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BS ISO 21882:2019

BS ISO 21882:2019

$142.49

Sterile packaged ready for filling glass vials

Published By Publication Date Number of Pages
BSI 2019 28
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This document specifies the characteristics of sterile and ready for filling empty glass vials for injectable preparations, including the minimum requirements of materials, packaging systems and analytical test methods.

PDF Catalog

PDF Pages PDF Title
2 National foreword
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
10 4 Quality system
4.1 General
11 4.2 Testing
5 Process description and requirements
5.1 Washing
5.2 Drying
5.3 Packaging
5.4 Sterilization
12 6 Requirements for glassware
6.1 General
6.2 Material
6.3 Dimensions
6.4 Particles
6.4.1 Visible particles
6.4.2 Sub-visible particles
13 6.5 Bacterial endotoxin level
7 Requirements for packaging system
7.1 General
14 7.2 Nest and tub configuration
7.3 Tray configuration
7.4 Nest
15 7.5 Tub and tray
7.6 Insert liner
7.7 Sealing lid
16 7.8 Protective bag
7.9 Information to be provided by the manufacturer
8 Marking of the tub or tray
17 9 Labelling
18 Annex A (informative) Design of tub
19 Annex B (informative) Design of nest
20 Annex C (informative) Design of tray
21 Annex D (informative) Schematic illustrations of examples for the orientation of tubs or trays within the protective bag
23 Annex E (informative) Sample preparation for endotoxin and particulate determination
26 Annex F (informative) Packaging configuration
27 Bibliography

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BS ISO 21882:2019
$142.49