1、BS ISO 11418-2:2016Containers and accessories forpharmaceutical preparationsPart 2: Screw-neck glass bottles for syrupsBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS ISO 11418-2:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation
2、of ISO 11418-2:2016. It supersedes BS ISO 11418-2:2005 which is withdrawn. The UK participation in its preparation was entrusted to TechnicalCommittee CH/212, IVDs.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to in
3、clude all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2016. Published by BSI Standards Limited 2016ISBN 978 0 580 88424 5ICS 11.040.20; 11.120.99Compliance with a British Standard cannot confer immunity fromlegal obligati
4、ons.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 November 2016.Amendments/Corrigenda issued since publicationDate Text affectedBS ISO 11418-2:2016 ISO 2016Containers and accessories for pharmaceutical preparations Part 2: Screw-neck glas
5、s bottles for syrupsRcipients et accessoires pour prparations pharmaceutiques Partie 2: Flacons en verre bouchon vis pour siropsINTERNATIONAL STANDARDISO11418-2Third edition2016-11-15Reference numberISO 11418-2:2016(E)BS ISO 11418-2:2016ISO 11418-2:2016(E)ii ISO 2016 All rights reservedCOPYRIGHT PRO
6、TECTED DOCUMENT ISO 2016, Published in SwitzerlandAll 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 pri
7、or written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 114
8、18-2:2016ISO 11418-2:2016(E)Foreword iv1 Scope . 12 Normative references 13 Terms and definitions . 14 Dimensions and designation . 24.1 Dimensions . 24.2 Designation 25 Requirements 25.1 Material . 25.2 Performance 25.2.1 Vertical load resistance 25.2.2 Hydrolytic resistance . 25.2.3 Thermal shock
9、resistance 26 Marking 2Annex A (normative) Neck finishes . 5 ISO 2016 All rights reserved iiiContents PageBS ISO 11418-2:2016ISO 11418-2:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of pre
10、paring 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
11、 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
12、 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 th
13、at 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 d
14、eclarations 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 on the meaning of ISO specific terms and expressions related to conformity assessment, as well as informatio
15、n about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.The committee responsible for this document is ISO/TC 76, Transfusion, infusion and injection, and blood processing equipment for medi
16、cal and pharmaceutical use.This third edition cancels and replaces the second edition (ISO 11418-2:2005), which has been technically revised by updating Figure 1 on typical screw-neck glass bottle and Table 1 on nominal volume, brimful capacity and dimensions of screw-neck glass bottles, adding the
17、size 105 ml in Table 1, including a normative annex on neck finishes, and editorially revising this document.A list of all the parts of ISO 11418 can be found on the ISO website.iv ISO 2016 All rights reservedBS ISO 11418-2:2016INTERNATIONAL STANDARD ISO 11418-2:2016(E)Containers and accessories for
18、 pharmaceutical preparations Part 2: Screw-neck glass bottles for syrups1 ScopeThis document specifies the design, dimensions, material and requirements of screw-neck glass bottles for pharmaceutical preparations in liquid form (syrups). Screw-neck glass bottles are applicable to primary packs used
19、in direct contact with a drug.This document is applicable to screw-neck glass bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not intended for parenteral use.NOTE The potency, purity, stability and safety of
20、 a drug during its manufacture and storage can be strongly affected by the nature and performance of the primary pack.2 Normative referencesThe 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 referen
21、ces, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 719, Glass Hydrolytic resistance of glass grains at 98 degrees C Method of test and classificationISO 720, Glass Hydrolytic resistance of glass grains at
22、121 degrees C Method of test and classificationISO 1101, Geometrical product specifications (GPS) Geometrical tolerancing Tolerances of form, orientation, location and run-outISO 4802-1, Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 1: Determination by titration m
23、ethod and classificationISO 4802-2, Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 2: Determination by flame spectrometry and classificationISO 7459, Glass containers Thermal shock resistance and thermal shock endurance Test methodsISO 8113, Glass containers Resist
