标准编号：ISO 21501-3:2019
中文名称：粒径分布测定 单粒子光相互作用法 第3部分：消光式液体载体粒子计数器
英文名称：Determination of particle size distribution — Single particle light interaction methods — Part 3: Light extinction liquid-borne particle counter
发布日期：2019-11
标准范围
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.
立即下载标准文件