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BSI BS EN ISO 8362-5:2016

Injection containers and accessories -- Freeze drying closures for injection vials
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BSI BS EN ISO 8362-5:2016

Injection containers and accessories -- Freeze drying closures for injection vials

PUBLISH DATE 2016
PAGES 20
BSI BS EN ISO 8362-5:2016

This part of ISO 8362 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 BSI: British Standards Institution
Document Number ISO 8362-5
Publication Date March 31, 2016
Language en - English
Page Count 20
Revision Level
Supercedes
Committee CH/212
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