24、ance to vertical load Test method3 Terms and definitionsNo terms and definitions are listed in this document.ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at http:/www.electropedia.org/ ISO Online browsing platform: a
25、vailable at http:/www.iso.org/obp ISO 2016 All rights reserved 1BS ISO 11418-2:2016ISO 11418-2:2016(E)4 Dimensions and designation4.1 DimensionsThe dimensions of screw-neck glass bottles for pharmaceutical preparations in liquid form shall be as shown in Figure 1 and as given in Table 1.The neck fin
26、ish of screw-neck glass bottles shall comply with Annex A, Figure A.1 or Figure A.2, as appropriate.Tolerancing of form, orientation, location and run-out not specified in this document shall be in accordance with ISO 1101.4.2 DesignationScrew-neck glass bottles for pharmaceutical use shall be desig
27、nated by a reference to this document, followed by the nominal volume, the colour of the glass and bore size.EXAMPLE A screw-neck glass bottle of nominal volume 500 ml, made of colourless glass (cl) of hydrolytic resistance container class ISO 4802-HC 3, in accordance with this document is designate
28、d as follows:Screw-neck glass bottle ISO 11418-2 500 cl5 Requirements5.1 MaterialThe material shall be colourless (cl) or amber (br) borosilicate glass (see ISO 4802-1 or ISO 4802-2) or soda-lime-silica glass (see ISO 4802-1 or ISO 4802-2) of hydrolytic resistance grain class ISO 719-HGB 3 or ISO 72
29、0-HGA 2.5.2 Performance5.2.1 Vertical load resistanceThe resistance to vertical load shall be in accordance with ISO 8113.5.2.2 Hydrolytic resistanceWhen tested in accordance with ISO 4802-1 and ISO 4802-2, the hydrolytic resistance of the internal surface of the screw-neck glass bottle shall comply
30、 with the requirements of the hydrolytic resistance container class ISO 4802-HC 3.5.2.3 Thermal shock resistanceScrew-neck glass bottles shall withstand the thermal shock of a temperature difference of 42 C when tested in accordance with the thermal shock resistance test specified in ISO 7459.6 Mark
31、ingThe screw-neck glass bottle shall be marked with the information specified in Figure 1.2 ISO 2016 All rights reservedBS ISO 11418-2:2016ISO 11418-2:2016(E)Key1 ISO letters (optional)2 manufacturers trademark3 nominal volume (optional)4 bottom surface may be granular, flat or riffled5 manufacturer
32、s code/designation of the mouldaThe number of the mould may be placed on the curve r3,on the bottom or on the shoulder of the bottle.Figure 1 Typical screw-neck glass bottle, showing marking locations ISO 2016 All rights reserved 3BS ISO 11418-2:2016ISO 11418-2:2016(E)Table 1 Nominal volume, brimful
33、 capacity and dimensions of screw-neck glass bottles for syrupsDimensions in millimetresNominal volumeMinimum brimful capacityd1h1h2h3h4r1r2r3r4Massgnom. tol. nom. tol.ml ml 30 35,7 35,0 0,7 67,0 0,8 8,8 48,8 30,4 6,5 29,0 18,0 2,5 3950 55,3 38,6 0,7 85,4 0,8 10,0 67,0 43,6 5,5 38,0 19,0 3,0 5560 65
34、,7 38,6 0,7 94 0,8 10,0 75,7 57,0 5,5 38,0 19,0 3,0 6075 81,0 43,9 0,7 95 0,8 11,3 79,6 49,3 6,0 39,0 19,6 3,0 6790 95,2 43,9 0,7 103,1 0,8 11,3 84,9 59,8 5,9 32,0 19,6 3,0 69100 105,5 46,1 0,8 104,8 0,9 11,7 86,4 58,3 6,5 36,0 19,9 3,5 72105 112,5 46,1 0,8 109 0,8 10,7 90,6 60,8 6,5 34,0 18,0 3,0 7
35、0125 130,0 49,0 0,8 114,4 0,9 12,5 96,0 62,9 7, 5 44,0 21,5 3,5 83150 154,5 51,6 0,8 122,8 0,9 13,0 104,4 68,9 8,0 46,0 23,0 3,5 98180 185,2 54,7 0,9 129,9 1,0 14,0 111,5 72,7 9,0 49,0 24,0 4,0 110200 204,9 57,0 0,9 133,3 1,0 14,5 114,4 73,0 10,5 51,0 25,0 4,0 120250 255,2 61,7 1,0 142,9 1,0 15,5 12
36、4,0 78,0 12,0 55,0 26,5 4,5 145300 309,2 65,6 1,0 151,3 1,0 16,5 132,4 82,3 13,0 59,0 28,0 5,0 170500 512,3 76,8 1,2 176,8 1,1 19,0 157,9 97, 3 15,0 69,0 32,5 5,5 2401 000 1 010 97, 5 1,5 215,6 1,3 24,0 196,7 119,2 17,0 84,0 41,0 7,0 4504 ISO 2016 All rights reservedBS ISO 11418-2:2016ISO 11418-2:20
37、16(E)Annex A (normative) Neck finishesNeck finishes of screw-neck glass bottles for syrups shall comply with Figure A.1 (19,4 mm bore) or Figure A.2 (20,0 mm bore), as appropriate.NOTE Diameter d2at 4 mm depth and 17 mm.Figure A.1 19,4 mm bore 28 mm Bottle Neck Finish ISO 2016 All rights reserved 5B
38、S ISO 11418-2:2016ISO 11418-2:2016(E)NOTE Diameter d2at 4 mm depth and 17 mm.Figure A.2 20 mm bore 28 mm Bottle Neck Finish6 ISO 2016 All rights reservedBS ISO 11418-2:2016BS ISO 11418-2:2016ISO 11418-2:2016(E) ISO 2016 All rights reservedICS 11.120.99; 11.040.20Price based on 6 pagesThis page delib
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