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Assurance Of Sterility For Sensitive Combination Products And Materials

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Assurance of Sterility for Sensitive Combination Products and Materials

Assurance of Sterility for Sensitive Combination Products and Materials Book
Author : Byron Lambert,Stan Lam,Joyce Hansen,Trabue D. Bryans
Publisher : Academic Press
Release : 2019-06-15
ISBN : 0128050829
Language : En, Es, Fr & De

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Book Description :

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 Book
Author : Byron J. Lambert,Stan Lam,Joyce M. Hansen,Trabue D. Bryans
Publisher : Academic Press
Release : 2019-12-12
ISBN : 0128131799
Language : En, Es, Fr & De

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Book Description :

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

Biomaterials Medical Devices and Combination Products

Biomaterials  Medical Devices  and Combination Products Book
Author : Shayne Cox Gad,Samantha Gad-McDonald
Publisher : CRC Press
Release : 2015-12-01
ISBN : 1482248387
Language : En, Es, Fr & De

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Book Description :

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 Book
Author : Shayne C. Gad,Marian G. McCord
Publisher : CRC Press
Release : 2008-10-20
ISBN : 1439809488
Language : En, Es, Fr & De

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Book Description :

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.

Biomaterials Science

Biomaterials Science Book
Author : Buddy D. Ratner,Allan S. Hoffman,Frederick J. Schoen,Jack E. Lemons
Publisher : Academic Press
Release : 2012-12-31
ISBN : 008087780X
Language : En, Es, Fr & De

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Book Description :

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

Sterile Drug Products

Sterile Drug Products Book
Author : Michael J. Akers
Publisher : CRC Press
Release : 2016-04-19
ISBN : 1420020560
Language : En, Es, Fr & De

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Book Description :

Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This book is based on the courses he has delivered for over three decades, to over 3000 participants, and is intended to remain relevant for the indefinite future even as new technologies and new applications of old technologies become common. This is an ideal reference book for those working directly and indirectly with sterile dosage forms, be it product development (formulation, package, process, analytical), manufacturing, quality control, quality assurance, regulatory, purchasing, or project management. This book is also intended as an educational resource for the pharmaceutical and biopharmaceutical industry and pharmacy schools, providing basic knowledge and principles in four main areas of parenteral science and technology: Product development, including formulation, packaging, and process development. Manufacturing, including basic teaching on all the primary unit operations involved in preparation of sterile products and the underlying importance of contamination control. Quality and regulatory, including the application of good manufacturing practice regulations, aseptic processing guidelines, and unique quality control testing methods for the sterile dosage form Clinical aspects, including administration, potential hazards, and biopharmaceutics of sterile products in a clinical setting.

Essential Microbiology for Pharmacy and Pharmaceutical Science

Essential Microbiology for Pharmacy and Pharmaceutical Science Book
Author : Geoff Hanlon,Norman A. Hodges
Publisher : John Wiley & Sons
Release : 2012-12-10
ISBN : 1118432436
Language : En, Es, Fr & De

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Book Description :

This text is an essential study guide for undergraduates studying microbiology modules on degree courses in pharmacy and the pharmaceutical sciences. Written by two pharmacists each with over 30 years experience of teaching, research and publishing in pharmaceutical microbiology, it distills the subject down into the essential elements that pharmacists and pharmaceutical scientists need to know in order to practice their profession, and it covers all the microbiology components of the Royal Pharmaceutical Society's indicative syllabus that is at the heart of every UK pharmacy degree. Much of the applied microbiology that a pharmacist or pharmaceutical scientist needs to know is unique: topics like the manufacture of microbiologically sterile medicines and their subsequent protection against microbial contamination and spoilage, the detection of hazardous microorganisms in medicines and antibiotics' manufacture and assay are all covered here. Essential Microbiology for Pharmacy and Pharmaceutical Science Students displays material in an easy to-digest format and concepts are explained using diagrams, tables and pictures wherever possible. The book contains an extensive self-assessment section that includes typical multiple choice, short answer and essay-style examination questions, and a companion website to further test your knowledge from a selection of questions along with further links to relevant sites.

