1、BS ISO 11418-1:2016Containers and accessories forpharmaceutical preparationsPart 1: Drop-dispensing glass bottlesBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS ISO 11418-1:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO
2、 11418-1:2016. It supersedes BS ISO 11418-1:2005 which is withdrawn.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 include
3、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 88403 0ICS 11.040.20; 11.120.99Compliance with a British Standard cannot confer immunity fromlegal obligations.Th
4、is 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 11418-1:2016 ISO 2016Containers and accessories for pharmaceutical preparations Part 1: Drop-dispensing glass
5、 bottlesRcipients et accessoires pour prparations pharmaceutiques Partie 1: Flacons compte-gouttes en verreINTERNATIONAL STANDARDISO11418-1Third edition2016-11-15Reference numberISO 11418-1:2016(E)BS ISO 11418-1:2016ISO 11418-1:2016(E)ii ISO 2016 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2
6、016, 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 prior written permission
7、. 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 11418-1:2016ISO 11418-1:
8、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 resistance 26 Marking
9、 2 ISO 2016 All rights reserved iiiContents PageBS ISO 11418-1:2016ISO 11418-1:2016(E)ForewordISO (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 thr
10、ough 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 collabo
11、rates 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
12、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 subjec
13、t 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 n
14、ame 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 information about ISOs adherence to the World Trade Organization (WT
15、O) 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 medical and pharmaceutical use.This third edition cancels and
16、replaces the second edition (ISO 11418-1:2005), which has been technically revised by updating Figure 1 on typical drop-dispensing glass bottle and Table 1 on nominal volume, brimful capacity and dimensions of drop-dispensing glass bottles, deleting the sizes 25 ml and 75 ml in Table 1, and editoria
17、lly 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 11418-1:2016INTERNATIONAL STANDARD ISO 11418-1:2016(E)Containers and accessories for pharmaceutical preparations Part 1: Drop-dispensing glass bottles1 ScopeThis docu
18、ment specifies the design, dimensions, material and requirements of drop-dispensing glass bottles. Drop-dispensing glass bottles are applicable to primary packs used in direct contact with a drug.This document is applicable to drop-dispensing glass bottles used in pharmacy. Together with the corresp
19、onding closure systems, they serve for packaging of pharmaceutical preparations 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
20、 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 references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendme
21、nts) 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 121 degrees C Method of test and classificationISO 1101, Geometrical product specifications (GPS) Geometrical tolerancing Toleran
22、ces of form, 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: Determin
23、ation by flame 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
24、 terminological 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 11418-1:2016ISO 11418-1:2016(E)4 Dimensions and designatio
25、n4.1 DimensionsThe dimensions of drop-dispensing glass bottles shall be as shown in Figure 1 and as given in Table 1.Tolerancing of form, orientation, location and run-out not specified in this document shall be in accordance with ISO 1101.4.2 DesignationDrop-dispensing glass bottles for pharmaceuti
26、cal use shall be designated by a reference to this document, followed by the nominal volume and the colour of the glass.EXAMPLE A drop-dispensing glass bottle of nominal volume 100 ml, made of colourless glass (cl) of hydrolytic resistance container class ISO 4802-HC 3, in accordance with this docum
27、ent is designated as follows:Drop-dispensing glass bottle ISO 11418-1 100 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 IS
28、O 719-HGB 3 or ISO 720-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 drop-dispensing
29、 glass bottle shall comply with the requirements of the hydrolytic resistance container class ISO 4802-HC 3.5.2.3 Thermal shock resistanceDrop-dispensing glass bottles shall withstand the thermal shock of a temperature difference of 42 C when tested in accordance with the thermal shock resistance te
30、st specified in ISO 7459.6 MarkingThe drop-dispensing glass bottle shall be marked with the information specified in Figure 1.2 ISO 2016 All rights reservedBS ISO 11418-1:2016ISO 11418-1:2016(E)Key1 ISO letters (optional)2 manufacturers trademark3 nominal volume (optional)4 bottom surface may be gra
31、nular, flat or riffled5 manufacturers code/designation of the mould6 blow back within the range 2 mm to 5 mm 0 mm to entry bore diameter for seating a plastic lineraThe number of the mould may be placed on the curve r3, on the bottom or on the shoulder of the bottle but not on the cylindrical part t
32、o avoid any conflict of contact.bEntry bore.cThe approximate values are at the manufacturers discretion.Figure 1 Typical drop-dispensing glass bottle, showing marking locations ISO 2016 All rights reserved 3BS ISO 11418-1:2016ISO 11418-1:2016(E)Table 1 Nominal volume, brimful capacity and dimensions
33、 of drop-dispensing glass bottlesDimensions in millimetresNominal volumeMinimum brimful capacityad1h1h2h3h4r1r2r4tMassgnom. tol. nom. tol.ml ml 5 7 0,80 22,5 0,5 53,2 0,6 37, 8 34,1 45,5 1,5 2,5 1,5 1,5 2710 14 0,85 25,0 0,5 60,7 0,8 45,2 37, 5 54,0 3,0 7,1 2,0 1,5 2815 20 1,00 28,5 0,5 65,2 0,9 49,
34、5 39,5 58,5 3,0 8,0 2,0 2,0 3320 25 1,00 29,5 0,6 72,2 0,9 56,5 46,0 65,5 4,0 8,0 2,0 1,5 3830 36 1,05 33,0 0,5 80,2 1,0 64,5 52,5 72,0 4,0 9,0 2,5 2,0 4550 58 1,20 38,0 0,6 91,7 1,0 76,0 60,0 84,0 5,0 12,0 2,5 2,0 65100 110 1,50 47,0 0,6 110,7 1,1 95,0 75,0 103,4 5,0 14,0 3,0 2,0 1084 ISO 2016 All
35、rights reservedBS ISO 11418-1:2016BS ISO 11418-1:2016ISO 11418-1:2016(E) ISO 2016 All rights reservedICS 11.120.99; 11.040.20Price based on 4 pagesThis page deliberately left blankBSI is the national body responsible for preparing British Standards and other standards-related publications, informati
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