Home SPE Model RangeSPE CSS
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Single Particle Explorer CSS (SPE CSS) |
CSS: Count, Size, Shape
The SPE CSS measures the number, shape, and size of particles ranging from 2 - 5000 µm on filter membranes. This device provides reproducible results using fully automated image acquisition and analysis/documentation units. The particles appearing on the filters are used to evaluate the components' cleanliness levels according to ISO 16232 standards or other customized standards. The SPE CSS is also applicable for hydraulic oil contamination control applications according to ISO 4406, SAE 4058, NAS 1638, or international standards set by the user.
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The system is fully automated with features such as: auto-focus, illumination feedback, binarization threshold, and a sample/objective changer making it is easy to use. The device is compliant with 21 CFR Part 11. Pharmaceutical applications include: incoming packaging material control, foreign particulate matter counting in accordance to USP <788>, and enumeration of foreign particulate matter in nasal drug products (OINDP).
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The particle monitor provides size distribution data for particles 0.5µm and larger: size, number and shape.
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The SPE CSS counts and measures the size and distribution of particles on filter membranes. This system provides reproducible results regarding particle size and shape within just a few minutes using fully automated image acquisition, analysis and documentation units. You are prepared for future applications and parameters thanks to the system's expandable material identification database.
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The Single Particle Explorer is designed for routine particle characterization. The Single Particle Explorer provides particle information for any particle 0.5 µm and larger using optimized particle: filtration, illumination and image analysis.
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The pre-installed methods enable you to analyze the entire sample with just a single mouse click |
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Upgradeable by adding an automated spectroscopy module to classify particles reliably and with a high degree of accuracy |
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Obtain standard-compliant, reproducible results, even for extremely small particles |
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Quickly and easily integrate in-house or official specifications, such as ISO 16232 and USP <788> |
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With the IQ/OQ/PQ documentation, you can qualify the SPE for your GxP application |
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Document the result, all raw data and the audit trail in accordance with 21 CFR Part 11 |
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Demonstrate the measurement system capability easily, using the particle size standard and the provided NIST/BAM-certified standards |
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Benefit from the various upgrade options to meet your future requirements |
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Globally comparable results |
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Integrated NIST traceable standard for routine calibration of count size and shape measurement |
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Image analysis: |
Particles – Number, size:
Feret's diameter
Length, width, area
Particles – Shape:
Angularity, rectangularity, convexity, elongation, fibrousness
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Result of the fully automated particle count: |
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6516 |
2368 |
1976 |
459 |
846 |
660 |
207 |
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