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BS EN ISO 8362-2:2024 – TC

BS EN ISO 8362-2:2024 – TC

$134.27

Tracked Changes. Injection containers and accessories – Closures for injection vials

Published By Publication Date Number of Pages
BSI 2024 35
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This document specifies the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO 8362-1 and ISO 8362-4. The dimensional requirements are not applicable to barrier-coated closures. Closures specified in this document are intended for single use only. NOTE            The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.

PDF Catalog

PDF Pages PDF Title
21 undefined
23 European foreword
Endorsement notice
25 Foreword
26 Introduction
28 1 Scope
2 Normative references
3 Terms and definitions
29 4 Classification
5 Shape and dimensions
31 6 Designation
7 Material
8 Performance requirements
8.1 General
32 8.2 Physical requirements
8.2.1 Hardness
8.2.2 Penetrability
8.2.3 Fragmentation
8.2.4 Self-sealing and aqueous solution tightness test
8.2.5 Aqueous solution tightness
8.2.6 Resistance to ageing
8.3 Chemical requirements
8.4 Biological requirements
8.5 Particulate contamination requirements
9 Labelling
33 Bibliography

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BS EN ISO 8362-2:2024 - TC
$134.27