Practical Guide To Single Use Technology

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Single-Use Technology

Author : Adriana G. Lopes
Publisher : Walter de Gruyter GmbH & Co KG
ISBN 13 : 3110640589
Total Pages : 154 pages
Book Rating : 4.1/5 (16 download)

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Book Synopsis Single-Use Technology by : Adriana G. Lopes

Download or read book Single-Use Technology written by Adriana G. Lopes and published by Walter de Gruyter GmbH & Co KG. This book was released on 2019-06-17 with total page 154 pages. Available in PDF, EPUB and Kindle. Book excerpt: Single-Use Technology (SUT) is the first comprehensive publication of practical considerations for each stage of the implementation process of SUT, and covers the selection, specification, design and qualification of systems to meet end-user requirements. Having become readily available for all processing operations within the biopharmaceutical industry, SUT has the potential to reduce capital costs, improve plant throughput and reduce the risk of cross-contamination. However, there are no clear guidelines to aid the end-user on implementation of these technologies into a validated, good manufacturing practice (GMP) environment. This book presents approaches for the implementation within various end-user facilities and systems, SUT within regulatory frameworks (ICH Q8, Q9, Q10 and GMP), standardisation and assessment strategies, specifation of user requirements and SUT design, risk assessment and evaluation as well as qualification for different SUT types.

Practical Guide to Single-use Technology

Author : Adriana G Lopes
Publisher : Smithers Rapra
ISBN 13 : 1910242047
Total Pages : 178 pages
Book Rating : 4.9/5 (12 download)

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Book Synopsis Practical Guide to Single-use Technology by : Adriana G Lopes

Download or read book Practical Guide to Single-use Technology written by Adriana G Lopes and published by Smithers Rapra. This book was released on 2016-08-31 with total page 178 pages. Available in PDF, EPUB and Kindle. Book excerpt: Single-use technology (SUT) is now available for all processing operations within the biopharmaceutical industry. It has the potential to reduce capital costs, improve plant throughput and reduce the risk of cross-contamination. However, there are no clear guidelines to aid the end-user on implementation of these technologies into a validated, good manufacturing practice (GMP) environment. This book is the first comprehensive publication of practical considerations for each stage of the implementation process of SUT, and covers the selection, specification, design and qualification of systems to meet end-user requirements.Serving as an introduction and practical reference to this growing area of application within the biopharmaceutical industry, this handbook presents:An approach for SUT implementation within an end-users facility with examples for bioreactors, tangential-flow filtration and fill-finish systems;SUT within the context of regulatory guidance, such as ICH Q8, Q9, Q10 and GMP;Strategy for standardisation of single-use bag systems and assessment of extractables and leachables;Specifications of user requirements and design of specific SUT alongside process descriptions and flow diagrams;Strategies and tools to evaluate risk with examples of risk assessments applicable to design, processing and product quality; andQualification approach for different SUT types.With the information presented in this book, engineers, researchers and professionals involved in biopharmaceuticals will be better prepared to plan and make effective decisions to design and implement SUT.

Practical Guide to Single-use Technology

Author : Adriana G. Lopes
Publisher :
ISBN 13 : 9781523105472
Total Pages : pages
Book Rating : 4.1/5 (54 download)

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Book Synopsis Practical Guide to Single-use Technology by : Adriana G. Lopes

Download or read book Practical Guide to Single-use Technology written by Adriana G. Lopes and published by . This book was released on 2016 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Single-Use Technology in Biopharmaceutical Manufacture

Author : Regine Eibl
Publisher : John Wiley & Sons
ISBN 13 : 1119477786
Total Pages : 368 pages
Book Rating : 4.1/5 (194 download)

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Book Synopsis Single-Use Technology in Biopharmaceutical Manufacture by : Regine Eibl

