Download or read book Handbook for Critical Cleaning Second Edition 2 Volume Set written by Barbara Kanegsberg and published by CRC Press. This book was released on 2020-01-02 with total page 1109 pages. Available in PDF, EPUB and Kindle. Book excerpt: This set consists of two volumes: Cleaning Agents and Systems and Applications, Processes, and Controls. Updated, expanded, re-organized, and rewritten, this two-volume handbook covers cleaning processes, applications, management, safety, and environmental concerns. The editors rigorously examine technical issues, cleaning agent options and systems, chemical and equipment integration, and contamination control, as well as cleanliness standards, analytical testing, process selection, implementation and maintenance, specific application areas, and regulatory issues. A collection of international contributors gives the text a global viewpoint. Color illustrations, video clips, and animation are available online to help readers better understand presented material.

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 Flow Cytometry written by Alice Longobardi Givan and published by John Wiley & Sons. This book was released on 2013-04-10 with total page 309 pages. Available in PDF, EPUB and Kindle. Book excerpt: Flow cytometry continually amazes scientists with its ever-expanding utility. Advances in flow cytometry have opened new directions in theoretical science, clinical diagnosis, and medical practice. The new edition of Flow Cytometry: First Principles provides a thorough update of this now classic text, reflecting innovations in the field while outlining the fundamental elements of instrumentation, sample preparation, and data analysis. Flow Cytometry: First Principles, Second Edition explains the basic principles of flow cytometry, surveying its primary scientific and clinical applications and highlighting state-of-the-art techniques at the frontiers of research. This edition contains extensive revisions of all chapters, including new discussions on fluorochrome and laser options for multicolor analysis, an additionalsection on apoptosis in the chapter on DNA, and new chapters onintracellular protein staining and cell sorting, including high-speed sorting and alternative sorting methods, as well as traditional technology. This essential resource: Assumes no prior knowledge of flow cytometry Progresses with an informal, engaging lecture style from simpleto more complex concepts Offers a clear introduction to new vocabulary, principles of instrumentation, and strategies for data analysis Emphasizes the theory relevant to all flow cytometry, with examples from a variety of clinical and scientific fields Flow Cytometry: First Principles, Second Edition provides scientists, clinicians, technologists, and students with the knowledge necessary for beginning the practice of flow cytometry and for understanding related literature.

Download or read book IEC 62304 A Complete Guide 2020 Edition written by Gerardus Blokdyk and published by 5starcooks. This book was released on 2019-09-29 with total page 314 pages. Available in PDF, EPUB and Kindle. Book excerpt: How do you produce usable, medical device regulated software? Does your organization have a product security function? Software cannot be released for use until validation has been completed? How frequent are computing technology-related medical device failures? Who is responsible for on-line help? This breakthrough IEC 62304 self-assessment will make you the reliable IEC 62304 domain authority by revealing just what you need to know to be fluent and ready for any IEC 62304 challenge. How do I reduce the effort in the IEC 62304 work to be done to get problems solved? How can I ensure that plans of action include every IEC 62304 task and that every IEC 62304 outcome is in place? How will I save time investigating strategic and tactical options and ensuring IEC 62304 costs are low? How can I deliver tailored IEC 62304 advice instantly with structured going-forward plans? There's no better guide through these mind-expanding questions than acclaimed best-selling author Gerard Blokdyk. Blokdyk ensures all IEC 62304 essentials are covered, from every angle: the IEC 62304 self-assessment shows succinctly and clearly that what needs to be clarified to organize the required activities and processes so that IEC 62304 outcomes are achieved. Contains extensive criteria grounded in past and current successful projects and activities by experienced IEC 62304 practitioners. Their mastery, combined with the easy elegance of the self-assessment, provides its superior value to you in knowing how to ensure the outcome of any efforts in IEC 62304 are maximized with professional results. Your purchase includes access details to the IEC 62304 self-assessment dashboard download which gives you your dynamically prioritized projects-ready tool and shows you exactly what to do next. Your exclusive instant access details can be found in your book. You will receive the following contents with New and Updated specific criteria: - The latest quick edition of the book in PDF - The latest complete edition of the book in PDF, which criteria correspond to the criteria in... - The Self-Assessment Excel Dashboard - Example pre-filled Self-Assessment Excel Dashboard to get familiar with results generation - In-depth and specific IEC 62304 Checklists - Project management checklists and templates to assist with implementation INCLUDES LIFETIME SELF ASSESSMENT UPDATES Every self assessment comes with Lifetime Updates and Lifetime Free Updated Books. Lifetime Updates is an industry-first feature which allows you to receive verified self assessment updates, ensuring you always have the most accurate information at your fingertips.

