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Assurance of Sterility for Sensitive Combination Products and Materials

Assurance of Sterility for Sensitive Combination Products and Materials
New Paradigms to Bring Innovative Healthcare Products to Patients

by Byron J. Lambert,Stan Lam,Joyce M. Hansen,Trabue D. Bryans

  • Publisher : Academic Press
  • Release : 2019-12-12
  • Pages : 262
  • ISBN : 0128131799
  • Language : En, Es, Fr & De
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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
Host Cell Recruitment and Biomaterial Design

by Sang Jin Lee,Anthony Atala,James J Yoo

  • Publisher : Academic Press
  • Release : 2016-07-17
  • Pages : 458
  • ISBN : 012802500X
  • Language : En, Es, Fr & De
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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
Biocompatibility Testing and Safety Assessment

by Shayne Cox Gad,Samantha Gad-McDonald

  • Publisher : CRC Press
  • Release : 2015-12-01
  • Pages : 606
  • ISBN : 1482248387
  • Language : En, Es, Fr & De
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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
A Book

by Shayne C. Gad,Marian G. McCord

  • Publisher : CRC Press
  • Release : 2008-10-20
  • Pages : 504
  • ISBN : 1439809488
  • Language : En, Es, Fr & De
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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.

Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals

Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals
Technology, Validation and Current Regulations

by Tim Sandle

  • Publisher : Elsevier
  • Release : 2013-10-31
  • Pages : 362
  • ISBN : 1908818638
  • Language : En, Es, Fr & De
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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

AAMI Standards and Recommended Practices

AAMI Standards and Recommended Practices
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 1992
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Polymers in Medical Applications

Polymers in Medical Applications
A Book

by B.J. Lambert,F.-W. Tang,W. J. Rogers

  • Publisher : iSmithers Rapra Publishing
  • Release : 2001
  • Pages : 146
  • ISBN : 9781859572597
  • Language : En, Es, Fr & De
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The use of polymers in medical devices is growing at a steady rate. These materials are generally relatively cheap and versatile, qualities required in many bulk applications. In more specialised medical devices, polymeric components have been developed to meet challenging property and performance requirements. This review describes the process of developing polymeric products for medical applications from design requirements through to specific examples of medical devices and packaging. An additional indexed section containing several hundred abstracts from the Rapra Polymer Library database gives useful references for further reading.

USP35 NF30, 2012

USP35 NF30, 2012
U. S. Pharmacopoeia National Formulary

by United States Pharmacopeial Convention

  • Publisher : U.S. Pharmacopeia
  • Release : 2011-11
  • Pages : 5089
  • ISBN : 9781936424009
  • Language : En, Es, Fr & De
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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).

Introduction to Sterilization and Disinfection

Introduction to Sterilization and Disinfection
A Book

by Joan F. Gardner,Margaret M. Peel

  • Publisher : Unknown Publisher
  • Release : 1986
  • Pages : 183
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Understanding Anesthesia Equipment

Understanding Anesthesia Equipment
Construction, Care, and Complications

by Jerry A. Dorsch,Susan E. Dorsch

  • Publisher : Unknown Publisher
  • Release : 1984
  • Pages : 458
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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JPMA. The Journal of the Pakistan Medical Association

JPMA. The Journal of the Pakistan Medical Association
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 1990
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Sterilization Manual for Health Centers

Sterilization Manual for Health Centers
A Book

by Silvia I. Acosta-Gnass,Valeska De Andrade Stempliuk

  • Publisher : Pan Amer Health Org
  • Release : 2010
  • Pages : 167
  • ISBN : 9789275129265
  • Language : En, Es, Fr & De
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This updated sterilisation manual informs health workers about the simple protocols and procedures that have been developed to prevent hospital-acquired infections both inside and outside the sterilisation plant. The guidelines included in this manual show the steps to follow in cleaning, preparing, sterilizing, storing and transporting hospital equipment so as to obtain sterile material. It is very important to be aware of this information in order to provide patients with safe health care.

