Home Life & SciencesSPE-ls CSS
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Single Particle Explorer CSS (SPE-ls CSS) |
CSS: Count, Size, Shape
The SPE-ls CSS measures the number, shape, and size of particles ranging from 2 - 40,000 µm on filter membranes in your cGMP environment. This device provides reproducible results using fully automated image acquisition and analysis/documentation units. The SPE-ls CSS is applicable for foreign particulate matter control in parenterals, primary packaging materials or medical devices applications according to USP <788>, ISO 8871-3:2004, or international standards set by the user.
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Produce results in a timely manner |
High reproducability – no user interaction is required to run samples. All measurement parameters are set in receipt files.
Total traceability – ensure valid results with built-in traceable standards and CFR 21 Part 11 raw data compatibilty.
Fast results – enumeration of a sample in just 5 minutes.
High sample throughput - load up to 4 samples into the system and run them fully automated.
Minimal user training - after 1-3 days of on site user training, anybody is able to work with the system.
Robust - integrated system with worldwide support.
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Free registration for Premium-access: |
Log in for Downloads: |
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The particle monitor provides size distribution data for particles 2 µm and larger: size, number and shape.
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Applications |
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The SPE-ls CSS is capable of analyzing GxP environments with varied norms and regulations. The SPE delivers validated documented results for pharmaceutical applications. |
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The SPE-ls CSS measures foreign particle levels by determining the particle count per unit of volume in a liquid. |
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Routine particle counting according to USP<788> "membrane counting method“ |
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Compliant with ISO 8871-3:2004 - Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of released-particle count |
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Image analysis -> number, size and shape: |
The system gathers morphological particles information without any user interaction. From each particle the system reports:
Number, size:
Feret's diameter (longest dimension)
Shape:
Aspect ratio, angularity, rectangularity, elongation, area, perimeter, circularity, solidity, fibrosity, convexity and height
Particle color image:
Automatically collect and document high resolution sharp (auto-focus) color images of the particles.
With pre-defined methods illumination, auto-thresholding and auto-focus a complete user bias is established. This ensures high repeatability and reproducability of the counting results.
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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.
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Software interface and result |
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