Download or read book Handbook of Nuclear Medicine and Molecular Imaging for Physicists written by Michael Ljungberg and published by CRC Press. This book was released on 2022-03-18 with total page 374 pages. Available in PDF, EPUB and Kindle. Book excerpt: This state-of-the-art handbook, the third and final in a series that provides medical physicists with a comprehensive overview into the field of nuclear medicine, focuses on highlighting the production and application of radiopharmaceuticals. With this, the book also describes the chemical composition of these compounds, as well as some of the main clinical applications where radiopharmaceuticals may be used. Following an introduction to the field of radiopharmacy, three chapters in this book are dedicated towards in-depth descriptions of common radionuclides and radiopharmaceuticals used during diagnostic studies utilizing planar/Single Photon Emission Computed Tomography (SPECT) imaging, in addition to during Positron Emission Tomography (PET) imaging, and, finally, radiotherapy. These chapters are followed by those describing procedures relating to quality control and manufacturing (good manufacturing practices) also encompassing aspects such as environmental compliance. Furthermore, this volume illustrates how facilities handling these chemicals should be designed to comply with set regulations. Like many pharmaceuticals, the development of radiopharmaceuticals relies heavily on the use of mouse models. Thus, the translation of radiopharmaceuticals (i.e., the process undertaken to assure that the functionality and safety of a newly developed drug is maintained also in a human context), is covered in a later chapter. This is followed by a chapter emphasising the importance of safe waste disposal and how to assure that these procedures meet the requirements set for the disposal of hazardous waste. Several chapters have also been dedicated towards describing various medical procedures utilizing clinical nuclear medicine as a tool for diagnostics and therapeutics. As physicists may be involved in clinical trials, a chapter describing the procedures and regulations associated with these types of studies is included. This is followed by a chapter focusing on patient safety and another on an imaging modality not based on ionizing radiation – ultrasound. Finally, the last chapter of this book discusses future perspectives of the field of nuclear medicine. This text will be an invaluable resource for libraries, institutions, and clinical and academic medical physicists searching for a complete account of what defines nuclear medicine. The most comprehensive reference available providing a state-of-the-art overview of the field of nuclear medicine Edited by a leader in the field, with contributions from a team of experienced medical physicists, chemists, engineers, scientists, and clinical medical personnel Includes the latest practical research in the field, in addition to explaining fundamental theory and the field's history

Download or read book WHO Expert Committee on Specifications for Pharmaceutical Preparations written by World Health Organization and published by World Health Organization. This book was released on 2020-04-21 with total page 345 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Quality assurance of pharmaceuticals a compendium of guidelines and related materials Volume 2 Good manufacturing practices and inspection written by World Health Organization and published by World Health Organization. This book was released on 2024-01-31 with total page 1354 pages. Available in PDF, EPUB and Kindle. Book excerpt: The GMP Compendium for Medical Products is a valuable resource for manufacturers, regulators, and other stakeholders involved in producing and distributing medical products. It covers various topics, from quality management systems to personnel hygiene, equipment validation, and complaint handling. The guidance provided is based on the latest scientific and technical knowledge and considers the evolving regulatory landscape and the challenges faced by the industry.

Download or read book WHO Drug Information written by and published by World Health Organization. This book was released on 2021-10-15 with total page 253 pages. Available in PDF, EPUB and Kindle. Book excerpt: The third issue of Volume 35, includes Consultation Documents: - WHO Biowaiver Project – Preparation for Cycle V (2022): Prioritization Exercise of Active Pharmaceutical Ingredients on the WHO Model List of Essential Medicines for Solubility Determination and Biopharmaceutics Classification System-Based Classification- IAEA/WHO Guideline on Good Manufacturing Practices for Investigational Radiopharmaceutical Products - WHO Good Practices for Research and Development Facilities of Pharmaceutical Products - WHO Good Manufacturing Practices for Investigational Products - Medicinal Oxygen (oxygenium medicinalis) - Dolutegravir Dispersible Tablets (dolutegraviri compressi dispersibili) Issue 3 concludes with List No. 86 of Recommended International Nonproprietary Names (INN) for Pharmaceutical Substances.