Download or read book Single-Use Technology in Biopharmaceutical Manufacture written by Regine Eibl and published by John Wiley & Sons. This book was released on 2019-07-18 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: Authoritative guide to the principles, characteristics, engineering aspects, economics, and applications of disposables in the manufacture of biopharmaceuticals The revised and updated second edition of Single-Use Technology in Biopharmaceutical Manufacture offers a comprehensive examination of the most-commonly used disposables in the manufacture of biopharmaceuticals. The authors—noted experts on the topic—provide the essential information on the principles, characteristics, engineering aspects, economics, and applications. This authoritative guide contains the basic knowledge and information about disposable equipment. The author also discusses biopharmaceuticals’ applications through the lens of case studies that clearly illustrate the role of manufacturing, quality assurance, and environmental influences. This updated second edition revises existing information with recent developments that have taken place since the first edition was published. The book also presents the latest advances in the field of single-use technology and explores topics including applying single-use devices for microorganisms, human mesenchymal stem cells, and T-cells. This important book: • Contains an updated and end-to-end view of the development and manufacturing of single-use biologics • Helps in the identification of appropriate disposables and relevant vendors • Offers illustrative case studies that examine manufacturing, quality assurance, and environmental influences • Includes updated coverage on cross-functional/transversal dependencies, significant improvements made by suppliers, and the successful application of the single-use technologies Written for biopharmaceutical manufacturers, process developers, and biological and chemical engineers, Single-Use Technology in Biopharmaceutical Manufacture, 2nd Edition provides the information needed for professionals to come to an easier decision for or against disposable alternatives and to choose the appropriate system.

Single-Use Technology

Author : Adriana G. Lopes
Publisher : Walter de Gruyter GmbH & Co KG
ISBN 13 : 3110640678
Total Pages : 174 pages
Book Rating : 4.1/5 (16 download)

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Book Synopsis Single-Use Technology by : Adriana G. Lopes

Download or read book Single-Use Technology written by Adriana G. Lopes and published by Walter de Gruyter GmbH & Co KG. This book was released on 2019-06-17 with total page 174 pages. Available in PDF, EPUB and Kindle. Book excerpt: Single-Use Technology (SUT) is the first comprehensive publication of practical considerations for each stage of the implementation process of SUT, and covers the selection, specification, design and qualification of systems to meet end-user requirements. Having become readily available for all processing operations within the biopharmaceutical industry, SUT has the potential to reduce capital costs, improve plant throughput and reduce the risk of cross-contamination. However, there are no clear guidelines to aid the end-user on implementation of these technologies into a validated, good manufacturing practice (GMP) environment. This book presents approaches for the implementation within various end-user facilities and systems, SUT within regulatory frameworks (ICH Q8, Q9, Q10 and GMP), standardisation and assessment strategies, specifation of user requirements and SUT design, risk assessment and evaluation as well as qualification for different SUT types.

ISPE Good Practice Guide

Author : Ispe
Publisher :
ISBN 13 : 9781946964120
Total Pages : 176 pages
Book Rating : 4.9/5 (641 download)

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Book Synopsis ISPE Good Practice Guide by : Ispe

Download or read book ISPE Good Practice Guide written by Ispe and published by . This book was released on 2018-11-30 with total page 176 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Modern Machining Technology

Author : J. Paulo Davim
Publisher : Elsevier
ISBN 13 : 0857094947
Total Pages : 412 pages
Book Rating : 4.8/5 (57 download)

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Book Synopsis Modern Machining Technology by : J. Paulo Davim

Download or read book Modern Machining Technology written by J. Paulo Davim and published by Elsevier. This book was released on 2011-10-18 with total page 412 pages. Available in PDF, EPUB and Kindle. Book excerpt: This forward-thinking, practical book provides essential information on modern machining technology for industry with emphasis on the processes used regularly across several major industries. Machining technology presents great interest for many important industries including automotive, aeronautics, aerospace, renewable energy, moulds and dies, biomedical, and many others. Machining processes are manufacturing processes in which parts are shaped by the removal of unwanted material; these processes cover several stages and are usually divided into the following categories: cutting (involving single point or multipoint cutting tools); abrasive processes (including grinding and advanced machining processes, such as EDM (electrical discharge machining), LBM (laser-beam machining), AWJM (abrasive water jet machining) and USM (ultrasonic machining). - Provides essential information on modern machining technology, with emphasis on the processes used regularly across several major industries - Covers several processes and outlines their many stages - Contributions come from a series of international, highly knowledgeable and well-respected experts

Practical Guide to LTE-A, VoLTE and IoT

Author : Ayman ElNashar
Publisher : John Wiley & Sons
ISBN 13 : 1119063418
Total Pages : 484 pages
Book Rating : 4.1/5 (19 download)

