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
Publsiher: Academic Press
Total Pages: 262
Release: 2019-12-12
ISBN 10: 0128131799
ISBN 13: 9780128131794
Language: EN, FR, DE, ES & NL

Assurance of Sterility for Sensitive Combination Products and Materials Book Review:

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

Assurance of Sterility for Sensitive Combination Products and Materials
Author: Byron Lambert,Stan Lam,Joyce Hansen,Trabue D. Bryans
Publsiher: Academic Press
Total Pages: 252
Release: 2019-06-15
ISBN 10: 0128050829
ISBN 13: 9780128050828
Language: EN, FR, DE, ES & NL

Assurance of Sterility for Sensitive Combination Products and Materials Book Review:

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

In Situ Tissue Regeneration

In Situ Tissue Regeneration
Author: Sang Jin Lee,Anthony Atala,James J Yoo
Publsiher: Academic Press
Total Pages: 458
Release: 2016-07-17
ISBN 10: 012802500X
ISBN 13: 9780128025000
Language: EN, FR, DE, ES & NL

In Situ Tissue Regeneration Book Review:

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

Biomaterials  Medical Devices  and Combination Products
Author: Shayne Cox Gad,Samantha Gad-McDonald
Publsiher: CRC Press
Total Pages: 606
Release: 2015-12-01
ISBN 10: 1482248387
ISBN 13: 9781482248388
Language: EN, FR, DE, ES & NL

Biomaterials Medical Devices and Combination Products Book Review:

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

Biomaterials Science
Author: Buddy D. Ratner,Allan S. Hoffman,Frederick J. Schoen,Jack E. Lemons
Publsiher: Academic Press
Total Pages: 1573
Release: 2012-12-31
ISBN 10: 008087780X
ISBN 13: 9780080877808
Language: EN, FR, DE, ES & NL

Biomaterials Science Book Review:

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

Safety Evaluation in the Development of Medical Devices and Combination Products  Third Edition
Author: Shayne C. Gad,Marian G. McCord
Publsiher: CRC Press
Total Pages: 504
Release: 2008-10-20
ISBN 10: 1439809488
ISBN 13: 9781439809488
Language: EN, FR, DE, ES & NL

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

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

Pharmaceutical Quality Assurance
Author: Mr. Manohar A. Potdar
Publsiher: Pragati Books Pvt. Ltd.
Total Pages: 420
Release: 2006
ISBN 10: 9788185790596
ISBN 13: 8185790590
Language: EN, FR, DE, ES & NL

Pharmaceutical Quality Assurance Book Review:

Radiation Source Use and Replacement

Radiation Source Use and Replacement
Author: National Research Council,Division on Earth and Life Studies,Nuclear and Radiation Studies Board,Committee on Radiation Source Use and Replacement
Publsiher: National Academies Press
Total Pages: 232
Release: 2008-05-25
ISBN 10: 0309110149
ISBN 13: 9780309110143
Language: EN, FR, DE, ES & NL

Radiation Source Use and Replacement Book Review:

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.

Pharmaceutical Microbiology Manual

Pharmaceutical Microbiology Manual
Author: United States Food and Drug Administration
Publsiher: Createspace Independent Publishing Platform
Total Pages: 92
Release: 2017-09-21
ISBN 10: 9781976578670
ISBN 13: 1976578671
Language: EN, FR, DE, ES & NL

Pharmaceutical Microbiology Manual Book Review:

