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 155 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.
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 170 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.
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
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.
Download or read book Pharmaceutical Dosage Forms Parenteral Medications written by Sandeep Nema and published by CRC Press. This book was released on 2016-04-19 with total page 420 pages. Available in PDF, EPUB and Kindle. Book excerpt: This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it is recommended for scientists and engineers in the
Download or read book Veterinary Pharmacology and Therapeutics written by Jim E. Riviere and published by John Wiley & Sons. This book was released on 2017-11-29 with total page 1552 pages. Available in PDF, EPUB and Kindle. Book excerpt: Veterinary Pharmacology and Therapeutics, Tenth Edition is a fully updated and revised version of the gold-standard reference on the use of drug therapy in all major veterinary species. Provides current, detailed information on using drug therapies in all major domestic animal species Organized logically by drug class and treatment indication, with exhaustive information on the rational use of drugs in veterinary medicine Includes extensive tables of pharmacokinetic data, products available, and dosage regimens Adds new chapters on pharmaceutics, ophthalmic pharmacology, food animal pharmacology, and aquatic animal pharmacology Includes access to a companion website with the figures from the book in PowerPoint
Download or read book Metals for Biomedical Devices written by Mitsuo Niinomi and published by Woodhead Publishing. This book was released on 2019-05-17 with total page 580 pages. Available in PDF, EPUB and Kindle. Book excerpt: Metals for Biomedical Devices, Second Edition, has been fully updated and builds upon the success of its first edition, discussing the latest techniques in metal processing methods and the behavior of this important material. Initial chapters review the current status and selection of metals for biomedical devices. Subsequent chapters cover mechanical behavior, degradation and testing, corrosion, wear testing and biocompatibility, the processing of metals for biomedical applications, including topics such as forging metals and alloys, surface treatment, coatings and sterilization. Chapters in the final section discuss the clinical applications of metals, such as cardiovascular, orthopedic and new generation biomaterials. With its distinguished editor and team of expert contributors, this book is a standard reference for materials scientists, researchers and engineers working in the medical devices industry and academia. - Reviews the latest techniques in metal processing methods, including surface treatment and sterilization - Examines metal selection for biomedical devices, considering the biocompatibility of various metals - Assesses mechanical behavior and the testing of metals, featuring the latest information on corrosion, fatigue and wear - Discusses biodegradable alloys, including a new section on Mg alloys - Includes a new section that discusses the use of additive manufacturing in the production of medical devices
Download or read book Compliance Handbook for Pharmaceuticals Medical Devices and Biologics written by Carmen Medina and published by CRC Press. This book was released on 2003-12-09 with total page 604 pages. Available in PDF, EPUB and Kindle. Book excerpt: This text lists the necessary steps for meeting compliance requirements during the drug development process. It presents comprehensive approaches for validating analytical methods for pharmaceutical applications.
Download or read book Springer Handbook of Medical Technology written by Rüdiger Kramme and published by Springer Science & Business Media. This book was released on 2011-10-02 with total page 1503 pages. Available in PDF, EPUB and Kindle. Book excerpt: This concise, user-oriented and up-to-date desk reference offers a broad introduction to the fascinating world of medical technology, fully considering today’s progress and further development in all relevant fields. The Springer Handbook of Medical Technology is a systemized and well-structured guideline which distinguishes itself through simplification and condensation of complex facts. This book is an indispensable resource for professionals working directly or indirectly with medical systems and appliances every day. It is also meant for graduate and post graduate students in hospital management, medical engineering, and medical physics.
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
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
Download or read book Radiation Sterilization for Health Care Products written by Barry P. Fairand and published by CRC Press. This book was released on 2001-09-26 with total page 162 pages. Available in PDF, EPUB and Kindle. Book excerpt: Focusing on how the radiation process works and how it is applied in sterilizing medical devices and healthcare products, this book provides the latest developments in radiation technology in the form of e-beams, gamma rays, and x-rays. It covers the design and operation of irradiators as well as factors that affect cost and efficiency. It offers readers practical insights on this critical step in healthcare product manufacturing, its current uses, and its related cost concerns. Bringing all the information into one source, Radiation Sterilization for Health Care Products is a uniquely comprehensive resource.
Download or read book Disposable Bioreactors II written by Dieter Eibl and published by Springer. This book was released on 2013-12-17 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dynamic Single-Use Bioreactors Used in Modern Liter- and m3- Scale Biotechnological Processes: Engineering Characteristics and Scaling Up, by Christian Löffelholz, Stephan C. Kaiser, Matthias Kraume, Regine Eibl , Dieter Eibl. Orbitally Shaken Single-Use Bioreactors, by Wolf Klöckner, Sylvia Diederichs, Jochen Büchs. Therapeutic Human Cells: Manufacture for Cell Therapy/Regenerative Medicine by Christian van den Bos, Robert Keefe, Carmen Schirmaier, Michael McCaman. Fast Single-Use VLP Vaccine Productions Based on Insect Cells and the Baculovirus Expression Vector System: Influenza as Case Study by Regine Eibl, Nina Steiger, Sabine Wellnitz, Tiago Vicente, Corinne John, Dieter Eibl. Microbial High Cell Density Fermentations in a Stirred Single-Use Bioreactor by Thomas Dreher, Bart Walcarius, Ute Husemann, Franziska Klingenberg, Christian Zahnow, Thorsten Adams, Davy de Wilde, Peter Casteels, Gerhard Greller. Quorus Bioreactor: A New Perfusion-Based Technology for Microbial Cultivation by Sheena J. Fraser, Christian Endres. Cultivation of Marine Microorganisms in Single-Use Systems by Friederike Hillig, Maciej Pilarek, Stefan Junne, Peter Neubauer. Flexible Biomanufacturing Processes that Address the Needs of the Future by Bernhard Diel, Christian Manzke, Thorsten Peuker. An Approach to Quality and Security of Supply for Single-Use Bioreactors by Magali Barbaroux, Susanne Gerighausen, Heiko Hackel. A Risk Analysis for Production Processes with Disposable Bioreactors by Tobias Merseburger, Ina Pahl, Daniel Müller, Markus Tanner.
