Containers and accessories for pharmaceutical preparations Drop-dispensing glass bottles

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

30-11-2016

Publisher

British Standards Institution

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Dimensions and designation
5 Requirements
6 Marking

Describes the design, dimensions, material and requirements of drop-dispensing glass bottles. Drop-dispensing glass bottles are applicable to primary packs used in direct contact with a drug.

This document specifies the design, dimensions, material and requirements of drop-dispensing glass bottles. Drop-dispensing glass bottles are applicable to primary packs used in direct contact with a drug.

This document is applicable to drop-dispensing glass bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not intended for parenteral use.

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.

Committee	CH/212
DevelopmentNote	Supersedes 03/106303 DC (10/2006) Supersedes 15/30314886 DC. (11/2016)
DocumentType	Standard
Pages	14
PublisherName	British Standards Institution
Status	Current
Supersedes	BS ISO 11418-1:2005 03/106303 DC : DRAFT APR 2003 15/30314886 DC : 0

Standards	Relationship
ISO 11418-1:2016	Identical

ISO 720:1985	Glass Hydrolytic resistance of glass grains at 121 degrees C Method of test and classification
ISO 1101:2017	Geometrical product specifications (GPS) — Geometrical tolerancing — Tolerances of form, orientation, location and run-out
ISO 4802-2:2016	Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 2: Determination by flame spectrometry and classification
ISO 8113:2004	Glass containers Resistance to vertical load Test method
ISO 7459:2004	Glass containers Thermal shock resistance and thermal shock endurance Test methods
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 11418-1:2016

Containers and accessories for pharmaceutical preparations Drop-dispensing glass bottles

Table of Contents

Abstract

Scope

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory