1 Scope
This part of ISO 21501 describes a calibration and verification method for a light extinction liquid-borne particle counter (LELPC), which is used to measure the size and particle number concentration of particles suspended in liquid. The light extinction method described in this part of ISO 21501 is based on single particle measurements. The typical size range of particles measured by this method is between 1 µm and 100 µm in particle size.
Instruments that conform to this part of ISO 21501 are used for the evaluation of the cleanliness of pharmaceutical products (e.g. injections, water for injections, infusions), as well as the measurement of number and size distribution of particles in various liquids.
The following are within the scope of this part of ISO 21501:
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— size calibration;
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— verification of size setting;
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— counting efficiency;
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— size resolution;
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— maximum particle number concentration;
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— sampling flow rate;
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— sampling time;
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— sampling volume;
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— calibration interval;
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— test report.