ISO INTERNATIONAL STANDARD 8871-3 First edition 2003-08-01 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of released-particle count Elements en élastomere pour administration parenterale et dispositifs a usagepharmaceutique Partie 3: Dénombrement des particules libérées Reference number ISO 8871-3:2003(E) @ ISO 2003 ISO 8871-3:2003(E) PDF disclaimer shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In accepts no liability in this area. Adobe is atrademarkof AdobeSystems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by IsO member bodies. In ISO2003 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either isO at the address below or IsO's memberbody in the country of the requester. ISO copyright office Case postale 56. CH-1211 Geneva 20 Tel.+4122 749 01 11 Fax + 41 22 749 09 47 E-mail [email protected] Web www.iso.org Published in Switzerland ii @ ISO 2003 - All rights reserved ISO 8871-3:2003(E) @ Contents Page Foreword. iv Introduction 1 Scope. 2 Normative references .. 3 Determination of visible-particle count . 4 Determination of subvisible-particle count. 3 Bibliography. @ IS0 2003 - All rights reserved ii ISO 8871-3:2003(E) Foreword IsO (the International Organization for Standardization) is a worldwide federation of national standards bodies 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 sO, 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 rules given in the ISO/lEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards International Standard requires approval by 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 8871-3 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use. Together with the other parts (see below), this part of ISO 8871 cancels and replaces ISO 8871:1990, 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: 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 testing iv @ ISO 2003 - All rights reserved ISO 8871-3:2003(E) Introduction When elastomeric closures are used as primary packaging materials in direct contact with pharmaceutical preparations, the pharmaceutical industry requires, to an increasing extent, definite details from the rubber manufacturer about the presence of particles the closures may release into an injectable. The test methods specified in Clauses 3 and 4 make it possible to meet this request. @ ISo 2003 - All rights reserved V INTERNATIONALSTANDARD ISO8871-3:2003(E) Elastomeric parts for parenterals and for devices for pharmaceutical use : Part 3: Determination of releas