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ISO 8362-5:2016

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

Standard Details

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
Standard Type: Main
Document No: ISO 8362-5:2016
Document Year: 2016
Pages: 9
Edition: 3
  • Section Volume:
  • ISO/TC 76. Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
  • ICS:
  • 11.040.20 Transfusion, infusion and injection equipment

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ISO 8362-5:2016
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