ISO 11040-5:2012

INTERNATIONAL ISO
STANDARD 11040-5
Third edition
2012-01-15
Prefilled syringes —
Part 5:
Plunger stoppers for injectables
Seringues préremplies —
Partie 5: Bouchons-pistons pour produits injectables
Reference number
©
ISO 2012
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 2012 – All rights reserved

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 11040-5 was prepared by Technical Committee 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 11040-5:2001), which has been technically
revised by:
— adjusting the title of this part of ISO 11040;
— aligning this International Standard with the ISO 8871 series;
— revising the requirements on the height of the spacers and requirements on material and hardness;
— adding requirements on resistance to ageing.
ISO 11040 consists of the following parts, under the general title Prefilled syringes:
— Part 1: Glass cylinders for dental local anaesthetic cartridges
— Part 2: Plunger stoppers for dental local anaesthetic cartridges
— Part 3: Seals for dental local anaesthetic cartridges
— Part 4: Glass barrels for injectables and ready-to-use prefillable syringes
— Part 5: Plunger stoppers for injectables
— Part 6: Plastics barrels for injectables
The following parts are under preparation:
— Part 7: Packaging systems for prefillable ready-to-use syringes
Introduction
Primary packaging components made of elastomeric materials are an integral part of medicinal products. Therefore,
the principles of current good manufacturing practices (cGMP) apply to the manufacturing of these components.
Principles of cGMP are described in e.g. ISO 15378 or in the GMP Guidelines published by the European
Community and the United States of America.
iv © ISO 2012 – All rights reserved

INTERNATIONAL STANDARD ISO 11040-5:2012(E)
Prefilled syringes —
Part 5:
Plunger stoppers for injectables
1 Scope
This part of ISO 11040 specifies the shape, dimensions, material, performance requirements and labelling of plunger
stoppers for glass barrels (single-chamber design) for injection preparations in accordance with ISO 11040-4.
Plunger stoppers specified in this part of ISO 11040 are intended for single use only.
This part of ISO 11040 is not applicable to barrier-coated plunger stoppers.
NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be
significantly affected by the nature and performance of the primary packaging.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced document
(including any amendments) applies.
ISO 3302-1, Rubber — Tolerances for products — Part 1: Dimensional tolerances
ISO 7619-1, Rubber, vulcanized or thermoplastic — Determination of indentation hardness — Part 1: Durometer
method (Shore hardness)
ISO 8871-1, Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables
in aqueous autoclavates
ISO 8871-4, Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 4: Biological
requirements and test methods
ISO 11040-4, Prefilled syringes — Part 4: Glass barrels for injectables
3 Classification
Plunger stoppers shall be classified as follows:
— type PSL: plunger stoppers with snap lid;
— type PST: plunger stoppers with thread.
4 Shape and dimensions
4.1 The shape and dimensions of plunger stoppers shall be as shown in Figure 1 and given in Table 1.
Dimensions in millimetres
a)  Plunger stoppe
...