ISO INTERNATIONAL STANDARD 11040-4 Third edition 2015-04-01 Prefilled syringes Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling Seringues preremplies- Partie 4: Cylindres en verre pour produits injectables et seringues pré- assembleessteriliséespreremplissables Reference number IS011040-4:2015(E) LSO Intemational Organization for Standardization @IS02015 dization5956617 ed without license from IHS IS011040-4:2015(E) COPYRIGHTPROTECTEDDOCUMENT @ ISO2015 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 Case postale 56.CH-1211 Geneva 20 Tel. +4122 749 0111 Fax +41 22 749 09 47 E-mail [email protected] Web www.iso.org Published in Switzerland PrganizationforStandardization networking permited without license from IHS NotforResale, 2015/6/2908:35:07 IS0 11040-4:2015(E) Contents Page Foreword ..iv Introduction.. .. i 1 Scope.. 2 Normative references 3 Terms and definitions ..2 4 General requirements .3 4.1 Quality systems. .3 4.2 Testing. .3 4.3 Documentation .3 5 Syringe barrel .4 5.1 Design including dimensions. .4 5.2 Functional testing of Luer connection 1 5.3 Material .7 5.4 Performance requirements .7 Hydrolytic resistance .7 5.4.1 5.4.2 Annealing quality .7 5.4.3 Lubrication ofthe inner surface 1 5.4.4 Flange breakage resistance. .7 5.4.5 Luer cone breakageresistance ..8 6 Sterilizedsubassembled syringesreadyforfilling .8 6.1 General .8 6.2 Sterility .8 6.3 Pyrogenicity/endotoxins 6.4 Particles. .9 6.5 Additional requirements to specific components of sterilized subassembled syringes ready for filling .9 6.5.1 Barrel. ..9 6.5.2 Needle ..10 6.5.3 Closure system .11 6.6 Closuresystembarrelintegrity ..12 7 Packaging ..12 8 Labelling. .12 Annex A (informative) Examples of types of sterilized subassembled syringes ready for filling ...13 AnnexB (informative)Headdesigns ..15 AnnexC (normative)Testmethodsforsyringebarrels ..17 AnnexD (informative)Samplepreparationforendotoxinandparticulatedetermination ..23 AnnexE (informative)Glideforcetestmethodtoevaluatesyringelubrication. .27 AnnexF (informative)Needlepenetrationtest ..30 AnnexG(normative)Testmethodsforclosuresystems ..33 AnnexH (informative) Dye solution tightnesstest. ..48 Bibliography .50 iii ithout license from IHS