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EN ISO 8362-5:2016

Current

Current

The latest, up-to-date edition.

Injection containers and accessories - Part 5: Freeze drying closures for injection vials (ISO 8362-5:2016)

Published date

03-16-2016

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European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Shape and dimensions
5 Designation
6 Material
7 Performance requirements
8 Labelling
Annex A (informative) - Determination of moisture
Bibliography

ISO 8362-5:2016 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for injection vials, as described in ISO 8362‑1 and ISO 8362‑4, which is used in connection with the freeze drying (or lyophilization) of drugs and biological materials.The dimensional requirements are not applicable to barrier-coated closures.Closures specified in this part of ISO 8362 are intended for single use only.NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be strongly affected by the nature and performance of the primary packaging.

Committee
CEN/TC 205
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current

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