A Practical Guide to Selecting Gametes and Embryos

A Practical Guide to Selecting Gametes and Embryos
A Book

by Markus Montag

  • Publisher : CRC Press
  • Release : 2014-06-16
  • Pages : 328
  • ISBN : 1842145487
  • Language : En, Es, Fr & De
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Among the many recent advances in assisted reproduction therapies (ART), improved technologies for identifying viable oocytes, sperm, and embryos are of primary importance. Paradoxically, the latest advances presented at conferences and symposia are often slow to become part of the daily routine in IVF laboratories. Detailing established and develo

Handbook of Pharmaceutical Manufacturing Formulations

Handbook of Pharmaceutical Manufacturing Formulations
Sterile Products

by Safaraz K. Niazi

  • Publisher : CRC Press
  • Release : 2016-04-19
  • Pages : 464
  • ISBN : 1420081314
  • Language : En, Es, Fr & De
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No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing ster

Sterilisation of Biomaterials and Medical Devices

Sterilisation of Biomaterials and Medical Devices
A Book

by Sophie Lerouge,Anne Simmons

  • Publisher : Elsevier
  • Release : 2012-09-27
  • Pages : 352
  • ISBN : 0857096265
  • Language : En, Es, Fr & De
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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

Hello World: A Life in Ham Radio

Hello World: A Life in Ham Radio
A Book

by Danny Gregory,Paul Sahre

  • Publisher : Princeton Architectural Press
  • Release : 2003-03
  • Pages : 255
  • ISBN : 9781568982816
  • Language : En, Es, Fr & De
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To an outsider, the world of ham radio is one of basement transmitters, clunky microphones, Morse code, and crackly, possibly clandestine, worldwide communications, a world both mysterious and geeky. But the real story is a lot more interesting: indeed, there are more than two million operators worldwide, including people like Walter Cronkite and Priscilla Presley. Gandhi had a ham radio, as do Marlon Brando and Juan Carlos, king of Spain. Hello World takes us on a seventy-year odyssey through the world of ham radio. From 1927 until his death in 2001, operator Jerry Powell transmitted radio signals from his bedroom in Hackensack, New Jersey, touring the worlds most remote locations and communicating with people from Greenland to occupied Japan. Once he made contact with a fellow ham operator, he exchanged postcards known as QSLs cards with them. For seven decades, Powell collected hundreds of these cards, documenting his fascinating career in amateur radio and providing a dazzling graphic inventory of people and places far flung. This book is both an introduction to the fascinating world of ham and a visual feast for anyone interested in the universal language of graphic design.

International Food Marketing & Technology

International Food Marketing & Technology
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 2000
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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National Standards and Recommended Practices for Sterilization

National Standards and Recommended Practices for Sterilization
A Book

by Association for the Advancement of Medical Instrumentation

  • Publisher : Assn for the Advancement of medical
  • Release : 1988
  • Pages : 343
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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"Contains the complete text of six AAMI recommended practices, six AAMI American National Standards, and two AAMI standards"--p. vii.

Plastics in Medical Devices

Plastics in Medical Devices
Properties, Requirements and Applications

by Vinny R. Sastri

  • Publisher : Elsevier
  • Release : 2010-03-05
  • Pages : 352
  • ISBN : 081552028X
  • Language : En, Es, Fr & De
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No book has been published that gives a detailed description of all the types of plastic materials used in medical devices, the unique requirements that the materials need to comply with and the ways standard plastics can be modified to meet such needs. This book will start with an introduction to medical devices, their classification and some of the regulations (both US and global) that affect their design, production and sale. A couple of chapters will focus on all the requirements that plastics need to meet for medical device applications. The subsequent chapters describe the various types of plastic materials, their properties profiles, the advantages and disadvantages for medical device applications, the techniques by which their properties can be enhanced, and real-world examples of their use. Comparative tables will allow readers to find the right classes of materials suitable for their applications or new product development needs.

The Encyclopedia of Cell Technology, 2 Volume Set

The Encyclopedia of Cell Technology, 2 Volume Set
A Book

by Raymond E. Spier

  • Publisher : Wiley-Interscience
  • Release : 2000-02-08
  • Pages : 1280
  • ISBN : 9780471161233
  • Language : En, Es, Fr & De
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Brings together up-to-date information on all key aspects of plant and animal cell technology in a single resource. Covers scientific, historical, and ethical aspects of biotechnology. Synthesizes a wealth of information in a valuable one-stop resource. Invaluable to researchers working animal or plant cell technology.