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(ISO 21501-3:2007, MOD) LIGHT EXTINCTION LIQUIDBORNE PARTICLE COUNTER

Standard Number : JIS B 9916:2010

Publishing Organization : Japanese Industrial Standards Committee

Publish Year : 2010

link : Related Link

ABSTRACT
ISO 21501-3:2007 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 ISO 21501-3:2007 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 ISO 21501-3:2007 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 ISO 21501-3:2007: • size calibration; • verification of size setting; • counting efficiency; • size resolution; • maximum particle number concentration; • sampling flow rate; • sampling time; • sampling volume; • calibration interval; • test report.