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Sterilization by Ionizing Radiation Single user license provided by AAMI. Further copying, networking, and distribution prohibited. STERILIZATION BY IONIZING RADIATION VOLUME II ISBN 0-919868-02-9 Single user license provided by AAMI. Further copying, networking, and distribution prohibited. © Johnson & Johnson Limited (1978) 2155 Pie IX Blvd. Montréal, Québec HIV 2E4, Canada Single user license provided by AAMI. Further copying, networking, and distribution prohibited. STERILIZATION OF MEDICAL PRODUCTS BY IONIZING RADIATION INTERNATIONAL CONFERENCE, VIENNA, AUSTRIA April 25-28, 1977 SPONSORED BY Johnson & Johnson Editors: E. R. L. Gaughran and A. J. Goudie MULTISCIENCE PUBLICATION LIMITED MONTRÉAL, QUÉBEC, CANADA Single user license provided by AAMI. Further copying, networking, and distribution prohibited. Acknowledgement Johnson & Johnson wishes to express its sincere appreciation to the United Kingdom Panel on Gamma and Electron Irradiation and to all others who assisted in planning the program and suggesting participants. Single user license provided by AAMI. Further copying, networking, and distribution prohibited. PREFACE The International Conference on the Technical Developments and Prospects of Sterilization by Ionizing Radiation held in April of 1974 provided a forum for the exchange of information on radiation sources, dosimetry and the effect of radiation on the materials of which medical devices are constituted or are packaged. It was impossible to include the equally important microbiological and regulatory aspects of radiation sterilization. The application of radiation sterilization to biological products and medical products, other than devices, was intentionally omitted. The Second Conference on the Sterilization of Medical Products by Ionizing Radiation held in Vienna, Austria on April 25-28, 1977 addressed these areas. The opening lecture presented the basic aspects of the mechanism of cell death due to ionizing radiation, thus providing an introduction to the First Session, which was devoted to microbiological considerations. Here the steps necessary for the commissioning of a new facility, the role of bioburden, and the methods of defining the degree of sterility assurance were examined. Discussed also in this session were the effect of dose rate on microbial kill and the role of water as a modulator of radiation damage to microorganisms. The Second Session was directed to the effects of ionizing radiation on biological tissues, such as bone, tendon, cartilage, heart valves, etc.; on drugs and cosmetics; and the use of ionizing radiation in the preparation of vaccines and antigens. The Third session was devoted to a review of the various national, international and compendial viewpoints on the regulation of sterilization by ionizing radiation. We hope that this volume, along with the Proceedings of the First Conference, will have accomplished our objective to provide an authoritative reference in the field of radiation sterilization and to convey our optimistic feeling for the future of this method of sterilization. New Brunswick E. R. L. Gaughran New Jersey A. J. Goudie Single user license provided by AAMI. Further copying, networking, and distribution prohibited. CONTENTS Copyright Preface INTRODUCTION SESSION Opening Remarks. W. J. Haines Welcome by President of Conference. 1. W. Sizer Mechanism of Cell Death Due to Ionizing Radiation. Tikvah Alper FIRST SESSION Environmental Control and Bioburden in Manufacturing Processes. W. S. Miller and R. Bérubé Ecological Studies of Radiation Sensitivity in Microorganisms at Some Enterprises of Medical Industry. V. V. Bochkarev, E. P. Pavlov, V. G. Khrushchev, V. V. Sedov and E. G. Tushov The Role of Microbiology in Commissioning a New Facility and in Routine Control. E. A. Christensen The Sub-Process Dose in Defining the Degree of Sterility Assurance. A. Tallentine and A. A. Khan Some Dose Rate Effects in Irradiated Microorganisms. G. E. Adams and I. J. Stratford Water as a Modulator of Radiation Damage to Microorganisms. E. L. Powers Experiences with Radiation Sterilization in Czechoslovakia. Vlasta Chýlková-Hóráková, P. Cerney, D. Sladká Panel — Questions and Answers General Discussion SECOND SESSION The Immunogenicity of Radiation Sterilized Biostatic Grafts. K. Ostrowski Effect of Radiation Sterilization on Biostatic Tissue Grafts and Their Constituents. AnnaSingle user Dziedzic-Gocławska license provided by AAMI. Further copying, networking, and distribution prohibited. Evaluation of Radiation Sterilized Tissues in Clinical Use. J. Komender and A. Komender Ionizing Radiation in the Preparation of Vaccines and Antigens. H. B. Rainey Irradiation of Drugs with Co-60 and Electrons. N. Diding, O. Flink, S. Johansson, B. Ohlson, G. Redmalm and B. Öhrner Physical and Chemical Studies on Some Irradiated Drugs. L. V. Basova, V. A. Gromov, T. R. Klimova, N. D. Konevskaya, V. I. Panin and A. F. Usatyi Physical-Chemical Changes in Irradiated Drugs. D. M. Power On the Theoretical and Practical Aspects of the use of Radiation Sterilization and Radiation Pasteurization in the Pharmaceutical and Cosmetic Industry. G. Hangay Radiation Sterilization of Some Sulphur Containing Compounds. I. Gałatzeanu Panel — Questions and Answers General Discussion THIRD SESSION Introduction to Regulatory Session. A. Bishop Pharmacopeial Viewpoints on Radiation Sterilization. A. S. Outschoorn Role of the International Atomic Energy Agency and Current Activities with Emphasis on Regulatory Aspects. R. N. Mukherjee Comments on the Situation Within the European Economic Community. R. S. M. Frohnsdorff A North American Viewpoint on Selection of Radiation Sterilization Dose. J. Masefield, K. W. Davis, W. E. Strawderman and J. L. Whitby Present State of Legislation in the Field of Radiation Sterilization of Drugs and Medical Products. — West Germany. G. Schwenker Safety and Regulatory Aspects of Radiation Sterilization in France. J. R. Puig Regulatory View Point — Egypt. H. M. Roushdy Regulatory View Point — Australia. Pamela A. Wills United Kingdom Approach to Radiation Sterilization. Marilyn Duncan Regulatory Aspects of the Radiation Sterilization of Medical Products in Scandinavia. L.Single O. user Kallings, license provided V. by G.AAMI. Jensen Further copying, and networking,C. Lerche and distribution prohibited. Panel — Questions and Answers The Future of Radiation Sterilization. K. H. Morganstern General Discussion Participants Single user license provided by AAMI. Further copying, networking, and distribution prohibited. INTRODUCTORY SESSION Conference President I. W. Sizer Single user license provided by AAMI. Further copying, networking, and distribution prohibited. Opening remarks Dr. W. J. Haines Johnson & Johnson, New Brunswick, New Jersey It is indeed a pleasure to be here this morning to welcome you to the Second International Conference on the Sterilization of Medical Products by Ionizing Radiation. It is of interest to note that the list of participants includes representatives from 30 nations. This, in itself, speaks to the importance and interest in this method of sterilization. Whereas English has been chosen as the “official publication language” of the Conference, simultaneous translation is being provided in English, French, German and Russian for use during oral presentations and discussions. We hope that whatever slight “language barrier membranes” remain will be fully penetrated by the high dose level or irradiation technology which will be developed at this Conference. The resulting high titre of satisfaction of all participants will then be directly correlated with the essential “conference components” of collaboration, communication and scientific fellowship which we believe will prevail throughout this meeting. In deference to and in recognition of our host city, Vienna, I would like to stray ever so slightly from “the common language of the Conference” and say just a few words in my uncommon form of the local language, which of course is German. Im Namen meiner Freunde und Kollegen in Wien, Habe ich die Ehre alle Teilnehmer an dieser Konferenz herzlich willkommen zu heissen. Es ist mein aufrichtig er Wunsch, dass die Zeit, die sie auf dieser Tagung verbringen und die sie auf diese schöne Stadt aufwenden wollen, nützlich und schöpferisch sein wird. (Speaking thusly on behalf of my friends and associates in Vienna, I am most pleased to bid a hearty welcome to all participants in this Conference and to express the sincere wish that your time at this meeting, and in this fair city, will be both productive and enjoyable.) Let me now say just a brief word about the company, which is sponsoring this Conference. My remarks are essentially equivalent to the break in radio or television programs when the announcer says, “We pause briefly for the identification of your local stations and for a commercial message from one of our sponsors.” These next few words, which are intended primarily to be explanatory, constitute the full “Johnson & Johnson commercial message” associated with this conference. As you may know, the Johnson & Johnson Worldwide Family of Companies is made up of 187 corporate organizations in 53 countries. We have 145 companies in 43 nations of the world which manufacture as well as market our products. As an aside, it is interesting to note that in our worldwide operations, we utilize about 13 languages. In view of our extensive multinational manufacturing operations, the Johnson & Johnson Family of Companies is one of the largest users of Ionizing Radiation for the sterilization of medical
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