Biocontamination Control for Pharmaceuticals and Healthcare

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Author :
Publisher : Elsevier
ISBN 13 : 0443216010
Total Pages : 510 pages
Book Rating : 4.4/5 (432 download)

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Book Synopsis Biocontamination Control for Pharmaceuticals and Healthcare by : Tim Sandle

Download or read book Biocontamination Control for Pharmaceuticals and Healthcare written by Tim Sandle and published by Elsevier. This book was released on 2024-02-09 with total page 510 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biocontamination Control for Pharmaceuticals and Healthcare outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. The first edition of the book covered many of the aspects of the strategy, but the new official guidance signals that a roadmap is required to fully comply with its requirements. Completely updated with the newest version of the EU-GPM (EN17141) the new edition expands the coverage of quality risk management and new complete examples to help professionals bridge the gap between regulation and implementation. Biocontamination Control for Pharmaceuticals and Healthcare offers professionals in pharma quality control and related areas guidance on building a complete biocontamination strategy. Includes the most current regulations Contains three new chapters, including Application of Quality Risk Management and its Application in Biocontamination Control, Designing an Environmental Monitoring Programme, and Synthesis: An Anatomy of a Contamination Control Strategy Offers practical guidance on building a complete biocontamination strategy

Contamination Control in Healthcare Product Manufacturing

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Author :
Publisher :
ISBN 13 : 9781942911326
Total Pages : pages
Book Rating : 4.9/5 (113 download)

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Book Synopsis Contamination Control in Healthcare Product Manufacturing by : Russell Madsen

Download or read book Contamination Control in Healthcare Product Manufacturing written by Russell Madsen and published by . This book was released on 2018-08 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Pharmaceutical Industrial Management

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Author :
Publisher : Educa Books
ISBN 13 : 9788188449125
Total Pages : 365 pages
Book Rating : 4.4/5 (491 download)

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Book Synopsis Pharmaceutical Industrial Management by : G. Vidya Sagar

Download or read book Pharmaceutical Industrial Management written by G. Vidya Sagar and published by Educa Books. This book was released on 2005-12-15 with total page 365 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Airborne Biocontaminants and their Impact on Human Health

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 139417893X
Total Pages : 420 pages
Book Rating : 4.3/5 (941 download)

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Book Synopsis Airborne Biocontaminants and their Impact on Human Health by : Rajeev Singh

Download or read book Airborne Biocontaminants and their Impact on Human Health written by Rajeev Singh and published by John Wiley & Sons. This book was released on 2024-09-11 with total page 420 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explores the relationships between biological contaminants and human health, as well as providing in-depth information of numerous biological contaminants found in diverse settings such as homes, hospitals, businesses, and schools. The current literature study has provided qualitative and quantitative data on bio-contaminants in these diverse indoor contexts. The main objective of this book is to investigate the pattern of morbidity among the people living in industrial, commercial, and residential due to poor air quality. Furthermore, biological sampling data obtained from indoor sites in different seasons provides seasonal adverse health problems explainations. The current study’s findings may aid in the development and implementation of preventative public health programs, as well as the creation of recommendations aimed at creating better indoor settings.

Aquatic Ecotoxicology

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Publisher : Academic Press
ISBN 13 : 0128011769
Total Pages : 518 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Aquatic Ecotoxicology by : Claude Amiard-Triquet

Download or read book Aquatic Ecotoxicology written by Claude Amiard-Triquet and published by Academic Press. This book was released on 2015-06-11 with total page 518 pages. Available in PDF, EPUB and Kindle. Book excerpt: Aquatic Ecotoxicology: Advancing Tools for Dealing with Emerging Risks presents a thorough look at recent advances in aquatic ecotoxicology and their application in assessing the risk of well-known and emerging environmental contaminants. This essential reference, brought together by leading experts in the field, guides users through existing and novel approaches to environmental risk assessment, then presenting recent advances in the field of ecotoxicology, including omics-based technologies, biomarkers, and reference species. The book then demonstrates how these advances can be used to design and perform assays to discover the toxicological endpoints of emerging risks within the aquatic environment, such as nanomaterials, personal care products, PFOS and chemical mixtures. The text is an invaluable reference for any scientist who studies the effects of contaminants on organisms that live within aquatic environments. Provides the latest perspectives on emerging toxic risks to aquatic environments, such as nanomaterials, pharmaceuticals, chemical mixtures, and perfluorooctane sulfonate (PFOS) Offers practical guidance on recent advances to help in choosing the most appropriate toxicological assay Presents case studies and information on a variety of reference species to help put the ecotoxicological theory into practical risk assess

Pharmaceutical Microbiology

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Publisher : Woodhead Publishing
ISBN 13 : 0081000448
Total Pages : 316 pages
Book Rating : 4.0/5 (81 download)

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Book Synopsis Pharmaceutical Microbiology by : Tim Sandle

Download or read book Pharmaceutical Microbiology written by Tim Sandle and published by Woodhead Publishing. This book was released on 2015-10-09 with total page 316 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control presents that latest information on protecting pharmaceutical and healthcare products from spoilage by microorganisms, and protecting patients and consumers. With both sterile and non-sterile products, the effects can range from discoloration to the potential for fatality. The book provides an overview of the function of the pharmaceutical microbiologist and what they need to know, from regulatory filing and GMP, to laboratory design and management, and compendia tests and risk assessment tools and techniques. These key aspects are discussed through a series of dedicated chapters, with topics covering auditing, validation, data analysis, bioburden, toxins, microbial identification, culture media, and contamination control. Contains the applications of pharmaceutical microbiology in sterile and non-sterile products Presents the practical aspects of pharmaceutical microbiology testing Provides contamination control risks and remediation strategies, along with rapid microbiological methods Includes bioburden, endotoxin, and specific microbial risks Highlights relevant case studies and risk assessment scenarios

Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals

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Author :
Publisher : Elsevier
ISBN 13 : 1908818638
Total Pages : 370 pages
Book Rating : 4.9/5 (88 download)

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Book Synopsis Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals by : Tim Sandle

Download or read book Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals written by Tim Sandle and published by Elsevier. This book was released on 2013-10-31 with total page 370 pages. Available in PDF, EPUB and Kindle. Book excerpt: Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. The book outlines and discusses sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging, as well as addressing the cleanroom environments in which products are prepared. Consisting of 18 chapters, the book comprehensively covers sterility, sterilisation and microorganisms; pyrogenicity and bacterial endotoxins; regulatory requirements and good manufacturing practices; and gamma radiation. Later chapters discuss e-beam; dry heat sterilisation; steam sterilisation; sterilisation by gas; vapour sterilisation; and sterile filtration, before final chapters analyse depyrogenation; cleanrooms; aseptic processing; media simulation; biological indicators; sterility testing; auditing; and new sterilisation techniques. Covers the main sterilisation methods of physical removal, physical alteration and inactivation Includes discussion of medical devices, aseptically filled products and terminally sterilised products Describes bacterial, pyrogenic, and endotoxin risks to devices and products

Microbial Limit and Bioburden Tests

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Publisher : CRC Press
ISBN 13 : 1420053493
Total Pages : 344 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Microbial Limit and Bioburden Tests by : Lucia Clontz

Download or read book Microbial Limit and Bioburden Tests written by Lucia Clontz and published by CRC Press. This book was released on 2008-10-14 with total page 344 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, the field of pharmaceutical microbiology has experienced numerous technological advances, accompanied by the publication of new and harmonized compendial methods. It is therefore imperative for those who are responsible for monitoring the microbial quality of pharmaceutical/biopharmaceutical products to keep abreast of the latest c

Good Manufacturing Practices for Pharmaceuticals

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Publisher : CRC Press
ISBN 13 : 1420020935
Total Pages : 418 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Good Manufacturing Practices for Pharmaceuticals by : Joseph D. Nally

Download or read book Good Manufacturing Practices for Pharmaceuticals written by Joseph D. Nally and published by CRC Press. This book was released on 2016-04-19 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.

Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices

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Author :
Publisher :
ISBN 13 : 9788190646741
Total Pages : 964 pages
Book Rating : 4.6/5 (467 download)

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Book Synopsis Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices by :

Download or read book Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices written by and published by . This book was released on 2011 with total page 964 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Aulton's Pharmaceutics E-Book

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Author :
Publisher : Elsevier Health Sciences
ISBN 13 : 0702081566
Total Pages : 1052 pages
Book Rating : 4.7/5 (2 download)

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Book Synopsis Aulton's Pharmaceutics E-Book by : Kevin M.G. Taylor

