ISO INTERNATIONAL STANDARD 13408-5 First edition 2006-11-15 Aseptic processing of health care products Part 5: Sterilization in place Traitement aseptique des produits de sante - Partie 5: Stérilisation sur place Reference number ISO 13408-5:2006(E) ISO @ ISO 2006 ISO 13408-5:2006(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems 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 optimizedforprinting.Every care has been taken to ensure thatthe file is suitableforuse by isO member bodies. In the @ISO2006 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 member body in the country of the requester. ISO copyright office Case postale 56· CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail [email protected] Web www.iso.org Published in Switzerland = @ ISO 2006 - All rights reserved ISO 13408-5:2006(E) Contents Page 1 Scope 2 Normative references 1 3 Terms and definitions 2 4 Quality system elements 3 4.1 General ... 3 4.2 Management responsibility ..... 3 4.3 Design control 3 4.4 Measuring instruments and measuring systems 3 5 Process and equipment characterization . 4 5.1 General concepts 4 5.2 Effectiveness of sterilization in place (SIP) 4 5.3 Equipment 4 6 Sterilizing agent characterization 6 6.1 Selection of sterilizing agent(s) 6 6.2 Quality of sterilizing agent(s) 6 6.3 Safety and the environment 6 SIP process 6 7.1 Process parameters 6 7.2 Cycle development . 7 8 Validation 7 8.1 Validation protocol ... 7 8.2 Design qualification 8.3 Installation qualification 8.4 Operational qualification . 8 8.5 Performance qualification . 8 8.6 Review and approval of validation 10 8.7 Requalification 10 9 Routine monitoring and control 10 9.1 SIP process control 10 9.2 Procedures ... 10 9.3 SIP process records 11 9.4 Change control 11 9.5 Maintenance of equipment 11 10Personnel training 11 Annex A (informative) Steam sterilization in place 12 Bibliography 14 @ ISO 2006 - All rights reserved ii ISO 13408-5:2006(E) Foreword IsO (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 Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. adopted by the technical committees are circulated to the member bodies for voting. Publication as an 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 ISO 13408-5 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. Part 1: General requirements — Part2:Filtration — Part 3: Lyophilization Part 4: Clean-in-place technologies Part 5: Sterilization in place Part 6: Isolator systems iv ISO 2006-All rights reserved ISO 13408-5:2006(E) Introduction During the process of preparing IsO 13408-1, several items, e.g. filtration, freeze drying and sterilization in place, were found to be in need of supplementary information which was too voluminous to be given in corresponding annexes. This part of isO 13408 includes requirements and guidance that are to be obse