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American National Standard ANSI/AAMI/ISO 13408-1:2008/(R)2011/A1:2013ANSI/AAMI/ISO 13408-1:2008/(R)2011 Aseptic processing of health care products — Part 1: General requirements Amendment 1 Developed by Association for the Advancement of Medical Instrumentation Approved 27 March 2013 by: Ameri can National Standards Institute, Inc. Abstract: Corrects spelling errors; clarifies a definition note; and replaces terms used in Table 1 and Table 2. Keywords: sterilization, aseptic AAMI 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 anyone, 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 CAUTION NOTICE: This AAMI standard may be revised or withdrawn at any time.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 5 years from the date of publication. Interested parties may obtain current information on all AAMI standards by calling or writing AAMI, or by visiting the AAMI website at www.aami.org. All 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 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 Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org ©2013 by the Association for the Advancement of Medical Instrumentation All Rights Reserved Publication, reproduction, photocopying, storage, or transmission, electronically or otherwise, of all or any part of this document without the prior written permission of the Association for the Advancement of Medical Instrumentation is strictly prohibited by law. 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 for 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, complete the reprint request form at www.aami.org or contact AAMI, 4301 N. Fairfax Dr., Suite 301, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-525-1067. Printed in the United States of America ISBN 1-57020-326-1 Contents Page Committee representation......................................................................................................................... iv Background on AAMI adoption of ISO 13408-1:2008 Amd 1 ................................................................. vi Foreword .................................................................................................................................................... vii Amendment ................................................................................................................................................. 1 iv 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 13408-1:2008/(R)2011/A1:2013 Committee representation Associ ation for the Advancement of Medical Instrumentation Steril ization Standards Committee The adoption of ISO 13408-1:2008/Amendment 1 as an American National Standard was initiated by the AAMI ST/WG 9, Aseptic Processing Working Group. The AAMI Aseptic Processing Working Group also functions as a U.S. Technical Advisory Group to the relevant work in the International Organization for Standardization (ISO). U.S. representatives from the AAMI Aseptic Processing Working Group (U.S. Sub-TAG for ISO/TC 198/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, FDA/CDRH Robert P Tomaselli, J ohnson & J ohnson Members: Thomas J . Arista, FDA/CDRH Charles Cogdill, Covidien Steven J . Elliot, NAMSA Kimbrell Darnell, CR Bard Susan Elwell, Medtronic Inc. WHQ Campus Gordon M. Ely, WuXi AppTec Inc Rosanna Fardo, RN BSN CIC CHSP, Department of Veterans Affairs Robert Fry, Baxter Healthcare Corporation Naomi Gamm, St J ude Medical Inc. Deborah A. Havlik, Hospira Worldwide Inc. Rachel Hill, CareFusion Roland C. Kippenhan, Medivators Inc. J ames P. Kulla, BS MS, LexaMed Ltd Carol M. Lampe, J M Hansen & Associates Daniel S. Larrimore, Alcon Laboratories Inc. Christine Loshbaugh, Edwards LifeSciences Lisa N. Macdonald, Becton Dickinson & Company Tonya M. Morris, BS, Nelson Laboratories Inc. J anet M. Prust, 3M Healthcare Manuel Saavedra, J r., Kimberly-Clark Corporation David SIlor, Zimmer Inc. Robert P Tomaselli, J ohnson & J ohnson Alternates: David J . Brodersen, Covidien Trabue D. Bryans, WuXi AppTec Inc. J onathan Bull, Becton Dickinson & Company Alyce Dobie, Bausch & Lomb David A. Dominguez, CareFusion J oyce M. Hansen, J ohnson & J ohnson Suzanne Leung, 3M Healthcare J eff Martin, Alcon Laboratories Inc. Elaine S. Mayhall, PhD, FDA/CDRH Terry Mistalski, Medivators Inc. Emily Mitzel, MS, Nelson Laboratories Inc. Robert R. Reich, BS MS, LexaMed Ltd Tyrone S Rouse, Kimberly-Clark Corporation Mike Sadowski, Baxter Healthcare Corporation Dennis L. Wildes, St J ude Medical Inc. Cheryl Work, Becton Dickinson & Company NOTE--Participation by federal agency representatives in the development of this document does not constitute endorsement by the federal government or any of its agencies. 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 13408-1:2008/(R)2011/A1:2013 v At the time this document was published, the AAMI Sterilization Standards Committee had the following members: Cochairs: Victoria M. Hitchins, PhD, FDA/CDRH Michael H. Scholla, Ph.D., Dupont Protection Technologies Members: Christopher Anderson, Boston Scientific Corporation Trabue D. Bryans, WuXi AppTec Inc. Peter A. Burke, PhD, Steris Corporation Nancy Chobin, RN CSPDM, St Barnabas Healthcare System Charles Cogdill, Covidien Ramona Conner, RN MSN CNOR, Association of Perioperative Registered Nurses J acqueline Daley, Sinai Hospital of Baltimore Kimbrell Darnell, CR Bard Lisa Foster, Adiuvo QS & SA Consulting J oel R. Gorski, PhD, NAMSA J oyce M. Hansen, J ohnson & J ohnson Deborah A. Havlik, Hospira Worldwide Inc. Susan G. Klacik, CCSMC FCS ACE, IAHCSMM Byron J . Lambert, PhD, Abbott Laboratories Colleen Patricia Landers, RN, Timmins & District Hospital Reynaldo Lopez, Cardinal Health (MP&S) Lisa N. Macdonald, Becton Dickinson & Company J eff Martin, Alcon Laboratories Inc. Patrick J . McCormick, PhD, Bausch & Lomb Inc. J anet M. Prust, 3M Healthcare Nancy Rakiewicz, Moog Medical Devices Mark Seybold, Baxter Healthcare Corporation Andrew Sharavara, PhD, Propper Manufacturing Co Inc. Mark N. Smith, Getinge USA Martell Kress Winters, BS SM, Nelson Laboratories Inc. William E. Young William T. Young, Sterigenics International Alternates: Lloyd Brown, Covidien Glenn W. Calvert, Becton Dickinson & Company Dave Dion, Cardinal Health (MP&S) Gordon M. Ely, WuXi AppTec Inc. Thomas J . Frazar, J ohnson & J ohnson Martha M. Kadas, Sterigenics International J im Kaiser, Bausch & Lomb Inc. Natalie Lind, IAHCSMM Ralph Makinen, Boston Scientific Corporation Mary S. Mayo, CR Bard Gerald E. McDonnell, PhD, Steris Corporation David Ford McGoldrick, BS, Abbott Laboratories J erry R. Nelson, PhD, Nelson Laboratories Inc. Patrick Polito, Moog Medical Devices Karen Polkinghorne, Dupont Protection Technologies Shaundrea L. Rechsteiner, NAMSA Mike Sadowski, Baxter Healthcare Corporation Craig A. Wallace, 3M Healthcare NOTE--Participation by federal agency representatives in the development of this document does not constitute endorsement by the federal government or any of its agencies. vi 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 13408-1:2008/(R)2011/A1:2013 Background on AAMI adoption of ISO 13408-1:2008 Amd. 1 As indicated in the foreword to the main body of this document (page vii), the International Organization for Standardization (ISO) is a worldwide federation of national standards bodies. The United States is one of the ISO members that took an active role in the development of this standard, which was developed by ISO Technical Committee 198, Sterilization of health care products, to correct errors; clarify language; and replace terms used in Table 1 and Table 2 of ISO 13408-1:2008. U.S. participation in this ISO TC is organized through the AAMI Sterilization Standards Committee which serves as the U.S. Technical Advisory Group for ISO/TC 198. AAMI ST Working Group 09, Aseptic processing, serves as the U.S. sub-TAG for the relevant ISO working group and supports the adoption of this amendment. The U.S. adoption of ANSI/AAMI/ISO 13408-1 Amd 1 was approved by the American National Standards Institute (ANSI) on 27 March 2013. AAMI and ANSI procedures require that standards be reviewed and, if necessary, revised every five years to reflect technological advances that may have occurred since publication. AAMI (and ANSI) have adopted other ISO standards. See the Glossary of Equivalent Standards for a list of ISO standards adopted by AAMI which gives the corresponding U.S. designation and the level of equivalency with the ISO standard. The concepts incorporated in this standard should not be considered inflexible or static. This standard, like any other, must be reviewed and updated periodically to assimilate progressive technological developments. To remain relevant, it must be modified as technological advances are made and as new data come to light. Suggestions for improving this standard are invited. Comments and suggested revisions should be sent to Standards Department, AAMI, 4301 N. Fairfax Dr., Ste. 301, Arlington, VA 22203-1633. NOTE—Beginning with the foreword on page vii, this American National Standard is identical to ISO 13408-1:2008 Amd. 1. 