BS ISO 21501-3:2019
$142.49
Determination of particle size distribution. Single particle light interaction methods – Light extinction liquid-borne particle counter
| Published By | Publication Date | Number of Pages |
| BSI | 2019 | 28 |
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:
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size setting error;
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counting efficiency;
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size resolution;
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maximum particle number concentration;
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sampling flow rate error;
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sampling time error;
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sampling volume error;
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calibration interval;
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reporting results from test and calibration.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | undefined |
| 6 | Foreword |
| 7 | Introduction |
| 9 | 1 Scope 2 Normative references 3 Terms and definitions |
| 11 | 4 Principle 5 Basic configuration 6 Requirements 6.1 Size setting error |
| 12 | 6.2 Counting efficiency 6.3 Size resolution 6.4 Maximum particle number concentration 6.5 Sampling flow rate error 6.6 Sampling time error 6.7 Sampling volume error 6.8 Calibration interval 6.9 Reporting of test and calibration results |
| 13 | 7 Test and calibration procedures 7.1 Size setting 7.1.1 Evaluation of size setting error 7.1.2 Procedure of size setting |
| 16 | 7.2 Evaluation of counting efficiency |
| 17 | 7.3 Evaluation of size resolution |
| 18 | 7.4 Estimation of coincidence loss at the maximum particle number concentration |
| 19 | 7.5 Evaluation of sampling flow rate error 7.6 Evaluation of sampling time error 7.7 Evaluation of sampling volume error |
| 20 | Annex A (informative) Size resolution |
| 21 | Annex B (informative) Procedure for evaluating the uncertainties of the results of the performance tests |
| 26 | Bibliography |
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BS ISO 21501-3:2019
Determination of particle size distribution. Single particle light interaction methods – Light extinction liquid-borne particle…
