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Normas BSI – AENOR
BS ISO 21501-3:2019

BS ISO 21501-3:2019

Determination of particle size distribution. Single particle light interaction methods. Light extinction liquid-borne particle counter

Fecha:
2019-12-04 /Definitive
Comité:
LBI/37
Equivalencias internacionales:

ISO 21501-3

Relación con otras normas BSI:

Reemplaza a: BS ISO 21501-3:2007

Resumen:

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.

Keywords:
Liquids, Calibration, Suspensions (chemical), Test equipment, Particulate materials, Counting, Optical measurement, Contaminants, Verification, Particle size distribution, Light divergence, Particle size measurement
201,61
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