ISO 11418-7:2016 医薬品用の容器と付属品—パート7：液体剤形用のガラス管で作られたスクリューネックバイアル | ページ 2

Foreword

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The committee responsible for this document is ISO/TC 76, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use.

This second edition cancels and replaces the first edition (ISO 11418-7:1998), which has been technically revised by

• amending the mass of screw-neck vials in Table 1, and
• editorially revising this part of ISO 11418.

ISO 11418 consists of the following parts, under the general title Containers and accessories for pharmaceutical preparations:

• Part 1: Drop-dispensing glass bottles
• Part 2: Screw-neck glass bottles for syrups
• Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms
• Part 4: Tablet glass bottles
• Part 5: Dropper assemblies
• Part 7: Screw-neck vials made of glass tubing for liquid dosage forms

Introduction

The purpose of this part of ISO 11418 is to specify the dimensions, capacities, form and requirements of screw-neck vials made from tubular glass intended for medical use. Vials made from glass tubing are considered to be suitable for the packaging and storage of pharmaceutical preparations until they are administered for medicinal purposes. Such vials may be made of different types of glass which can affect chemical resistance properties. For example, those made from borosilicate glass will have a very high level of chemical resistance where others made from soda-lime-silica glass will have a lower but adequate chemical resistance for the purposes for which they are intended.

Because vials may be made from different types of glass and because it is the chemical behaviour of the internal surface which is important when they are filled with pharmaceutical preparations, it is essential to specify the test procedures by which the performance can be measured.

1 Scope

This part of ISO 11418 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 ISO 11418 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.

2 Normative references

The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.