Automated shading corrector
    • Ensures that even illumination is present in all images
  • Unlimited number of calibration settings available
  • Autoexposure
    • Automatically adjusts camera lighting
  • Object tracking
    • Allows users to validate measurements
    • Eliminates any potential artifacts found during analysis
  • Contrast Thresholding
    • Allows for transparent objects to be effectively detected and analyzed
  • Up to 6 samples can be run at any given time without requiring any user intervention
    • Each sample will have its own set of raw data and measurement results
    • Data browser allows the user to select objects and send them to a different category for separate analysis if necessary
  • Adjacent objects can be separated if individual measurements are required
  • Circular stage patterns available for filters and wafer analysis
  • Camera and microscope can be easily controlled with integrated software

High Precision Solutions for Cleanliness Analysis

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