ANSI AAMI 13408-5-2006 Aseptic processing of health care products - Part 5 Sterilization in place.pdf

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1、ANSI/AAMI/ISO 13408-5: 2006/(R)2015Aseptic processing of health care products Part 5: Sterilization in placeAmerican National StandardAmerican National Standard ANSI/AAMI/ISO 13408-5:2006(R)2015 Aseptic processing of health care products Part 5: Sterilization in place Approved 23 September 2008 by A

2、ssociation for the Advancement of Medical Instrumentation Approved 14 October 2008 and reaffirmed 3 August 2015 by American National Standards Institute, Inc. Abstract: Specifies the general requirements for sterilization in place (SIP) applied to product contact surfaces of the equipment used in th

3、e manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control. This document applies to processes where sterilizing agents are delivered to the internal surfaces of the equipment that can come in contact with the product.

4、Keywords: SIP, sterilizing agents, internal surfacesAAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those substantially concerned with its scope and provisions. The existence of an AAMI standard does not in any respect preclude any

5、one, whether they have approved the standard or not, from manufacturing, marketing, purchasing, or using products, processes, or procedures not conforming to the standard. AAMI standards are subject to periodic review, and users are cautioned to obtain the latest editions. CAUTION NOTICE: This AAMI

6、standard may be revised or withdrawn at any time. AAMI procedures require that action be taken to reaffirm, revise, or withdraw this standard no later than five years from the date of publication. Interested parties may obtain current information on all AAMI standards by calling or writing AAMI. All

7、 AAMI standards, recommended practices, technical information reports, and other types of technical documents developed by AAMI are voluntary, and their application is solely within the discretion and professional judgment of the user of the document. Occasionally, voluntary technical documents are

8、adopted by government regulatory agencies or procurement authorities, in which case the adopting agency is responsible for enforcement of its rules and regulations. Published by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Dr., Suite 301Arlington, VA 22203-1633 www.aami

9、.org 2008 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of ISO, ANSI, and AAMI. No part of this publication may be reproduced or distributed in any form, including an electronic retrieval system, without the prio

10、r written permission of AAMI. All requests pertaining to this document should be submitted to AAMI. It is illegal under federal law (17 U.S.C. 101, et seq.) to make copies of all or any part of this document (whether internally or externally) without the prior written permission of the Association f

11、or the Advancement of Medical Instrumentation. Violators risk legal action, including civil and criminal penalties, and damages of $100,000 per offense. For permission regarding the use of all or any part of this document, contact AAMI, 4301 N. Fairfax Dr., Suite 301, Arlington, VA 22203-1633. Phone

12、: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America ISBN 157020330X Contents Page Glossary of equivalent standards v Committee representation. vii Background of ANSI/AAMI adoption of ISO 13408-5:2006 . ix Foreword xi Introduction xii 1 Scope 1 2 Normative references . 1 3

13、Terms and definitions. 2 4 Quality system elements 3 4.1 General. 3 4.2 Management responsibility 4 4.3 Design control. 4 4.4 Measuring instruments and measuring systems 4 5 Process and equipment characterization. 4 5.1 General concepts 4 5.2 Effectiveness of sterilization in place (SIP) 5 5.3 Equip

14、ment 5 5.3.1 Equipment to be subjected to SIP. 5 5.3.2 Equipment to be used for SIP 6 5.3.3 Failure detection . 7 6 Sterilizing agent characterization 7 6.1 Selection of sterilizing agent(s). 7 6.2 Quality of sterilizing agent(s). 7 6.3 Safety and the environment. 7 7 SIP process 8 7.1 Process param

15、eters 8 7.2 Cycle development . 8 8 Validation . 8 8.1 Validation protocol 8 8.2 Design qualification 9 8.3 Installation qualification. 9 8.3.1 General. 9 8.3.2 Installation . 9 8.4 Operational qualification 9 8.5 Performance qualification 10 8.5.1 General requirements. 10 8.5.2 Microbicidal effecti

16、veness . 11 8.6 Review and approval of validation 11 8.7 Requalification 12 9 Routine monitoring and control 12 9.1 SIP process control 12 9.2 Procedures 12 9.3 SIP process records . 12 9.4 Change control 13 9.5 Maintenance of equipment. 13 10 Personnel training. 13 Annex A (informative) Steam steri

