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Determination of particle size distribution — Single particle light interaction methods — Part 3: Light extinction liquid-borne particle counter
The method is applicable to instruments 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 document:
— size setting error;
— counting efficiency;
— size resolution;
— maximum particle number concentration;
— sampling flow rate error;
— sampling time error;
— sampling volume error;
— calibration interval;
— reporting results from test and calibration.
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