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ČSN EN ISO 8362-5 (703360)
Injection containers and accessories - Part 5: Freeze drying closures for injection vials
Translate name
STANDARD published on 1.9.2016
The information about the standard:
Designation standards: ČSN EN ISO 8362-5
Classification mark: 703360
Catalog number: 500403
Publication date standards: 1.9.2016
SKU: NS-650354
The number of pages: 24
Approximate weight : 72 g (0.16 lbs)
Country: Czech technical standard
Category: Technical standards ČSN
The category - similar standards:
Annotation of standard text ČSN EN ISO 8362-5 (703360):
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