Innovative Food Processing Technologies

Innovative Food Processing Technologies Book
Author : Anonim
Publisher : Elsevier
Release : 2020-08-18
ISBN : 0128157828
Language : En, Es, Fr & De

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Book Description :

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.

SRB s Surgical Operations

SRB s Surgical Operations Book
Author : Sriram Bhat M
Publisher : JP Medical Ltd
Release : 2017-11-30
ISBN : 9352702115
Language : En, Es, Fr & De

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Book Description :

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

Nuclear Science Abstracts

Nuclear Science Abstracts Book
Author : Anonim
Publisher : Unknown
Release : 1974
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

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.

Parenteral Medications Fourth Edition

Parenteral Medications  Fourth Edition Book
Author : Sandeep Nema,John D. Ludwig
Publisher : CRC Press
Release : 2019-07-19
ISBN : 0429576838
Language : En, Es, Fr & De

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Book Description :

Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacturing of parenteral dosage forms, effectively balancing theoretical considerations with practical aspects of their development. Previously published as a three-volume set, all volumes have been combined into one comprehensive publication that addresses the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. Key Features: Provides a comprehensive reference work on the formulation and manufacturing of parenteral dosage forms Addresses changes in the science and advances in the technology associated with parenteral medications and routes of administration Includes 13 new chapters and updated chapters throughout Contains the contributors of leading researchers in the field of parenteral medications Uses full color detailed illustrations, enhancing the learning process The fourth edition not only reflects enhanced content in all the chapters but also highlights the rapidly advancing formulation, processing, manufacturing parenteral technology including advanced delivery and cell therapies. The book is divided into seven sectionss: Section 1 - Parenteral Drug Administration and Delivery Devices; Section 2 - Formulation Design and Development; Section 3 - Specialized Drug Delivery Systems; Section 4 - Primary Packaging and Container Closure Integrity; Section 5 - Facility Design and Environmental Control; Section 6 - Sterilization and Pharmaceutical Processing; Section 7 - Quality Testing and Regulatory Requirements

Cells and Materials for Disease Modeling and Regenerative Medicine

Cells and Materials for Disease Modeling and Regenerative Medicine Book
Author : Ander Abarrategi,Senentxu Lanceros-Mendez
Publisher : MDPI
Release : 2021-05-05
ISBN : 3036502629
Language : En, Es, Fr & De

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Book Description :

Materials science and engineering are strongly developing tools with increasing impact in the biotechnological and biomedical areas. Interestingly, research in molecular and cellular biology is often at the core of the design and development of materials-based approaches, providing biological rationale. Focused on research relying on biology–materials interaction, IJMS launched a Special Issue named “Cells and Materials for Disease Modeling and Regenerative Medicine”. The aim of the Special Issue was to generate a compilation of in vitro and in vivo strategies based on cell–material interactions. This book compiles the papers published in that Special Issue and includes a selection of six original scientific experimental articles and six comprehensive reviews. We are convinced that this collection of articles shows representative examples of the state of the art in the field, unveiling the relevance of materials research in generating new regenerative medicine and disease modeling approaches.

AAMI Standards and Recommended Practices

AAMI Standards and Recommended Practices Book
Author : Anonim
Publisher : Unknown
Release : 1992
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download AAMI Standards and Recommended Practices book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Textbook on Cutaneous and Aesthetic Surgery

Textbook on Cutaneous and Aesthetic Surgery Book
Author : Mysore Venkataram
Publisher : JP Medical Ltd
Release : 2012-08-31
ISBN : 9350258900
Language : En, Es, Fr & De

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Book Description :

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

Bennett Brachman s Hospital Infections

Bennett   Brachman s Hospital Infections Book
Author : John V. Bennett,William Robert Jarvis,Philip S. Brachman
Publisher : Lippincott Williams & Wilkins
Release : 2007
ISBN : 9780781763837
Language : En, Es, Fr & De

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Book Description :

