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Manual on Radiation Sterilization of Medical and Biological Materials

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Manual on Radiation Sterilization of Medical and Biological Materials TECHNICAL REPORTS SERIES No. 149 Manual on Radiation Sterilization of Medical and Biological Materials INTERNATIONAL ATOMIC ENERGY AGENCY, VIENNA, 1973 MANUAL ON RADIATION STERILIZATION OF MEDICAL AND BIOLOGICAL MATERIALS The following States are Members of the International Atomic Energy Agency : AFGHANISTAN GUATEMALA PANAMA ALBANIA HAITI PARAGUAY ALGERIA HOLY SEE PERU ARGENTINA HUNGARY PHILIPPINES AUSTRALIA ICELAND POLAND AUSTRIA INDIA PORTUGAL BANGLADESH INDONESIA ROMANIA BELGIUM IRAN SAUDI ARABIA BOLIVIA IRAQ SENEGAL BRAZIL IRELAND SIERRA LEONE BULGARIA ISRAEL SINGAPORE BURMA ITALY SOUTH AFRICA BYELORUSSIAN SOVIET IVORY COAST SPAIN SOCIALIST REPUBLIC JAMAICA SRI LANKA CAMEROON JAPAN SUDAN CANADA JORDAN SWEDEN CHILE KENYA SWITZERLAND CHINA KHMER REPUBLIC SYRIAN ARAB REPUBLIC COLOMBIA KOREA, REPUBLIC OF THAILAND COSTA RICA KUWAIT TUNISIA CUBA LEBANON TURKEY CYPRUS LIBERIA UGANDA CZECHOSLOVAK SOCIALIST LIBYAN ARAB REPUBLIC UKRAINIAN SOVIET SOCIALIST REPUBLIC LIECHTENSTEIN REPUBLIC DENMARK LUXEMBOURG UNION OF SOVIET SOCIALIST DOMINICAN REPUBLIC MADAGASCAR REPUBLICS ECUADOR MALAYSIA UNITED KINGDOM OF GREAT EGYPT, ARAB REPUBLIC OF MALI BRITAIN AND NORTHERN EL SALVADOR MEXICO IRELAND ETHIOPIA MONACO UNITED STATES OF AMERICA FINLAND MOROCCO URUGUAY FRANCE NETHERLANDS VENEZUELA GABON NEW ZEALAND VIET-NAM GERMANY, FEDERAL REPUBLIC OF NIGER YUGOSLAVIA GHANA NIGERIA ZAIRE, REPUBLIC OF GREECE NORWAY ZAMBIA PAKISTAN The Agency's Statute was approved on 23 October 1956 by the Conference on the Statute of the IAEA held at United Nations Headquarters, New York; it entered into force on 29 July 1957. The Headquarters of the Agency are situated in Vienna. Its principal objective is "to accelerate and enlarge the contribution of atomic energy to peace, health and prosperity throughout the world". © IAEA, 1973 Permission to reproduce or translate the information contained in this publication may be obtained by writing to the International Atomic Energy Agency, Karntner Ring 11, P.O. Box 590, A-1011 Vienna, Austria. Printed by the IAEA in Austria October 1973 TECHNICAL REPORTS SERIES No. 149 MANUAL ON RADIATION STERILIZATION OF MEDICAL AND BIOLOGICAL MATERIALS INTERNATIONAL ATOMIC ENERGY AGENCY VIENNA, 197 3 MANUAL ON RADIATION STERILIZATION OF MEDICAL AND BIOLOGICAL MATERIALS IAEA, VIENNA, 1973 STI/DOC/10/149 FOREWORD As a result of extensive investigations into the bactericidal effects of radiation and of the continuing improvements in irradiation technology, ionizing radiation is. increasingly being employed for the sterilization of medical products. It has already become a well-established industrial practice in a number of technologically advanced countries, and a growing number of developing countries are planning to install radiation steriliza- tion plants in the near future. Since the early 1960s approximately fifty gamma irradiation facilities on a commercial scale have been commissioned to sterilize various medical products ranging from complicated medical instruments to sutures and from pharmaceutical starting materials to bio- logical tissues. At the present time radiation sterilization of medical products constitutes the most important industrial application of large radi- ation sources. The rapid increase in this application of radiation can be attributed to its high efficiency, its unique suitability for the newly intro- duced and inexpensive plastic constituents of medical products for which heat, chemicals and other conventional methods of sterilization have proved inadequate, and to its hygienic advantages that permit sterilization of pre- packed items. During the last ten years, the Agency has attached great importance to this development, aiming at early application in both the developing and the developed Member States. The Agency's active role in the accumulation and dissemination of the relevant technical information in the fields con- cerned has been through panels, symposia, research contracts, and techni- cal advisory and expert services to the Member States. This Manual on Radiation Sterilization of Medical and Biological Materials is planned to serve as a guide and valuable source book for those who want to establish this sterilization technique or use radiosterilized products for medical practices. Furthermore, the Manual will provide useful information in the effort to standardize the procedures for sterility testing and quality control of the radiosterilized materials in the light of the experience gained by several technologically advanced countries. The authors of the various chapters, most of whom have been partici- pants in relevant Agency meetings and research contracts, are recognized international experts. It is hopedthat the Manual will prove useful to scien- tific and technical personnel engaged in the radiation sterilization of medi- cal products, radiation biologists, microbiologists and pharmaceutical quality control experts of national pharmacopoeias and experts in radiation dosimetry. CONTENTS GENERAL INTRODUCTION (V. Agranenko, F. Antoni) PARTI. THEORETICAL BASIS CHAPTER 1. PHYSICAL CHARACTERISTICS OF IONIZING RADIATION (W. L. McLaughlin, N. W. Holm) 1. Introduction 2. Types of radiation and their basic properties 3. Practical consequences 4. Conclusions CHAPTER 2. THE EFFECT OF IONIZING RADIATION ON SOME MOLECULES OF BIOLOGICAL IMPORTANCE (F. Antoni) . 