Sterilization Of Drugs And Devices
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Sterilization Of Drugs And Devices
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Author : Fred M. Nordhauser
language : en
Publisher: CRC Press
Release Date : 2018-03-29
Sterilization Of Drugs And Devices written by Fred M. Nordhauser and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-03-29 with Medical categories.
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.
Sterilization Of Drugs And Devices
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Author : WayneP. Olson
language : en
Publisher:
Release Date : 2017
Sterilization Of Drugs And Devices written by WayneP. Olson and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017 with Electronic books categories.
Sterilization Of Drugs And Devices
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Author : Fred M. Nordhauser
language : en
Publisher:
Release Date : 2001
Sterilization Of Drugs And Devices written by Fred M. Nordhauser and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001 with categories.
Sterilization Of Medical Devices
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Author : Anne Booth
language : en
Publisher: Routledge
Release Date : 2018-12-12
Sterilization Of Medical Devices written by Anne Booth and has been published by Routledge this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-12-12 with Medical categories.
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.
Sterilization Validation And Routine Operation Handbook 2001
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Author : Anne F Booth
language : en
Publisher: CRC Press
Release Date : 2017-11-22
Sterilization Validation And Routine Operation Handbook 2001 written by Anne F Booth and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-11-22 with Medical categories.
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.
Sterilization Validation And Routine Operation Handbook 2001
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Author : Anne F Booth
language : en
Publisher: CRC Press
Release Date : 2017-11-22
Sterilization Validation And Routine Operation Handbook 2001 written by Anne F Booth and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-11-22 with Medical categories.
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.
Sterility Sterilisation And Sterility Assurance For Pharmaceuticals
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Author : Tim Sandle
language : en
Publisher: Elsevier
Release Date : 2013-10-31
Sterility Sterilisation And Sterility Assurance For Pharmaceuticals written by Tim Sandle and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-10-31 with Medical categories.
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
Sterile Product Development
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Author : Parag Kolhe
language : en
Publisher: Springer Science & Business Media
Release Date : 2013-10-12
Sterile Product Development written by Parag Kolhe and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-10-12 with Medical categories.
This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book: • Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines • Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures • Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers This book is a useful resource to scientists and researchers in both industry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development.
Sterilisation Of Biomaterials And Medical Devices
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Author : Sophie Lerouge
language : en
Publisher: Elsevier
Release Date : 2012-09-27
Sterilisation Of Biomaterials And Medical Devices written by Sophie Lerouge and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-09-27 with Medical categories.
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
Sterilization Of Medical Devices
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Author :
language : en
Publisher:
Release Date : 1982
Sterilization Of Medical Devices written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1982 with categories.