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Sterilization Of Health Care Products Chemical Indicators General Requirements
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Book Synopsis Decontamination in Hospitals and Healthcare by : James T. Walker
Download or read book Decontamination in Hospitals and Healthcare written by James T. Walker and published by Woodhead Publishing. This book was released on 2019-11-26 with total page 594 pages. Available in PDF, EPUB and Kindle. Book excerpt: Decontamination in Hospitals and Healthcare, Second Edition, enables users to obtain detailed knowledge of decontamination practices in healthcare settings, including surfaces, devices, clothing and people, with a specific focus on hospitals and dental clinics. - Offers in-depth coverage of all aspects of decontamination in healthcare - Examines the decontamination of surgical equipment and endoscopes - Expanded to include new information on behavioral principles in decontamination, control of microbiological problems, waterborne microorganisms, pseudomonas and the decontamination of laundry
Book Synopsis Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition by : Stephen P. Denyer
Download or read book Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition written by Stephen P. Denyer and published by CRC Press. This book was released on 2006-12-26 with total page 500 pages. Available in PDF, EPUB and Kindle. Book excerpt: Microbiological matters continue to exercise considerable influence on product quality. In both the pharmaceutical and medical device industries, products of greater sophistication, along with evolving regulatory requirements, are elevating the challenges related to maintaining microbiological integrity. Updated to reflect technological and regulatory changes, the Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition covers thoseprincipal aspects of microbiology that arerelevant to the preformulation, formulation, manufacturing, and license application stages involved with the production of pharmaceuticals and medical devices. In recognition of the diverse disciplines involved in pharmaceutical and medical device production, this work provides a brief introduction to microbiology geared towards the nonmicrobiologist. Covering good manufacturing practice in the control of contamination, the text explores quality control, the preservation of formulations, and principles of sterilization, including microbiological-specific considerations for biotechnological products and other medical devices. It also provides additional materials on package integrity and contamination risks in clean rooms. The editors have produced a companion text, the Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices (see reverse), which when paired with the Guide offers a complete theoretical and practical treatment of microbiological control. This book provides a comprehensive distillation of information concerning methodology and regulations that would otherwise remain scattered throughout the literature. It allows scientists from many fields to address potential problems in advance and implement suitable strategies at the earliest stages of development.
Book Synopsis Sterile Drug Products by : Michael J. Akers
Download or read book Sterile Drug Products written by Michael J. Akers and published by CRC Press. This book was released on 2016-04-19 with total page 517 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 Synopsis A Practical Guide to Decontamination in Healthcare by : Gerald E. McDonnell
Download or read book A Practical Guide to Decontamination in Healthcare written by Gerald E. McDonnell and published by John Wiley & Sons. This book was released on 2012-07-23 with total page 466 pages. Available in PDF, EPUB and Kindle. Book excerpt: Prevention is the first line of defence in the fight against infection. As antibiotics and other antimicrobials encounter increasing reports of microbial resistance, the field of decontamination science is undergoing a major revival. A Practical Guide to Decontamination in Healthcare is a comprehensive training manual, providing practical guidance on all aspects of decontamination including: microbiology and infection control; regulations and standards; containment, transportation, handling, cleaning, disinfection and sterilization of patient used devices; surgical instrumentation; endoscopes; and quality management systems. Written by highly experienced professionals, A Practical Guide to Decontaminationin Healthcare comprises a systematic review of decontamination methods, with uses and advantages outlined for each. Up-to-date regulations, standards and guidelines are incorporated throughout, to better equip healthcare professionals with the information they need to meet the technical and operational challenges of medical decontamination. A Practical Guide to Decontaminationin Healthcare is an important new volume on state-of-the-art decontamination processes and a key reference source for all healthcare professionals working in infectious diseases, infection control/prevention and decontamination services.
Download or read book Federal Register written by and published by . This book was released on 2014 with total page 426 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Medical Device Guidelines and Regulations Handbook by : Prakash Srinivasan Timiri Shanmugam
Download or read book Medical Device Guidelines and Regulations Handbook written by Prakash Srinivasan Timiri Shanmugam and published by Springer Nature. This book was released on 2022-04-22 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive resource features in-depth discussions of important guidelines and regulations needed to understand and properly meet medical device code-related requirements. Focusing on the practical application of the regulations, the Medical Device Guidelines and Regulations Handbook delivers clear explanations, real-world examples, and annotation on the applicable provisions that will allow you to safely and confidently choose materials and processes for medical device development, testing, and manufacturing. A critical resource for researchers and professionals in the medical device field; Thoroughly covers ISO 10993, ISO 22442, ISO 14971, ISO 13485, ISO 21534, REACH, RoHS, CLP, EU MDR; Presents simplified guidelines and regulation points.
