BS ISO 11418-3-2016 Containers and accessories for pharmaceutical preparations Screw-neck glass bottles (veral) for solid and liquid dosage forms《药剂制备容器及附件 固体和液体计量方式螺口玻璃瓶》.pdf

1、BS ISO 11418-3:2016Containers and accessories for pharmaceutical preparationsPart 3: Screw-neck glass bottles (veral) for solid and liquid dosage formsBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS ISO 11418-3:2016 BRITISH STANDARDNational forewordThis British St

2、andard is the UK implementation of ISO 11418-3:2016. It supersedes BS ISO 11418-3:2005 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs.A list of organizations represented on this committee can be obtained on request to its secretary.This p

3、ublication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 88425 2 ICS 11.040.20; 11.120.99 Compliance with a British Standard canno

4、t confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 November 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dBS ISO 11418-3:2016 ISO 2016Containers and accessories for pha

5、rmaceutical preparations Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage formsRcipients et accessoires pour prparations pharmaceutiques Partie 3: Flacons en verre bouchon vis (veral) pour formes sches et liquidesINTERNATIONAL STANDARDISO11418-3Third edition2016-11-15Reference nu

6、mberISO 11418-3:2016(E)BS ISO 11418-3:2016ISO 11418-3:2016(E)ii ISO 2016 All rights reservedCOPYRIGHT PROTECTED 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,

7、 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 ISOs member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 V

8、ernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 11418-3:2016ISO 11418-3:2016(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 Materia

9、l . 25.2 Performance 25.2.1 Vertical load resistance 25.2.2 Hydrolytic resistance . 25.2.3 Thermal shock resistance 26 Marking 2Annex A (normative) Neck finishes . 5 ISO 2016 All rights reserved iiiContents PageBS ISO 11418-3:2016ISO 11418-3:2016(E)ForewordISO (the International Organization for Sta

10、ndardization) 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 righ

11、t 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

12、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 rule

13、s 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 identif

14、ied 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 on

15、the meaning of ISO specific terms and expressions related to conformity assessment, as well as information 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

16、 this document is ISO/TC 76, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use.This third edition cancels and replaces the second edition (ISO 11418-3:2005), which has been technically revised by updating Figure 1 on typical screw-neck glass bottl

17、e and Table 1 on nominal volume, brimful capacity and dimensions of screw-neck glass bottles, 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 11418-3:2016IN

18、TERNATIONAL STANDARD ISO 11418-3:2016(E)Containers and accessories for pharmaceutical preparations Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms1 ScopeThis document specifies the design, dimensions, material and requirements of screw-neck glass bottles (veral) for pharma

19、ceutical preparations in solid and liquid dosage forms. Screw-neck glass bottles are applicable to primary packs used in direct contact with a drug.This document is applicable to screw-neck glass bottles (veral) used in pharmacy. Together with the corresponding closure systems, they serve for packag

20、ing of pharmaceutical preparations in solid and liquid dosage forms which are not intended for parenteral use.NOTE 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 pack.2 Normative referencesT

21、he 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 references, the latest edition of the referenced document (including any amendments) applies

22、.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 121 degrees C Method of test and classificationISO 1101, Geometrical product specifications (GPS) Geometrical tolerancing Tolerances of form,

23、 orientation, location and run-outISO 4802-1, Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 1: Determination by titration method and classificationISO 4802-2, Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 2: Determination by fla

24、me spectrometry and classificationISO 7459, Glass containers Thermal shock resistance and thermal shock endurance Test methodsISO 8113, Glass containers Resistance to vertical load Test method3 Terms and definitionsNo terms and definitions are listed in this document.ISO and IEC maintain terminologi

25、cal databases for use in standardization at the following addresses: IEC Electropedia: available at http:/www.electropedia.org/ ISO Online browsing platform: available at http:/www.iso.org/obp ISO 2016 All rights reserved 1BS ISO 11418-3:2016ISO 11418-3:2016(E)4 Dimensions and designation4.1 Dimensi

26、onsThe dimensions of screw-neck glass bottles veral1)for pharmaceutical preparations in solid and liquid dosage forms shall be as shown in Figure 1 and as given in Table 1.The neck finish of screw-neck glass bottles (veral) for solid and liquid dosage shall comply with Figure A.1 or Figure A.2 as ap

