1、BS ISO 11418-7:2016Containers and accessories forpharmaceutical preparationsPart 7: Screw-neck vials made of glasstubing for liquid dosage formsBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS ISO 11418-7:2016 BRITISH STANDARDNational forewordThis British Standard
2、is the UK implementation of ISO 11418-7:2016.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 all the necessaryprovisi
3、ons of a contract. Users are responsible for its correctapplication. The British Standards Institution 2016. Published by BSI StandardsLimited 2016ISBN 978 0 580 88391 0ICS 11.040.20; 11.120.99Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was p
4、ublished under the authority of theStandards Policy and Strategy Committee on 30 June 2016.Amendments issued since publicationDate Text affectedBS ISO 11418-7:2016 ISO 2016Containers and accessories for pharmaceutical preparations Part 7: Screw-neck vials made of glass tubing for liquid dosage forms
5、Rcipients et accessoires pour prparations pharmaceutiques Partie 7: Flacons avec bague vis en verre tir pour diagnostics forme liquideINTERNATIONAL STANDARDISO11418-7Second edition2016-06-15Reference numberISO 11418-7:2016(E)BS ISO 11418-7:2016ISO 11418-7:2016(E)ii ISO 2016 All rights reservedCOPYRI
6、GHT 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, electronic or mechanical, including photocopying, or posting on the internet or an intranet, with
7、out 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 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS
8、ISO 11418-7:2016ISO 11418-7:2016(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Dimensions and designation . 13.1 Dimensions . 13.2 Designation 14 Material 25 Characteristics 36 Requirements 36.1 Hydrolytic resistance . 36.2 Annealing quality 36.3 Light resistance 37 Marking 38 Pack
9、aging . 3 ISO 2016 All rights reserved iiiContents PageBS ISO 11418-7:2016ISO 11418-7:2016(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
10、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
11、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 ap
12、proval 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
13、 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
14、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 information about ISOs adherence to the World Trade Organizat
15、ion (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 medical and pharmaceutical use.This second edition canc
16、els and replaces the first edition (ISO 11418-7:1998), which has been technically revised by amending the mass of screw-neck vials in Table 1, and editorially revising this part of ISO 11418.ISO 11418 consists of the following parts, under the general title Containers and accessories for pharmaceuti
17、cal preparations: Part 1: Drop-dispensing glass bottles Part 2: Screw-neck glass bottles for syrups Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms Part 4: Tablet glass bottles Part 5: Dropper assemblies Part 7: Screw-neck vials made of glass tubing for liquid dosage forms
18、iv ISO 2016 All rights reservedBS ISO 11418-7:2016ISO 11418-7:2016(E)IntroductionThe purpose of this part of ISO 11418 is to specify the dimensions, capacities, form and requirements of screw-neck vials made from tubular glass intended for medical use. Vials made from glass tubing are considered to
19、be suitable for the packaging and storage of pharmaceutical preparations until they are administered for medicinal purposes. Such vials may be made of different types of glass which can affect chemical resistance properties. For example, those made from borosilicate glass will have a very high level
20、 of chemical resistance where others made from soda-lime-silica glass will have a lower but adequate chemical resistance for the purposes for which they are intended.Because vials may be made from different types of glass and because it is the chemical behaviour of the internal surface which is impo
21、rtant when they are filled with pharmaceutical preparations, it is essential to specify the test procedures by which the performance can be measured. ISO 2016 All rights reserved vBS ISO 11418-7:2016BS ISO 11418-7:2016Containers and accessories for pharmaceutical preparations Part 7: Screw-neck vial
22、s made of glass tubing for liquid dosage forms1 ScopeThis part of ISO 11418 specifies the design, dimensions, material and requirements of screw-neck vials for pharmaceutical preparations. Screw-neck vials are applicable to primary packs used in direct contact with a drug.This part of ISO 11418 appl
23、ies to colourless or amber glass vials made from borosilicate or soda-lime-silica glass, made from glass tubing and intended to be used in the packaging, storage or transportation of pharmaceutical products.NOTE The potency, purity, stability and safety of a drug during its manufacture and storage c
24、an be strongly affected by the nature and performance of the primary pack.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated refer
25、ences, 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 121 degrees C Method of test and classificationISO 480
26、2-1, 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 flame spectrometry and classification3 Dimen
