Containers and accessories for pharmaceutical preparations Screw-neck vials made of glass tubing for liquid dosage forms

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

30-06-2016

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Dimensions and designation
4 Material
5 Characteristics
6 Requirements
7 Marking
8 Packaging

Defines the design, dimensions, material and requirements of screw-neck vials for pharmaceutical preparations. Pertains 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.

Committee	CH/212
DevelopmentNote	Supersedes 15/30314850 DC. (06/2016)
DocumentType	Standard
Pages	16
PublisherName	British Standards Institution
Status	Current
Supersedes	15/30314850 DC : 0

This part of ISO11418 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.

This part of ISO11418 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.

Standards	Relationship
ISO 11418-7:2016	Identical

ISO 720:1985	Glass Hydrolytic resistance of glass grains at 121 degrees C Method of test and classification
ISO 4802-2:2016	Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 2: Determination by flame spectrometry and classification
ISO 4802-1:2016	Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 1: Determination by titration method and classification
ISO 719:1985	Glass Hydrolytic resistance of glass grains at 98 degrees C Method of test and classification

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BS ISO 11418-7:2016

Containers and accessories for pharmaceutical preparations Screw-neck vials made of glass tubing for liquid dosage forms

Table of Contents

Abstract

General Product Information

Scope

International Equivalents

Standards Referencing This Book

Category

Subcategory