ISO DIS 21501-3
Determination of particle size distribution - Single particle light interaction methods - Part 3: Light extinction liquid-borne particle counter
|Publication Date:||28 December 2018|
|ICS Code (Particle size analysis. Sieving):||19.120|
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.
Instruments that conform to this document 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 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.