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Book Synopsis Practical Guide to LTE-A, VoLTE and IoT by : Ayman ElNashar

Download or read book Practical Guide to LTE-A, VoLTE and IoT written by Ayman ElNashar and published by John Wiley & Sons. This book was released on 2018-06-19 with total page 484 pages. Available in PDF, EPUB and Kindle. Book excerpt: Essential reference providing best practice of LTE-A, VoLTE, and IoT Design/deployment/Performance and evolution towards 5G This book is a practical guide to the design, deployment, and performance of LTE-A, VoLTE/IMS and IoT. A comprehensive practical performance analysis for VoLTE is conducted based on field measurement results from live LTE networks. Also, it provides a comprehensive introduction to IoT and 5G evolutions. Practical aspects and best practice of LTE-A/IMS/VoLTE/IoT are presented. Practical aspects of LTE-Advanced features are presented. In addition, LTE/LTE-A network capacity dimensioning and analysis are demonstrated based on live LTE/LTE-A networks KPIs. A comprehensive foundation for 5G technologies is provided including massive MIMO, eMBB, URLLC, mMTC, NGCN and network slicing, cloudification, virtualization and SDN. Practical Guide to LTE-A, VoLTE and IoT: Paving the Way Towards 5G can be used as a practical comprehensive guide for best practices in LTE/LTE-A/VoLTE/IoT design, deployment, performance analysis and network architecture and dimensioning. It offers tutorial introduction on LTE-A/IoT/5G networks, enabling the reader to use this advanced book without the need to refer to more introductory texts. Offers a complete overview of LTE and LTE-A, IMS, VoLTE and IoT and 5G Introduces readers to IP Multimedia Subsystems (IMS)Performs a comprehensive evaluation of VoLTE/CSFB Provides LTE/LTE-A network capacity and dimensioning Examines IoT and 5G evolutions towards a super connected world Introduce 3GPP NB-IoT evolution for low power wide area (LPWA) network Provide a comprehensive introduction for 5G evolution including eMBB, URLLC, mMTC, network slicing, cloudification, virtualization, SDN and orchestration Practical Guide to LTE-A, VoLTE and IoT will appeal to all deployment and service engineers, network designers, and planning and optimization engineers working in mobile communications. Also, it is a practical guide for R&D and standardization experts to evolve the LTE/LTE-A, VoLTE and IoT towards 5G evolution.

A Practical Guide to Global Point-of-Care Testing

Author : Mark Shephard OAM
Publisher : CSIRO PUBLISHING
ISBN 13 : 1486305199
Total Pages : 488 pages
Book Rating : 4.4/5 (863 download)

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Book Synopsis A Practical Guide to Global Point-of-Care Testing by : Mark Shephard OAM

Download or read book A Practical Guide to Global Point-of-Care Testing written by Mark Shephard OAM and published by CSIRO PUBLISHING. This book was released on 2016-11 with total page 488 pages. Available in PDF, EPUB and Kindle. Book excerpt: Point-of-care testing (POCT) refers to pathology testing performed in a clinical setting at the time of patient consultation, generating a rapid test result that enables informed and timely clinical action to be taken on patient care. It offers patients greater convenience and access to health services and helps to improve clinical outcomes. POCT also provides innovative solutions for the detection and management of chronic, acute and infectious diseases, in settings including family practices, Indigenous medical services, community health facilities, rural and remote areas and in developing countries, where health-care services are often geographically isolated from the nearest pathology laboratory. A Practical Guide to Global Point-of-Care Testing shows health professionals how to set up and manage POCT services under a quality-assured, sustainable, clinically and culturally effective framework, as well as understand the wide global scope and clinical applications of POCT. The book is divided into three major themes: the management of POCT services, a global perspective on the clinical use of POCT, and POCT for specific clinical settings. Chapters within each theme are written by experts and explore wide-ranging topics such as selecting and evaluating devices, POCT for diabetes, coagulation disorders, HIV, malaria and Ebola, and the use of POCT for disaster management and in extreme environments. Figures are included throughout to illustrate the concepts, principles and practice of POCT. Written for a broad range of practicing health professionals from the fields of medical science, health science, nursing, medicine, paramedic science, Indigenous health, public health, pharmacy, aged care and sports medicine, A Practical Guide to Global Point-of-Care Testing will also benefit university students studying these health-related disciplines.

