ISO 21501:2019

Description

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 µm and 100 µm 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.