Manual and is a supplement to the United States Pharmacopeia (USP) for pharmaceutical microbiology testing, including antimicrobial effectiveness testing, microbial examination of non-sterile products, sterility testing, bacterial endotoxin testing, particulate matter, device bioburden and environmental monitoring testing. The goal of this manual is to provide an ORA/CDER harmonized framework on the knowledge, methods and tools needed, and to apply the appropriate scientific standards required to assess the safety and efficacy of medical products within FDA testing laboratories. The PMM has expanded to include some rapid screening techniques along with a new section that covers inspectional guidance for microbiologists that conduct team inspections. This manual was developed by members of the Pharmaceutical Microbiology Workgroup and includes individuals with specialized experience and training. The instructions in this document are guidelines for FDA analysts. When available, analysts should use procedures and worksheets that are standardized and harmonized across all ORA field labs, along with the PMM, when performing analyses related to product testing of pharmaceuticals and medical devices. When changes or deviations are necessary, documentation should be completed per the laboratory's Quality Management System. Generally, these changes should originate from situations such as new products, unusual products, or unique situations. This manual was written to reduce compendia method ambiguity and increase standardization between FDA field laboratories. By providing clearer instructions to FDA ORA labs, greater transparency can be provided to both industry and the public. However, it should be emphasized that this manual is a supplement, and does not replace any information in USP or applicable FDA official guidance references. The PMM does not relieve any person or laboratory from the responsibility of ensuring that the methods being employed from the manual are fit for use, and that all testing is validated and/or verified by the user. The PMM will continually be revised as newer products, platforms and technologies emerge or any significant scientific gaps are identified with product testing. Reference to any commercial materials, equipment, or process in the PMM does not in any way constitute approval, endorsement, or recommendation by the U.S. Food and Drug Administration.

SRB s Surgical Operations

SRB s Surgical Operations
Author: Sriram Bhat M
Publsiher: JP Medical Ltd
Total Pages: 1438
Release: 2017-11-30
ISBN 10: 9352702115
ISBN 13: 9789352702114
Language: EN, FR, DE, ES & NL

SRB s Surgical Operations Book Review:

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

Antimicrobial Materials for Biomedical Applications
Author: Abraham J Domb,Konda Reddy Kunduru,Shady Farah
Publsiher: Royal Society of Chemistry
Total Pages: 526
Release: 2019-07-31
ISBN 10: 1788018540
ISBN 13: 9781788018548
Language: EN, FR, DE, ES & NL

Antimicrobial Materials for Biomedical Applications Book Review:

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.

ICARST 2017 International Conference on Applications of Radiation Science and Technology

ICARST 2017 International Conference on Applications of Radiation Science and Technology
Author: Anonim
Publsiher: IAEA
Total Pages: 467
Release: 2017-04-24
ISBN 10: 1928374650XXX
ISBN 13: 9182736450XXX
Language: EN, FR, DE, ES & NL

ICARST 2017 International Conference on Applications of Radiation Science and Technology Book Review:

Innovative Food Processing Technologies

Innovative Food Processing Technologies
Author: Anonim
Publsiher: Elsevier
Total Pages: 2480
Release: 2020-08-18
ISBN 10: 0128157828
ISBN 13: 9780128157824
Language: EN, FR, DE, ES & NL

Innovative Food Processing Technologies Book Review:

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 nonthermal processing, such as high pressure, pulsed electric fields, radiofrequency, high intensity pulsed light, ultrasound, irradiation and new hurdle technology. Each section will have an introductory article covering the basic principles and applications of each technology, and in-depth articles covering the currently available equipment (and/or the current state of development), food quality and safety, application to various sectors, food laws and regulations, consumer acceptance, advancements and future scope. It will also contain case studies and examples to illustrate state-of-the-art applications. Each section will serve as an excellent reference to food industry professionals involved in the processing of a wide range of food categories, e.g., meat, seafood, beverage, dairy, eggs, fruits and vegetable products, spices, herbs among others.

