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ISO 8362-5:2016

Current Revision

Injection containers and accessories - Part 5: Freeze drying closures for injection vials

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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.


SDO ISO: International Organization for Standardization
Document Number ISO 8362
Publication Date Not Available
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 76
Publish Date Document Id Type View
Not Available ISO 8362-5:2016 Revision