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Author: Barry P. Fairand Publisher: CRC Press ISBN: 9781587160745 Category : Technology & Engineering Languages : en Pages : 162
Book Description
Focusing on how the radiation process works and how it is applied in sterilizing medical devices and healthcare products, this book provides the latest developments in radiation technology in the form of e-beams, gamma rays, and x-rays. It covers the design and operation of irradiators as well as factors that affect cost and efficiency. It offers readers practical insights on this critical step in healthcare product manufacturing, its current uses, and its related cost concerns. Bringing all the information into one source, Radiation Sterilization for Health Care Products is a uniquely comprehensive resource.
Author: Barry P. Fairand Publisher: CRC Press ISBN: 9781587160745 Category : Technology & Engineering Languages : en Pages : 162
Book Description
Focusing on how the radiation process works and how it is applied in sterilizing medical devices and healthcare products, this book provides the latest developments in radiation technology in the form of e-beams, gamma rays, and x-rays. It covers the design and operation of irradiators as well as factors that affect cost and efficiency. It offers readers practical insights on this critical step in healthcare product manufacturing, its current uses, and its related cost concerns. Bringing all the information into one source, Radiation Sterilization for Health Care Products is a uniquely comprehensive resource.
Author: Sophie Lerouge Publisher: Elsevier ISBN: 0857096265 Category : Medical Languages : en Pages : 347
Book Description
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
Author: Anne Booth Publisher: CRC Press ISBN: 9781587160578 Category : Medical Languages : en Pages : 172
Book Description
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.
Author: Ebbing Lautenbach Publisher: Cambridge University Press ISBN: 1107153166 Category : Medical Languages : en Pages : 455
Book Description
A clear, hands-on outline of best practices for infection prevention that directly improve patient outcomes across the healthcare continuum.
Author: Tim Sandle Publisher: Elsevier ISBN: 1908818638 Category : Medical Languages : en Pages : 370
Book Description
Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. The book outlines and discusses sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging, as well as addressing the cleanroom environments in which products are prepared. Consisting of 18 chapters, the book comprehensively covers sterility, sterilisation and microorganisms; pyrogenicity and bacterial endotoxins; regulatory requirements and good manufacturing practices; and gamma radiation. Later chapters discuss e-beam; dry heat sterilisation; steam sterilisation; sterilisation by gas; vapour sterilisation; and sterile filtration, before final chapters analyse depyrogenation; cleanrooms; aseptic processing; media simulation; biological indicators; sterility testing; auditing; and new sterilisation techniques. - Covers the main sterilisation methods of physical removal, physical alteration and inactivation - Includes discussion of medical devices, aseptically filled products and terminally sterilised products - Describes bacterial, pyrogenic, and endotoxin risks to devices and products
Author: Yves Chartier Publisher: World Health Organization ISBN: 9241548568 Category : Medical Languages : en Pages : 327
Book Description
This is the second edition of the WHO handbook on the safe, sustainable and affordable management of health-care waste--commonly known as "the Blue Book". The original Blue Book was a comprehensive publication used widely in health-care centers and government agencies to assist in the adoption of national guidance. It also provided support to committed medical directors and managers to make improvements and presented practical information on waste-management techniques for medical staff and waste workers. It has been more than ten years since the first edition of the Blue Book. During the intervening period, the requirements on generators of health-care wastes have evolved and new methods have become available. Consequently, WHO recognized that it was an appropriate time to update the original text. The purpose of the second edition is to expand and update the practical information in the original Blue Book. The new Blue Book is designed to continue to be a source of impartial health-care information and guidance on safe waste-management practices. The editors' intention has been to keep the best of the original publication and supplement it with the latest relevant information. The audience for the Blue Book has expanded. Initially, the publication was intended for those directly involved in the creation and handling of health-care wastes: medical staff, health-care facility directors, ancillary health workers, infection-control officers and waste workers. This is no longer the situation. A wider range of people and organizations now have an active interest in the safe management of health-care wastes: regulators, policy-makers, development organizations, voluntary groups, environmental bodies, environmental health practitioners, advisers, researchers and students. They should also find the new Blue Book of benefit to their activities. Chapters 2 and 3 explain the various types of waste produced from health-care facilities, their typical characteristics and the hazards these wastes pose to patients, staff and the general environment. Chapters 4 and 5 introduce the guiding regulatory principles for developing local or national approaches to tackling health-care waste management and transposing these into practical plans for regions and individual health-care facilities. Specific methods and technologies are described for waste minimization, segregation and treatment of health-care wastes in Chapters 6, 7 and 8. These chapters introduce the basic features of each technology and the operational and environmental characteristics required to be achieved, followed by information on the potential advantages and disadvantages of each system. To reflect concerns about the difficulties of handling health-care wastewaters, Chapter 9 is an expanded chapter with new guidance on the various sources of wastewater and wastewater treatment options for places not connected to central sewerage systems. Further chapters address issues on economics (Chapter 10), occupational safety (Chapter 11), hygiene and infection control (Chapter 12), and staff training and public awareness (Chapter 13). A wider range of information has been incorporated into this edition of the Blue Book, with the addition of two new chapters on health-care waste management in emergencies (Chapter 14) and an overview of the emerging issues of pandemics, drug-resistant pathogens, climate change and technology advances in medical techniques that will have to be accommodated by health-care waste systems in the future (Chapter 15).
Author: Gerald McDonnell Publisher: Lippincott Williams & Wilkins ISBN: 1496381505 Category : Medical Languages : en Pages : 3015
Book Description
With more international contributors than ever before, Block’s Disinfection, Sterilization, and Preservation, 6th Edition, is the first new edition in nearly 20 years of the definitive technical manual for anyone involved in physical and chemical disinfection and sterilization methods. The book focuses on disease prevention—rather than eradication—and has been thoroughly updated with new information based on recent advances in the field and understanding of the risks, the technologies available, and the regulatory environments.
Author: Gerald E. McDonnell Publisher: John Wiley & Sons ISBN: 1555819680 Category : Medical Languages : en Pages : 431
Book Description
Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance, by Gerald E. McDonnell, is a detailed and accessible presentation of the current methods of microbial control. Each major category, such as physical disinfection methods, is given a chapter, in which theory, spectrum of activity, advantages, disadvantages, and modes of action of the methods are thoroughly and clearly presented. Sufficient background on the life cycles and general anatomy of microorganisms is provided so that the reader who is new to microbiology will better appreciate how physical and chemical biocides work their magic on microbes. Other topics in the book include: Evaluating the efficacy of chemical antiseptics and disinfectants, and of physical methods of microbial control and sterilization. Understanding how to choose the proper biocidal product and process for specific applications. Classic physical and chemical disinfection methods, such as heat, cold, non-ionizing radiation, acids, oxidizing agents, and metals. Newer chemical disinfectants, including, isothiazolones, micro-and nano-particles, and bacteriophages as control agents. Antisepsis of skin and wounds and the biocides that can be used as antiseptics. Classic methods of physical sterilization, such as, moist heat and dry heat sterilization, ionizing radiation, and filtration, along with newer methods, including, the use of plasma or pulsed light. Chemical sterilization methods that use ethylene oxide, formaldehyde, or a variety of other oxidizing agents. A detailed look at the modes of action of biocides in controlling microbial growth and disrupting microbial physiology. Mechanisms that microorganisms use to resist the effects of biocides. The second edition of Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance is well suited as a textbook and is outstanding as a reference book for facilities managers and application engineers in manufacturing plants, hospitals, and food production facilities. It is also essential for public health officials, healthcare professionals, and infection control practitioners.
Author: Denise Bohrer Publisher: John Wiley & Sons ISBN: 1118449053 Category : Science Languages : en Pages : 592
Book Description
The first one-volume guide to sources of contamination in pharmaceuticals and medical devices Most books dealing with contaminants in medicinal products often focus on analytical methods for detecting nonspecific impurities. Key to the work of the pharmaceutical chemist, this unique reference helps identify the sources of contamination in medicinal and pharmaceutical products and medical devices. Divided into three parts, Sources of Contamination in Medicinal Products and Medical Devices covers chemical, microbiological, and physical (particulate matter) contamination, including those originating from sterilization procedures. As compelling as a medical documentary, the book sheds light on how impurities and contaminants can enter the human body transported via a specific product or treatment. Focusing on only those medicinal products and medical devices that may lead to exposure to contaminants harmful to human health, the book offers a comprehensive, systematic look at the entire universe of medical contamination: Chemical contaminants including residual solvents, catalyst residuals, and genotoxic impurities in active pharmaceutical ingredients (APIs) Diagnostic imaging agents (i.e., radiopharmaceuticals and contrast agents) Microbiological and endotoxin contamination involving single and multiple dose products, medical devices, and biofilms Contamination from sterilization procedures, residuals from radiation sterilization, ionizing radiation on packaging materials and medical devices Medicinal gases and volatile anesthetics Biopharmaceuticals including recombinant DNA technology products Extractables and leachables from containers made of glass, plastics, and metal Each section of the book contains information on what contaminants could be expected in a particular product, and how they were generated and reached that product. With up-to-date regulatory guidelines for determining contamination, as well as methods for assessing, quantifying, avoiding and removing contaminants, Sources of Contamination in Medicinal Products and Medical Devices is essential to fully understanding the specific threats that undermine the safety of medicines and medical devices.
Author: Barry P. Fairand
Author: Barry P. Fairand
Author: Sophie Lerouge
Author: Anne Booth
Author: Ebbing Lautenbach
Author: Tim Sandle
Author: Yves Chartier
Author: G. Briggs Phillips
Author: Gerald McDonnell
Author: Gerald E. McDonnell
Author: Denise Bohrer