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BS ISO 23416:2023

BS ISO 23416:2023

$142.49

General specifications and testing methods for temperature-sensitive medicinal packages in good distribution practice principles

Published By Publication Date Number of Pages
BSI 2023 26
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PDF Catalog

PDF Pages PDF Title
2 National foreword
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
11 4 General specifications
4.1 General
4.2 Physical performance
4.3 Dimensional stability
4.4 Safety
4.5 Thermal performance
12 5 Preparing a packaging system
5.1 General considerations before packing
5.2 Temperature-recording equipment
5.3 Packing into the heat insulated containers
13 6 Test procedure
6.1 Thermal performance
6.1.1 Temperature profiling
6.1.2 Location of temperature sensors
14 6.1.3 Temperature-recording
16 6.2 Storage and weight capacity
6.2.1 Storage capacity measurement
19 6.2.2 Weight measurement
6.3 Robustness test
20 7 Test Report
21 Annex A (informative) Example of performance test of insulated container for a temperature-sensitive medicinal product
24 Bibliography

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BS ISO 23416:2023
$142.49