27、sions and designation3.1 DimensionsThe dimensions of screw-neck vials shall be as shown in Figure 1 and as given in Table 1.3.2 DesignationScrew-neck vials for pharmaceutical preparations in liquid form made of glass tubing shall be designated by a reference to this part of ISO 11418, followed by th
28、e letters Glt, for glass tubing, together with the nominal tubing size, followed by the colour of the glass, followed by the hydrolytic resistance class.INTERNATIONAL STANDARD ISO 11418-7:2016(E) ISO 2016 All rights reserved 1BS ISO 11418-7:2016ISO 11418-7:2016(E)EXAMPLE A screw-neck vial for pharma
29、ceutical preparations in liquid form, made of amber glass (br), glass tubing of nominal size 10, of hydrolytic resistance container class ISO 4802 HC 1, in accordance with this part of ISO 11418 is designated as follows:Vial ISO 11418-7 - Glt 10 - br - 1Dimensions in millimetresk5= p4()+23kb = p dd
30、1 3Keyd5diameter of the flankb width of the thread profilec depth of the thread profilek 0,675 (constant for construction of the thread profile)p pitchaThe neck finish shall be cylindrical and shall have the diameter d2until the depth h3. A form of a truncated cone is permitted if at the same time t
31、he following conditions are fulfilled: the truncated cone has the height h3; the admissible tolerances of d2are retained; the larger diameter is located at the bottle opening; the larger diameter is maximum of 0,3 mm longer than the smaller one.Figure 1 Typical example of a screw-neck vial with a ro
32、und thread (knuckle thread) with two complete threads4 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 one of the following hydrolytic resistance grain classes. ISO 720 HGA 1 or2
33、 ISO 2016 All rights reservedBS ISO 11418-7:2016ISO 11418-7:2016(E) ISO 719 HGB 3 or ISO 720 HGA 2.5 Characteristics5.1 Screw-neck vials shall not contain seed or bubbles to an extent which interfere with the visual examination of the contents.5.2 Screw-neck vials shall have a sealing surface which
34、shall not affect the sealing performance of the closure.6 Requirements6.1 Hydrolytic resistanceWhen tested in accordance with ISO 4802-1 or ISO 4802-2, the hydrolytic resistance of the internal surface of the screw-neck vials shall comply with the requirements specified for one of the following hydr
35、olytical resistance container classes: ISO 4802 HC 1 ISO 4802 HC 2 ISO 4802 HC 36.2 Annealing qualityThe screw-neck vials shall be annealed so that the maximum residual stress does not produce an optical retardation exceeding 40 nm per millimetre of glass thickness when the vials are inspected in a
36、strain viewer.6.3 Light resistanceLight-resistance requirements met by using amber coloured glass are not specified in this part of ISO 11418; light-resistance test methods are, however, specified in relevant pharmacopoeias, e.g. Ph. Eur.1)or USP2).7 MarkingThe number of pieces and the designation,
37、together with the name or symbol of the manufacturer, shall be shown on the package. Further information may appear, subject to agreement.8 PackagingThe recommended packaging size for a paper carton, a plastic carton or a shrink-pack in foil can be agreed upon between manufacturer and customer.1) Se
38、e https:/www.edqm.eu2) See http:/www.usp.org/ ISO 2016 All rights reserved 3BS ISO 11418-7:2016ISO 11418-7:2016(E)Table 1 Dimensions,overflowcapacity,threaddesignationandmassofscrewneckvialsDimensions in millimetresNominalsizeOverflowcapacity(brimful)mlANominalthreadd Pitchpd1d2cd3R1R2d4h1h2h3r1r2aS
39、1S2btMassd, eg tol.tol.min.0,50,05+0,3-0,2tol.56,51,0142,5180,208,60,2012,30,40,620,2514,0-0,4450,52910,53,011,50,51,20,80,50,37,17,59,01,2183,0220,2011,50,2016,00,50,740,318,0-0,5400,52311,03,512,00,51,20,80,50,38,81012,51,2183,0240,2011,50,2016,00,50,740,318,0-0,5450,52811,03,512,00,51,20,80,50,31
40、0,51517,51,2183,0240,2011,50,2016,00,50,740,318,0-0,5600,54311,03,512,00,51,20,80,50,313,72025,51,52230300,3015,20,2520,00,50,740,322,0-0,5550,73611,05,51,52,511,20,80,60,416,52531,51,5223,0300,3015,20,2520,00,50,740,322,0-0,5650,74611,05,51,52,511,20,80,60,418,63037,51,5223,0300,3015,20,2520,00,50,
41、740,322,0-0,5750,75611,05,51,52,511,20,80,60,421,2aIn case of using screw-neck vials forfreeze-drying, radius r2maybepossiblybiggerthanthevaluespecifiedinTable1.Thisvalueandtheconcavityofthebottomshallbeagreeduponbetweenmanufacturerandcustomer.bThe pip in the middle of the bottom internal surface sh
42、ould be not more than 0,5mm high.cIn the case of special closure types, the bore, d2, could differ from the specified value. The difference shall be agreed upon between manufacturer and customer.dMean values that can deviate about 10%.eThemassspecificationsapplytoscrew-neckvialsmadeofcolourlessboros
43、ilicateglasshavingalinearexpansioncoefficientofapproximately5,1106K1,density2,34g/cm2. The mass of vials made of other glass types (e.g. amber glass or borosilicate glass 3.3) need to be calculated using the density of the particular glass.4 ISO 2016 All rights reservedBS ISO 11418-7:2016BS ISO 1141
44、8-7:2016ISO 11418-7:2016(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, information and services.BSI is incorporated by Royal
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