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Author: Tim Sandle
Publisher: Elsevier
ISBN: 1908818638
Category : Medical
Languages : en
Pages : 370
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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: Tim Sandle
Publisher: Elsevier
ISBN: 1908818638
Category : Medical
Languages : en
Pages : 370
Get Book Here
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: Sophie Lerouge
Publisher: Elsevier
ISBN: 0857096265
Category : Medical
Languages : en
Pages : 347
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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: T. D. Whittet
Publisher: Elsevier
ISBN: 1483196135
Category : Medical
Languages : en
Pages : 289
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Book Description
Pharmaceutical Monographs, Volume 3: Sterilisation and Disinfection provides a strong foundation for the proper use of disinfectants in practice. This monograph surveys the types of preparations required to be produced in a sterile condition and explains in detail the methods available for sterilization. This monograph is comprised of four parts. Part 1 discusses the purposes of sterilizing pharmaceutical preparations to prevent the infection of body tissues, fluids, or cavities with organisms that may produce damage or disease. Part 2 provides information concerning the extent of contamination of pharmaceutical materials, which is obtained by means of sterility tests. Part 3 focuses on autoclave design and an explanation is offered of the background against which sterilizers have been developed and the method in which their major components operate. Part 4 describes the various types of disinfectants, including halogens, phenols, alcohols, aldehydes, dyes, furan derivatives, amidines, surface-active compounds, and derivatives of quinolone and isoquinoline. This monograph is a valuable resource for undergraduate students of pharmacy and allied subjects.
Author: Annily Campbell
Publisher: A&C Black
ISBN: 9780304337477
Category : Social Science
Languages : en
Pages : 226
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Book Description
This book examines the relatively new social and medical phenomenon of women in the developed countries of the world choosing to remain childfree and electing for sterilization rather than continuing with other forms of contraception. Twenty-three voluntarily childfree, sterilized women, aged 22 to 51 years, tell their stories, revealing the struggles they faced in being women without children in a society which expects women to be mothers. They describe the many barriers encountered on the way to being sterilized, including prejudice from those around them as well as hostility and refusal from the medical profession. The women recall how their reasons and decisions were ignored or pathologized by doctors who held unquestioned assumptions about how women should be. Feminist and sociological perspectives are employed to highlight that voluntarily childfree women are perceived as abnormal, not "real" women, and are often the target of negative and critical comment.
Author: Wayne J. Rogers
Publisher: iSmithers Rapra Publishing
ISBN: 9781859574904
Category : Medical instruments and apparatus
Languages : en
Pages : 344
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Book Description
Sterilisation has always been challenging but sterilisation of healthcare products and polymers, especially together is an even greater challenge - how do you sterilise without adversely affecting the end use or the end user? This book discusses all the sterilisation methods used for polymeric healthcare products both traditional and new.
Author: Anne Line Dalsgaard
Publisher: Museum Tusculanum Press
ISBN: 9788772899015
Category : Birth control
Languages : en
Pages : 260
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Book Description
This book presents and describes Northeast Brazilian women's motives for accepting and often actively seeking sterilization. It centers on individual subjects and their life-worlds but shows, too, that immersion in lived phenomenological worlds does not preclude the study of political economy. The book is written in a lucid and accessible language and will be of interest to a wide and varied audience, including both graduate and undergraduate students. This book merited an Honorable Mention in the competition for the Eileen Basker Memorial Prize in Gender and Health 2004
Author: Wayne J Rogers
Publisher: Smithers Rapra
ISBN: 1909030708
Category : Medical
Languages : en
Pages : 562
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Book Description
The collection of topics in the second volume of this book challenges the reader to think beyond standard methods and question why certain current procedures remain static while technological advances abound in other aspects of sterilisation technology. By small means, better practices may come to pass to help answer some of the residual healthcare sterilisation and nosocomial infection queries: What are some of the current challenges in healthcare sterilisation, and how can they be handled? What are some of the acceptable current non-traditional sterilisation methods, challenging alternatives, and novel modalities? What are some of the packaging, validation and statistical considerations of sterilisation practices? How does design-of-product and packaging interrelate with sterilisation processing? Are the current sterility media and practices optimal for recovery of more modified and more resistant viable organism entities and product? Are there increased sterility and product quality needs with new types of implantables and technological advances within the three dimensional combinations of diagnostics, drug release and challenging medical devices?
Author: J F Kennedy
Publisher: Elsevier
ISBN: 184569077X
Category : Technology & Engineering
Languages : en
Pages : 353
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Book Description
Existing methods and processing for sterilising tissues are proving inadequate in many instances. Infections have been transmitted from the graft to the recipient and in the USA the Centre for Disease Control and other regulatory bodies have drawn attention to the need for a reliable end sterilisation method which does not damage the functionality of the final tissue. Safety of surgical allografts is, therefore, a major concern due to microbial and viral contamination of tissues which is now a problem even in the most sophisticated centres.The Presidents of the main Professional Association of Tissue Banks; American, European and Latin American met in Vienna to review the situation and concluded that the time was opportune to organise an international high level expert meeting, which would identify the best method of using radiation technology to assist in the production of safe tissue allograftsSterilisation of biological tissues with ionising radiations provides the information on this subject presented at an international meeting in Wales, supported by the International Atomic Energy Agency. New methods of protecting the tissues were presented which at the same time allow the use of sufficiently high doses of ionising radiations to inactivate invading organisms. A Code of Practice for the Radiation Sterilisation of Tissues was evaluated and the outcome and the full Code is included in this volume, as well as explorations of all of the methodologies used in the field.Sterilisation of biological tissues with ionising radiations is the only volume of its kind and as such is an invaluable source of information for those working in tissue banks, transplant surgeons and the safety regulators. - High-quality papers highlighting the most recent developments in this important area - Includes the full code of practice for the radiation sterilisation of tissues - Edited by a highly respected team of experts
Author: Mitsuo Niinomi
Publisher: Elsevier
ISBN: 1845699246
Category : Technology & Engineering
Languages : en
Pages : 439
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Book Description
Despite recent advances in medical devices using other materials, metallic implants are still one of the most commercially significant sectors of the industry. Given the widespread use of metals in medical devices, it is vital that the fundamentals and behaviour of this material are understood. Metals in biomedical devices reviews the latest techniques in metal processing methods and the behaviour of this important material.Initial chapters review the current status and selection of metals for biomedical devices. Chapters in part two discuss the mechanical behaviour, degradation and testing of metals with specific chapters on corrosion, wear testing and biocompatibility of biomaterials. Part three covers the processing of metals for biomedical applications with chapters on such topics as forging metals and alloys, surface treatment, coatings and sterilisation. Chapters in the final section discuss clinical applications of metals such as cardiovascular, orthopaedic and new generation biomaterials.With its distinguished editor and team of expert contributors, Metals for biomedical devices is a standard reference for materials scientists, researchers and engineers working in the medical devices industry and academia. - Reviews the latest techniques in metal processing methods including surface treatment and sterilisation - Examines metal selection for biomedical devices considering biocompatibility of various metals - Assesses mechanical behaviour and testing of metals featuring corrosion, fatigue and wear
Author: Lois Hamlin
Publisher: Elsevier Australia
ISBN: 0729538877
Category : Medical
Languages : en
Pages : 353
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Book Description
This new text discusses the roles and responsibilities of those working within the perioperative environment in Australia and New Zealand. It highlights the changing face of perioperative nursing and gives an overview of key concepts including anaesthetic, intraoperative and postanaesthesia recovery care; day surgery and endoscopy. Professional development and medico-legal aspects are also discussed. This is an introductory text which will appeal to a broad market from trainee enrolled nurses; to undergraduate nursing students doing a perioperative clinical placement; to postgraduate students of perioperative nursing. Registered nurses working within or preparing to work within this area, as well as other operating room staff such as anaesthetic technicians will also find this text invaluable.