17、lization in place . 14 A.1 Introduction . 14 A.2 Process and equipment characterization. 14 A.3 Quality of steam 15 A.4 Microbicidal effectiveness . 15 A.5 Routine monitoring and control 16 Bibliography . 17 2008 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 13408-5:2006 v

18、 Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. For each International Standard that has been adopted by AAMI (and ANSI), the table below gives the corresponding U.S. designation and level of eq

19、uivalency to the International Standard. NOTE: Documents are sorted by international designation. Other normatively referenced International Standards may be under consideration for U.S. adoption by AAMI; therefore, this list should not be considered exhaustive. International designation U.S. design

20、ation Equivalency IEC 60601-1:2005 ANSI/AAMI ES60601-1:2005 Major technical variations IEC 60601-1-2:2007 ANSI/AAMI/IEC 60601-1-2:2007 Identical IEC 60601-2-2:2006 ANSI/AAMI/IEC 60601-2-2:2006 Identical IEC 60601-2-4:2002 ANSI/AAMI DF80:2003 Major technical variations IEC 60601-2-19:1990 and A1:1996

21、 ANSI/AAMI II36:2004 Major technical variations IEC 60601-2-20:1990 and A1:1996 ANSI/AAMI II51:2004 Major technical variations IEC 60601-2-21:1994 and Amendment 1:1996 ANSI/AAMI/IEC 60601-2-21 and Amendment 1:2000 (consolidated texts) Identical IEC 60601-2-24:1998 ANSI/AAMI ID26:2004 Major technical

22、 variations IEC 60601-2-47:2001 ANSI/AAMI EC38:2007 Major technical variations IEC 60601-2-50:2001 ANSI/AAMI/IEC 60601-2-50:2006 Identical IEC 80601-2-58:2008 ANSI/AAMI/IEC 80601-2-58:2008 Identical IEC/TR 60878:2003 ANSI/AAMI/IEC TIR60878:2003 Identical IEC/TR 62296:2003 ANSI/AAMI/IEC TIR62296:2003

23、 Identical IEC 62304:2006 ANSI/AAMI/IEC 62304:2006 Identical IEC/TR 62348:2006ANSI/AAMI/IEC TIR62348:2006 Identical ISO 5840:2005 ANSI/AAMI/ISO 5840:2005 Identical ISO 7198:1998 ANSI/AAMI/ISO 7198:1998/2001/(R)2004 Identical ISO 7199:1996 ANSI/AAMI/ISO 7199:1996/(R)2002 Identical ISO 8637:2004 ANSI/

24、AAMI RD16:2007 Major technical variations ISO 8638:2004 ANSI/AAMI RD17:2007 Major technical variations ISO 10993-1:2003 ANSI/AAMI/ISO 10993-1:2003 Identical ISO 10993-2:2006 ANSI/AAMI/ISO 10993-2:2006 Identical ISO 10993-3:2003 ANSI/AAMI/ISO 10993-3:2003 Identical ISO 10993-4:2002 and A1:2006 ANSI/A

25、AMI/ISO 10993-4:2002 and A1:2006 Identical ISO 10993-5:1999 ANSI/AAMI/ISO 10993-5:1999 Identical ISO 10993-6:2007 ANSI/AAMI/ISO 10993-6:2007 Identical ISO 10993-7:2008 ANSI/AAMI/ISO 10993-7:2008 Identical ISO 10993-9:1999 ANSI/AAMI/ISO 10993-9:1999/(R)2005 Identical ISO 10993-10:2002 and Amendment 1

26、:2006 ANSI/AAMI BE78:2002/(R)2008 ANSI/AAMI BE78:2002/A1:2006/(R)2008 Minor technical variations Identical ISO 10993-11:2006 ANSI/AAMI/ISO 10993-11:2006 Identical ISO 10993-12:2007 ANSI/AAMI/ISO 10993-12:2007 Identical ISO 10993-13:1998 ANSI/AAMI/ISO 10993-13:1999/(R)2004 Identical ISO 10993-14:2001

27、 ANSI/AAMI/ISO 10993-14:2001/(R)2006 Identical ISO 10993-15:2000 ANSI/AAMI/ISO 10993-15:2000/(R)2006 Identical ISO 10993-16:1997 ANSI/AAMI/ISO 10993-16:1997/(R)2003 Identical ISO 10993-17:2002 ANSI/AAMI/ISO 10993-17:2002/(R)2008 Identical ISO 10993-18:2005 ANSI/AAMI BE83:2006 Major technical variati

