Sterility Sterilisation And Sterility Assurance For Pharmaceuticals

Author : Tim Sandle
Publisher : Woodhead Publishing
ISBN 13 : 9780081013601
Total Pages : 362 pages
Book Rating : 4.04/5 ( download)

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Download or read book Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals: Technology, Validation and Current Regulations written by Tim Sandle and published by Woodhead Publishing. This book was released on 2017-11-13 with total page 362 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 inactivationIncludes discussion of medical devices, aseptically filled products and terminally sterilised productsDescribes bacterial, pyrogenic, and endotoxin risks to devices and products

Author : Tim Sandle
Publisher : Elsevier
ISBN 13 : 1908818638
Total Pages : 370 pages
Book Rating : 4.38/5 ( download)

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Download or read book Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals written by Tim Sandle and published by Elsevier. This book was released on 2013-10-31 with total page 370 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 :
Publisher :
ISBN 13 : 9788190646741
Total Pages : 964 pages
Book Rating : 4.45/5 ( download)

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Download or read book Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices written by and published by . This book was released on 2011 with total page 964 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Michael J. Groves
Publisher : CRC Press
ISBN 13 : 9780935184778
Total Pages : 544 pages
Book Rating : 4.75/5 ( download)

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Download or read book Aseptic Pharmaceutical Manufacturing II written by Michael J. Groves and published by CRC Press. This book was released on 1995-05-31 with total page 544 pages. Available in PDF, EPUB and Kindle. Book excerpt: Asceptic Pharmaceutical Manufacturing II explores the sophisticated technology, developments, and applications that allow aseptic processing to approach the sterility levels achieved with terminal sterilization. Written by experts in sterile manufacturing, this book covers aseptic technology, developments, and applications and makes a valuable contribution to understanding the issues involved in aseptic manufacture. Topics include the processing of biopharmaceuticals, lyophilization, personnel training, radiopharmaceuticals, hydrogen peroxide vapor sterilization, regulatory requirements, validation, and quality systems.

Author : T. D. Whittet
Publisher : Elsevier
ISBN 13 : 1483196135
Total Pages : 289 pages
Book Rating : 4.38/5 ( download)

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Download or read book Sterilisation and Disinfection written by T. D. Whittet and published by Elsevier. This book was released on 2013-10-22 with total page 289 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 :
Publisher :
ISBN 13 : 9780910275774
Total Pages : 38 pages
Book Rating : 4.77/5 ( download)

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Download or read book Good Hospital Practice written by and published by . This book was released on 1988 with total page 38 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Nigel Halls
Publisher : CRC Press
ISBN 13 : 9780824790141
Total Pages : 296 pages
Book Rating : 4.46/5 ( download)

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Download or read book Achieving Sterility in Medical and Pharmaceutical Products written by Nigel Halls and published by CRC Press. This book was released on 1994-05-10 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: Detailing the scientific principles underlying the achievement of sterility, this unique reference examines both a broad spectrum of practical, commonly used sterilization procedures and the methods available to confirm sterility-assessing the strengths and limitations of each technology. Delineates current regulatory requirements for sterility-emphasizing the importance of aseptic processes in the medical establishment and the pharmaceutical industry! Achieving Sterility in Medical and Pharmaceutical Products discusses sterilization approaches that utilize saturated steam dry heat ethylene oxide gamma radiation sterile filtration and more!

Author : Anne Booth
Publisher : Routledge
ISBN 13 : 1351413813
Total Pages : 425 pages
Book Rating : 4.17/5 ( download)

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Download or read book Sterilization of Medical Devices written by Anne Booth and published by Routledge. This book was released on 2018-12-12 with total page 425 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Association for the Advancement of Medical Instrumentation
Publisher :
ISBN 13 :
Total Pages : 52 pages
Book Rating : 4.69/5 ( download)

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Download or read book Steam Sterilization and Sterility Assurance Using Table-top Sterilizers in Office-based, Ambulatory-care Medical, Surgical, and Dental Facilities written by Association for the Advancement of Medical Instrumentation and published by . This book was released on 1998 with total page 52 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Association for the Advancement of Medical Instrumentation
Publisher : Association for the Advancement of Medical Instrumentation (AAMI)
ISBN 13 :
Total Pages : 96 pages
Book Rating : 4.10/5 ( download)

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Download or read book Steam Sterilization and Sterility Assurance in Health Care Facilities written by Association for the Advancement of Medical Instrumentation and published by Association for the Advancement of Medical Instrumentation (AAMI). This book was released on 2002 with total page 96 pages. Available in PDF, EPUB and Kindle. Book excerpt: