ISO INTERNATIONAL STANDARD 8362-7 Second edition 2006-04-15 Injection containers and accessories Part 7: Injection caps made of aluminium- plastics combinations without overlapping plastics part Récipients et accessoires pour produits injectables- Partie 7: Capsules d'injection en combinaison aluminium-plastique avec élément plastique non débordant Reference number ISO 8362-7:2006(E) @ ISO 2006 THS unde Not for Resale ISO 8362-7:2006(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 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. ?ISO2006 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 memberbody in the country of the requester. ISO copyright office Case postale 56.CH-1211Geneva 20 Tel. + 4122 749 01 11 Fax + 41 22 749 09 47 E-mail [email protected] Web www.iso.org Published in Switzerland @ ISO 2006 - All rights reserved ted without license from IHS Not for Resale ISO 8362-7:2006(E) Foreword IsO (the International Organization for Standardization) is a worldwide federation of national standards bodies International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. 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 8362-7 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 8362-7:1995), of which it constitutes a minor revision. Part 1: Injection vials made of glass tubing Part 2: Closures for injection vials Part3:Aluminium caps for injectionvials Part 4: Injection vials made of moulded glass Part 5: Freeze drying closures for injection vials Part 6: Caps made of aluminium-plastics combinations for injection vials Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part alOorganizationfrstandardiallonghtsreserved ili ISO 8362-7:2006(E) Introduction The materials from which injection containers (including elastomeric closures) are made are suitable primary packaging materials for storing injectable products until they are administered. However, in this part of IsO 8362, injection caps are not considered as primary packaging materials in direct contact with pharmaceutical preparations. During the processing of injection vials 2R and 4R, according to ISO 8362-1, and injection vials 6R, 8R, 10l, injection caps made of aluminium-plastics combinations corresponding to IsO 8362-6 because the diameter d2 of the plastics element is larger than the diameter d of the injection vial body. In order to avoid problems during the automatic working process, e.g. labelling of the vials or intermediate storage on a turntable, injection caps made of aluminium-plastics combinations are designed in such a way that the