Download or read book Sterilization Validation and Routine Operation Handbook written by Anne Booth and published by CRC Press. This book was released on 2001-04-04 with total page 171 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

Download or read book Parenteral Medications Fourth Edition written by Sandeep Nema and published by CRC Press. This book was released on 2019-07-19 with total page 1145 pages. Available in PDF, EPUB and Kindle. Book excerpt: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacturing of parenteral dosage forms, effectively balancing theoretical considerations with practical aspects of their development. Previously published as a three-volume set, all volumes have been combined into one comprehensive publication that addresses the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. Key Features: Provides a comprehensive reference work on the formulation and manufacturing of parenteral dosage forms Addresses changes in the science and advances in the technology associated with parenteral medications and routes of administration Includes 13 new chapters and updated chapters throughout Contains the contributors of leading researchers in the field of parenteral medications Uses full color detailed illustrations, enhancing the learning process The fourth edition not only reflects enhanced content in all the chapters but also highlights the rapidly advancing formulation, processing, manufacturing parenteral technology including advanced delivery and cell therapies. The book is divided into seven sectionss: Section 1 - Parenteral Drug Administration and Delivery Devices; Section 2 - Formulation Design and Development; Section 3 - Specialized Drug Delivery Systems; Section 4 - Primary Packaging and Container Closure Integrity; Section 5 - Facility Design and Environmental Control; Section 6 - Sterilization and Pharmaceutical Processing; Section 7 - Quality Testing and Regulatory Requirements

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 2012-11-19 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.

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 718 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.

Download or read book Plastics Design Handbook written by Marlene G. Rosato and published by Springer Science & Business Media. This book was released on 2013-11-27 with total page 697 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a simplified and practical approach to designing with plastics that funda mentally relates to the load, temperature, time, and environment subjected to a product. It will provide the basic behaviors in what to consider when designing plastic products to meet performance and cost requirements. Important aspects are presented such as understanding the advantages of different shapes and how they influence designs. Information is concise, comprehensive, and practical. Review includes designing with plastics based on material and process behaviors. As de signing with any materials (plastic, steel, aluminum, wood, etc.) it is important to know their behaviors in order to maximize product performance-to-cost efficiency. Examples of many different designed products are reviewed. They range from toys to medical devices to cars to boats to underwater devices to containers to springs to pipes to buildings to aircraft to space craft. The reader's product to be designed can directly or indirectly be related to product design reviews in the book. Important are behaviors associated and interrelated with plastic materials (thermoplastics, thermosets, elastomers, reinforced plastics, etc.) and fabricating processes (extrusion, injec tion molding, blow molding, forming, foaming, rotational molding, etc.). They are presented so that the technical or non-technical reader can readily understand the interrelationships.

Download or read book Pharmaceutical Dosage Forms written by Sandeep Nema and published by CRC Press. This book was released on 2010-08-26 with total page 1168 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Dosage Forms: Parenteral Medications explores the administration of medications through other than the enteral route. First published in 1984 (as two volumes) and then last revised in 1993, this three-volume set presents the plethora of changes in the science and considerable advances in the technology associated with these products

Download or read book Sterilisation of Polymer Healthcare Products written by Wayne J. Rogers and published by iSmithers Rapra Publishing. This book was released on 2005 with total page 344 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sterilisation has always been challenging but sterilisation of healthcare products and polymers, especially together is an even greater challenge - how do you sterilise without adversely affecting the end use or the end user? This book discusses all the sterilisation methods used for polymeric healthcare products both traditional and new.

Download or read book Freeze Drying Lyophilization of Pharmaceutical and Biological Products written by Louis Rey and published by CRC Press. This book was released on 2016-04-19 with total page 580 pages. Available in PDF, EPUB and Kindle. Book excerpt: Freeze-drying, or lyophilization, is a well established technology used in the preservation of numerous pharmaceutical and biological products. This highly effective dehydration method involves the removal of water from frozen materials via the direct sublimation of ice. In recent years, this process has met with many changes, as have the regulatio

Download or read book Medical Plastics written by Robert C Portnoy and published by Cambridge University Press. This book was released on 2008-12-10 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: The use of plastics is widespread. Less widespread, however, is a clear understanding and examination of the many forms of degradation inherent within the very environments these materials must perform. Medical PlasticsùDegradation Resistance & Failure Analysis fills that void. The introductory chapter gives an overview of the medical applications of plastics and the specific performance requirements they need to meet. The following chapters discuss various degrading environments and their effects including environmental stress cracking, effect of body liquids, effect of harsh environments, and various methods of sterilization. The book also discusses the failure of medical devices due to contamination, low temperature, the effects of UV light, migration of formulation components, mechanical stresses, and problems with design and fabrication. Case histories of failures of some common products used in medicine are also provided.

Download or read book Cumulated Index Medicus written by and published by . This book was released on 1988 with total page 1320 pages. Available in PDF, EPUB and Kindle. Book excerpt:

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 Scientific and Technical Aerospace Reports written by and published by . This book was released on 1990 with total page 996 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Nuclear Science Abstracts written by and published by . This book was released on 1976 with total page 612 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Toxicity Bibliography written by and published by . This book was released on 1975 with total page 916 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Biotextiles as Medical Implants written by M W King and published by Elsevier. This book was released on 2013-10-31 with total page 739 pages. Available in PDF, EPUB and Kindle. Book excerpt: Textiles play a vital role in the manufacture of various medical devices, including the replacement of diseased, injured or non-functioning organs within the body. Biotextiles as medical implants provides an invaluable single source of information on the main types of textile materials and products used for medical implants. The first part of the book focuses on polymers, fibers and textile technologies, and these chapters discuss the manufacture, sterilization, properties and types of biotextiles used for medical applications, including nanofibers, resorbable polymers and shaped biotextiles. The chapters in part two provide a comprehensive discussion of a range of different clinical applications of biotextiles, including surgical sutures, arterial prostheses, stent grafts, percutaneous heart valves and drug delivery systems.This book provides a concise review of the technologies, properties and types of biotextiles used as medical devices. In addition, it addresses the biological dimension of how to design devices for different clinical applications, providing an invaluable reference for biomedical engineers of medical textiles, quality control and risk assessment specialists, as well as managers of regulatory affairs. The subject matter will also be of interest to professionals within the healthcare system including surgeons, nurses, therapists, sourcing and purchasing agents, researchers and students in different disciplines. - Provides an invaluable single source of information on the main types of textile materials and products used for medical implants - Addresses the technologies used and discusses the manufacture, properties and types of biotextiles - Examines applications of biotextiles as medical implants, including drug delivery systems and stent grafts and percutaneous heart valves

Download or read book Biotextiles as medical implants written by C.C. Chu and published by Elsevier Inc. Chapters. This book was released on 2013-10-31 with total page 49 pages. Available in PDF, EPUB and Kindle. Book excerpt: The chapter describes properties of materials used for sutures that may be: absorbable or nonabsorbable; of varying size; made from monofilament, multifilament, twisted or braided threads. The characteristics of a large number of synthetic suture materials are described, together with essential suture properties such as tensile strength, knot strength, elasticity, tissue reaction and biodegradability. The interrelated nature of the essential physical and mechanical, handling, biological and biodegradation properties is emphasized. The use of dyes and coatings to improve suture identification and properties is also covered.

Download or read book Index Medicus written by and published by . This book was released on 2004 with total page 2292 pages. Available in PDF, EPUB and Kindle. Book excerpt: Vols. for 1963- include as pt. 2 of the Jan. issue: Medical subject headings.