Reference number
ISO 8362-5:2016
International Standard
ISO 8362-5:2016
Injection containers and accessories — Part 5: Freeze drying closures for injection vials
Edition 3
2016-02
Read sample
ISO 8362-5:2016
65448
Published (Edition 3, 2016)
This publication was last reviewed and confirmed in 2021. Therefore this version remains current.

ISO 8362-5:2016

ISO 8362-5:2016
65448
Language
Format
CHF 63
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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

  •  : Published
     : 2016-02
    : International Standard confirmed [90.93]
  •  : 3
     : 9
  • ISO/TC 76
    11.040.20 
  • RSS updates

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

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