| Author | : William V. Collentro |
| Publisher | : CRC Press |
| Release Date | : 2016-04-19 |
| ISBN 10 | : 142007783X |
| Pages | : 478 pages |
A major new work on all aspects of water, the most used raw material ingredient in the pharmaceutical and biotechnology industries-used as an excipient in pharmaceutical formulations, as a cleaning agent, and as a separately packaged product diluent.Drawing on the author's extensive field experience with more than 400 pharmaceutical and related wat
| Author | : Theodore H. Meltzer |
| Publisher | : Tall Oaks Pub |
| Release Date | : 1996-01-01 |
| ISBN 10 | : 9780927188067 |
| Pages | : 871 pages |
| Author | : Gongchen Zhang |
| Publisher | : Academic Press |
| Release Date | : 2019-12-15 |
| ISBN 10 | : 9780128154397 |
| Pages | : 500 pages |
Pharmaceutical water systems are an important part of good manufacturing practice. With development in design, installation and validation, pharmaceutical water systems are becoming key to new projects in the contemporary pharmaceutical industry. Pharmaceutical companies realize that pharmaceutical water systems can provide competitive advantage, consistent quality assurance, and cost saving. Pharmaceutical Water Systems offers comprehensive and in-depth coverage of the topic, presenting successful system operation examples selected from thousands of real-life systems. The title offers those working in pharma a deeper and more visual understanding of pharmaceutical water systems, promoting the popularization of design, manufacturing and validation through pharmaceutical water systems. The book introduces new and innovative technological concepts, including WFI generation with the purification method, online microorganism detecting technology, design and practice of WFI systems at normal temperature, residual chlorine removal technology with UV radiation, and rouge remediation and prevention, among others. The book consists in 13 chapters, covering pharmacopeia and regulations; design concepts; unit operation and components; generation of purified water; generation of water for injection; storage and distribution systems; pharmaceutical steam systems; sanitation and sterilization technology; rouge formation; derouging stainless steel systems; quality management; automatic control technology; and validation Presents successful system examples selected from real-life systems Introduces novel technological innovations Details how pharmaceutical companies can gain competitive advantage through pharmaceutical water systems Offers access to many combined years of practical experience and real-world examples applied to pharmaceutical water systems Promotes the popularization of design, manufacturing and validation through pharmaceutical water systems
| Author | : Diana S. Aga |
| Publisher | : CRC Press |
| Release Date | : 2007-12-26 |
| ISBN 10 | : 9781420052336 |
| Pages | : 408 pages |
The detection of pharmaceutical residues remained elusive until instruments such as liquid chromatography and mass spectrometry became commonplace in environmental laboratories. The documentation of the occurrence of pharmaceutical residues and endocrine disrupting chemicals in water resources has raused questions about their long-term effects in the ecosystem and their potential effects on human health. Fate of Pharmaceuticals in the Environment and in Water Treatment Systems covers critical issues regarding the occurrence, persistence, treatment, and transformations of pharmaceuticals in the environment and in drinking water and wastewater treatment systems. Acompilation of the recent literature, the book reviews advances in instrumentation and sample preparation techniques and includes an example of how risk assessment is conducted to investigate the fate and effects of pharmaceutical contaminants. Several chapters explore the behavior of pharmaceuticals in soil and the potential side effects of antibiotics on plants after uptake. Experts in drinking water and wastewater treatment systems present new findings on the effectiveness of current treatment practices to reduce the concentrations of pharmaceuticals at the source, providing new insights on how to better mitigate future problems brought about by emerging environmental contaminants. Contributing authors from academia, government, and industry provide a well-balanced multi-disciplinary perspective on the issues, discussing topics ranging from field studies documenting the occurrence of pharmaceuticals in environmental compartments, to laboratory studies determining the degradation kinetics and formation of by-products during treatment. The text discusses the factors that affect the environmental fate of pharmaceuticals in soil and water, facilitate the development of best management practices, and optimize treatment systems for removal of these compounds from the environment.
| Author | : James P. Agalloco,Frederick J. Carleton |
| Publisher | : CRC Press |
| Release Date | : 2007-09-25 |
| ISBN 10 | : 9781420019797 |
| Pages | : 760 pages |
Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine va
| Author | : Tim Sandle |
| Publisher | : Academic Press |
| Release Date | : 2018-11-30 |
| ISBN 10 | : 0128149124 |
| Pages | : 374 pages |
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. This key part of controlling risk escalation can lead to the contamination of medicinal products, hence necessary tracking precautions are essential. Regulatory authorities have challenged pharmaceutical companies, healthcare providers, and those in manufacturing practice to adopt a holistic approach to contamination control. New technologies are needed to introduce barriers between personnel and the environment, and to provide a rapid and more accurate assessment of risk. This book offers guidance on building a complete biocontamination strategy. Provides the information necessary for a facility to build a complete biocontamination strategy Helps facilities understand the main biocontamination risks to medicinal products Assists the reader in navigating regulatory requirements Provides insight into developing an environmental monitoring program Covers the types of rapid microbiological monitoring methods now available, as well as current legislation
| Author | : Shayne Cox Gad |
| Publisher | : John Wiley & Sons |
| Release Date | : 2008-04-04 |
| ISBN 10 | : 9780470259825 |
| Pages | : 832 pages |
With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.
| Author | : KennethE. Avis |
| Publisher | : Routledge |
| Release Date | : 2018-03-29 |
| ISBN 10 | : 1351413864 |
| Pages | : 428 pages |
Sterile Pharmaceutical Products: Process Engineering Applications addresses the key concepts and applications of the sterile pharmaceutical manufacturing industry. It covers elements of the design, installation, validation, and usage of critical processes associated with sterile product manufacture. From water systems to clean-in-place systems, to sterile powder handling and robotic applications in sterile production environments, this book addresses the issues of system implementation, integration, and operations. Written by recognized experts and peer reviewed for accuracy, all chapters include references to supplemental resources and numerous illustrations.
| Author | : Hans-Curt Flemming,Gill G. Geesey |
| Publisher | : Springer Science & Business Media |
| Release Date | : 2012-12-06 |
| ISBN 10 | : 3642765432 |
| Pages | : 220 pages |
Microbial growth and contamination ("Biofouling") in water systems represents a significant threat to the quality of waters produced for the microelectronic, pharmaceutical, petroleum, paper, food and other manufacturing industries. Biofouling can lead to biologically induced corrosion ("Biocorrosion"), which can cause severe damage to the equipment. Both biofouling and biocorrosion are frequently not recognized in time, underestimated, or linked with the wrong causes. The book represents a new approach by introducing biofilm properties and dynamics as basic principles of biofouling and biocorrosion, thus providing a better understanding and the means of fighting the undesired effects of biofilms. The most important features are: Case histories of biofouling in water treatment.- Detection and monitoring of biofouling.- Reverse osmosis membrane biofouling.- Biocide efficacy and biofouling control.- Plant design considerations for preventing biofouling.- Case histories of biocorrosion.- Detection, monitoring, control and prevention of biocorrosion.- Fundamentals of biofouling and biocorrosion mechanisms.
| Author | : David S. Reid,Tanaboon Sajjaanantakul,Peter J. Lillford,Sanguansri Charoenrein |
| Publisher | : John Wiley & Sons |
| Release Date | : 2010-07-06 |
| ISBN 10 | : 0813812739 |
| Pages | : 804 pages |
This title focuses on the comprehension of the properties of water in foods, enriched by the approaches from polymer and materials sciences, and by the advances of analytical techniques. The International Symposium on the Properties of Water (ISOPOW) promotes the exchange of knowledge between scientists involved in the study of food materials and scientists interested in water from a more basic point of view and the dialogue between academic and industrial scientists/technologists. This comprehensive book covers the topics presented at the 10th ISOPOW held in Bangkok, Thailand in 2007, including water dynamics in various systems, the role of water in functional food and nano-structured biomaterials. Special features include: Latest findings in the properties of water in food, pharmaceutical and biological systems Coverage of the 10th International Symposium on the Properties of Water (ISOPOW) Includes water dynamics, water in foods stability, and water in micro and nano-structured food and biomaterials Reflects the vast array of research and applications of water world wide
| Author | : Alexandru Grumezescu |
| Publisher | : Academic Press |
| Release Date | : 2016-12-28 |
| ISBN 10 | : 0128043717 |
| Pages | : 772 pages |
Water Purification, a volume in the Nanotechnology in the Food Industry series, provides an in-depth review of the current technologies and emerging application of nanotechnology in drinking water purification, also presenting an overview of the common drinking water contaminants, such as heavy metals, organics, microorganisms, pharmaceuticals, and their occurrences in drinking water sources. As the global water crisis has motivated the industry to look for alternative water supplies, nanotechnology presents significant potential for utilizing previously unacceptable water sources. This books explores the practical methodologies for transforming water using nanotechnologies, and is a comprehensive reference to a wide audience of food science research professionals, professors, and students who are doing research in this field. Includes the most up-to-date information on nanotechnology applications and research methods for water purification and treatment Presents applications of nanotechnology and engineered nanomaterials in drinking water purification to improve efficiency and reduce cost Provides water purification research methods that are important to water quality, including precipitation, adsorption, membrane separation, and ion exchange Covers the potential risks of nanotechnology, such as the toxicological effects of engineered nanomaterials in water and how to minimize risks based on research studies
| Author | : Maria del Pilar Buera,Jorge Welti-Chanes,Peter J. Lillford,Horacio R. Corti |
| