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Author : Marimargaret Reichert,Jack H. Young
Publisher : Jones & Bartlett Learning
Page : 328 pages
File Size : 42,8 Mb
Release : 1997
Category : Medical instruments and apparatus
ISBN : 0834208385
This Second Edition is a comprehensive resource on sterilization and disinfection of reusable instruments and medical devices
Author : Robert F. Morrissey,G. Briggs Phillips
Publisher : Springer
Page : 536 pages
File Size : 53,7 Mb
Release : 1993-02-28
Category : Medical
ISBN : UOM:39015057696620
Includes as many case studies as the contributors could identify, with the goal of answering questions that arise as a result of conducting day-to-day sterilization activities. Discussion of the theory of microbial inactivation and the philosophy of sterilization validation is followed by practical information on methods of interest to a broad audience. Chapters on special considerations for ethylene oxide, packaging of sterile products, contract sterilization, and regulations complete the coverage. Annotation copyright by Book News, Inc., Portland, OR
Author : Fred M. Nordhauser,Wayne P. Olson
Publisher : CRC Press
Page : 579 pages
File Size : 51,7 Mb
Release : 2018-03-29
Category : Medical
ISBN : 9781351413848
Editors Fred M. Nordhauser and Wayne P. Olson have gathered a team of 18 experts from multi-national and leading edge companies to explore the advantages and disadvantages of current sterilization technologies. They cover the theory behind the technology, the practical concerns of installation from engineering and product development perspectives, the "how to validate" concern, and the pragmatics of implementation in a manner that will satisfy the regulatory agencies. The broad range of in-depth information on numerous technologies will help readers design sterile manufacturing processes cost effectively and efficiently.
Author : Laurence W. McKeen
Publisher : William Andrew
Page : 468 pages
File Size : 51,5 Mb
Release : 2018-02-22
Category : Technology & Engineering
ISBN : 9780128145128
The Effect of Sterilization Methods on Plastics and Elastomers, Fourth Edition brings together a wide range of essential data on the sterilization of plastics and elastomers, thus enabling engineers to make optimal material choices and design decisions. The data tables in this book enable engineers and scientists to select the right materials and sterilization method for a given product or application. The book is a unique and essential reference for anybody working with plastic materials that are likely to be exposed to sterilization methods, be it in medical device or packaging development, food packaging or other applications. Presents essential data and practical guidance for engineers and scientists working with plastics in applications that require sterile packaging and equipment Updated edition removes obsolete data, updates manufacturers, verifies data accuracy, and adds new plastics materials for comparison Provides essential information and guidance for FDA submissions required for new medical devices
Author : Anne Booth
Publisher : Routledge
Page : 380 pages
File Size : 42,9 Mb
Release : 2018-12-12
Category : Medical
ISBN : 9781351413800
This book presents vital information on international sterilization standards and guidance on practical application of these standards in the manufacturing process. It covers validation, industrial sterilization methods, emerging sterilization techniques, laboratory testing, manufacturing of sterile devices, and device reuse. Excerpted from The Validator, edited by Anne F. Booth, more than fifty experts share their knowledge of current technologies in easy-to-understand articles that establish methods to ensure compliance. Contents include reviews of ISO sterilization standards, industrial sterilization methods and technologies, and support testing methodologies.
Author : John J. Perkins
Publisher : Charles C. Thomas Publisher
Page : 590 pages
File Size : 48,8 Mb
Release : 1969
Category : Sterilization
ISBN : UCAL:B4175197
Author : Anonim
Publisher : Unknown
Page : 644 pages
File Size : 55,8 Mb
Release : 1966
Category : Space medicine
ISBN : UIUC:30112000419140
Author : Charles Olin Ball,Franklyn Carl Wester Olson
Publisher : Unknown
Page : 768 pages
File Size : 40,9 Mb
Release : 1957
Category : House & Home
ISBN : UOM:39015023191367
Author : WayneP. Olson
Publisher : Unknown
Page : 128 pages
File Size : 48,8 Mb
Release : 2017
Category : Electronic books
ISBN : 0203738314
Author : Tim Sandle
Publisher : Elsevier
Page : 362 pages
File Size : 53,5 Mb
Release : 2013-10-31
Category : Medical
ISBN : 9781908818638
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 : Gerald McDonnell
Publisher : Lippincott Williams & Wilkins
Page : 2941 pages
File Size : 54,7 Mb
Release : 2020-06-26
Category : Medical
ISBN : 9781496381507
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 : Wayne J. Rogers
Publisher : iSmithers Rapra Publishing
Page : 344 pages
File Size : 40,9 Mb
Release : 2005
Category : Medical instruments and apparatus
ISBN : 1859574904
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 Booth
Publisher : CRC Press
Page : 170 pages
File Size : 40,8 Mb
Release : 2001-04-04
Category : Medical
ISBN : 1587160579
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 : Anonim
Publisher : Unknown
Page : 128 pages
File Size : 42,8 Mb
Release : 1991
Category : Sterilization
ISBN : 0730942996
Author : T. D. Whittet,W. B. Hugo,G. R. Wilkinson
Publisher : Elsevier
Page : 288 pages
File Size : 53,5 Mb
Release : 2013-10-22
Category : Medical
ISBN : 9781483196138
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.