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Quality assurance is vital for the success of radiation technologies and requires the development of standardized procedures and the harmonization of process validation and control. The guidelines in this publication have been developed based on requests from Member States to provide guidance on fulfilling the requirements of the International Standard for Development, Validation and Routine Control for a Radiation Process, published by the International Organization for Standardization (ISO). While the ISO standard was developed for the sterilization of healthcare products, the present guidelines are generalized and are therefore relevant to any radiation process. This is possible since the principles involved in regulating a radiation process for achieving quality products are generally the same for any product or application. In several places, additional information has been included to provide insight into the radiation process that could help irradiator operators and their quality managers to provide better service to their customers.
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
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.
Ionizing Radiation Technologies An authoritative overview of major advances in the application of ionizing radiation technologies to industrial, agricultural, and municipal waste products In Ionizing Radiation Technologies: Managing and Extracting Value from Wastes, a team of expert researchers delivers a broad overview of the value trapped in waste streams and how a strategic application of ionizing radiation technologies can be valuable from both an environmental and an economic perspective. A valuable addition to the discussions around sustainability and green technologies, the book introduces ionizing radiation technologies, including gamma (cobalt-60) irradiation and high and low energy electron beam technologies. The contributions included explore the major advances taking place in the application of ionizing radiation technologies to derive high value end-products from agricultural, municipal, and industrial wastes. Each chapter reviews original research and data and considers likely future directions in research and development. The book also includes: A thorough introduction to the application of ionizing radiation technologies to agricultural waste, including the production of activated carbon Comprehensive explorations of the application of ionizing radiation technologies to municipal waste, including municipal solid wastes and recycling wastewater Practical discussions of the application of ionizing radiation technologies to industrial waste, including textile wastewater management and polymer recycling In-depth examinations of the economics of waste valorization, including several case studies of businesses involved in waste valorization Perfect for consulting engineers and industry professionals involved in waste management and mitigation, Ionizing Radiation Technologies will also earn a place in the libraries of professionals at government agencies, international food organizations, and NGOs focused on waste management, environment sustainability, and urban planning.
This practical book sets the standard as a valuable, time-saving resource offering systematic fundamental information about industrial radiation technologies. This new edition explores updates to emerging applications of ultraviolet (UV) and electron beam (EB) radiation to polymer processing and offers updates throughout to detail changes changes, new trends, and general issues in radiation technology. It presents vital, cutting-edge information to aid further reduction of volatile organic compounds and toxic substances in the environment, develop alternative sources of energy, and harness energy in both medical and industrial applications. New features of this edition include: Stresses the practical aspects of UV/EB technology and its industrial application Includes updates on UV radiation processes and applications of UV radiation Explores new engineering data of selected commercial products Written by an expert with over forty years of experience, this book would make an excellent resource for scientists and engineers in the fields of materials science and polymer chemistry.
A comprehensive source of in-depth information provided on existing and emerging food technologies based on the electromagnetic spectrum Electromagnetic Technologies in Food Science examines various methods employed in food applications that are based on the entire electromagnetic (EM) spectrum. Focusing on recent advances and challenges in food science and technology, this is an up-to-date volume that features vital contributions coming from an international panel of experts who have shared both fundamental and advanced knowledge of information on the dosimetry methods, and on potential applications of gamma irradiation, electron beams, X-rays, radio and microwaves, ultraviolet, visible, pulsed light, and more. Organized into four parts, the text begins with an accessible overview of the physics of the electromagnetic spectrum, followed by discussion on the application of the EM spectrum to non-thermal food processing. The physics of infrared radiation, microwaves, and other advanced heating methods are then deliberated in detail—supported by case studies and examples that illustrate a range of both current and potential applications of EM-based methods. The concluding section of the book describes analytical techniques adopted for quality control, such as hyperspectral imaging, infrared and Raman spectroscopy. This authoritative book resource: Covers advanced theoretical knowledge and practical applications on the use of EM spectrum as novel methods in food processing technology Discusses the latest progress in developing quality control methods, thus enabling the control of continuous fast-speed processes Explores future challenges and benefits of employing electromagnetic spectrum in food technology applications Addresses emerging processing technologies related to improving safety, preservation, and overall quality of various food commodities Electromagnetic Technologies in Food Science is an essential reading material for undergraduate and graduate students, researchers, academics, and agri-food professionals working in the area of food preservation, novel food processing techniques and sustainable food production.
The series Topics in Current Chemistry Collections presents critical reviews from the journal Topics in Current Chemistry organized in topical volumes. The scope of coverage is all areas of chemical science including the interfaces with related disciplines such as biology, medicine and materials science. The goal of each thematic volume is to give the non-specialist reader, whether in academia or industry, a comprehensive insight into an area where new research is emerging which is of interest to a larger scientific audience. Each review within the volume critically surveys one aspect of that topic and places it within the context of the volume as a whole. The most significant developments of the last 5 to 10 years are presented using selected examples to illustrate the principles discussed. The coverage is not intended to be an exhaustive summary of the field or include large quantities of data, but should rather be conceptual, concentrating on the methodological thinking that will allow the non-specialist reader to understand the information presented. Contributions also offer an outlook on potential future developments in the field.
The Biomedical Quality Auditor Handbook was developed by the ASQ Biomedical Division in support of its mission to promote the awareness and use of quality principles, concepts, and technologies in the biomedical community. This third edition correlates to the 2013 exam Body of Knowledge (BoK) and reference list for ASQ’s Certified Biomedical Auditor program. It includes updates and corrections to errors and omissions in the second edition. Most notably it has been re-organized to align more closely with the BoK.