Aulton s Pharmaceutics E Book

Aulton s Pharmaceutics E Book
Author: Michael E. Aulton,Kevin M.G. Taylor
Publsiher: Elsevier Health Sciences
Total Pages: 944
Release: 2017-08-26
ISBN 10: 0702070017
ISBN 13: 9780702070013
Language: EN, FR, DE, ES & NL

Aulton s Pharmaceutics E Book Book Review:

From a review of the previous edition: ‘For all the pharmacy students out there part of your pharmacy degree will be to study formulation design and pharmaceutics. This is the holy grail of pharmaceutical technology books. The text reads well and introduces difficult concepts in a more easy-to-understand way, it is definitely worth the money to help you get through the module, if you’re doing a research project in pharmaceutical design then this would also be an excellent buy...This is essential for passing exams and developing professional competence.’ This is the best known text on pharmaceutics. Its strength lies mainly in being a complete course in one book. Reviewers consistently praise its comprehensiveness and its extremely high quality-quality content. Pharmaceutics is one of the most diverse subject areas in pharmaceutical science and an understanding of it is vital for all pharmacists and scientists involved in converting drugs to medicines that can be safely delivered to a patient. The editorial and author team deliver a tour de force of accessibility, coverage and currency in this new edition of a world-class textbook. Relevant chemistry covered throughout Reflects current and future use of biotechnology products throughout Covers ongoing changes in our understanding of biopharmaceutics, certain areas of drug delivery and the significance of the solid state Includes the science of formulation and drug delivery Designed and written for newcomers to the design of dosage forms Key points boxes throughout Summaries at the end of each chapter Fully updated throughout, with particular focus on delivery of biopharmaceuticals, nanotechnology and nanomedicines, parenteral and ocular drug delivery mechanisms. Now comes with online access on StudentConsult.

Biomaterials Science

Biomaterials Science
Author: William R Wagner,Shelly E. Sakiyama-Elbert,Guigen Zhang,Michael J. Yaszemski
Publsiher: Academic Press
Total Pages: 1616
Release: 2020-05-23
ISBN 10: 0128161388
ISBN 13: 9780128161388
Language: EN, FR, DE, ES & NL

Biomaterials Science Book Review:

The revised edition of the renowned and bestselling title is the most comprehensive single text on all aspects of biomaterials science from principles to applications. Biomaterials Science, fourth edition, 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. This new edition incorporates key updates to reflect the latest relevant research in the field, particularly in the applications section, which includes the latest in topics such as nanotechnology, robotic implantation, and biomaterials utilized in cancer research detection and therapy. Other additions include regenerative engineering, 3D printing, personalized medicine and organs on a chip. Translation from the lab to commercial products is emphasized with new content dedicated to medical device development, global issues related to translation, and issues of quality assurance and reimbursement. In response to customer feedback, the new edition also features consolidation of redundant material to ensure clarity and focus. Biomaterials Science, 4th edition is an important update to the best-selling text, vital to the biomaterials’ community. The most comprehensive coverage of principles and applications of all classes of biomaterials Edited and contributed by the best-known figures in the biomaterials field today; fully endorsed and supported by the Society for Biomaterials Fully revised and updated to address issues of translation, nanotechnology, additive manufacturing, organs on chip, precision medicine and much more. Online chapter exercises available for each chapter

Nuclear Science Abstracts

Nuclear Science Abstracts
Author: Anonim
Publsiher: Unknown
Total Pages: 135
Release: 1974
ISBN 10: 1928374650XXX
ISBN 13: PSU:000047758995
Language: EN, FR, DE, ES & NL

Nuclear Science Abstracts Book Review:

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.

Darby and Walsh Dental Hygiene E Book

Darby and Walsh Dental Hygiene E Book
Author: Jennifer A Pieren,Denise M. Bowen
Publsiher: Elsevier Health Sciences
Total Pages: 1072
Release: 2019-03-04
ISBN 10: 0323549780
ISBN 13: 9780323549783
Language: EN, FR, DE, ES & NL

Darby and Walsh Dental Hygiene E Book Book Review:

Back and better than ever, Darby and Walsh’s Dental Hygiene: Theory and Practice, 5th Edition offers everything you need to succeed in your coursework, at certification, and in clinical practice. No other dental hygiene text incorporates the clinical skills, theory, and evidence-based practice in such an approachable way. All discussions — from foundational concepts to diagnosis to pain management — are presented within the context of a unique patient-centered model that takes the entire person into consideration. New to this fifth edition is a much more streamlined approach — one that stays focused on need-to-know information, yet also houses expanded content on things like alternative practice settings, pediatric care, risk assessment, and dental hygiene diagnosis to give you added context when needed. This edition is also filled with new modern illustrations and new clinical photos to augment your learning. If you want a better grasp of all the dental hygienist’s roles and responsibilities in today’s practice, they Darby and Walsh’s renowned text is a must-have. Focus on research and evidence-base practice provide proven findings and practical applications for topics of interest in modern dental hygiene care. Step-by-step procedure boxes with accompanying illustrations, clinical photos, and rationales outline the equipment required and the steps involved in performing key procedures. Critical thinking exercises, cases, and scenarios help hone your application and problem-solving skills. Feature boxes highlight patient education, law, ethics, and safety. UNIQUE! Discussions of theory provide a solid foundation for practice. Key terms are called out within chapters and defined in glossary with cross-references to chapters. Practice quizzes enable you to self-assess your understanding. NEW! Streamlined approach focuses on the information you need to know along with the practical applications. NEW! Added content covers alternative practice settings, new infection control guidelines, pediatric care, risk assessment, dental hygiene diagnosis, the electronic health record (EHR), and more. NEW! Modern illustrations and updated clinical photos give you a better picture of how to perform essential skills and utilize clinical technology. NEW! Online procedures videos guide you step-by-step through core clinical skills. NEW! Editorial team brings a fresh perspective and more than 30 years of experience in dental hygiene education, practice, and research.

AAMI Standards and Recommended Practices

AAMI Standards and Recommended Practices
Author: Anonim
Publsiher: Unknown
Total Pages: 135
Release: 1992
ISBN 10: 1928374650XXX
ISBN 13: UOM:39015031258547
Language: EN, FR, DE, ES & NL

AAMI Standards and Recommended Practices Book Review:

Validation of Pharmaceutical Processes

Validation of Pharmaceutical Processes
Author: James P. Agalloco,Frederick J. Carleton
Publsiher: CRC Press
Total Pages: 760
Release: 2007-09-25
ISBN 10: 1420019791
ISBN 13: 9781420019797
Language: EN, FR, DE, ES & NL

Validation of Pharmaceutical Processes Book Review:

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

Textbook on Cutaneous and Aesthetic Surgery

Textbook on Cutaneous and Aesthetic Surgery
Author: Mysore Venkataram
Publsiher: JP Medical Ltd
Total Pages: 988
Release: 2012-08-31
ISBN 10: 9350258900
ISBN 13: 9789350258903
Language: EN, FR, DE, ES & NL

Textbook on Cutaneous and Aesthetic Surgery Book Review:

Textbook on Cutaneous & Aesthetic Surgery is a complete guide to the subspecialty. Beginning with an introduction to the principles of cutaneous surgery – anatomy, operating theatre, instruments, anaesthesia, emergencies and antibiotics - the following chapters examine both basic and advanced cutaneous surgical techniques and aesthetic procedures, with a separate section dedicated to the use of lasers and lights for surgery. The final section discusses topics such as patient satisfaction, psychological issues, medico-legal aspects, photography and teledermatology. With almost 1000 colour images and illustrations, this comprehensive manual is the official textbook of the ACS(I) (Association of Cutaneous Surgeons India). Key Features Comprehensive guide to cutaneous and aesthetic surgery for dermatosurgeons Discusses principles, basic and advanced cutaneous surgery and aesthetic procedures Section dedicated to lasers, lights and other technologies Examines miscellaneous topics such as psychological issues, medico0legal aspects and teledermatology Nearly 1000 colour images and illustrations