Download or read book HVAC written by Arthur A. Bell and published by McGraw-Hill Professional Publishing. This book was released on 2000 with total page 792 pages. Available in PDF, EPUB and Kindle. Book excerpt: The ultimate reference book on the most frequently used HVAC data, chock-full of equations, data, and rules of thumb--a necessary addition to any library for mechanical, architectural, and electrical engineers, HVAC contractors and technicians, and others. Features over 216 equations for everything from air change rates to swimming pools to steel pipes. Includes both ASME and ASHRAE code information, and follows the CSI MasterFormat "TM."

Download or read book Advanced Concepts for Renewable Energy Supply of Data Centres written by Jaume Salom and published by CRC Press. This book was released on 2022-09-01 with total page 337 pages. Available in PDF, EPUB and Kindle. Book excerpt: The rapid increase of cloud computing, high performance computing (HPC) and the vast growth in Internet and Social Media use have aroused the interest in energy consumption and the carbon footprint of Data Centres. Data Centres primarily contain electronic equipment used for data processing (servers), data storage (storage equipment), and communications (network equipment). Collectively, this equipment processes, stores, and transmits digital information and is known as information technology (IT) equipment. Advanced Concepts for Renewable Energy Supply of Data Centres introduces a number of technical solutions for the supply of power and cooling energy into Data Centres with enhanced utilisation of renewable energy sources in order to achieve low energy Data Centres. Because of the high energy density nature of these unique infrastructures, it is essential to implement energy efficiency measures and reduce consumption before introducing any renewable energy source. A holistic approach is used with the objective of integrating many technical solutions such as management of the IT (Information Technology) load, efficient electrical supply to the IT systems, Low-Ex air-conditioning systems, interaction with district heating and cooling networks, re-use of heat, free cooling (air, seawater, groundwater), optimal use of heat and cold storage, electrical storage and integration in smart grids. This book is therefore a catalogue of advanced technical concepts that could be integrated into Data Centres portfolio in order to increase the overall efficiency and the share of renewable energies in power and cooling supply. Based on dynamic energy models implemented in TRNSYS some concepts are deeply evaluated through yearly simulations. The results of the simulation are illustrated with Sankey charts, where the energy flows per year within the subsystems of each concept for a selected scenario are shown, and graphs showing the results of parametric analysis. A set of environmental metrics (as the non-renewable primary energy) and financial metrics (CAPEX and OPEX) as well of energy efficiency metrics like the well-known PUE, are described and used to evaluate the different technical concepts.

Download or read book Enterprise Architecture Body of Knowledge written by Gerard Blokdyk and published by Createspace Independent Publishing Platform. This book was released on 2017-11-10 with total page 132 pages. Available in PDF, EPUB and Kindle. Book excerpt: What are the success criteria that will indicate that Enterprise Architecture Body of Knowledge objectives have been met and the benefits delivered? What are the compelling business reasons for embarking on Enterprise Architecture Body of Knowledge? Do you monitor the effectiveness of your Enterprise Architecture Body of Knowledge activities? How can you negotiate Enterprise Architecture Body of Knowledge successfully with a stubborn boss, an irate client, or a deceitful coworker? How can we improve Enterprise Architecture Body of Knowledge? Defining, designing, creating, and implementing a process to solve a business challenge or meet a business objective is the most valuable role... In EVERY company, organization and department. Unless you are talking a one-time, single-use project within a business, there should be a process. Whether that process is managed and implemented by humans, AI, or a combination of the two, it needs to be designed by someone with a complex enough perspective to ask the right questions. Someone capable of asking the right questions and step back and say, 'What are we really trying to accomplish here? And is there a different way to look at it?' For more than twenty years, The Art of Service's Self-Assessments empower people who can do just that - whether their title is marketer, entrepreneur, manager, salesperson, consultant, business process manager, executive assistant, IT Manager, CxO etc... - they are the people who rule the future. They are people who watch the process as it happens, and ask the right questions to make the process work better. This book is for managers, advisors, consultants, specialists, professionals and anyone interested in Enterprise Architecture Body of Knowledge assessment. All the tools you need to an in-depth Enterprise Architecture Body of Knowledge Self-Assessment. Featuring 693 new and updated case-based questions, organized into seven core areas of process design, this Self-Assessment will help you identify areas in which Enterprise Architecture Body of Knowledge improvements can be made. In using the questions you will be better able to: - diagnose Enterprise Architecture Body of Knowledge projects, initiatives, organizations, businesses and processes using accepted diagnostic standards and practices - implement evidence-based best practice strategies aligned with overall goals - integrate recent advances in Enterprise Architecture Body of Knowledge and process design strategies into practice according to best practice guidelines Using a Self-Assessment tool known as the Enterprise Architecture Body of Knowledge Scorecard, you will develop a clear picture of which Enterprise Architecture Body of Knowledge areas need attention. Included with your purchase of the book is the Enterprise Architecture Body of Knowledge Self-Assessment downloadable resource, which contains all questions and Self-Assessment areas of this book in a ready to use Excel dashboard, including the self-assessment, graphic insights, and project planning automation - all with examples to get you started with the assessment right away. Access instructions can be found in the book. You are free to use the Self-Assessment contents in your presentations and materials for customers without asking us - we are here to help.