1. Radiolysis of water 2. Proteins 3. Carbohydrates CHAPTER 3. THE EFFECT OF IONIZING RADIATION ON BACTERIA (F.J. Ley) 1. Inactivation of bacterial populations 2. Factors influencing resistance 3. Mechanisms of inactivation 4. Implications of background knowledge CHAPTER 4. THE EFFECT OF IONIZING RADIATION ON VIRUSES (E.C. Pollard) 1. Introduction 2. Phenomenology 3. Inactivation of the various attributes of viruses 4. Rationale for sterilization 5. Outlook CHAPTER 5. THE EFFECT OF IONIZING RADIATION ON FUNGI (N. Sommer) 1. Introduction 2. Nature of fungus contaminants 3. Radiation sensitivity of fungus spores 4. Radiation sensitivity of fungus structures other than spores 5. Some dose modifying factors 6. Summary CHAPTER 6. THE EFFECT OF IONIZING RADIATION ON ANIMAL PARASITES (I. Varga) 81 1. Introduction 2. The radiosensitivity of animal parasites 3. Factors influencing the efficacity of irradiation 4. Lethal effects of the irradiation of parasites 5. The patho-physiological effects of irradiation of parasitic helminths 6. Immunogenic properties of irradiated protozoa PART II. GENERAL ASPECTS CHAPTER 7. FACILITIES REQUIRED FOR RADIOSTERILIZATION (S. Jefferson) 89 1. Experimental plants 2. Pilot plants 3. Production plants 4. Electron accelerators 5. Gamma-radiation plants CHAPTER 8. ORGANIZATION OF INDUSTRIAL AND MEDICAL CENTRES FOR RADIOSTERILIZATION (S. Jefferson) ... 95 1. Industrial centres 2. Medical centres CHAPTER 9. DOSIMETRY (N.W. Holm) 99 1. Introduction 2. The dosimetry procedure 3. Criteria for choice of system for absorbed dose measurement 4. Some comments on process dosimeters in present use 5. Calibration of process dosimeters 6. Conclusions APPENDIX: Excerpts from the IAEA Recommended Code of Practice for Radiosterilization of Medical Products 105 CHAPTER 10. PACKAGING REQUIREMENTS (D. B. Powell) Ill 1. Suitability of packaging material for the sterilization method 2. Resistance of the material to bacteria 3. Type of package 4. Type of opening 5. Strength of package 6. Testing a package CHAPTER 11. HYGIENIC REQUIREMENTS, STERILITY CRITERIA, AND QUALITY AND STERILITY CONTROL (E. A. Christensen) 131 1. Introduction 2. Sterility criteria 3. Sterility control measures (co-authors: O. Ringertz, N. W. Holm) 4. Biological efficiency monitors 5. The choice of dose for radiation sterilization of disposable medical equipment CHAPTER 12. LEGAL ASPECTS (C. G. Crawford) 153 1. Code of practice 2. National legislation 3. Enforcement and application of regulations CHAPTER 13. SAFETY RULES (S. Jefferson) ' 163 . 1. Transport and loading of 60Co • 2. Log-book and standing orders CHAPTER 14. THE ECONOMICS OF RADIOSTERILIZATION (S. Jefferson) 167 PART III. RADIATION STERILIZATION OF MEDICAL SUPPLIES AND MATERIALS INTRODUCTION (C. Artandi) 171 CHAPTER 15. SUTURES (C. Artandi) 173 1. Absorbable sutures 2. Non-absorbable sutures CHAPTER 16. PLASTIC AND RUBBER INSTRUMENTS AND APPARATUS (C. Artandi) 187 CHAPTER 17. EQUIPMENT FOR PRESERVATION OF BLOOD AND BLOOD TRANSFUSION (C. Emborg) 191 1. Introduction 2. Sterilization standards for blood bank equipment 3. Choice of sterilization method 4. Initial counts - sterilization dose 5. Conclusion CHAPTER 18. NON-BIOLOGICAL MATERIALS FOR IMPLANTATION AND FOR USE IN CONTACT WITH CIRCULATING BLOOD (K. Little) 199 1. Physical and mechanical properties after sterilization 2. Retention of physical and chemical stability 3. Physical damage to the tissues 4. Toxicity CHAPTER 19. MEDICINES AND PHARMACEUTICAL BASIC MATERIALS (G. O. Phillips) 207 1. Antibiotics and other drugs 2. Vitamins 3. Steroids and hormones 4. Alkaloids 5. Carbohydrates 6. Miscellaneous pharmaceutical systems 7. Excipients 8. Microbiological aspects 9. Conclusions PART IV. RADIATION STERILIZATION OF BIOLOGICAL TISSUES AND PRODUCTS INTRODUCTION (J. R. P. Gibbons) 231 CHAPTER 20. BIOLOGICAL MECHANISMS (K. Little) 233 1. Stimulation of tissue growth and regeneration 2. Resorption and remodelling 3. Bone formation and removal 4. Inflammatory reactions 5. Effects of irradiation on tissues CHAPTER 21. A REVIEW OF PREPARING TISSUE GRAFTS FOR SURGICAL USE WITH SPECIAL REFERENCE TO GAMMA RADIATION (F. Dexter) 245 1. Skin 2. Fascia lata 3. Dura mater
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