Book Synopsis Sterilization of Medical Devices by : Anne Booth
Download or read book Sterilization of Medical Devices written by Anne Booth and published by Routledge. This book was released on 2018-12-12 with total page 430 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents vital information on international sterilization standards and guidance on practical application of these standards in the manufacturing process. It covers validation, industrial sterilization methods, emerging sterilization techniques, laboratory testing, manufacturing of sterile devices, and device reuse. Excerpted from The Validator, edited by Anne F. Booth, more than fifty experts share their knowledge of current technologies in easy-to-understand articles that establish methods to ensure compliance. Contents include reviews of ISO sterilization standards, industrial sterilization methods and technologies, and support testing methodologies.
Book Synopsis Sterilization Technology for the Health Care Facility by : Marimargaret Reichert
Download or read book Sterilization Technology for the Health Care Facility written by Marimargaret Reichert and published by Jones & Bartlett Learning. This book was released on 1997 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Second Edition is a comprehensive resource on sterilization and disinfection of reusable instruments and medical devices
Book Synopsis Biomaterials Science by : William R Wagner
Download or read book Biomaterials Science written by William R Wagner and published by Academic Press. This book was released on 2020-05-23 with total page 1612 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 most chapters
Book Synopsis Handbook of Validation in Pharmaceutical Processes, Fourth Edition by : James Agalloco
Download or read book Handbook of Validation in Pharmaceutical Processes, Fourth Edition written by James Agalloco and published by CRC Press. This book was released on 2021-10-28 with total page 1062 pages. Available in PDF, EPUB and Kindle. Book excerpt: Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals. Key Features: Provides an in-depth discussion of recent advances in sterilization Identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions Explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture
Book Synopsis Antisepsis, Disinfection, and Sterilization by : Gerald E. McDonnell
Download or read book Antisepsis, Disinfection, and Sterilization written by Gerald E. McDonnell and published by John Wiley & Sons. This book was released on 2020-07-10 with total page 431 pages. Available in PDF, EPUB and Kindle. Book excerpt: Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance, by Gerald E. McDonnell, is a detailed and accessible presentation of the current methods of microbial control. Each major category, such as physical disinfection methods, is given a chapter, in which theory, spectrum of activity, advantages, disadvantages, and modes of action of the methods are thoroughly and clearly presented. Sufficient background on the life cycles and general anatomy of microorganisms is provided so that the reader who is new to microbiology will better appreciate how physical and chemical biocides work their magic on microbes. Other topics in the book include: Evaluating the efficacy of chemical antiseptics and disinfectants, and of physical methods of microbial control and sterilization. Understanding how to choose the proper biocidal product and process for specific applications. Classic physical and chemical disinfection methods, such as heat, cold, non-ionizing radiation, acids, oxidizing agents, and metals. Newer chemical disinfectants, including, isothiazolones, micro-and nano-particles, and bacteriophages as control agents. Antisepsis of skin and wounds and the biocides that can be used as antiseptics. Classic methods of physical sterilization, such as, moist heat and dry heat sterilization, ionizing radiation, and filtration, along with newer methods, including, the use of plasma or pulsed light. Chemical sterilization methods that use ethylene oxide, formaldehyde, or a variety of other oxidizing agents. A detailed look at the modes of action of biocides in controlling microbial growth and disrupting microbial physiology. Mechanisms that microorganisms use to resist the effects of biocides. The second edition of Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance is well suited as a textbook and is outstanding as a reference book for facilities managers and application engineers in manufacturing plants, hospitals, and food production facilities. It is also essential for public health officials, healthcare professionals, and infection control practitioners.
Book Synopsis Hospital Epidemiology and Infection Control by : C. Glen Mayhall
Download or read book Hospital Epidemiology and Infection Control written by C. Glen Mayhall and published by Lippincott Williams & Wilkins. This book was released on 2012-02-20 with total page 5027 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thoroughly revised and updated for its Fourth Edition, this highly acclaimed volume is the most comprehensive reference on hospital epidemiology and infection control. Written by over 150 leading experts, this new edition examines every type of hospital-acquired (nosocomial) infection and addresses every issue relating to surveillance, prevention, and control of these infections in patients and in healthcare workers. This new edition features new or significantly increased coverage of emerging infectious diseases, avian influenza, governmental regulation of infection control and payment practices related to hospital-acquired infections, molecular epidemiology, the increasing prevalence of community-acquired MRSA in healthcare facilities, system-wide infection control provisions for healthcare systems, hospital infection control issues following natural disasters, and antimicrobial stewardship in reducing the development of antimicrobial-resistant organisms.
Book Synopsis Healthcare-Associated Infections in Australia by : Ramon Z Shaban
Download or read book Healthcare-Associated Infections in Australia written by Ramon Z Shaban and published by Elsevier Health Sciences. This book was released on 2023-04 with total page 979 pages. Available in PDF, EPUB and Kindle. Book excerpt: Infection prevention and control (IPC) is everybody's responsibility. Healthcare-associated Infections in Australia is the first Australian text to address the challenges posed by infectious diseases and healthcareassociated infections (HAIs) for all members of the multidisciplinary healthcare team. Drawing on the expertise of a wide author team, and based on current research, this important and comprehensive text provides a clear pathway for the reader to increase their knowledge and understanding of IPC. The text is designed for both students and practising clinicians, and is presented in two sections - Principles and Practice - for ease of use. With IPC principles and guidelines now embedded into all health-related curricula, and mandated by standards and guidelines across all areas of healthcare, this is a book no health professional should miss. - Includes practice tips, case studies and video-based learning materials providing real-life examples across more than 20 health professions - Suitable for increasing IPC knowledge across all members of the multidisciplinary team. Content is pitched at different levels, with examples ranging from novice to expert - Aligned to the Australian National Infection Control Guidelines 2019 and the NSQHS Standard Preventing and Controlling Healthcare Associated Infections, as well as the nine hospital-acquired complication (HAC) HAIs addressed in specific chapters - Endorsed by the Australian College for Infection Prevention and Control (ACIPC) and the Australian Society for Infectious Diseases (ASID) - Supported by a companion text, Epidemiology of Healthcare-associated Infections in Australia, providing data on the epidemiology of healthcare-associated surveillance in Australia Instructor and Student resources on Evolve: Multiple Choice Questions Case Studies Abbreviations and Glossary Useful Websites / Resources Video-based learning materials
Book Synopsis Integrated Pharmaceutics by : Antoine Al-Achi
Download or read book Integrated Pharmaceutics written by Antoine Al-Achi and published by John Wiley & Sons. This book was released on 2013-02-11 with total page 1024 pages. Available in PDF, EPUB and Kindle. Book excerpt: Focusing on the application of physical pharmacy, drug design, and drug regulations as they relate to produce effective dosage forms for drug delivery, Integrated Pharmaceutics provides a comprehensive picture of pharmaceutical product design, describing the science and art behind the concepts of dosage form development. Combining physical pharmacy, product design, and regulatory affairs issues in a single book, the authors address topics governing drug regulations of United States, European, and Japanese agencies and detail new regulatory guidelines, including quality by design, design space analysis, and blend sample uniformity.
Book Synopsis Handbook of Humanitarian Health Care Logistics by : George Mc Guire
Download or read book Handbook of Humanitarian Health Care Logistics written by George Mc Guire and published by George Mc Guire. This book was released on 2015-10-31 with total page 1441 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Block’s Disinfection, Sterilization, and Preservation by : Gerald McDonnell
Download or read book Block’s Disinfection, Sterilization, and Preservation written by Gerald McDonnell and published by Lippincott Williams & Wilkins. This book was released on 2020-06-26 with total page 3015 pages. Available in PDF, EPUB and Kindle. Book excerpt: With more international contributors than ever before, Block’s Disinfection, Sterilization, and Preservation, 6th Edition, is the first new edition in nearly 20 years of the definitive technical manual for anyone involved in physical and chemical disinfection and sterilization methods. The book focuses on disease prevention—rather than eradication—and has been thoroughly updated with new information based on recent advances in the field and understanding of the risks, the technologies available, and the regulatory environments.
Book Synopsis Safety Evaluation of Medical Devices by : Shayne C. Gad
Download or read book Safety Evaluation of Medical Devices written by Shayne C. Gad and published by CRC Press. This book was released on 2001-12-04 with total page 576 pages. Available in PDF, EPUB and Kindle. Book 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.