Assurance of Sterility for Sensitive Combination Products and Materials

Assurance of Sterility for Sensitive Combination Products and Materials: New Paradigms for the Next Generation of Medical Devices and Pharmaceuticals discusses the medical device industry and existing challenges regarding the exciting new world of sensitive combination products (SCPs) and their terminal sterilization. This book reassesses the current assumptions to assure the patient’s best interests are met in the development of increasingly rigorous sterilization methods used to counteract MRSA and other 'super-bugs'. In addition, the book discusses the special challenges faced with implantable medical devices, sterilization requirements and further methods needed for material selection and the design process. This book is unique in taking a holistic, end-to-end approach to sterilization, with a particular focus on materials selection and product design. Introduces sterilization principles at the material selection and design stages Addresses the industry need for new sterilization processes for new medical devices and biomaterials Provides guidance to select the appropriate sterilization technique for newly developed sensitive combination products Examines forward thinking tactics for matching new developments in material compatibility with possible regulatory and QSR strategies

Produk Detail:

  • Author : Byron J. Lambert
  • Publisher : Academic Press
  • Pages : 262 pages
  • ISBN : 0128131799
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKAssurance of Sterility for Sensitive Combination Products and Materials

Assurance of Sterility for Sensitive Combination Products and Materials

Assurance of Sterility for Sensitive Combination Products and Materials
  • Author : Byron J. Lambert,Stan Lam,Joyce M. Hansen,Trabue D. Bryans
  • Publisher : Academic Press
  • Release : 12 December 2019
GET THIS BOOKAssurance of Sterility for Sensitive Combination Products and Materials

Assurance of Sterility for Sensitive Combination Products and Materials: New Paradigms for the Next Generation of Medical Devices and Pharmaceuticals discusses the medical device industry and existing challenges regarding the exciting new world of sensitive combination products (SCPs) and their terminal sterilization. This book reassesses the current assumptions to assure the patient’s best interests are met in the development of increasingly rigorous sterilization methods used to counteract MRSA and other 'super-bugs'. In addition, the book discusses the special challenges

Biomaterials, Medical Devices, and Combination Products

Biomaterials, Medical Devices, and Combination Products
  • Author : Shayne Cox Gad,Samantha Gad-McDonald
  • Publisher : CRC Press
  • Release : 01 December 2015
GET THIS BOOKBiomaterials, Medical Devices, and Combination Products

Biomaterials, Medical Devices, and Combination Products is a single-volume guide for those responsible for-or concerned with-developing and ensuring patient safety in the use and manufacture of medical devices.The book provides a clear presentation of the global regulatory requirements and challenges in evaluating the biocompatibility and clinical

Safety Evaluation in the Development of Medical Devices and Combination Products, Third Edition

Safety Evaluation in the Development of Medical Devices and Combination Products, Third Edition
  • Author : Shayne C. Gad,Marian G. McCord
  • Publisher : CRC Press
  • Release : 20 October 2008
GET THIS BOOKSafety Evaluation in the Development of Medical Devices and Combination Products, Third Edition

Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-life problems in the field. The Third Edition explores these key current trends: global device markets continually advancing technology the increasing harmonization of device safety regulation worldwide Each

Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals

Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals
  • Author : Tim Sandle
  • Publisher : Elsevier
  • Release : 31 October 2013
GET THIS BOOKSterility, Sterilisation and Sterility Assurance for Pharmaceuticals

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

Biomaterials Science

Biomaterials Science
  • Author : Buddy D. Ratner,Allan S. Hoffman,Frederick J. Schoen,Jack E. Lemons
  • Publisher : Academic Press
  • Release : 31 December 2012
GET THIS BOOKBiomaterials Science

The revised edition of this renowned and bestselling title is the most comprehensive single text on all aspects of biomaterials science. It provides a balanced, insightful approach to both the learning of the science and technology of biomaterials and acts as the key reference for practitioners who are involved in the applications of materials in medicine. Over 29,000 copies sold, this is the most comprehensive coverage of principles and applications of all classes of biomaterials: "the only such text that currently

Sterilisation of Biomaterials and Medical Devices

Sterilisation of Biomaterials and Medical Devices
  • Author : Sophie Lerouge,Anne Simmons
  • Publisher : Elsevier
  • Release : 27 September 2012
GET THIS BOOKSterilisation of Biomaterials and Medical Devices

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.

Biomedical Engineering and Design Handbook, Volume 2

Biomedical Engineering and Design Handbook, Volume 2
  • Author : Myer Kutz
  • Publisher : McGraw Hill Professional
  • Release : 13 July 2009
GET THIS BOOKBiomedical Engineering and Design Handbook, Volume 2

A State-of-the-Art Guide to Biomedical Engineering and Design Fundamentals and Applications The two-volume Biomedical Engineering and Design Handbook, Second Edition, offers unsurpassed coverage of the entire biomedical engineering field, including fundamental concepts, design and development processes, and applications. This landmark work contains contributions on a wide range of topics from nearly 80 leading experts at universities, medical centers, and commercial and law firms. Volume 2 provides timely information on breakthrough developments in medical device design, diagnostic equipment design, surgery, rehabilitation engineering, prosthetics

The Future of Pharmaceutical Product Development and Research

The Future of Pharmaceutical Product Development and Research
  • Author : Anonim
  • Publisher : Academic Press
  • Release : 02 September 2020
GET THIS BOOKThe Future of Pharmaceutical Product Development and Research

The Future of Pharmaceutical Product Development and Research examines the latest developments in the pharmaceutical sciences, also highlighting key developments, research and future opportunities. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of the product development phase of drug discovery and drug development. Each chapter covers fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and the pharmaceutical industry. The book focuses on excipients, radiopharmaceuticals,

USP35 NF30, 2012

USP35 NF30, 2012
  • Author : United States Pharmacopeial Convention
  • Publisher : U.S. Pharmacopeia
  • Release : 01 November 2011
GET THIS BOOKUSP35 NF30, 2012

The USP-NF is a combination of two official compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). It contains standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutics. USP-NF standards are enforceable by the U.S. Food and Drug Administration for medicines manufactured and marketed in the United States. Learn more about USP-NF. Highlights & Features: * More than 4,500 monographs with specifications for identity, strength, quality, purity, packaging, and labeling for