Containers and accessories for pharmaceutical preparations

ISO 11418-3:2016 specifies the design, dimensions, material and requirements of screw-neck glass bottles (veral) for pharmaceutical preparations in solid and liquid dosage forms. Screw-neck glass bottles are applicable to primary packs used in direct contact with a drug. It is applicable to screw-neck glass bottles (veral) used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations in solid and liquid dosage forms which are not intended for parenteral use.

Récipients et accessoires pour préparations pharmaceutiques

General Information

Status
Published
Publication Date
13-Nov-2016
Current Stage
9020 - International Standard under periodical review
Start Date
15-Oct-2021
Ref Project

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ISO 11418-3:2016 - Containers and accessories for pharmaceutical preparations
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INTERNATIONAL ISO
STANDARD 11418-3
Third edition
2016-11-15
Containers and accessories for
pharmaceutical preparations —
Part 3:
Screw-neck glass bottles (veral) for
solid and liquid dosage forms
Récipients et accessoires pour préparations pharmaceutiques —
Partie 3: Flacons en verre à bouchon à vis (veral) pour formes sèches
et liquides
Reference number
ISO 11418-3:2016(E)
ISO 2016
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ISO 11418-3:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form

or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior

written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of

the requester.
ISO copyright office
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Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
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ISO 11418-3:2016(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Dimensions and designation ................................................................................................................................................................... 2

4.1 Dimensions ................................................................................................................................................................................................. 2

4.2 Designation ................................................................................................................................................................................................ 2

5 Requirements .......................................................................................................................................................................................................... 2

5.1 Material ......................................................................................................................................................................................................... 2

5.2 Performance .............................................................................................................................................................................................. 2

5.2.1 Vertical load resistance .............................................................................................................................................. 2

5.2.2 Hydrolytic resistance ................................................................................................................................................... 2

5.2.3 Thermal shock resistance ........................................................................................................................................ 2

6 Marking .......................................................................................................................................................................................................................... 2

Annex A (normative) Neck finishes ....................................................................................................................................................................... 5

© ISO 2016 – All rights reserved iii
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ISO 11418-3:2016(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment,

as well as information about ISO’s adherence to the World Trade Organization (WTO) principles in the

Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.

The committee responsible for this document is ISO/TC 76, Transfusion, infusion and injection, and blood

processing equipment for medical and pharmaceutical use.

This third edition cancels and replaces the second edition (ISO 11418-3:2005), which has been

technically revised by

— updating Figure 1 on typical screw-neck glass bottle and Table 1 on nominal volume, brimful

capacity and dimensions of screw-neck glass bottles,
— including a normative annex on neck finishes, and
— editorially revising this document.
A list of all the parts of ISO 11418 can be found on the ISO website.
iv © ISO 2016 – All rights reserved
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INTERNATIONAL STAND
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