27、propriate.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 (veral) for pharmaceutical preparations in solid and liquid dosage forms shall be designated by a reference to this document, f

28、ollowed by the nominal volume, the colour of the glass and bore size.EXAMPLE A screw-neck glass bottle (veral) of nominal volume 100 ml, made of amber glass (br) of hydrolytic resistance container class ISO 4802-HC 3, in accordance with this document is designated as follows:Screw-neck glass bottle

29、ISO 11418-3 100 br5 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 720-HGA 2.5.2 Performance5.2.1 Vertical

30、 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 with the requirements of the hydroly

31、tic resistance container class ISO 4802-HC 3.5.2.3 Thermal shock resistanceScrew-neck glass bottles (veral) 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 MarkingThe screw-neck glass bottl

32、e (veral) shall be marked with the information specified in Figure 1.1) From the French term “verre allg” “lightweight glass”.2 ISO 2016 All rights reservedBS ISO 11418-3:2016ISO 11418-3:2016(E)Key1 ISO letters (optional)2 manufacturers trademark3 nominal volume (optional)4 bottom surface may be gra

33、nular, flat or riffled5 manufacturers 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 (veral), showing marking locations ISO 2016 All rights reserved 3BS ISO 11418-3:2016ISO 11

34、418-3:2016(E)Table 1 Nominal volume, brimful capacity and dimensions of screw-neck glass bottles (veral) for solid and liquid dosage formsDimensions in millimetresNominal volumeMinimum brimful capacityd1h1h2h3h4r1r2r3r4Massgnom. tol. nom. tol.ml ml 30 33,5 34,2 1 70,5 1,0 2,0 52,6 38,0 8,0 17,0 2,0

35、2,0 4750 58,0 40,5 1 81,0 1,0 13,0 62,6 49,5 4,0 6,0 30,0 3,0 5560 70,5 44,0 1,1 82,0 1,0 12,5 64,5 51,0 3,5 8,0 26,0 2,0 6375 83,8 47,4 0,8 91,4 0,8 13,0 73,0 56,5 6,0 9,0 28,0 2,8 86100 115,0 51,2 0,8 96,8 0,9 13,0 78,8 61,5 5,0 9,0 22,0 4,0 86125 136,0 56,0 1,2 97, 5 1,0 15,0 79,6 60,5 5,0 10,0 3

36、0,0 3,5 102150 165,0 56,8 1,2 111,0 1,1 14,0 89,0 70,0 8,0 12,0 30,0 3,0 115200 221,5 63,0 1,3 118,5 1,1 17,0 100,5 73,5 7,0 14,0 33,0 4,5 125250 275,0 65,0 1,3 136,0 1,2 19,0 118,6 88,0 6,0 15,0 40,0 4,0 160300 323,0 72,3 1,2 134,5 1,2 18,5 117,0 84,5 7,0 16,8 36,0 3,5 200500 541,0 82,0 1,5 161,0 1

37、,3 18,3 143,5 105,3 7, 5 18,0 29,3 5,0 2851 000 1 079,0 100,6 1,6 206,2 1,2 24,0 187, 5 140,5 10,0 23,0 45,0 5,0 4804 ISO 2016 All rights reservedBS ISO 11418-3:2016ISO 11418-3:2016(E)Annex A (normative) Neck finishesNeck finishes of screw-neck glass bottles for syrups shall comply with Figure A.1 (

38、19,4 mm bore) or Figure A.2 (20 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 5BS ISO 11418-3:2016ISO 11418-3:2016(E)NOTE Diameter d2at 4 mm depth and 17 mm.Figure A.2 20 mm bore - 28 mm Bottle Neck Fini

39、sh6 ISO 2016 All rights reservedBS ISO 11418-3:2016BS ISO 11418-3:2016ISO 11418-3:2016(E) ISO 2016 All rights reservedICS 11.120.99; 11.040.20Price based on 6 pagesThis page deliberately left blankBSI is the national body responsible for preparing British Standards and other standards-related public

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