28、ons ISO/TS 10993-19:2006 ANSI/AAMI/ISO TIR10993-19:2006 Identical ISO/TS 10993-20:2006 ANSI/AAMI/ISO TIR10993-20:2006 Identical ISO 11135-1:2007 ANSI/AAMI/ISO 11135-1:2007 Identical International designation U.S. designation Equivalency ISO/TS 11135-2:2008 ANSI/AAMI/ISO TIR11135-2:2008 Identical ISO

29、 11137-1:2006ANSI/AAMI/ISO 11137-1:2006 Identical ISO 11137-2:2006 (2006-08-01 corrected version)ANSI/AAMI/ISO 11137-2:2006 Identical ISO 11137-3:2006ANSI/AAMI/ISO 11137-3:2006 Identical ISO 11138-1: 2006 ANSI/AAMI/ISO 11138-1:2006 Identical ISO 11138-2: 2006 ANSI/AAMI/ISO 11138-2:2006 Identical ISO

30、 11138-3: 2006 ANSI/AAMI/ISO 11138-3:2006 Identical ISO 11138-4: 2006 ANSI/AAMI/ISO 11138-4:2006 Identical ISO 11138-5: 2006 ANSI/AAMI/ISO 11138-5:2006 Identical ISO/TS 11139:2006 ANSI/AAMI/ISO 11139:2006 Identical ISO 11140-1:2005 ANSI/AAMI/ISO 11140-1:2005 Identical ISO 11140-3:2007 ANSI/AAMI/ISO

31、11140-3:2007 Identical ISO 11140-4:2007 ANSI/AAMI/ISO 11140-4:2007 Identical ISO 11140-5:2007 ANSI/AAMI/ISO 11140-5:2007 Identical ISO 11607-1:2006ANSI/AAMI/ISO 11607-1:2006 Identical ISO 11607-2:2006ANSI/AAMI/ISO 11607-2:2006 Identical ISO 11737-1: 2006 ANSI/AAMI/ISO 11737-1:2006 Identical ISO 1173

32、7-2:1998 ANSI/AAMI/ISO 11737-2:1998 Identical ISO 13408-1:2008 ANSI/AAMI/ISO 13408-1:2008 Identical ISO 13408-2:2003 ANSI/AAMI/ISO 13408-2:2003 Identical ISO 13408-3:2006 ANSI/AAMI/ISO 13408-3:2006 Identical ISO 13408-4:2005 ANSI/AAMI/ISO 13408-4:2005 Identical ISO 13408-5:2006 ANSI/AAMI/ISO 13408-5

33、:2006 Identical ISO 13408-6:2006 ANSI/AAMI/ISO 13408-6:2006 Identical ISO 13485:2003 ANSI/AAMI/ISO 13485:2003 Identical ISO 14155-1:2003 ANSI/AAMI/ISO 14155-1:2003/(R)2008 Identical ISO 14155-2:2003 ANSI/AAMI/ISO 14155-2:2003/(R)2008 Identical ISO 14160:1998 ANSI/AAMI/ISO 14160:1998/(R)2008 Identica

34、l ISO 14161:2000 ANSI/AAMI/ISO 14161:2000 Identical ISO 14937:2000 ANSI/AAMI/ISO 14937:2000 Identical ISO/TR 14969:2004 ANSI/AAMI/ISO TIR14969:2004 Identical ISO 14971:2007 ANSI/AAMI/ISO 14971:2007 Identical ISO 15223-1:2007 and A1:2008 ANSI/AAMI/ISO 15223-1:2007 and A1:2008 Identical ISO 15225:2000

35、 and A1:2004 ANSI/AAMI/ISO 15225:2000/(R)2006 and A1:2004/(R)2006 Identical ISO 15674:2001 ANSI/AAMI/ISO 15674:2001 Identical ISO 15675:2001 ANSI/AAMI/ISO 15675:2001 Identical ISO 15882:2008 ANSI/AAMI/ISO 15882:2008 Identical ISO/TR 16142:2006 ANSI/AAMI/ISO TIR16142:2005 Identical ISO 17664:2004 ANS

