ISO 8362-5:2016

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

Publication date: 15 shk 2016

General information

Current stage: 90.20 Effective date: 15 pri 2026

Originator: ISO

Owner: ISO/TC 76

Type: International Standard

ICS: 11.040.20

Gjuha: anglisht frëngjisht

Buying

Statusi: Publikuar

PDF - 7 576 Lekë

Paper - 7 576 Lekë

CD - 7 576 Lekë

Language

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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WITHDRAWN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
90.20 Standard under periodical review
15 pri 2026

National adoptions

SSH EN ISO 8362-5:2016

DPS

Enë mbajtëse dhe pajisje ndihmëse për injeksionet - Pjesa 5: Mbyllje liofilitike për shishet e injeksionit (ISO 8362-5:2016)

60.60 Standard published

DPS/KT 205 më tepër

Preview

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