ISO 13926-1:2018 — Pen Systems: Glass Cylinders for Pen-Injectors for Medical Use: Part 1: Glass cylinders for pen-injectors — Fourth edition

ISO 13926-1 INTERNATIONAL STANDARD Fourth edition 2018-11 Pen systems — Glass cylinders for pen-injectors for Pmaerdt 1ic:a l use Systèmes de stylos-injecteurs — Partie 1: Cylindres en verre pour des stylos-injecteurs à usage médical Reference number ISO 13926-1:2018(E) --,,,,`,,,,,`,`,`,,,,,```,`-`-`,,`,,`,`,,`--- Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reproduction or networking permitted without license from IHS Not for Resale, 10/14/2019 19:21:52 MDT © ISO 2018 ISO 13926-1:2018(E) COPYRIGHT PROTECTED DOCUMENT © ISO 2018 All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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 CP 401 • Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +41 22 749 01 11 Fax: +41 22 749 09 47 Email: copyright@iso.org Website: www.iso.org Published in Switzerland Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reprodu i ct i ion or networking permitted without license from IHS Not for Resale, 10/14/2019 19:21:52 MDT © ISO 2018 – All rights reserved ---`,,`,`,,`,,`-`-`,```,,,,,`,`,`,,,,,`,,,,-- ISO 13926-1:2018(E) Contents Page Foreword iv Introduction v ........................................................................................................................................................................................................................................ 1 Scope 1 .................................................................................................................................................................................................................................. 2 Normative references 1 ................................................................................................................................................................................................................................. 3 Terms and definitions 1 ...................................................................................................................................................................................... 4 Dimensions 1 ..................................................................................................................................................................................... 5 Requirements 3 ................................................................................................................................................................................................................. .......................................................................................................................................................................................................... 5.1 Material .........................................................................................................................................................................................................3 5.2 Performance ..............................................................................................................................................................................................3 5.2.1 Sealing surface ...................................................................................................................................................................3 5.2.2 Hydrolytic resistance ...................................................................................................................................................3 6 Designation 4 5.2.3 Annealing quality ............................................................................................................................................................3 7 Package marking 4 ................................................................................................................................................................................................................ Bibliography 5 .................................................................................................................................................................................................. ................................................................................................................................................................................................................................ Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reproduction or network©ing pIeSrmOit te2d0 w1ith8ou t– lic Aenlsle rfroimg hIHtSs reserved Not for Resale, 10/14/2019 19:21:52 MDT iii ---,,,,,,,--,```,,,,,,,,,,,,,,,,``-- ISO 13926-1:2018(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. The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives). 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. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www .iso .org/patents). Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement. For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso .org/iso/foreword .html. Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use This document was prepared by Technical Committee ISO/TC 76, . This fourth edition cancels and replaces the third edition (ISO 13926-1:2004), which has been technically revised. The maind chdanges cdompared to the previous edition are as follows: — changing the dimension 1, 2 and 3 in Table 1 from normative to informative. A list of all parts in the ISO 13926 series can be found on the ISO website. Any feedback or questions on this document should be directed to the user’s national standards body. A complete listing of these bodies can be found at www .iso .org/members .html. Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reprodu i ct v ion or networking permitted without license from IHS Not for Resale, 10/14/2019 19:21:52 MDT © ISO 2018 – All rights reserved --``,,,,,,,,,,,,,,,,```,--,,,,,,,--- ISO 13926-1:2018(E) Introduction 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 packaging. This document deals with glass cylinders used with pen-injectors in accordance with ISO 11608-1. Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reproduction or network©ing pIeSrmOit te2d0 w1ith8ou t– lic Aenlsle rfroimg hIHtSs reserved Not for Resale, 10/14/2019 19:21:52 MDT v ---,,,,,,,--,```,,,,,,,,,,,,,,,,``-- Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reproduction or networking permitted without license from IHS Not for Resale, 10/14/2019 19:21:52 MDT ---,,,,,,,--,,,,,,`,`,`,,,,,`,,,,``-- INTERNATIONAL STANDARD ISO 13926-1:2018(E) Pen systems — Glass cylinders for pen-injectors for medical use Part 1: 1 Scope This document specifies the design, materials, performance and test methods, and gives recommendations for dimensions for glass cylinders used with pen-injectors for medical use. It applies to the primary containers used in direct contact with the drug. 2 Normative references The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated Grelafesrs e—nc Hesy,d trhoel yltaitce rset seisdtiatinocne ooff tghlaes rse gferareinnsc aetd 1d2o1c duemgerneet s( iCn —clu Mdientgh oadn yo fa tmesetn adnmde cnlatss)s iafipcpaltiieosn. ISO 720, Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 1: Determination by titration method and classification ISO 4802-1, Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 2: Determination by flame spectrometry and classification ISO 4802-2, Needle-based injection systems for medical use — Requirements and test methods — Part 3: Finished containers ISO 11608-3, Pen systems — Part 2: Plunger stoppers for pen-injectors for medical use ISO 13926-2, Pen systems —Part 3: Seals for pen-injectors for medical use ISO 13926-3, 3 Terms and definitions No terms and definitions are listed in this document. ISO and IEC maintain terminological databases for use in standardization at the following addresses: — ISO Online browsing platform: available at https: //www .iso .org/obp — IEC Electropedia: available at http: //www .electropedia .org/ 4 Dimensions d d d The dimensions of the glass cylinders shall be as shown in Figure 1 and as given in Table 1, except for the diameters 1, 2 and 3, which are for information only. d d d Glass cylinder, as shown in Figure 1 and Table 1 are typically available in different diameters 1, 2 and 3. Diameters as they are available are given for information only in Table 1. --``,,,,`,,,,,`,`,`,,,,,,--,,,,,,,`--- 1 Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reproduction or network©ing pIeSrmOit te2d0 w1ith8ou t– lic Aenlsle rfroimg hIHtSs reserved Not for Resale, 10/14/2019 19:21:52 MDT ISO 13926-1:2018(E) Dimensions in millimetres Key l a Length 1 and l2 shall be agreed upon between manufacturer and customer.

[Figure 1 — Configuration of glass cylinders for pen-injectors]

d The dimension 2 shall be specified in such a way that in combination with the selected plunger stopper according to ISO 13926-2 and the selected seal as per ISO 13926-3, the system can be validated as described in ISO 11608-3. d h The dimensions of the bore ( 6) shall be maintained for a depth of 1. h The opening of the glass cylinder should have a constant diameter, over the entire distance, 1, i.e. it should exhibit a cylindrical shape. A slightly conical shape can be accepted if the following requirements are fulfilled: h — the truncated cone has the height 1; Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reproduction or networking permitted without license from IHS Not for Resale, 10/14/2019 19:21:52 MDT © ISO 2018 – All rights reserved ---,,,,,,,--,```,,,,,,,,,,,,`,,,,``-- ISO 13926-1:2018(E) — the larger diameter is located at the flange or as agreed upon; — the larger diameter does not exceed the smaller one by more than 0,3 mm. Table 1 — Dimensions of glass cylinders for pen-injectors d d d d d d h h Dimensions in millimetres a a a 1 2 3 4 5 6 1 2 tol. tol. min. tol. tol. tol. tol. tol. ± ± ± ± ± ± ± 8,65 0,1 6,85 0,1 6,55 7,15 0,2 5,5 0,35 3,15 0,2 5,0 0,20 2,9 0,1 10,85 0,1 8,65 0,1 8,35 7,15 0,2 5,5 0,35 3,15 0,2 5,0 0,20 2,9 0,1 10,95 0,15 9,25 0,1 8,95 7,15 0,2 5,5 0,35 3,15 0,2 5,0 0,20 2,9 0,1 d d d 11,60 0,15 9,65 0,1 9,35 7,15 0,2 5,5 0,35 3,15 0,2 5,0 0,20 2,9 0,1 a The values for dimensions 1, 2 and 3 are for information only. For rubber plunger stoppers, refer to ISO 13926–2 and for seals, refer to ISO 13926–3. The compatibility of the components (glass barrel, rubber plunger stopper and seal) shall be validated as described in ISO 11608–3. 5 Requirements

5.1 Material

Colourless (cl) or amber (br) glass of the hydrolytic resistance grain glass in accordance with ISO 720 – HGA 1 shall be used. It shall correspond to the glass type 1 of the relevant pharmacopoeia. A change in the chemical composition of the glass material shall be notified to the user at least nine months in advance. The glass material used for glass cylinders shall not contain seeds or bubbles to an extent which will interfere with the visual examination of the contents.

5.2 Performance

5.2.1 Sealing surface

Glass cylinders shall have a sealing surface which is flat and free from ripples or undulations.

5.2.2 Hydrolytic resistance

When tested in accordance with ISO 4802-1 or ISO 4802-2, the hydrolytic resistance of the internal surface of the glass cylinder shall comply with the requirements for class HC 1 container class. Before conducting the test, the bottom end of the cylinder shall be sealed with a suitable closure element, e.g. silicone rubber.

5.2.3 Annealing quality

After the glass cylinder is annealed, the maximum residual stress shall not produce an optical retardation exceeding 40 nm per millimetre of glass thickness, when the glass cylinder is viewed in a strain viewer. Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reproduction or network©ing pIeSrmOit te2d0 w1ith8ou t– lic Aenlsle rfroimg hIHtSs reserved Not for Resale, 10/14/2019 19:21:52 MDT ---,,,,,,,--,```,,,,,,,,,,,,,,,,``-- ISO 13926-1:2018(E) The optical retardation test method shall be agreed upon between glass manufacturer and customer. 6 Designation d Glass cylinders for pen-injectors for medical use shall be designated by a reference to this document, followed by the colour of the glass and the nominal diameter 1 expressed in millimetres. d EXAMPLE A glass cylinder for pen-injectors for medical use, made of colourless (cl) glass tubing of the hydrolytic resistance container class ISO 4802 – HC 1 and a nominal diameter 1 = 11,6 mm, complying with the requirements oIf StOhi s1 3do9c2u6m-1e-nctl- i1s1 d,6esignated as follows: Cylinder 7 Package marking The package shall be marked with the following information: a) the designation of the cylinders; b) the identifying number (if the cylinders are printed), e.g. lot, batch, etc.; c) the number of cylinders it contains; d) the name or symbol of the manufacturer. Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reproduction or networking permitted without license from IHS Not for Resale, 10/14/2019 19:21:52 MDT © ISO 2018 – All rights reserved ---,,,,,,,--,,,,,,`,`,`,,,,,`,,,,``-- ISO 13926-1:2018(E) Bibliography Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems [1] ISO 11608-1, Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reproduction or network©ing pIeSrmOit te2d0 w1ith8ou t– lic Aenlsle rfroimg hIHtSs reserved Not for Resale, 10/14/2019 19:21:52 MDT ---`,,`,`,,`,,`-`-`,,,,,,,,,,,,,,,,,-- ISO 13926-1:2018(E) ICS 11.040.25 Price based on 5 pages Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reprodu©ctio nI oSr One t2wo0rk1ing8 p e–rm Aittelld wriithgohutt lisce rnsees freomr vIHeSd Not for Resale, 10/14/2019 19:21:52 MDT ---`,,`,`,,`,,`-`-`,```,,,,,`,`,`,,,,,`,,,,--