International ISO Standard IS011040-4 Fourth edition Prefilled syringes - 2024-06 Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling Seringuespreremplies- Partie 4: Cylindres en verre pour produits injectables et seringues pré-assemblées stériliséespréremplissables Reference number IS0 11040-4:2024(en) @ ISO 2024 @IS02024 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 CP 40i : Ch. de Blandonnet 8 CH-1214Vernier,Geneva Phone: +41 22 749 01 11 Email: [email protected] Website: www.iso.org Published in Switzerland @ IS0 2024- All rights reserved i Contents Page Foreword. V Introduction .vii 1 Scope .1 2 Normative references .1 .2 3 Terms and definitions. General requirements. .4 4.1 Quality systems. ..4 4.2 Testing ..4 4.3 Documentation. ..4 5 Syringe barrel ..4 5.1 Design including dimensions .4 5.1.1 Dimensions for 6 % Luer slip and 6 % Luer slip for Luer lock adapter front end .4 syringes 5.1.2 Specific dimensions for front end design for 6 % Luer slip and 6 % Luer slip for Luer lock adapter ..6 5.1.3 Dimensions for staked needle (SN) syringes > Front end design for staked needle syringe 5.1.4 ..9 5.2 Functional testing of Luer connection. .10 5.3 10 Material 5.4 Performance requirements. .10 5.4.1 Hydrolytic resistance glass barrel .10 5.4.2 ..10 Annealing quality . Lubrication of the inner surface 5.4.3 .10 5.4.4 Flange breakage resistance .10 5.4.5 Front end breakage resistance. .11 .11 6 Sterilized subassembled syringes ready for filling 6.1 General .11 6.1.1 .11 Design 6.1.2 Raw materials properties. .11 6.1.3 Documentation. ..11 ..11 6.2 Sterility 6.3 Pyrogenicity/endotoxins 12 6.4 Particulate matter 12 6.5 Additional requirements to specific components of sterilized subassembled syringes 12 ready for filling. .12 6.5.1 Syringe barrel 6.5.2 Needle .13 6.5.3 Syringe closure system ..14 ..15 6.6 Syringe closure system tightness 7 Packaging. ..15 8 Labelling ..16 Annex A (informative) Examples of types of sterilized subassembled syringes ready for filling ...17. Annex B (informative) Additional components for a subassembled syringe ready for filling ..19 Annex C (normative) Test methods for syringe barrels .20 Annex D (informative) Sample preparation for endotoxin and particulate determination ..26 ..29 Annex E (informative) Glide force test method .32 Annex F (informative) Needle penetration test .35 Annex G (normative) Test methods for front end components @ IS0 2024 - All rights reserved iii