Assurance of Sterility for Sensitive Combination Products and Materials Book

Assurance of Sterility for Sensitive Combination Products and Materials


  • Author : Byron Lambert
  • Publisher : Academic Press
  • Release Date : 2019-06-15
  • Genre: Technology & Engineering
  • Pages : 252
  • ISBN 10 : 9780128050828

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Assurance of Sterility for Sensitive Combination Products and Materials Excerpt :

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

Assurance of Sterility for Sensitive Combination Products and Materials Book

Assurance of Sterility for Sensitive Combination Products and Materials


  • Author : Byron J. Lambert
  • Publisher : Academic Press
  • Release Date : 2019-12-12
  • Genre: Technology & Engineering
  • Pages : 262
  • ISBN 10 : 9780128131794

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Assurance of Sterility for Sensitive Combination Products and Materials Excerpt :

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

Green Sustainable Process for Chemical and Environmental Engineering and Science Book

Green Sustainable Process for Chemical and Environmental Engineering and Science


  • Author : Inamuddin
  • Publisher : Academic Press
  • Release Date : 2022-03-25
  • Genre: Science
  • Pages : 708
  • ISBN 10 : 9780323984171

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Green Sustainable Process for Chemical and Environmental Engineering and Science Excerpt :

Green Sustainable Process for Chemical and Environmental Engineering and Science: Biomedical Application of Biosurfactant in Medical Sector highlights the numerous applications of biosurfactants in the field of medicine, especially as a replacement to synthetic drugs which have developed several levels of resistance over the years. Special emphasis is laid on their application as non-pyrogenic and non-toxic immunological adjuvants and their inhibitory characteristics against H+, K+, -ATPase and defense against gastric ulcers, along with their practical application as anti-adhesive coating agents for medical insert materials. The book addresses issues by combining knowledge of their production with information on a range of medical applications. Drawing on the knowledge of its expert team of global contributors, this book provides useful insights for all those currently or potentially interested in developing or applying biosurfactants in their own work. Reflects on differing strains of fungi, bacteria, actinomycetes and yeast, and reviews genetic modification of such strains for enhanced biosurfactant production Explores the use of biosurfactants across a broad range of medical applications Provides mathematical modeling, metabolomics, bioinformatics, metabolic engineering, systems biology and computer technology for solving real-life challenges using biosurfactants Presents biosurfactants as an innovative green, biotechnological solution to improve human health Highlights the numerous applications of biosurfactants in the field of medicine, most especially as a replacement to synthetic drugs which have been reported to develop several levels of resistance over the years

In Situ Tissue Regeneration Book

In Situ Tissue Regeneration


  • Author : Sang Jin Lee
  • Publisher : Academic Press
  • Release Date : 2016-07-17
  • Genre: Medical
  • Pages : 458
  • ISBN 10 : 9780128025000

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In Situ Tissue Regeneration Excerpt :

In Situ Tissue Regeneration: Host Cell Recruitment and Biomaterial Design explores the body’s ability to mobilize endogenous stem cells to the site of injury and details the latest strategies developed for inducing and supporting the body’s own regenerating capacity. From the perspective of regenerative medicine and tissue engineering, this book describes the mechanism of host cell recruitment, cell sourcing, cellular and molecular roles in cell differentiation, navigational cues and niche signals, and a tissue-specific smart biomaterial system that can be applied to a wide range of therapies. The work is divided into four sections to provide a thorough overview and helpful hints for future discoveries: endogenous cell sources; biochemical and physical cues; smart biomaterial development; and applications. Explores the body’s ability to mobilize endogenous stem cells to the site of injury Details the latest strategies developed for inducing and supporting the body’s own regenerating capacity Presents smart biomaterials in cell-based tissue engineering applications—from the cell level to applications—in the first unified volume Features chapter authors and editors who are authorities in this emerging field Prioritizes a discussion of the future direction of smart biomaterials for in situ tissue regeneration, which will affect an emerging and lucrative industry

Biomaterials  Medical Devices  and Combination Products Book

Biomaterials Medical Devices and Combination Products


  • Author : Shayne Cox Gad
  • Publisher : CRC Press
  • Release Date : 2015-12-01
  • Genre: Medical
  • Pages : 606
  • ISBN 10 : 9781482248388

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Biomaterials Medical Devices and Combination Products Excerpt :

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

Biomaterials Science Book
Score: 5
From 1 Ratings

Biomaterials Science


  • Author : Buddy D. Ratner
  • Publisher : Academic Press
  • Release Date : 2012-12-31
  • Genre: Medical
  • Pages : 1573
  • ISBN 10 : 9780080877808

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Biomaterials Science Excerpt :

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 covers this area comprehensively" - Materials Today Edited by four of the best-known figures in the biomaterials field today; fully endorsed and supported by the Society for Biomaterials Fully revised and expanded, key new topics include of tissue engineering, drug delivery systems, and new clinical applications, with new teaching and learning material throughout, case studies and a downloadable image bank

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

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


  • Author : Shayne C. Gad
  • Publisher : CRC Press
  • Release Date : 2008-10-20
  • Genre: Medical
  • Pages : 504
  • ISBN 10 : 9781439809488

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

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 aspect of safety evaluation is considered in terms of International Standards Organization (ISO), US Food and Drug Administration (FDA), European Union (EU), and Japanese Ministry of Health and Welfare (MHW) perspectives. In addition, the book reflects the role of the continuing growth of technology in the incorporation of science, particularly in the areas of immunotoxicology and toxicokinetics.

Pharmaceutical Quality Assurance Book
Score: 4.5
From 4 Ratings

Pharmaceutical Quality Assurance


  • Author : Mr. Manohar A. Potdar
  • Publisher : Pragati Books Pvt. Ltd.
  • Release Date : 2006
  • Genre: Pharmaceutical industry
  • Pages : 420
  • ISBN 10 : 8185790590

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Pharmaceutical Quality Assurance Excerpt :

Radiation Source Use and Replacement Book

Radiation Source Use and Replacement


  • Author : National Research Council
  • Publisher : National Academies Press
  • Release Date : 2008-05-25
  • Genre: Medical
  • Pages : 232
  • ISBN 10 : 9780309110143

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Radiation Source Use and Replacement Excerpt :

In the United States there are several thousand devices containing high-activity radiation sources licensed for use in areas ranging from medical uses such as cancer therapy to safety uses such as testing of structures and industrial equipment. Those radiation sources are licensed by the U.S. Nuclear Regulatory Commission and state agencies. Concerns have been raised about the safety and security of the radiation sources, particularly amid fears that they could be used to create dirty bombs, or radiological dispersal device (RDD). In response to a request from Congress, the U.S. Nuclear Regulatory Commission asked the National Research Council to conduct a study to review the uses of high-risk radiation sources and the feasibility of replacing them with lower risk alternatives. The study concludes that the U.S. government should consider factors such as potential economic consequences of misuse of the radiation sources into its assessments of risk. Although the committee found that replacements of most sources are possible, it is not economically feasible in some cases. The committee recommends that the U.S. government take steps to in the near term to replace radioactive cesium chloride radiation sources, a potential "dirty bomb" ingredient used in some medical and research equipment, with lower-risk alternatives. The committee further recommends that longer term efforts be undertaken to replace other sources. The book presents a number of options for making those replacements.

Innovative Food Processing Technologies Book

Innovative Food Processing Technologies


  • Author : Anonim
  • Publisher : Elsevier
  • Release Date : 2020-08-18
  • Genre: Technology & Engineering
  • Pages : 2480
  • ISBN 10 : 9780128157824

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Innovative Food Processing Technologies Excerpt :

Food process engineering, a branch of both food science and chemical engineering, has evolved over the years since its inception and still is a rapidly changing discipline. While traditionally the main objective of food process engineering was preservation and stabilization, the focus today has shifted to enhance health aspects, flavour and taste, nutrition, sustainable production, food security and also to ensure more diversity for the increasing demand of consumers. The food industry is becoming increasingly competitive and dynamic, and strives to develop high quality, freshly prepared food products. To achieve this objective, food manufacturers are today presented with a growing array of new technologies that have the potential to improve, or replace, conventional processing technologies, to deliver higher quality and better consumer targeted food products, which meet many, if not all, of the demands of the modern consumer. These new, or innovative, technologies are in various stages of development, including some still at the R&D stage, and others that have been commercialised as alternatives to conventional processing technologies. Food process engineering comprises a series of unit operations traditionally applied in the food industry. One major component of these operations relates to the application of heat, directly or indirectly, to provide foods free from pathogenic microorganisms, but also to enhance or intensify other processes, such as extraction, separation or modification of components. The last three decades have also witnessed the advent and adaptation of several operations, processes, and techniques aimed at producing high quality foods, with minimum alteration of sensory and nutritive properties. Some of these innovative technologies have significantly reduced the thermal component in food processing, offering alternative nonthermal methods. Food Processing Technologies: A Comprehensive Review covers the latest advances in innovative and nontherm

SRB s Surgical Operations Book

SRB s Surgical Operations


  • Author : Sriram Bhat M
  • Publisher : JP Medical Ltd
  • Release Date : 2017-11-30
  • Genre: Medical
  • Pages : 1438
  • ISBN 10 : 9789352702114

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SRB s Surgical Operations Excerpt :

This new edition has been fully revised to provide general surgeons with the latest advances and knowledge in their field. Beginning with an overview of preoperative preparation, the operation room, principles of incision, and instruments, the following sections discuss surgical techniques for diseases and disorders in different parts of the body including breast diseases, salivary glands, stomach and duodenum, urologic surgeries, and much more. Each procedure is presented in a step by step approach, explaining the technique, potential complications, and their avoidance. The comprehensive text of nearly 1500 pages is highly illustrated with more than 3000 clinical photographs, detailed diagrams, and tables. Key points Fully revised, new edition providing latest advances in general surgery Nearly 1500 pages cover techniques for diseases and disorders throughout the body Highly illustrated with more than 3000 clinical images and tables Previous edition (9789350251218) published in 2014

Antimicrobial Materials for Biomedical Applications Book

Antimicrobial Materials for Biomedical Applications


  • Author : Abraham J Domb
  • Publisher : Royal Society of Chemistry
  • Release Date : 2019-07-31
  • Genre: Technology & Engineering
  • Pages : 526
  • ISBN 10 : 9781788018548

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Antimicrobial Materials for Biomedical Applications Excerpt :

With the need to combat emerging infectious diseases, research around antimicrobial biomaterials and their applications is booming. This book provides the field with a much-needed fundamental overview of the science, addressing the chemistry of a broad range of biomaterial types, and their applications in the biomedical industry. Materials covered include polymers, from those with inherent antimicrobial activity to those that release antimicrobial agents, antimicrobial ceramics and inorganic compounds, such as metal based antimicrobial additives, and the developing field of biomimetic materials, are discussed. Surfaces, coatings and adhesives are covered, whilst the applications of these antimicrobial materials in biomedical applications, from catheters to orthopaedics, dentistry to ophthalmology, are explored. Edited by international leaders and with contributions from the best in the field, this book is the go-to resource for graduates and researchers in biomaterials science, biomedical engineering, chemical engineering, and materials and polymer chemistry.

Nuclear Science Abstracts Book

Nuclear Science Abstracts


  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 1974
  • Genre: Nuclear energy
  • Pages : null
  • ISBN 10 : PSU:000047758995

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Nuclear Science Abstracts Excerpt :

NSA is a comprehensive collection of international nuclear science and technology literature for the period 1948 through 1976, pre-dating the prestigious INIS database, which began in 1970. NSA existed as a printed product (Volumes 1-33) initially, created by DOE's predecessor, the U.S. Atomic Energy Commission (AEC). NSA includes citations to scientific and technical reports from the AEC, the U.S. Energy Research and Development Administration and its contractors, plus other agencies and international organizations, universities, and industrial and research organizations. References to books, conference proceedings, papers, patents, dissertations, engineering drawings, and journal articles from worldwide sources are also included. Abstracts and full text are provided if available.

Validation of Pharmaceutical Processes Book
Score: 4
From 5 Ratings

Validation of Pharmaceutical Processes


  • Author : James P. Agalloco
  • Publisher : CRC Press
  • Release Date : 2007-09-25
  • Genre: Medical
  • Pages : 760
  • ISBN 10 : 9781420019797

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Validation of Pharmaceutical Processes Excerpt :

Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine va