ISO 8362-5:2016
Injection containers and accessories - Part 5: Freeze drying closures for injection vials
standard by International Organization for Standardization , 02/15/2016
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About This Item
Full Description
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.
Document History
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ISO 8362-5:2016
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Injection containers and accessories - Part 5: Freeze drying closures for injection vials- Most Recent
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ISO 8362-5:2008
Injection containers and accessories - Part 5: Freeze drying closures for injection vials- Historical Version
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ISO 8362-5:1995
Injection containers for injectables and accessories -- Part 5: Freeze drying closures for injection vials- Historical Version
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