Download or read book Cell Therapy written by Adrian P. Gee and published by Springer Nature. This book was released on 2021-11-10 with total page 681 pages. Available in PDF, EPUB and Kindle. Book excerpt: This new edition presents a fully-updated and expanded look at current Good Manufacturing Practice (cGMP) for cell therapy products. It provides a complete discussion of facility design and operation including details specific to cord blood banking, cell processing, vector production and qualification of a new facility. Several chapters cover facility infrastructure including cleaning and maintenance, vendor qualification, writing a Standard Operating Procedure, staff training, and process validation. The detailed and invaluable product information covers topics like labelling, release and administration, transportation and shipment, et al. Further chapters cover relevant topics like writing and maintaining investigational new drug applications, support opportunities in North America and the European Union, commercial cell processing and quality testing services, and financial considerations for academic GMP facilities. A chapter on future directions rounds out Cell Therapy: cGMP Facilities and Manufacturing making it essential reading for any cell therapy professional involved in the development, use, or management of this type of facility.

Download or read book Statistics for the Social Sciences written by R. Mark Sirkin and published by SAGE Publications, Incorporated. This book was released on 1999-05-14 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Do your students lack confidence in handling quantitative work? Do they get confused about how to enter statistical data on SAS and SPSS programs? This Second Edition of Mark Sirkin's popular textbook is the solution for these dilemmas. The book progresses from concepts that require little computational work to the more demanding. It emphasizes utilization so that students appreciate the usefulness of statistics and shows how the interpretation of data is related to the methods by which data was obtained. The author includes coverage of the scientific method, levels of measurement and the interpretation of tables.

Download or read book Biopharmaceutical Manufacturing written by Gary Gilleskie and published by Walter de Gruyter GmbH & Co KG. This book was released on 2021-09-07 with total page 347 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biopharmaceuticals, medicines made by or from living organisms (including cells from living organisms), are extremely effective in treating a broad range of diseases. Their importance to human health has grown significantly over the years as more biopharmaceutical products have entered the market, and now the biggest selling drugs in the world are biopharmaceuticals. Biopharmaceutical Manufacturing: Principles, Processes and Practices provides concise, comprehensive, and up-to-date coverage of biopharmaceutical manufacturing. Written in a clear and informal style, the content has been influenced by the authors’ substantial industry experience and teaching expertise. That expertise enables the authors to address the many questions posed over the years both by university students and professionals with experience in the field. Consequently, the book will appeal both to undergraduate or graduate students using it as a textbook and specialized industry practitioners seeking to understand the big picture of biopharmaceutical manufacturing. This book:

Download or read book Pharmaceutical Microbiological Quality Assurance and Control written by David Roesti and published by John Wiley & Sons. This book was released on 2020-01-02 with total page 594 pages. Available in PDF, EPUB and Kindle. Book excerpt: Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks

Download or read book Pharmaceutical Manufacturing Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2008-03-11 with total page 1386 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.

Download or read book Flow Cytometry and Cell Sorting written by Andreas Radbruch and published by Springer Science & Business Media. This book was released on 2013-03-14 with total page 365 pages. Available in PDF, EPUB and Kindle. Book excerpt: The analysis and sorting of large numbers of cells with a fluorescence-activated cell sorter (FACS) was first achieved some 30 years ago. Since then, this technology has been rapidly developed and is used today in many laboratories. A Springer Lab Manual Review of the First Edition: "This is a most useful volume which will be a welcome addition for personal use and also for laboratories in a wide range of disciplines. Highly recommended." CYTOBIOS