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Sterilization Of Drugs And Devices
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Book Synopsis Sterilization of Drugs and Devices by : Fred M. Nordhauser
Download or read book Sterilization of Drugs and Devices written by Fred M. Nordhauser and published by Routledge. This book was released on 2018-03-29 with total page 383 pages. Available in PDF, EPUB and Kindle. Book excerpt: Editors Fred M. Nordhauser and Wayne P. Olson have gathered a team of 18 experts from multi-national and leading edge companies to explore the advantages and disadvantages of current sterilization technologies. They cover the theory behind the technology, the practical concerns of installation from engineering and product development perspectives, the "how to validate" concern, and the pragmatics of implementation in a manner that will satisfy the regulatory agencies. The broad range of in-depth information on numerous technologies will help readers design sterile manufacturing processes cost effectively and efficiently.
Book Synopsis Sterilization of Drugs and Devices by : WayneP. Olson
Download or read book Sterilization of Drugs and Devices written by WayneP. Olson and published by . This book was released on 2017 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Sterilization of Drugs and Devices by : Fred M. Nordhauser
Download or read book Sterilization of Drugs and Devices written by Fred M. Nordhauser and published by CRC Press. This book was released on 2018-03-29 with total page 579 pages. Available in PDF, EPUB and Kindle. Book excerpt: Editors Fred M. Nordhauser and Wayne P. Olson have gathered a team of 18 experts from multi-national and leading edge companies to explore the advantages and disadvantages of current sterilization technologies. They cover the theory behind the technology, the practical concerns of installation from engineering and product development perspectives, the "how to validate" concern, and the pragmatics of implementation in a manner that will satisfy the regulatory agencies. The broad range of in-depth information on numerous technologies will help readers design sterile manufacturing processes cost effectively and efficiently.
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 425 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 of Drugs and Devices by : Fred M. Nordhauser
Download or read book Sterilization of Drugs and Devices written by Fred M. Nordhauser and published by . This book was released on 2001 with total page 554 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Sterilization Validation and Routine Operation Handbook (2001) by : Anne F Booth
Download or read book Sterilization Validation and Routine Operation Handbook (2001) written by Anne F Booth and published by CRC Press. This book was released on 2017-11-22 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt: The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by precise accuracy in execution and documentation. This in-depth guide details all steps from prevalidation planning to final report and ongoing monitoring and control. Sterilization Validation & Routine Operation Handbook: Radiation provides a framework for the validation and routine operation of an irradiation sterilization process. The guidance presented complies with ANSI/AAMI/ISO 11137: 1994, Sterilization of health care product-Requirements for validation and routine control-Radiation sterilization and the newly published AAMI substantiation of 25 kGy using VDmax procedure. The author discusses methods to aid in comprehending the requirements in these standards. She also provides practical procedures for the validation and routine monitoring and control of specific gamma and electron beam radiation sterilization processes. Background chapters provide needed information on radiation sterilization technologies, sterilization microbiology, validation approaches and working with a radiation sterilization contractor. Much of the information in this new book is presented in convenient tables and charts, with diagrams and other schematics that simply illustrate appropriate validation methodologies. Sterilization Validation & Routine Operation Handbook: Radiation brings together in one resource information scattered throughout many documents and will be useful to all those involved in the sterilization of medical materials, drugs and devices.
