1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 8362-2:2010Injection containers andaccessoriesPart 2: Closures for injection vials (ISO8362-2:2008)Copyright European Committee for Standardization Provided by IHS unde
2、r license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 8362-2:2010 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO8362-2:2010. It is identical to ISO 8362-2:2008. It supersedes BS EN28362-2:1993 which i
3、s withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/212, IVDs.A list of organizations represented on this committee can beobtained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 all the necessaryprovisions of a contract. Users are resp
4、onsible for its correctapplication. BSI 2010ISBN 978 0 580 56904 3ICS 11.040.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 September 2010.Amendments issued
5、since publicationDate Text affectedCopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8362-2 September 2010 ICS 11.040.20 Su
6、persedes EN 28362-2:1993English Version Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2008) Rcipients et accessoires pour produits injectables - Partie 2: Bouchons pour flacons (ISO 8362-2:2008) Injektionsbehltnisse und Zubehr - Teil 2: Stopfen fr Injektions
7、flaschen (ISO 8362-2:2008) This European Standard was approved by CEN on 5 August 2010. CEN members 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 list
8、s and bibliographical references concerning such national standards may be obtained on application to the CEN 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 resp
9、onsibility of a CEN member into its own language and notified to the CEN Management 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, France, Germany, Greece, H
10、ungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Ce
11、ntre: Avenue Marnix 17, B-1000 Brussels 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 8362-2:2010: ECopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or
12、networking permitted without license from IHS-,-,-BS EN ISO 8362-2:2010EN ISO 8362-2:2010 (E) 3 Foreword The text of ISO 8362-2:2008 has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection equipment for medical and pharmaceutical use” of the International Organization
13、 for Standardization (ISO) and has been taken over as EN ISO 8362-2:2010. 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 March 2011, and conflicting national standards shall be withdrawn at the late
14、st by March 2011. 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 28362-2:1993. According to the CEN/CENEL
15、EC 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania
16、, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 8362-2:2008 has been approved by CEN as a EN ISO 8362-2:2010 without any modification. Copyright European Committee for Stand
17、ardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 8362-2:2010ISO 8362-2:2008(E) ISO 2008 All rights reserved iiiForeword ISO (the International Organization for Standardization) is a worldwide federation of n
18、ational 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 right to be represented on that committee. Inter
19、national 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. International Standards are drafted in accordance with the
20、 rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by
21、 at least 75 % of the member bodies casting a vote. 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. ISO 8362-2 was prepared by Technical Committee IS
22、O/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use. This second edition cancels and replaces the first edition (ISO 8362-2:1988) which has been technically revised in order to align this part with ISO 8871-1, ISO 8871-4 and ISO 8871-5. ISO 8362 consists of the
23、following parts, under the general title Injection containers and accessories: Part 1: Injection vials made of glass tubing Part 2: Closures for injection vials Part 3: Aluminium caps for injection vials Part 4: Injection vials made of moulded glass Part 5: Freeze drying closures for injection vials
24、 Part 6: Caps made of aluminium-plastics combinations for injection vials Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networkin
25、g permitted without license from IHS-,-,-BS EN ISO 8362-2:2010ISO 8362-2:2008(E) iv ISO 2008 All rights reservedIntroduction The 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 f
26、rom elastomeric materials are suitable 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 cor
27、responding parts of ISO 8362. Primary 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,
28、 ISO 15378 or GMP Guidelines as published by the European Community and the United States of America. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 8362-2:2010INTERNA
29、TIONAL STANDARD ISO 8362-2:2008(E) ISO 2008 All rights reserved 1Injection containers and accessories Part 2: Closures for injection vials 1 Scope This part of ISO 8362 specifies the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO 83
30、62-1 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 medicinal product during its manufacture and storage can strongly be affe
31、cted by the nature and performance of the primary packaging. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (
32、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: Dimensional tolerances ISO 3302-2, Rubber Tolerances for products Part 2: Geometrical tolerances ISO 761
33、9-1, Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 1: Durometer method (Shore hardness) ISO 8871-1, Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates ISO 8871-4, Elastomeric parts for parenterals and
34、 for devices for pharmaceutical use Part 4: Biological requirements and test methods ISO 8871-5:2005, Elastomeric parts for parenterals and for devices for pharmaceutical use Part 5: Functional requirements and testing 3 Classification Closures for injection vials shall be classified as follows: Typ
35、e A: closures for injection vials without no-pop/blow-back feature. Type B: closures for injection vials with no-pop/blow-back feature. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IH
36、S-,-,-BS EN ISO 8362-2:2010ISO 8362-2:2008(E) 2 ISO 2008 All rights reserved4 Shape and dimensions 4.1 The shape and dimensions of closures shall 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 millimetres a) Type A b) Type B
37、Key 1 no-pop/blow-back feature aInner diameter shall not be wider than inner lumen. Figure 1 Dimensions and configuration of Types A and B closures Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without lic
38、ense from IHS-,-,-BS EN ISO 8362-2:2010ISO 8362-2:2008(E) ISO 2008 All rights reserved 3Table 1 Dimensions of injection closures Dimensions in millimetres Injection vials Type Nominal size d1 0,15 d2max. d3 0,2 d4 0,2 h1 min.h2 0,25 h3 min.h4 min. ISO 8362-1 ISO 8362-4 13 7,50 5 12,5 6,2 2,00 2,0 1,
39、5 2 R and 4 R A 20 13,20 10 18,8 8,5 3,30 2,0 1,5 6 R to 30 R 5 H to 100 H 13 7,40 5 12,5 7,6 6,2 2,00 2,0 1,5 2 I to 10 I B 20 13,00 10 18,8 13,3 8,5 3,30 2,0 1,5 6 H to 100 H 4.2 If not otherwise specified, general dimensional tolerances shall be in accordance with ISO 3302-1 and ISO 3302-2. 4.3 I
40、f spacers are located on top of the flange, they 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 th
41、e requirements of this part of ISO 8362. 4.4 If 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 fo
42、r diameter d3. 4.5 All edges of the closure may be rounded. 5 Designation Closures 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
43、Type A closure for injection vials of nominal size 13 complying with the requirements laid down in this part of ISO 8362 is designated as follows: Injection closure ISO 8362-2 - 13 - A 6 Material The elastomeric material used shall meet the requirements specified in Clause 7. The elastomeric materia
44、l shall withstand two sterilization cycles when autoclaving 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,
45、the suitability of the material shall be evaluated. Closures 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
46、 and compendial requirements. 7 Performance requirements 7.1 General The 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. Copyright European Committee for Standardization Provided by IHS under license
47、 with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 8362-2:2010ISO 8362-2:2008(E) 4 ISO 2008 All rights reserved7.2 Physical requirements 7.2.1 Hardness The hardness agreed between manufacturer and user shall not differ from the nominal value by more
48、 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 not differ by more than 5 IRHD from the type sample. 7.2.2 Penetrability The requirements of ISO 8871-5:2005, 4.1, shall apply. 7.2.3 Fragmentation The requirements of ISO 8871-5:2005, 4.2, shall apply. 7.2.4 Self-sealing and container closure seal integrity The requirements of ISO 8871-5:2005, 4.3, sh
