ISO 21501-3:2019

Current Revision
Determination of particle size distribution - Single particle light interaction methods - Part 3: Light extinction liquid-borne particle counter

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ISO 21501-3:2019

Determination of particle size distribution - Single particle light interaction methods - Part 3: Light extinction liquid-borne particle counter

PUBLISH DATE 2019
ISO 21501-3:2019

This document 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 document is based on *single particle measurements*. The typical size range of particles measured by this method is between 1 ยตm and 100 ยตm in particle size.

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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