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Radiation Sterilization for Health Care Products

Radiation Sterilization for Health Care Products
Author: Barry P. Fairand
Publisher: CRC Press
Total Pages: 154
Release: 2001-09-26
Genre: Medical
ISBN: 1482286203

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Focusing on how the radiation process works and how it is applied in sterilizing medical devices and healthcare products, Radiation Sterilization for Health Care Products covers recent developments in radiation technology such as e-beams, gamma rays, and x-rays. The author discusses the design and operation of irradiators as well as factors that affect cost and efficiency. He offers readers practical insights on this critical step in healthcare product manufacturing, its current uses, and its related cost concerns. Authortitative and comprehensive, the book brings togehter information scattered throughout the literature into one convenient resource.


Sterilization of Health Care Products

Sterilization of Health Care Products
Author: Standards Australia (Organization)
Publisher:
Total Pages: 38
Release: 2006-01-01
Genre: Medical instruments and apparatus
ISBN: 9780733779176

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Trends in Radiation Sterilization of Health Care Products

Trends in Radiation Sterilization of Health Care Products
Author: International Atomic Energy Agency
Publisher:
Total Pages: 261
Release: 2008
Genre: Business & Economics
ISBN: 9789201110077

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In the last decades, radiation processing has become significant in many industries worldwide. Sterilisation, polymer cross-linking and the irradiation of certain food items for hygienization, for example, are well established technologies. Either gamma radiation from isotopic sources or high energy electrons from accelerators are being applied in these processes. With the support of the IAEA, several gamma and electron beam irradiation facilities have been built in developing countries, and some new technologies have been developed and transferred to Member States over the past ten years. The market for disposable medical products has undergone enormous growth, and with it the use of ionising radiation as a method of sterilisation. Currently 40-50 per cent of disposable medical products manufactured in developed countries are radiation sterilised. This publication serves as a status report on recent developments and provides information about the entire field of radiation sterilisation. It is addressed to professionals and administrators involved in the planning, development, implementation and management of radiation sterilisation programmes.


Sterilization Validation and Routine Operation Handbook (2001)

Sterilization Validation and Routine Operation Handbook (2001)
Author: Anne F Booth
Publisher: CRC Press
Total Pages: 155
Release: 2017-11-22
Genre: Medical
ISBN: 1351357565

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The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by precise accuracy in execution and documentation. This in-depth guide details all steps from prevalidation planning to final report and ongoing monitoring and control. Sterilization Validation & Routine Operation Handbook: Radiation provides a framework for the validation and routine operation of an irradiation sterilization process. The guidance presented complies with ANSI/AAMI/ISO 11137: 1994, Sterilization of health care product-Requirements for validation and routine control-Radiation sterilization and the newly published AAMI substantiation of 25 kGy using VDmax procedure. The author discusses methods to aid in comprehending the requirements in these standards. She also provides practical procedures for the validation and routine monitoring and control of specific gamma and electron beam radiation sterilization processes. Background chapters provide needed information on radiation sterilization technologies, sterilization microbiology, validation approaches and working with a radiation sterilization contractor. Much of the information in this new book is presented in convenient tables and charts, with diagrams and other schematics that simply illustrate appropriate validation methodologies. Sterilization Validation & Routine Operation Handbook: Radiation brings together in one resource information scattered throughout many documents and will be useful to all those involved in the sterilization of medical materials, drugs and devices.


Sterilisation of Biomaterials and Medical Devices

Sterilisation of Biomaterials and Medical Devices
Author: Sophie Lerouge
Publisher: Elsevier
Total Pages: 347
Release: 2012-09-27
Genre: Medical
ISBN: 0857096265

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The effective sterilisation of any material or device to be implanted in or used in close contact with the human body is essential for the elimination of harmful agents such as bacteria. Sterilisation of biomaterials and medical devices reviews established and commonly used technologies alongside new and emerging processes.Following an introduction to the key concepts and challenges involved in sterilisation, the sterilisation of biomaterials and medical devices using steam and dry heat, ionising radiation and ethylene oxide is reviewed. A range of non-traditional sterilisation techniques, such as hydrogen peroxide gas plasma, ozone and steam formaldehyde, is then discussed together with research in sterilisation and decontamination of surfaces by plasma discharges. Sterilisation techniques for polymers, drug-device products and tissue allografts are then reviewed, together with antimicrobial coatings for ‘self-sterilisation’ and the challenge presented by prions and endotoxins in the sterilisation of reusable medical devices. The book concludes with a discussion of future trends in the sterilisation of biomaterials and medical devices.With its distinguished editors and expert team of international contributors, Sterilisation of biomaterials and medical devices is an essential reference for all materials scientists, engineers and researchers within the medical devices industry. It also provides a thorough overview for academics and clinicians working in this area. Reviews established and commonly used technologies alongside new and emerging processes Introduces and reviews the key concepts and challenges involved in sterilisation Discusses future trends in the sterilisation of biomaterials and medical devices