BS EN ISO 8871-5-2016 Elastomeric parts for parenterals and for devices for pharmaceutical use Functional requirements and testing《非肠道和制药设备用弹性件 功能要求和试验》.pdf

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1、BS EN ISO 8871-5:2016Elastomeric parts forparenterals and for devices forpharmaceutical usePart 5: Functional requirements and testingBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 8871-5:2016 BRITISH STANDARDNational forewordThis British Standard is the U

2、K implementation of EN ISO8871-5:2016. It supersedes BS EN ISO 8871-5:2014 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/212, IVDs.A list of organizations represented on this committee can beobtained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 doe

3、s not purport to include 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 90320 5ICS 11.040.20Compliance with a British Standard cannot confer immunity fromlegal

4、obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 November 2016.Amendments/Corrigenda issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8871-5 November 2016 ICS 11.040.20 Supersedes

5、 EN ISO 8871-5:2014English Version Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2016) lments en lastomre pour administration parentrale et dispositifs usage pharmaceutique - Partie 5: Exigences fonctionnelles et es

6、sais (ISO 8871-5:2016) Elastomere Teile fr Parenteralia und fr Gerte zur pharmazeutischen Verwendung - Teil 5: Funktionelle Anforderungen und Prfung (ISO 8871-5:2016) This European Standard was approved by CEN on 6 August 2016. CEN members are bound to comply with the CEN/CENELEC Internal Regulation

7、s 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 application to the CEN-CENELEC Management Centre or to any CEN member. Th

8、is 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 Management Centre has the same status as the official versions. CEN mem

9、bers 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, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portu

10、gal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any fo

11、rm and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 8871-5:2016 EBS EN ISO 8871-5:2016EN ISO 8871-5:2016 (E) 3 European foreword This document (EN ISO 8871-5:2016) has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection, and blood processi

12、ng equipment for medical and pharmaceutical use“ in collaboration with Technical Committee CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endors

13、ement, at the latest by May 2017 and conflicting national standards shall be withdrawn at the latest by May 2017. 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

14、 or all such patent rights. This document supersedes EN ISO 8871-5:2014. According 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, Denm

15、ark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, 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 no

16、tice The text of ISO 8871-5:2016 has been approved by CEN as EN ISO 8871-5:2016 without any modification. BS EN ISO 8871-5:2016ISO 8871-5:2016(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Requirements 24.1 Penetrability 24.2 Fragmentation . 24.3 Self-sea

17、ling and aqueous solution tightness . 24.4 Aqueous solution tightness 25 Preparation of elastomeric closures for testing 25.1 Sampling . 25.2 Cleaning . 25.3 Sterilization 2Annex A (normative) Test for penetrability 3Annex B (normative) Test for fragmentation 4Annex C (normative) Test for self-seali

18、ng and dye solution tightness 6Annex D (normative) Test for dye solution tightness 8Bibliography .10 ISO 2016 All rights reserved iiiContents PageBS EN ISO 8871-5:2016ISO 8871-5:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bo

19、dies (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. International organizatio

20、ns, 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 used to develop this document and those intended for its further

21、 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 rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives)

22、.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 identified during the development of the document will be in the Introd

23、uction 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 the meaning of ISO specific terms and expressions related to con

24、formity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 76, Transfusion, infusion and injection, and blood processin

25、g equipment for medical and pharmaceutical use.This second edition cancels and replaces the first edition (ISO 8871-5:2005), which has been technically revised.ISO 8871 consists of the following parts, under the general title Elastomeric parts for parenterals and for devices for pharmaceutical use:

26、Part 1: Extractables in aqueous autoclavates Part 2: Identification and characterization Part 3: Determination of released-particle count Part 4: Biological requirements and test methods Part 5: Functional requirements and testingiv ISO 2016 All rights reservedBS EN ISO 8871-5:2016ISO 8871-5:2016(E)

27、IntroductionElastomeric or rubber closures for pharmaceutical use are used in combination with vials and many times in conjunction with piercing devices. There are three functional parameters which are important to the piercing process. These are penetrability, fragmentation and self-sealing. The th

28、ree functional tests described in this part of ISO 8871 can be used as a reference method for testing elastomeric closures that are pierced using injection needles made from metal. In addition, the aqueous solution tightness test can be used to verify the effectiveness of the sealing of a specific c

29、losure/vial combination. ISO 2016 All rights reserved vBS EN ISO 8871-5:2016BS EN ISO 8871-5:2016Elastomeric parts for parenterals and for devices for pharmaceutical use Part 5: Functional requirements and testing1 ScopeThis part of ISO 8871 specifies requirements and test methods for functional par

30、ameters of elastomeric closures used in combination with vials and when pierced by an injection needle.NOTE Functional testing with spikes is specified in ISO 8536-2 and in ISO 8536-6.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and

31、are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 7864, Sterile hypodermic needles for single useISO 8362-1, Injection containers and accessories Pa

32、rt 1: Injection vials made of glass tubingISO 8362-3, Injection containers and accessories Part 3: Aluminium caps for injection vialsISO 8362-4, Injection containers and accessories Part 4: Injection vials made of moulded glassISO 8362-6, Injection containers and accessories Part 6: Caps made of alu

