ISO 11418-3:2005

INTERNATIONAL ISO
STANDARD 11418-3
Second edition
2005-02-01

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 11418-3:2005(E)
©
ISO 2005

---------------------- Page: 1 ----------------------
ISO 11418-3:2005(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.


©  ISO 2005
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland

ii © ISO 2005 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 11418-3:2005(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 114183 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment
for medical and pharmaceutical use.
This second edition cancels and replaces the first edition (ISO 11418-3:1996), which has been technically
revised.
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

© ISO 2005 – All rights reserved iii

---------------------- Page: 3 ----------------------
INTERNATIONAL STANDARD ISO 11418-3:2005(E)

Containers and accessories for pharmaceutical preparations —
Part 3:
Screw-neck glass bottles (veral) for solid and liquid dosage
forms
1 Scope
This part of ISO 11418 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.
This part of ISO 11418 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.
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.
2 Normative references
The following referenced documents ar
...