Book Synopsis Sterilisation of Biomaterials and Medical Devices by : Sophie Lerouge
Download or read book Sterilisation of Biomaterials and Medical Devices written by Sophie Lerouge and published by Elsevier. This book was released on 2012-09-27 with total page 347 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis Sources of Contamination in Medicinal Products and Medical Devices by : Denise Bohrer
Download or read book Sources of Contamination in Medicinal Products and Medical Devices written by Denise Bohrer and published by John Wiley & Sons. This book was released on 2012-09-25 with total page 592 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first one-volume guide to sources of contamination in pharmaceuticals and medical devices Most books dealing with contaminants in medicinal products often focus on analytical methods for detecting nonspecific impurities. Key to the work of the pharmaceutical chemist, this unique reference helps identify the sources of contamination in medicinal and pharmaceutical products and medical devices. Divided into three parts, Sources of Contamination in Medicinal Products and Medical Devices covers chemical, microbiological, and physical (particulate matter) contamination, including those originating from sterilization procedures. As compelling as a medical documentary, the book sheds light on how impurities and contaminants can enter the human body transported via a specific product or treatment. Focusing on only those medicinal products and medical devices that may lead to exposure to contaminants harmful to human health, the book offers a comprehensive, systematic look at the entire universe of medical contamination: Chemical contaminants including residual solvents, catalyst residuals, and genotoxic impurities in active pharmaceutical ingredients (APIs) Diagnostic imaging agents (i.e., radiopharmaceuticals and contrast agents) Microbiological and endotoxin contamination involving single and multiple dose products, medical devices, and biofilms Contamination from sterilization procedures, residuals from radiation sterilization, ionizing radiation on packaging materials and medical devices Medicinal gases and volatile anesthetics Biopharmaceuticals including recombinant DNA technology products Extractables and leachables from containers made of glass, plastics, and metal Each section of the book contains information on what contaminants could be expected in a particular product, and how they were generated and reached that product. With up-to-date regulatory guidelines for determining contamination, as well as methods for assessing, quantifying, avoiding and removing contaminants, Sources of Contamination in Medicinal Products and Medical Devices is essential to fully understanding the specific threats that undermine the safety of medicines and medical devices.
Book Synopsis Chemical Engineering in the Pharmaceutical Industry by : Mary T. am Ende
Download or read book Chemical Engineering in the Pharmaceutical Industry written by Mary T. am Ende and published by John Wiley & Sons. This book was released on 2019-04-08 with total page 1435 pages. Available in PDF, EPUB and Kindle. Book excerpt: A guide to the important chemical engineering concepts for the development of new drugs, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition: Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up Offers analytical methods and applied statistics that highlight drug product quality attributes as design features Presents updated and new example calculations and associated solutions Includes contributions from leading experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sciences and manufacturing, Chemical Engineering in the Pharmaceutical Industry, Second Edition contains information designed to be of use from the engineer's perspective and spans information from solid to semi-solid to lyophilized drug products.
Download or read book Dosage Form Design Parameters written by and published by Academic Press. This book was released on 2018-07-25 with total page 810 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dosage Form Design Parameters, Volume II, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. Examines the history and recent developments in drug dosage forms for pharmaceutical sciences Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design
Book Synopsis Sterile Pharmaceutical Products by : KennethE. Avis
Download or read book Sterile Pharmaceutical Products written by KennethE. Avis and published by Routledge. This book was released on 2018-03-29 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sterile Pharmaceutical Products: Process Engineering Applications addresses the key concepts and applications of the sterile pharmaceutical manufacturing industry. It covers elements of the design, installation, validation, and usage of critical processes associated with sterile product manufacture. From water systems to clean-in-place systems, to sterile powder handling and robotic applications in sterile production environments, this book addresses the issues of system implementation, integration, and operations. Written by recognized experts and peer reviewed for accuracy, all chapters include references to supplemental resources and numerous illustrations.
Book Synopsis Chemical Engineering in the Pharmaceutical Industry by : David J. am Ende
Download or read book Chemical Engineering in the Pharmaceutical Industry written by David J. am Ende and published by John Wiley & Sons. This book was released on 2019-04-23 with total page 1172 pages. Available in PDF, EPUB and Kindle. Book excerpt: A guide to the development and manufacturing of pharmaceutical products written for professionals in the industry, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry is a practical book that highlights chemistry and chemical engineering. The book’s regulatory quality strategies target the development and manufacturing of pharmaceutically active ingredients of pharmaceutical products. The expanded second edition contains revised content with many new case studies and additional example calculations that are of interest to chemical engineers. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The active pharmaceutical ingredients book puts the focus on the chemistry, chemical engineering, and unit operations specific to development and manufacturing of the active ingredients of the pharmaceutical product. The drug substance operations section includes information on chemical reactions, mixing, distillations, extractions, crystallizations, filtration, drying, and wet and dry milling. In addition, the book includes many applications of process modeling and modern software tools that are geared toward batch-scale and continuous drug substance pharmaceutical operations. This updated second edition: Contains 30new chapters or revised chapters specific to API, covering topics including: manufacturing quality by design, computational approaches, continuous manufacturing, crystallization and final form, process safety Expanded topics of scale-up, continuous processing, applications of thermodynamics and thermodynamic modeling, filtration and drying Presents updated and expanded example calculations Includes contributions from noted experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduate students, and professionals in the field of pharmaceutical sciences and manufacturing, the second edition of Chemical Engineering in the Pharmaceutical Industryf ocuses on the development and chemical engineering as well as operations specific to the design, formulation, and manufacture of drug substance and products.
