ISO 8362-5:2016

Status : Published (Under review)

This standard was last reviewed and confirmed in 2021. Therefore this version remains current.

	Format	Language
std 1 61	PDF
std 2 61	Paper
std 3 61	PDF + ePub

CHF61

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Abstract

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.

General information

Status
: Published

Publication date
: 2016-02

Stage
: International Standard confirmed [90.93]
Edition
: 3

Number of pages
: 9
Technical Committee :
ISO/TC 76

ICS :
11.040.20
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