The most influential reference in the field for nearly thirty years, Bennett and Brachman's Hospital Infections is in its thoroughly updated Fifth Edition. Written by internationally recognized experts—many affiliated with the Centers for Disease Control and Prevention—the book is the most comprehensive, up-to-date, authoritative guide to the recognition, management, prevention, and control of infections in all types of healthcare facilities. More than half of this edition's chapters have new authors who are current experts in the field. Important new chapters cover patient safety, public reporting, controlling antimicrobial-resistant pathogens (especially MRSA and VRE), fungi, and healthcare-associated infections caused by newer treatments such as invasive cardiology. This edition has a new two-color design.

Comprehensive Biotechnology

Comprehensive Biotechnology Book
Author : Anonim
Publisher : Elsevier
Release : 2019-07-17
ISBN : 0444640479
Language : En, Es, Fr & De

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Book Description :

Comprehensive Biotechnology, Third Edition unifies, in a single source, a huge amount of information in this growing field. The book covers scientific fundamentals, along with engineering considerations and applications in industry, agriculture, medicine, the environment and socio-economics, including the related government regulatory overviews. This new edition builds on the solid basis provided by previous editions, incorporating all recent advances in the field since the second edition was published in 2011. Offers researchers a one-stop shop for information on the subject of biotechnology Provides in-depth treatment of relevant topics from recognized authorities, including the contributions of a Nobel laureate Presents the perspective of researchers in different fields, such as biochemistry, agriculture, engineering, biomedicine and environmental science

Sterilization Technology

Sterilization Technology Book
Author : Robert F. Morrissey,G. Briggs Phillips
Publisher : Springer
Release : 1993-02-28
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Includes as many case studies as the contributors could identify, with the goal of answering questions that arise as a result of conducting day-to-day sterilization activities. Discussion of the theory of microbial inactivation and the philosophy of sterilization validation is followed by practical information on methods of interest to a broad audience. Chapters on special considerations for ethylene oxide, packaging of sterile products, contract sterilization, and regulations complete the coverage. Annotation copyright by Book News, Inc., Portland, OR

USP35 NF30 2012

USP35 NF30  2012 Book
Author : United States Pharmacopeial Convention
Publisher : U.S. Pharmacopeia
Release : 2011-11
ISBN : 9781936424009
Language : En, Es, Fr & De

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Book Description :

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 substances and dosage forms. View a sample USP-NF monograph (100KB). * Over 230 General Chapters providing clear, step-by-step guidance for assays, tests, and procedures * Focus-specific charts and a combined index helps you find the information you need * Helpful sections on reagents, indicators, and solutions, plus reference tables * Published annually in an official English edition (print, CD, and new USB flash drive formats ) and an official Spanish edition (print).

Handbook of Intelligent Scaffolds for Tissue Engineering and Regenerative Medicine

Handbook of Intelligent Scaffolds for Tissue Engineering and Regenerative Medicine Book
Author : Gilson Khang
Publisher : CRC Press
Release : 2017-06-26
ISBN : 1315341026
Language : En, Es, Fr & De

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Book Description :

Millions of patients suffer from end-stage organ failure or tissue loss annually, and the only solution might be organ and/or tissue transplantation. To avoid poor biocompatibility–related problems and donor organ shortage, however, around 20 years ago a new, hybridized method combining cells and biomaterials was introduced as an alternative to whole-organ and tissue transplantation for diseased, failing, or malfunctioning organs—regenerative medicine and tissue engineering. This handbook focuses on all aspects of intelligent scaffolds, from basic science to industry to clinical applications. Its 10 parts, illustrated throughout with excellent figures, cover stem cell engineering research, drug delivery systems, nanomaterials and nanodevices, and novel and natural biomaterials. The book can be used by advanced undergraduate- and graduate-level students of stem cell and tissue engineering and researchers in macromolecular science, ceramics, metals for biomaterials, nanotechnology, chemistry, biology, and medicine, especially those interested in tissue engineering, stem cell engineering, and regenerative medicine.