Book Synopsis Sterilization Validation and Routine Operation Handbook by : Anne F. Booth
Download or read book Sterilization Validation and Routine Operation Handbook written by Anne F. Booth and published by CRC Press. This book was released on 1999-09-01 with total page 142 pages. Available in PDF, EPUB and Kindle. Book excerpt: Stringent regulations require you to validate sterilization processes and step-by-step guidelines are needed to develop and implement a suitable validation program. Sterilization Validation and Routine Operation Handbook: Ethylene Oxide is the best practical guide available for the validation of EtO process. The information provided complies with ANSI/AAMI/ISO 11135: 1994, Medical devices-Validation and routine control of ethylene oxide sterilization which is based on a standard developed by the European Standardization Committee (CEN) entitled EN 550, Sterilization of medical devices- Validation and routine control of ethylene oxide sterilization. The text defines methods to assist you in the interpretation and understanding of the requirements in the standard and offers logical procedures for the validation and routine monitoring of your specific ethylene oxide process.
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 Handbook of Downstream Processing by : E. Goldberg
Download or read book Handbook of Downstream Processing written by E. Goldberg and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 745 pages. Available in PDF, EPUB and Kindle. Book excerpt: The last two decades have seen a phenomenal growth of the field of genetic or biochemical engineering and have witnessed the development and ultimately marketing of a variety of products-typically through the manipulation and growth of different types of microorganisms, followed by the recovery and purification of the associated products. The engineers and biotechnologists who are involved in the full-scale process design of such facilities must be familiar with the variety of unit operations and equipment and the applicable regulatory requirements. This book describes current commercial practice and will be useful to those engineers working in this field in the design, construction and operation of pharmaceutical and biotechnology plants. It will be of help to the chemical or pharmaceutical engineer who is developing a plant design and who faces issues such as: Should the process be batch or continuous or a combination of batch and continuous? How should the optimum process design be developed? Should one employ a new revolutionary separation which could be potentially difficult to validate or use accepted technology which involves less risk? Should the process be run with ingredients formulated from water for injection, deionized water, or even filtered tap water? Should any of the separations be run in cold rooms or in glycol jacketed lines to minimize microbial growth where sterilization is not possible? Should the process equipment and lines be designed to be sterilized in-place, cleaned-in-place, or should every piece be broken down, cleaned and autoclaved after every turn?
Book Synopsis Sterilization Manual for Health Centers by : Silvia I. Acosta-Gnass
Download or read book Sterilization Manual for Health Centers written by Silvia I. Acosta-Gnass and published by Pan Amer Health Org. This book was released on 2010 with total page 167 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author :National Research Council and Institute of Medicine Publisher :National Academies Press ISBN 13 :0309041473 Total Pages :206 pages Book Rating :4.3/5 (9 download)
Book Synopsis Developing New Contraceptives by : National Research Council and Institute of Medicine
Download or read book Developing New Contraceptives written by National Research Council and Institute of Medicine and published by National Academies Press. This book was released on 1990-01-01 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt: There are numerous reasons to hasten the introduction of new and improved contraceptivesâ€"from health concerns about the pill to the continuing medical liability crisis. Yet, U.S. organizations are far from taking a leadership position in funding, researching, and introducing new contraceptivesâ€"in fact, the United States lags behind Europe and even some developing countries in this field. Why is research and development of contraceptives stagnating? What must the nation do to energize this critical arena? This book presents an overall examination of contraceptive development in the United Statesâ€"covering research, funding, regulation, product liability, and the effect of public opinion. The distinguished authoring committee presents a blueprint for substantial change, with specific policy recommendations that promise to gain the attention of specialists, the media, and the American public. The highly readable and well-organized volume will quickly become basic reading for legislators, government agencies, the pharmaceutical industry, private organizations, legal professionals, and researchersâ€"everyone concerned about family planning, reproductive health, and the impact of the liability and regulatory systems on scientific innovations.