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 2021-04-23 with total page 1052 pages. Available in PDF, EPUB and Kindle. Book excerpt: The essential pharmaceutics textbook One of the world’s best-known texts on pharmaceutics, Aulton's Pharmaceutics offers a complete course in one book for students in all years of undergraduate pharmacy and pharmaceutical sciences degrees. Thoroughly revised, updated and extended by experts in their fields and edited by Professors Kevin Taylor and Michael Aulton, this new edition includes the science of formulation, pharmaceutical manufacturing and drug delivery. All aspects of pharmaceutics are covered in a clear and readily accessible way and extensively illustrated throughout, providing an essential companion to the entire pharmaceutics curriculum from day one until the end of the course. Fully updated throughout, with the addition of new chapters, to reflect advances in formulation and drug delivery science, pharmaceutical manufacturing and medicines regulation Designed and written for newcomers to the design and manufacture of dosage forms Relevant pharmaceutical science covered throughout Includes the science of formulation and drug delivery Reflects current practices and future applications of formulation and drug delivery science to small drug molecules, biotechnology products and nanomedicines Key points boxes throughout Over 400 online multiple choice questions

One Health

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Publisher : John Wiley & Sons
ISBN 13 : 1119867304
Total Pages : 500 pages
Book Rating : 4.1/5 (198 download)

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Book Synopsis One Health by : Meththika Vithanage

Download or read book One Health written by Meththika Vithanage and published by John Wiley & Sons. This book was released on 2023-07-19 with total page 500 pages. Available in PDF, EPUB and Kindle. Book excerpt: A balanced and multidisciplinary exploration of the One Health concept In One Health: Human, Animal, and Environment Triad, a team of distinguished researchers introduces and explains the concept of One Health by providing an overview of the One Health idea from the perspective of diverse disciplines, from earth and environmental science to ecology and conservation to veterinary and human medicine. The authors also present case studies demonstrating the real-world challenges and opportunities of this interdisciplinary approach to sustainable human well-being. Readers will find insightful discussions of the interactions between chemical pollutants and water, soil, and the atmosphere, as well as detailed examinations of sustainable food supply, waste management, and pathogen control, backed up by extensive reference data. One Health: Human, Animal, and Environment Triad also includes: The emergence and re-emergence of zoonoses and other infectious diseases The behavior of microplastics in soil and water Organic farming and its influence on soil health The role of light for human well-being Perfect for researchers interested in global health, ecological health, medical geology, toxicology, epidemiology, and zoonotic diseases, One Health: Human, Animal, and Environment Triad will also benefit professionals with an interest in public health and other public services, resource conservation, waste management, and the circular economy.

An Industrial IoT Approach for Pharmaceutical Industry Growth

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Publisher : Academic Press
ISBN 13 : 0128213272
Total Pages : 383 pages
Book Rating : 4.1/5 (282 download)

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Book Synopsis An Industrial IoT Approach for Pharmaceutical Industry Growth by : Valentina Emilia Balas

Download or read book An Industrial IoT Approach for Pharmaceutical Industry Growth written by Valentina Emilia Balas and published by Academic Press. This book was released on 2020-05-15 with total page 383 pages. Available in PDF, EPUB and Kindle. Book excerpt: An Industrial IoT Approach for Pharmaceutical Industry Growth, Volume Two uses an innovative approach to explore how the Internet of Things (IoT) and big data can improve approaches and make discoveries. Rapid growth of the IoT has encouraged many companies in the manufacturing sector to make use of this technology to unlock its potential. Using clear language and real-world case studies, this book discusses systems level from both a human-factors point-of-view and the perspective of networking, databases, privacy and anti-spoofing. The wide variety in topics presented offers multiple perspectives on how to integrate the Internet of Things into pharmaceutical manufacturing. This book represents a useful resource for researchers in pharmaceutical sciences, information and communication technologies, and those who specialize in healthcare and pharmacovigilance. Emphasizes efficiency in pharmaceutical manufacturing through an IoT/Big Data approach Explores cutting-edge technologies through sensor enabled environments in the pharmaceutical industry Discusses system levels from both a human-factors point-of-view and the perspective of networking, databases, privacy and anti-spoofing

Principles of Aseptic Processing and Packaging

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Publisher : Purdue University Press
ISBN 13 : 1557534969
Total Pages : 170 pages
Book Rating : 4.5/5 (575 download)

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Book Synopsis Principles of Aseptic Processing and Packaging by : Philip E. Nelson

Download or read book Principles of Aseptic Processing and Packaging written by Philip E. Nelson and published by Purdue University Press. This book was released on 2010 with total page 170 pages. Available in PDF, EPUB and Kindle. Book excerpt: In aseptic processing, food is stored at ambient temperatures in sterilized containers free of spoilage organisms and pathogens. The results of this food technology come in all shapes and sizes, from the consumer packages of milk on the shelves of the supermarket to the huge containers full of orange juice transported around the world by cargo ships. Over the last couple of decades, aseptic bulk storage and distribution has revolutionized the global food trade. For example, more than 90 percent of the approximately 24 million tons of fresh tomatoes harvested globally each year are aseptically processed and packaged for year-round remanufacture into various food products. The technology has also been applied to bring potable water and emergency food aid to survivors of the 2004 tsunami in Southeast Asia and the victims of Hurricane Katrina in 2005, as well as to other crisis situations worldwide. The construction of new aseptic facilities continues around the world, and an up-to-date understanding of the technology is essential for a new generation of food scientists and engineers alike. The contributors to this important textbook discuss all aspects of aseptic processing and packaging, focusing on the areas that most influence the success or failure of the process. Fully updated, this new edition covers all areas of chemistry, microbiology, engineering, packaging, and regulations as they relate to aseptic processing.

Pharmaceutical Manufacturing Handbook

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Publisher : John Wiley & Sons
ISBN 13 : 0470259809
Total Pages : 1384 pages
Book Rating : 4.4/5 (72 download)

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Book Synopsis Pharmaceutical Manufacturing Handbook by : Shayne Cox Gad

Download or read book Pharmaceutical Manufacturing Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2008-03-21 with total page 1384 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.

Microbiome Therapeutics

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Publisher : Elsevier
ISBN 13 : 0323993370
Total Pages : 530 pages
Book Rating : 4.3/5 (239 download)

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Book Synopsis Microbiome Therapeutics by : Nar Singh Chauhan

Download or read book Microbiome Therapeutics written by Nar Singh Chauhan and published by Elsevier. This book was released on 2023-05-17 with total page 530 pages. Available in PDF, EPUB and Kindle. Book excerpt: Microbiome Therapeutics: Personalized Therapy Beyond Conventional Approaches addresses the current knowledge and landscape of microbiome therapeutics, providing an overview of existing applications in health and disease as well as potential future directions of microbiome modulations and subsequent translation to the global industry and market. This important reference provides the most current status of microbiome therapeutics as well as possible future perspectives through coverage of topics including the application of microbiome therapeutics; various additive, subtractive and modulatory approaches; microbiome composition of health and diseases, insights into live bio-therapeutics and the clinical data supporting their efficacy. Case studies are provided throughout the book to further define, describe and evaluate microbiome therapeutics success and failure. Provides chapters focused on illness types to address the potential of microbiome therapeutics in several significant disorders Offers human gut microbiome explorations that have enriched the understanding of microbiome colonization, maturation, and dysbiosis in health and disease subsets Addresses important concepts like economic potential in the global therapeutics market as well as ethical, technical, and regulatory aspects

Cannabis Laboratory Fundamentals

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Author :
Publisher : Springer Nature
ISBN 13 : 3030627160
Total Pages : 325 pages
Book Rating : 4.0/5 (36 download)

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Book Synopsis Cannabis Laboratory Fundamentals by : Shaun R. Opie

Download or read book Cannabis Laboratory Fundamentals written by Shaun R. Opie and published by Springer Nature. This book was released on 2021-03-09 with total page 325 pages. Available in PDF, EPUB and Kindle. Book excerpt: The legislative requirement for cannabis to undergo laboratory testing has followed legalization of medical and recreational use in every U.S. state to date. Cannabis safety testing is a new investment opportunity within the emerging cannabis market that is separate from cultivation, processing, and distribution, allowing individuals and organizations who may have been reluctant to enter previously a new entry route to the cannabis space. However, many of the costs, timelines, operational requirements, and compliance issues are overlooked by people who have not been exposed to regulated laboratory testing. Cannabis Laboratory Fundamentals provides an in-depth review of the key issues that impact cannabis testing laboratories and provides recommendations and solutions to avoid common – but expensive – mistakes. The text goes beyond methodology to include sections on economics, regulation, and operational challenges, making it useful for both new and experienced cannabis laboratory operators, as well as all those who want to understand the opportunities and risks of this industry.