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 13408-1:2008/(R)2011/A1:2013 vii 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 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 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 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 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. Amendment 1 to ISO 13408-1:2008 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. viii 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 13408-1:2008/(R)2011/A1:2013 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 13408-1:2008/(R)2011/A1:2013 1 American National Standard ANSI/AAMI/ISO 13408-1:2008/(R)2011/A1:2013 Aseptic processing of health care products — Part 1: General requirements Page xi, Introduction In the second paragraph, replace the second sentence with the following: ISO/TC 198 has prepared standards for terminal sterilization of health care products by irradiation (ISO 11137 series), by moist heat (ISO 17665 series), by dry heat (ISO 20857), by ethylene oxide (ISO 11135) and by liquid chemical sterilants (ISO 14160). Page vii, Introduction At the end of the last sentence of the penultimate paragraph, add the word "component" so that it reads: "... of which process simulation studies are an essential component." Page 1, Normative references Delete the following reference: ISO 9001, Quality management systems — Requirements Page 2, Normative references Delete footnote 1 and renumber footnote 2 accordingly. Page 3, 3.7 Delete the following: [ISO 13408-6:2005, definition 3.1] Page 4, 3.14 Correct the spelling of the term to read "depyrogenation". 2 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 13408-1:2008/(R)2011/A1:2013 Page 5, 3.24 Replace the note with the following: NOTE The required grade of cleanliness of the indirect support zone depends on the aseptic processing technologies and activities performed. Page 7, 4.1.1 In the first sentence, replace "over all activities affecting aseptic processing" with "over all activities affecting aseptic processing (e.g. ISO 9001 and/or ISO 13485)". Delete the second sentence. Page 8, 4.3.2 Replace the text with the following: The accuracy and tolerance of all measuring instruments shall be adequate for the parameters to be measured. Page 9, 5.2.1.2 At the end of the subclause, insert the following note: NOTEAssessment of risk to condone poor or improper practice during aseptic processing is not appropriate. Page 10, 5.2.4.4 Replace item a) with the following: a) microbiological quality of the product at defined stages during the manufacturing process, alert and action levels shall be established; Page 11, 6.1.2 Replace the second sentence of the note with the following: Where highly potent, cytotoxic or radioactive health care products are to be processed, protection of personnel and the environment is considered an ancillary element of aseptic processing design. 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 13408-1:2008/(R)2011/A1:2013 3 Page 40, Table 1, fifth column In the first, third and fifth rows, replace "restart validation" with "repeat initial performance qualification" to be in line with the title of Table 1. Page 36, Table 2, fourth column In the first, third and fifth rows, replace "revalidation" with "repeat initial performance qualification" to be in line with the title of Table 1. Page 36, 11.1 Replace the text of 11.1 (excluding the notes) with the following: Where a test for sterility is required for aseptically-filled products, then this testing shall be conducted for each batch of product. The pharmacopoeia test for sterility is used when the method is applicable. Where there is no specific method in the pharmacopoeia that is applicable to a particular product, then the manufacturer of the product shall specify the method to be used. Replace NOTE 2 with the following: NOTE 2 In certain jurisdictions approval of a non-pharmacopoeia test for sterility is required by the relevant competent authorities. Page 41, 11.2.2 Replace "from positive units using tests for sterility" with "from positive units during tests for sterility". In the note, replace "from positive units using tests for sterility can be found in the pharmacopoeias" with "from positive units during tests for sterility can be found in the pharmacopoeias". 4 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 13408-1:2008/(R)2011/A1:2013 Page 42, Figure A.1 Replace Figure A.1 with the following: Key indirect support zone direct support zone outside APA critical processing zone direct support zone indirect support zone +grade A air flushing Figure A.1 — Example of an aseptic process divided into unit operations 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 13408-1:2008/(R)2011/A1:2013 5 Page 45, Table D.1 In footnote b, replace "EU GMP Guide, Annex 1:2003 (drafted revision 2005)" with "EU GMP Guide, Annex 1:2009". Page 49, Bibliography Insert the following new reference: [2] ISO 9001, Quality management systems — Requirements Renumber subsequent references accordingly. Replace Reference [16] with the following: [16] EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use (GMP), Volume 4 — Annex 1:2009 Manufacture of Sterile Medicinal Products
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