Practical (and Fun) Guide to Assistive Technology in Public Schools

Author : Christopher R. Bugaj
Publisher : International Society for Technology in Education
ISBN 13 : 1564845648
Total Pages : 314 pages
Book Rating : 4.5/5 (648 download)

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Book Synopsis Practical (and Fun) Guide to Assistive Technology in Public Schools by : Christopher R. Bugaj

Download or read book Practical (and Fun) Guide to Assistive Technology in Public Schools written by Christopher R. Bugaj and published by International Society for Technology in Education. This book was released on 2010-03-21 with total page 314 pages. Available in PDF, EPUB and Kindle. Book excerpt: From setting up a stellar team to consultations and evaluations, and from implementation to assessing success, this guide presents detailed advice and ideas to provide assistive technology (AT) services that effectively and efficiently help students. The nuts and bolts of each area are presented in a practical way (with amusing metaphors thrown in for good measure) so that you can directly apply what's in the book and see tangible results.

Introduction to Quality by Design (QbD)

Author : N. K. Jain
Publisher : Springer Nature
ISBN 13 : 9819980348
Total Pages : 505 pages
Book Rating : 4.8/5 (199 download)

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Book Synopsis Introduction to Quality by Design (QbD) by : N. K. Jain

Download or read book Introduction to Quality by Design (QbD) written by N. K. Jain and published by Springer Nature. This book was released on with total page 505 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Clean Room Technology in ART Clinics

Author : Sandro C. Esteves
Publisher : CRC Press
ISBN 13 : 1482254085
Total Pages : 461 pages
Book Rating : 4.4/5 (822 download)

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Book Synopsis Clean Room Technology in ART Clinics by : Sandro C. Esteves

Download or read book Clean Room Technology in ART Clinics written by Sandro C. Esteves and published by CRC Press. This book was released on 2016-11-18 with total page 461 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regulatory agencies worldwide have issued directives or such requirements for air quality standards in embryology laboratories. This practical guide reviews the application of clean room technology or controlled environments specifically suited for Assisted Reproductive Technology (ART) Units. Its comprehensive coverage includes material on airborne particles and volatile organic compounds, including basic concepts, regulation, construction, materials, certification, clinical results in humans, and more.

The Technology Procurement Handbook

Author : Sergii Dovgalenko
Publisher : Kogan Page Publishers
ISBN 13 : 1789662117
Total Pages : 329 pages
Book Rating : 4.7/5 (896 download)

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Book Synopsis The Technology Procurement Handbook by : Sergii Dovgalenko

Download or read book The Technology Procurement Handbook written by Sergii Dovgalenko and published by Kogan Page Publishers. This book was released on 2020-04-03 with total page 329 pages. Available in PDF, EPUB and Kindle. Book excerpt: With the rise of cloud services and the digitization of all business units, procurement managers need to understand how to buy technology services in order to generate revenue, drive innovation and retain customers. The Technology Procurement Handbook provides a structured and logical view of the digital buying process. It includes invaluable advice on how to manage digital demand, prepare sourcing strategies, analyze the cost and benefits of proposed solutions and negotiate and implement comprehensive agreements. The Technology Procurement Handbook examines the multiple streams of data that feed into the technology procurement process, such as ITIL service lifecycle data, PMI project management and cloud and software contract provisions. The book includes case studies and extensive practical advice based on the authors experience from recent procurement projects. There is also a chapter on modular contracting for the US market, explaining the use of agile contracts for IT projects.

Practical Guide to Polyvinyl Chloride

Author : Stuart Patrick
Publisher : iSmithers Rapra Publishing
ISBN 13 : 9781859575116
Total Pages : 178 pages
Book Rating : 4.5/5 (751 download)

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Book Synopsis Practical Guide to Polyvinyl Chloride by : Stuart Patrick

