1、BSI Standards PublicationBS EN ISO 8362-2:2015Injection containers andaccessoriesPart 2: Closures for injection vialsBS EN ISO 8362-2:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO8362-2:2015. It supersedes BS EN ISO 8362-2:2010 which is withdrawn.The
2、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 necessaryprovisions of a contract. Users are responsible for its
3、correctapplication. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 86782 8ICS 11.040.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Stra
4、tegy Committee on 31 October 2015.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8362-2 October 2015 ICS 11.040.20 Supersedes EN ISO 8362-2:2010English Version Injection containers and accessories - Part 2: Closures
5、for injection vials (ISO 8362-2:2015) Rcipients et accessoires pour produits injectables - Partie 2 : Bouchons pour flacons (ISO 8362-2:2015) Injektionsbehltnisse und Zubehr - Teil 2: Stopfen fr Injektionsflaschen (ISO 8362-2:2015) This European Standard was approved by CEN on 29 August 2015. CEN me
6、mbers are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on applica
7、tion to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Manag
8、ement Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia
9、, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix
10、17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 8362-2:2015 EBS EN ISO 8362-2:2015EN ISO 8362-2:2015 (E) 3 European foreword This document (EN ISO 8362-2:2015) has been prepared by Technical Committee I
11、SO/TC 76 “Transfusion, infusion and injection equipment for medical and pharmaceutical use“. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by April 2016, and conflicting national standards shall be
12、 withdrawn at the latest by April 2016. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 8362-2:2010. A
13、ccording to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germ
14、any, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 8362-2:2015 has been approved by CEN as EN ISO 8362-2
15、:2015 without any modification. BS EN ISO 8362-2:2015ISO 8362-2:2015(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Classification 14 Shape and dimensions 25 Designation 36 Material 37 Performance requirements . 47.1 General . 47.2 Physical requirements 47.2.1 Hardness . 47.2.2 Pene
16、trability 47.2.3 Fragmentation 47.2.4 Self-sealing and aqueous solution tightness test . 47.2.5 Dye solution tightness test 47.2.6 Resistance to ageing 47.3 Chemical requirements 47.4 Biological requirements 47.5 Particulate contamination requirements . 58 Labelling 5Bibliography 6 ISO 2015 All righ
17、ts reserved iiiContents PageBS EN ISO 8362-2:2015ISO 8362-2:2015(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 through ISO technical
18、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
19、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
20、 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
21、. 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
22、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 WTO principles in the Technical Barriers to T
23、rade (TBT) see the following URL: Foreword - Supplementary informationThe 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 replaces the second edition (ISO 8362-
24、2:2008), which has been technically revised in order to include a new 7.5 particulate contamination requirements.ISO 8362 consists of the following parts, under the general title Injection containers and accessories: Part 1: Injection vials made of glass tubing Part 2: Closures for injection vials P
25、art 3: Aluminium caps for injection vials Part 4: Injection vials made of moulded glass Part 5: Freeze drying closures for injection vials Part 6: Caps made of aluminium-plastics combinations for injection vials Part 7: Injection caps made of aluminium-plastics combinations without overlapping plast
26、ics partiv ISO 2015 All rights reservedBS EN ISO 8362-2:2015ISO 8362-2:2015(E)IntroductionThe purpose of this part of ISO 8362 is to specify the shape and dimensions of, and the requirements for, elastomeric closures intended for pharmaceutical use. Closures made from elastomeric materials are suita
27、ble primary packaging materials for parenteral preparations. In order to provide seal integrity of the container closure systems, the dimensions of the elastomeric closures have to be compatible with the dimensions of the glass vials and the caps as specified in corresponding parts of ISO 8362.Prima
28、ry packaging components made of elastomeric materials are an integral part of medicinal products and thus the principles of current Good Manufacturing Practices (cGMP) apply to the manufacturing of these components.Principles of cGMP are described in, for example, ISO 15378 or GMP Guidelines as publ
29、ished by the European Community and the United States of America. ISO 2015 All rights reserved vBS EN ISO 8362-2:2015BS EN ISO 8362-2:2015Injection containers and accessories Part 2: Closures for injection vials1 ScopeThis part of ISO 8362 specifies the shape, dimensions, material, performance requi
30、rements and labelling of closures for injection vials covered by ISO 8362-1 and ISO 8362-4.The dimensional requirements are not applicable to barrier-coated closures.Closures specified in this part of ISO 8362 are intended for single use only.NOTE The potency, purity, stability and safety of a medic
31、inal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated referen
32、ces, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 48, Rubber, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRHD)ISO 3302-1, Rubber Tolerances for products Part 1
33、: Dimensional tolerancesISO 3302-2, Rubber Tolerances for products Part 2: Geometrical tolerancesISO 7619-1, Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 1: Durometer method (Shore hardness)ISO 8362-1, Injection containers and accessories Part 1: Injection vials mad
34、e of glass tubingISO 8362-4, Injection containers and accessories Part 4: Injection vials made of moulded glassISO 8871-1, Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavatesISO 8871-4, Elastomeric parts for parenterals and for device
35、s for pharmaceutical use Part 4: Biological requirements and test methodsISO 8871-5:2005, Elastomeric parts for parenterals and for devices for pharmaceutical use Part 5: Functional requirements and testing3 ClassificationClosures for injection vials shall be classified as follows: Type A: closures
36、for injection vials without no-pop/blow-back feature; Type B: closures for injection vials with no-pop/blow-back feature.INTERNATIONAL STANDARD ISO 8362-2:2015(E) ISO 2015 All rights reserved 1BS EN ISO 8362-2:2015ISO 8362-2:2015(E)4 Shape and dimensions4.1 The shape and dimensions of closures shall
37、 be as shown in Figure 1 and as given in Table 1. Figure 1 illustrates two types of closures, Types A and B.Dimensions in millimetresa) Type Ab) Type BKey1 no-pop/blow-back featureaInner diameter shall not be wider than inner lumen.Figure 1 Dimensions and configuration of Types A and B closures2 ISO
38、 2015 All rights reservedBS EN ISO 8362-2:2015ISO 8362-2:2015(E)Table 1 Dimensions of injection closuresDimensions in millimetresType Nomi-nal sized10,15d2max.d30,2d40,2h1min.h20,25h3min.h4min.Injection vialsISO 8362-1 ISO 8362-4A13 7, 50 5 12,5 6,2 2,00 2,0 1,5 2 R and 4 R 20 13,20 10 18,8 8,5 3,30
39、 2,0 1,5 6 R to 30 R 5 H to 100 HB13 7,40 5 12,5 7,6 6,2 2,00 2,0 1,5 2 I to 10 I20 13,00 10 18,8 13,3 8,5 3,30 2,0 1,5 6 H to 100 H4.2 If not otherwise specified, general dimensional tolerances shall be in accordance with ISO 3302-1 and ISO 3302-2.4.3 If spacers are located on top of the flange, th
40、ey shall not interfere with the marks for the piercing area (see Figure 1). The height of the spacers shall not exceed 0,3 mm.NOTE The spacers in Figure 1 for Type A and Type B closures are shown for illustrative purposes only and do not form part of the requirements of this part of ISO 8362.4.4 If
41、the flange of the closure has a slightly conical shape, it shall be 0,3 mm maximum in relation to the diameter in order to facilitate production. The tolerances of the trimming edge of the flange shall comply with the tolerances specified in Table 1 for diameter, d3.4.5 All edges of the closure may
42、be rounded.5 DesignationClosures can be designated according to their type (see 4.1 and Figure 1). The designation is expressed as the number of this part of ISO 8362 followed by the nominal size of the closure followed by the type letter.EXAMPLE A Type A closure for injection vials of nominal size
43、13 complying with the requirements laid down in this part of ISO 8362 is designated as follows:Injection closure ISO 8362-2 - 13 A6 MaterialThe elastomeric material used shall meet the requirements specified in Clause 7.The elastomeric material shall withstand two sterilization cycles when autoclavi
44、ng in saturated steam at (121 2) C for 30 min without exceeding the specified limits and without impairment of its performance characteristics under the conditions of normal use. In case other sterilization methods are used, e.g. irradiation, the suitability of the material shall be evaluated.Closur
45、es shall be made from the elastomeric formulation originally tested and approved by the end user. The closure manufacturer shall ensure the conformance of each delivery with the type sample and the compliance with previously agreed functional and compendial requirements. ISO 2015 All rights reserved
46、 3BS EN ISO 8362-2:2015ISO 8362-2:2015(E)7 Performance requirements7.1 GeneralThe requirements specified in 7.2 to 7.4 represent minimum requirements which refer to the condition of the elastomeric closures on receipt by the user.7.2 Physical requirements7.2.1 HardnessThe hardness agreed between man
47、ufacturer and user shall not differ from the nominal value by more than 5 Shore A when tested in accordance with ISO 7619-1 on a special test specimen. Alternatively, the hardness can be tested on the closures in accordance with ISO 48. If tested in accordance with ISO 48, the microhardness shall no
48、t differ by more than 5 IRHD from the type sample.7.2.2 PenetrabilityThe requirements of ISO 8871-5:2005, 4.1, shall apply.7.2.3 FragmentationThe requirements of ISO 8871-5:2005, 4.2, shall apply.7.2.4 Self-sealing and aqueous solution tightness testThe requirements of ISO 8871-5:2005, 4.3, shall ap
49、ply.7.2.5 Dye solution tightness testThe requirements of ISO 8871-5:2005, 4.4, shall apply. If the test specimen complies with 7.2.4, the requirements of this subclause have also been met and separate testing according to this subclause is not needed.7.2.6 Resistance to ageingThe maximum time between the date of manufacture and pharmaceutical use should be agreed upon between the manufacturer of the closures and the user.The closures shall maintain their performance characteristics throughout the enti