36、I/AAMI ST81:2004 Major technical variations ISO 17665-1:2006 ANSI/AAMI/ISO 17665-1:2006 Identical ISO 18472:2006 ANSI/AAMI/ISO 18472:2006 Identical ISO/TS 19218:2005 ANSI/AAMI/ISO 19218:2005 Identical ISO 22442-1:2007 ANSI/AAMI/ISO 22442-1:2007 Identical ISO 22442-2:2007 ANSI/AAMI/ISO 22442-2:2007 I

37、dentical ISO 22442-3:2007 ANSI/AAMI/ISO 22442-3:2007 Identical ISO 25539-1:2003 and A1:2005 ANSI/AAMI/ISO 25539-1:2003 and A1:2005 Identical ISO 25539-2:2008 ANSI/AAMI/ISO 25539-2:2008 Identical ISO 81060-1:2007 ANSI/AAMI/ISO 81060-1:2007 Identical vi 2008 Association for the Advancement of Medical

38、Instrumentation ANSI/AAMI/ISO 13408-5:2006 Committee representation Association for the Advancement of Medical Instrumentation Aseptic Processing Working Group The adoption of ISO 13408-5:2006 as an American National Standard was initiated by the AAMI Aseptic Processing Working Group of the AAMI Ste

39、rilization Standards Committee. The AAMI Aseptic Processing Working Group also functions as a U.S. Technical Advisory Group to the relevant work in the International Organization for Sterilization (ISO). U.S. representatives from the AAMI Aseptic Processing Working Group (U.S. Sub-TAG for ISO/TC 198

40、/WG 9) played an active part in developing the ISO standard. At the time this document was published, the AAMI Aseptic Processing Working Group had the following members: Cochairs: Thomas J. Arista Lisa N. Macdonald Members: Thomas J. Arista, FDA/CDRH Kimbrell Darnell, CR Bard William Facemire, Ster

41、ilization Science Inc. Catherine J. Finocchario, Bausch b) pre-requisite cleaning procedure, where necessary; c) introduction, homogeneity, distribution and contact time with the sterilizing agent; d) physical and/or chemical characteristics of sterilizing agent(s); e) demonstration of the efficacy

42、of the process; f) sterilizing agent residuals or degradation products; g) drying of product contact surfaces, where necessary; h) maintenance of sterility after the completion of the process; i) acceptable tolerances for any potential residues from the process in the product to be made in the equip

43、ment; j) physical integrity testing and establishing limits. 5.1.2 Process parameters and their tolerances shall be specified, documented and reviewed. 4 2008 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 13408-5:2006 5.1.3 During production processes, the sterilizing cond

44、itions achieved shall be monitored, maintained within specified tolerances, and documented throughout the duration of the sterilization process. 5.1.4 Although the entire processing system can be sterilized as a single entity in SIP, it can be advantageous to divide the system into several parts in

45、order to simplify the sterilization procedures. When a large system is sterilized by dividing it into several segments, the segments should overlap to ensure that all portions of the system are adequately and effectively sterilized. 5.1.5 Complex sequences of opening and shutting of valves in the pi

46、pes of a system could be required. Where this is controlled manually, detailed documentation of individual steps is required. Where automation is used, electronic automation systems should be carefully designed and validated. 5.2 Effectiveness of sterilization in place (SIP) The sterility assurance

47、level of the process shall be established and documented. Justification of the process parameters shall be included in the documentation. 5.3 Equipment 5.3.1 Equipment to be subjected to SIP 5.3.1.1 The equipment shall be designed and manufactured to facilitate SIP and to ensure that the sterilizing

48、 agent(s) can enter all internal product contact parts of the equipment to be sterilized (such as filter housings, pipe branches, and valves). Design considerations shall include, but not be limited to: a) smoothness of inner surface of equipment; b) accessibility of the sterilizing agent to all rel

49、evant surfaces; c) correct placement of ports to admit the sterilizing agent(s) and, where applicable, to allow bleeding to facilitate sterilizing agent distribution; d) absence of dead legs in piping systems; e) drainability of the system (e.g. slope of piping to ensure the complete removal of remaining liquid in the system); f) correct placement of ports to permit inclusion of process monitoring devices; g) where applicable, exhaust port for safe removal of gaseous sterilizing agent; h) where applicable, resistance of the equipment to pressure, vacuum and heat; i) co