0

ISO 8362-5:2016

Injection containers and accessories — Part 5: Freeze drying closures for injection vials ISO 8362-5:2016

Publication date:   Feb 15, 2016

General information

90.93 Standard confirmed   Jun 9, 2021

ISO

ISO/TC 76 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use

International Standard

11.040.20   Transfusion, infusion and injection equipment

Buying

Published

Language in which you want to receive the document.

Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 8362-5:2008

NOW

PUBLISHED
ISO 8362-5:2016
90.93 Standard confirmed
Jun 9, 2021