ČSN EN ISO 8362-5

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

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Detail information

Designation: ČSN EN ISO 8362-5

Publication date: 01/09/2016

Pages: 24

Country: Czech technical standard

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Anotation

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

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