33、minium-plastics combinations for injection vials3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1penetrabilityforce required for piercing an elastomeric closure3.2fragmentationmeasure of the number of elastomeric particles which are generated by

34、the piercing process3.3self-sealingmeasure of the resealing efficiency of elastomeric closures following penetration and withdrawal of a needle3.4aqueous solution tightnessmeasure for the effective sealing of a specific elastomeric closure/vial combinationINTERNATIONAL STANDARD ISO 8871-5:2016(E) IS

35、O 2016 All rights reserved 1BS EN ISO 8871-5:2016ISO 8871-5:2016(E)4 Requirements4.1 PenetrabilityWhen tested in accordance with Annex A, the force required for piercing shall not be greater than 10 N for each closure.4.2 FragmentationWhen tested in accordance with Annex B, the number of elastomeric

36、 fragments per 48 piercings visible with the naked eye shall not be greater than 5.4.3 Self-sealing and aqueous solution tightnessWhen tested in accordance with Annex C, none of the vials shall contain any trace of coloured solution when observed with the naked eye. This requirement applies to multi

37、-dose containers only, i.e. containers which utilize elastomeric closures that are pierced multiple times.Materials that meet the requirements are not required to undergo further testing in accordance with 4.4.4.4 Aqueous solution tightnessWhen tested in accordance with Annex D, none of the vials sh

38、all contain any trace of coloured solution when observed with the naked eye.5 Preparation of elastomeric closures for testing5.1 SamplingThe number of closures required for each test is as follows. Penetrability: 10 Fragmentation: 12 Self-sealing and aqueous solution tightness: 10 Aqueous solution t

39、ightness: 10In practice, it is recommended that more than the minimum required number of closures be prepared for testing.5.2 CleaningClosures shall be sterilized in the as-delivered condition. If samples from regular production cleaning processes are not available, the stoppers shall be cleaned in

40、accordance with the following procedure.Introduce an appropriate number of rubber closures in a suitable glass container, cover with particle-free water, boil for 5 min, then rinse five times with cold particle-free water.5.3 SterilizationThe closures shall be tested after having been subjected to t

41、he sterilization method actually used.2 ISO 2016 All rights reservedBS EN ISO 8871-5:2016ISO 8871-5:2016(E)Annex A (normative) Test for penetrabilityA.1 GeneralMany elastomeric closures for pharmaceutical use are used in conjunction with injection needles. The force necessary to penetrate or pierce

42、a rubber closure is an important parameter in evaluating the suitability of the closure for its intended use.A.2 PrincipleThe force necessary to completely pierce an elastomeric closure is measured using a suitable apparatus.A.3 Apparatus, equipment and reagentsA.3.1 10 closures, prepared in accorda

43、nce with Clause 5.A.3.2 10 clean vials, in accordance with ISO 8362-1 or ISO 8362-4, neck finish size to match the size of closures (A.3.1) (e.g. 13 mm, 20 mm).A.3.3 10 aluminium or plastic/aluminium crimp seals, in accordance with ISO 8362-3 or ISO 8362-6, sized to match the size of closures (A.3.1

44、) (e.g. 13 mm, 20 mm), and crimping apparatus.A.3.4 10 lubricated long-bevel bevel angle (11 2) metal hypodermic needles, external diameter of 0,8 mm in accordance with ISO 7864.A.3.5 Apparatus, capable of measuring a force of 10 N with an accuracy of 0,25 N.A.4 ProcedureA.4.1 Close the vials (A.3.2

45、) with the closures (A.3.1) to be tested and secure with a crimp seal (A.3.3).A.4.2 Fit the force-measuring apparatus (A.3.5) with a hypodermic needle (A.3.4) and pierce a closure perpendicular to the surface. Record the maximum force. Use a new needle for each of the 9 remaining closures and repeat

46、 the procedure.A.5 Expression of resultsRecord the force required for piercing each closure and compare the test results with the requirement in 4.1. ISO 2016 All rights reserved 3BS EN ISO 8871-5:2016ISO 8871-5:2016(E)Annex B (normative) Test for fragmentationB.1 GeneralMany elastomeric closures fo

47、r pharmaceutical use are used in conjunction with injection needles. Elastomeric fragments may be released upon penetration with these injection needles. The number and size of these fragments can affect the quality of drug products with which the elastomeric closures are used.B.2 PrincipleElastomer

48、ic closures for injection vials are pierced with an injection needle. Elastomeric fragments which have been caused by piercing are collected on a filter and counted.B.3 Apparatus, equipment and reagentsB.3.1 12 closures, prepared in accordance with Clause 5.B.3.2 12 clean vials, in accordance with I

49、SO 8362-1 or ISO 8362-4, neck finish size to match the size of closures (B.3.1) (e.g. 13 mm, 20 mm).B.3.3 12 aluminium or plastic/aluminium crimp seals, in accordance with ISO 8362-3 or ISO 8362-6, size to match the size of closures (B.3.1) (e.g. 13 mm, 20 mm), and crimping apparatus.B.3.4 Particle-free water, to fit the fill volumes of the vials (B.3.2) and syringe (B.3.6).B.3.5 12 lubricated long-bevel bevel angle (11 2) metal hypodermic needles, external diameter of 0,8 mm in accordance with ISO 7864.B.3.6 Syringe, ca