industrial sterilization: research from the...

© AAMI

Industrial SterilizationResearch from the Field

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Industrial Ethylene Oxide Sterilization

1Industrial Sterilization© AAMI

By the mid-20th century, the basic science of sterilization was well established. As an applied industrial process in the production of medical devices, however, sterilization was still in its infancy. Utilizing techniques developed by the food industry to combat botulism and other microorganisms in canned foods and by the pharmaceutical industry to minimize microbiological contamination in drugs, manufacturers were producing a variety of sterile medical devices for use in healthcare.

Research by the National Aeronautics and Space Administration in the 1960s provided a boost to this applied field, as sterile condi-tions were needed on spacecraft to ensure that astronauts did not inadvertently con-taminate the moon (or Earth on their return).

By the time AAMI began developing standards in the United States in the early 1970s, the industry had the expertise and community of experts needed to create stand-ards for the industrial sterilization of medical devices. AAMI standards in this area were groundbreaking and used worldwide to ensure that products sold and distributed as sterile were safe and did not pose an infec-tion risk to patients.

Medical technology did not stop develop-ing, however, and as medical devices became more complex and began incorporating more varied (and often more delicate) materials, the task of ensuring sterility became more and more challenging. The medical device industry has responded to this challenge. Through its efforts and research, industrial medical device sterilization has become more sophisticated, and an applied science in its own right.

Research in this field is reflected in the industrial sterilization standards that continue to be produced by AAMI and the International Organization for Standardization (ISO) Technical Committee 198 Sterilization of Health Care Products. That committee was founded and is managed by AAMI.

However, because of the sometimes narrow and applied nature of their work, industrial sterilization scientists have had difficulty publishing their research in traditional scientific journals and publica-tions. There is a need for important work in this field to have its own venue for publica-tion and distribution.

This publication, Industrial Sterilization: Research from the Field, is an effort by AAMI to provide this venue and promote the develop-ment of industrial sterilization science, furthering the association’s goal of advancing safety in medical technology. We hope the medical device community and other readers find the peer-reviewed articles in this publica-tion to be both informative and useful. n

Joseph LewellingVP, Standards Development, AAMI

An Evolving Field




Industrial Ethylene Oxide Sterilization

7 Activities of Water in Ethylene Oxide Sterilization Zhangwu Zhu, Bill Young, George Christman, and John Gilbert

15 Flexible-Chamber EO Sterilization Systems: Part 1—Spore Lethality at Low EO Gas Concentration at Atmospheric Pressure

Daryl L. Woodman, William K. Andersen, and A.E. Ted May

23 Flexible-Chamber EO Sterilization Systems—Part 2: Homogenous Temperature and EO Concentration Throughout a Flexible Sterlization Bag Daryl L. Woodman, William K. Andersen, and A.E. Ted May

31 Effects of EO Concentration And Temperature on Inactivation of B. Atrophaeus Gary R. Mitchel and Kenneth K. Pricer

37 Modeling of Load Effect on Ethylene Oxide Lethality Gary R. Mitchel

Microbiological Methods

47 Assessment of Bioburden on Samples of Human and Animal Tissues: Part 3—Implications

Validation Studies on Underlying Premises in ISO 11737-1

Gregg A. Mosley and John B. Kowalski

53 The Bioburden Estimate: Not Just Math, But Microbiology

Trabue D. Bryans and Joyce M. Hansen

Steam Sterilization

63 A Simplified Approach to Establishing the Lethal Rate of a Steam Sterlization Cycle

Jason Hedrick

Quality Management Systems And Sterility Assurance

75 Basic Concepts in Process Validation

Donna Swenson

84 Dealing with Nonconformity in The Sterilization Process

Lisa Foster and Joyce M. Hansen

94 Using Statistics as a Risk Analysis Tool for Selecting an Alternate SAL

Brian Nissen, Sopheak Srun, and Martell K. Winters

Table of Contents

AAMI President Mary Logan, JD, CAE Chief Marketing and Communications Officer Steve Campbell Director of Publications Sean Loughlin Managing Editor Erika Hatva Project Coordinator Judy Veale Graphic Designer Kristin Blair Copy Editor Barbara Saxton

Editorial Board

Alan TallentireUniversity of Manchester

Byron LambertAbbott Vascular

David OpieNoxilizer

Eamonn HoxeyJohnson & Johnson

Gary MitchelJohnson & Johnson

Gerry O’DellGerry O’Dell Consulting

Harry BusharU.S. Food and Drug Administration

Jeffrey MartinAlcon Labs

Trabue BryansBryKor, LLC

Industrial Sterilization: Research from the Field is published by the Association for the Advancement of Medical Instrumentation (AAMI), 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633; +1-703-525-4890. © 2013, Association for the Advancement of Medical Instrumentation.

ISBN 1-57020-506-X

To Obtain Copies: Visit http://market-place.aami.org or call +1-877-249-8226.

Advertising and Business: Mention of any commercial product, process, or service by trade name, trademark, manufacturer, or otherwise in Industrial Sterilization: Research from the Field does not constitute or imply an endorsement or recommendation by AAMI. The views and opinions of the authors in this publication do not state or reflect the opinion of AAMI.

Visit AAMI on the web at www.aami.org

Of Results of Bioburden Method




4 Industrial Sterilization © AAMI

BD (Becton, Dickinson and Company) is a global medical technology company that is focused on improving drug delivery, enhancing the diagnosis of infectious diseases

Biotest Laboratories, Inc. was founded in 1988 as a manufacturer and test laboratory for the medical products industry. www.biotestlabs.com

BryKor offers regulatory and technical consulting for the medical device and biologics industries. www.brykor.com

For 50 years Nordion has provided world leading gamma processing systems and Cobalt 60 for reliable sterilization of medical devices. www.nordion.com/gamma

STERIS is a global leader in infection prevention, contamination control, surgical and critical care technologies, and more. www.steris.com

Toxikon is a preclinical contract research organization. We contract and partner with the biotech, pharmaceutical, and medical device industries to deliver exceptional product development services from concept to final product. www.toxikon.com

WuXi AppTec is a leading global pharmaceutical, biopharmaceutical, and medical device outsourcing company with operations in China and the United States. www.wuxiapptec.com

Thank You Sponsors

This publication was made possible by the financial support of these companies:

and cancers, and advancing drug discovery. www.bd.com




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