Download or read book Practical Guide to Polyvinyl Chloride written by Stuart Patrick and published by iSmithers Rapra Publishing. This book was released on 2005 with total page 178 pages. Available in PDF, EPUB and Kindle. Book excerpt: Polyvinyl chloride (PVC) has been around since the late part of the 19th century, although it was not produced commercially until the 1920s; it is the second largest consumed plastic material after polyethylene. PVC products can be rigid or flexible, opaque or transparent, coloured, and insulating or conducting. There is not just one PVC but a whole family of products tailor-made to suit the needs of each application. PVC is extremely cost effective in comparison to other plastics with a high degree of versatility in end-use and processing possibilities, as the reader will note from this book. It is durable, easily maintained, and can be produced in a large range of colours. As a result PVC finds use in an extensive range of applications in virtually all areas of human activity, including medical equipment, construction applications such as flexible roof membranes, pipes and window profiles, toys, automotive parts and electrical cabling. The PVC industry has also started to tackle some of its end-of-life issues. This practical guide provides comprehensive background on the resins and additives, their properties and processing characteristics, as well as discussion of product design and development issues. There have been, and still are, issues and perceptions over environmental and health acceptance covering vinyl chloride monomer, dioxins, phthalate plasticisers, and lead (and cadmium) based heat stabilisers and these are discussed in depth in this book. This book will be of interest to raw materials suppliers and processors or end-users of PVC, as well as anyone with a general interest in this versatile material: resins and additives properties and testing design issues processing, including post processing and assembly property enhancement sustainable development

A Practical Guide to Compressor Technology

Author : Heinz P. Bloch
Publisher : John Wiley & Sons
ISBN 13 : 0471929522
Total Pages : 592 pages
Book Rating : 4.4/5 (719 download)

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Book Synopsis A Practical Guide to Compressor Technology by : Heinz P. Bloch

Download or read book A Practical Guide to Compressor Technology written by Heinz P. Bloch and published by John Wiley & Sons. This book was released on 2006-09-18 with total page 592 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Complete overview of theory, selection, design, operation, and maintenance This text offers a thorough overview of the operating characteristics, efficiencies, design features, troubleshooting, and maintenance of dynamic and positive displacement process gas compressors. The author examines a wide spectrum of compressors used in heavy process industries, with an emphasis on improving reliability and avoiding failure. Readers learn both the theory underlying compressors as well as the myriad day-to-day practical issues and challenges that chemical engineers and plant operation personnel must address. The text features: Latest design and manufacturing details of dynamic and positive displacement process gas compressors Examination of the full range of machines available for the heavy process industries Thorough presentation of the arrangements, material composition, and basic laws governing the design of all important process gas compressors Guidance on selecting optimum compressor configurations, controls, components, and auxiliaries to maximize reliability Monitoring and performance analysis for optimal machinery condition Systematic methods to avoid failure through the application of field-tested reliability enhancement concepts Fluid instability and externally pressurized bearings Reliability-driven asset management strategies for compressors Upstream separator and filter issues The text's structure is carefully designed to build knowledge and skills by starting with key principles and then moving to more advanced material. Hundreds of photos depicting various types of compressors, components, and processes are provided throughout. Compressors often represent a multi-million dollar investment for such applications as petrochemical processing and refining, refrigeration, pipeline transport, and turbochargers and superchargers for internal combustion engines. This text enables the broad range of engineers and plant managers who work with these compressors to make the most of the investment by leading them to the best decisions for selecting, operating, upgrading, maintaining, and troubleshooting.

Promoting quality in TVET using technology

Author : UNESCO International Centre for Technical and Vocational Education and Training
Publisher : UNESCO Publishing
ISBN 13 : 9231004026
Total Pages : 44 pages
Book Rating : 4.2/5 (31 download)

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Book Synopsis Promoting quality in TVET using technology by : UNESCO International Centre for Technical and Vocational Education and Training

Download or read book Promoting quality in TVET using technology written by UNESCO International Centre for Technical and Vocational Education and Training and published by UNESCO Publishing. This book was released on 2020-10-17 with total page 44 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Practical Guide to Single-Use Technology

Author : Adriana G. Lopes
Publisher :
ISBN 13 : 9781910242032
Total Pages : 178 pages
Book Rating : 4.2/5 (42 download)

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Book Synopsis Practical Guide to Single-Use Technology by : Adriana G. Lopes

Download or read book Practical Guide to Single-Use Technology written by Adriana G. Lopes and published by . This book was released on 2016-08-25 with total page 178 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is the first comprehensive publication of practical considerations for each stage of the implementation process of SUT, and covers the selection, specification, design and qualification of systems to meet end-user requirements.