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ISO 11418-7:2016

Containers and accessories for pharmaceutical preparations — Part 7: Screw-neck vials made of glass tubing for liquid dosage forms ISO 11418-7:2016

General information

90.93 Standard confirmed   Sep 7, 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 | 11.120.99   Other standards related to pharmaceutics

Scope

ISO 11418-7:2016 specifies the design, dimensions, material and requirements of screw-neck vials for pharmaceutical preparations. Screw-neck vials are applicable to primary packs used in direct contact with a drug.
It applies to colourless or amber glass vials made from borosilicate or soda-lime-silica glass, made from glass tubing and intended to be used in the packaging, storage or transportation of pharmaceutical products.
NOTE The potency, purity, stability and safety of a drug during its manufacture and storage can be strongly affected by the nature and performance of the primary pack.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 11418-7:1998

NOW

PUBLISHED
ISO 11418-7:2016
90.93 Standard confirmed
Sep 7, 2021