Single-Use Technology
Single-Use Technology

Author: Adriana G. Lopes

Publisher: Walter de Gruyter GmbH & Co KG

Published: 2019-06-17

Total Pages: 154

ISBN-13: 3110640589

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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
Practical Guide to Single-use Technology

Author: Adriana G Lopes

Publisher: Smithers Rapra

Published: 2016-08-31

Total Pages: 178

ISBN-13: 1910242047

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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.

Single-Use Technology in Biopharmaceutical Manufacture
Single-Use Technology in Biopharmaceutical Manufacture

Author: Regine Eibl

Publisher: John Wiley & Sons

Published: 2019-07-18

Total Pages: 368

ISBN-13: 1119477786

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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.

Modern Machining Technology
Modern Machining Technology

Author: J. Paulo Davim

Publisher: Elsevier

Published: 2011-10-18

Total Pages: 412

ISBN-13: 0857094947

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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

Single-Use Technology
Single-Use Technology

Author: Adriana G. Lopes

Publisher: Walter de Gruyter GmbH & Co KG

Published: 2019-06-17

Total Pages: 174

ISBN-13: 3110640678

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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 LTE-A, VoLTE and IoT
Practical Guide to LTE-A, VoLTE and IoT

Author: Ayman ElNashar

Publisher: John Wiley & Sons

Published: 2018-06-19

Total Pages: 484

ISBN-13: 1119063418

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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
A Practical Guide to Global Point-of-Care Testing

Author: Mark Shephard OAM

Publisher: CSIRO PUBLISHING

Published: 2016-11

Total Pages: 488

ISBN-13: 1486305199

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

Author: Christopher R. Bugaj

Publisher: International Society for Technology in Education

Published: 2010-03-21

Total Pages: 314

ISBN-13: 1564845648

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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.