ISO 21501-3:2019 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

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

本文件描述了消光液载粒子计数器（LELPC）的校准和验证方法，该计数器用于测量悬浮在液体中的粒子的大小和粒子数浓度。本文中描述的消光方法基于单粒子测量。通过该方法测量的颗粒的典型尺寸范围为1μm至100μm。该方法适用于用于评估药品清洁度的仪器（如注射剂、注射用水、输液），以及测量各种液体中颗粒的数量和尺寸分布。以下内容属于本文件的范围:-尺寸设置错误；-计数效率；-尺寸分辨率；-最大颗粒数浓度；-采样流量误差；-采样时间误差；-采样体积误差；-校准间隔；-报告测试和校准结果。

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.

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