Download or read book Degradable Aliphatic Polyesters written by A.-C. Albertsson and published by Springer Science & Business Media. This book was released on 2001-12-03 with total page 188 pages. Available in PDF, EPUB and Kindle. Book excerpt: A renewed interest in aliphatic polyesters has resulted in developing materials important in the biomedical and ecological fields. Mainly materials such as PLA and PCL homopolymers have so far been used in most applications. There are many other monomers which can be used. Different molecular structures give a wider range of physical properties as well as the possibility of regulating the degradation rate. By using different types of initiators and catalysts, ring-opening polymerization of lactones and lactides provides macromolecules with advanced molecular architectures. In the future, new degradable polymers should be able to participate in the metabolism of nature. Some examples of novel polymers with inherent environmentally favorable properties such as renewability and degradability and a series of interesting monomers found in the metabolisms and cycles of nature are given.
Download or read book Noyes Knee Disorders Surgery Rehabilitation Clinical Outcomes E Book written by Frank R. Noyes and published by Elsevier Health Sciences. This book was released on 2009-08-20 with total page 1244 pages. Available in PDF, EPUB and Kindle. Book excerpt: Frank R. Noyes, MD—internationally-renowned knee surgeon and orthopaedic sports medicine specialist—presents Noyes’ Knee Disorders, an unparalleled resource on the diagnosis, management, and outcomes analysis for the full range of complex knee disorders. Master the technical details of procedures such as anterior cruciate ligament reconstruction, meniscus repair, articular cartilage restoration, and many others, and implement appropriate post-operative rehabilitation programs and protocols. Analyze and manage gender disparities in anterior cruciate ligament injuries. You can access the full text, as well as downloadable images, PubMed links, and alerts to new research online at www.expertconsult.com. Offers online access to the full text, downloadable images, PubMed links, and alerts to new research online at expertconsult.com through Expert Consult functionality for convenient reference. Presents step-by-step descriptions on the full range of complex soft tissue knee operative procedures for the anterior cruciate ligament reconstruction, meniscus repair, soft tissue transplants, osseous malalignments, articular cartilage restoration, posterior cruciate ligament reconstruction, and more to provide you with guidance for the management of any patient. Relies on Dr. Noyes’ meticulous published clinical studies and outcomes data from other peer-reviewed publications as a scientifically valid foundation for patient care. Features detailed post-operative rehabilitation programs and protocols so that you can apply proven techniques and ease your patients’ progression from one phase to the next. Bonus video available only from the website provides live presentations from the 2009 Advances on the Knee and Shoulder course, step-by-step surgical demonstration of an opening wedge tibial osteotomy, and a 4-part series on the Diagnosis of Knee Ligament Injuries.
Download or read book Aulton s Pharmaceutics E Book written by Kevin M.G. Taylor and published by Elsevier Health Sciences. This book was released on 2017-07-07 with total page 933 pages. Available in PDF, EPUB and Kindle. Book excerpt: From a review of the previous edition: 'For all the pharmacy students out there part of your pharmacy degree will be to study formulation design and pharmaceutics. This is the holy grail of pharmaceutical technology books. The text reads well and introduces difficult concepts in a more easy-to-understand way, it is definitely worth the money to help you get through the module, if you're doing a research project in pharmaceutical design then this would also be an excellent buy...This is essential for passing exams and developing professional competence.' This is the best known text on pharmaceutics. Its strength lies mainly in being a complete course in one book. Reviewers consistently praise its comprehensiveness and its extremely high quality-quality content. Pharmaceutics is one of the most diverse subject areas in pharmaceutical science and an understanding of it is vital for all pharmacists and scientists involved in converting drugs to medicines that can be safely delivered to a patient. The editorial and author team deliver a tour de force of accessibility, coverage and currency in this new edition of a world-class textbook. - Relevant chemistry covered throughout - Reflects current and future use of biotechnology products throughout - Covers ongoing changes in our understanding of biopharmaceutics, certain areas of drug delivery and the significance of the solid state - Includes the science of formulation and drug delivery - Designed and written for newcomers to the design of dosage forms - Key points boxes throughout - Summaries at the end of each chapter - Fully updated throughout, with particular focus on delivery of biopharmaceuticals, nanotechnology and nanomedicines, parenteral and ocular drug delivery mechanisms. - Now comes with online access on StudentConsult.
Download or read book Validation of Pharmaceutical Processes written by James P. Agalloco and published by CRC Press. This book was released on 2007-09-25 with total page 762 pages. Available in PDF, EPUB and Kindle. Book excerpt: Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine va
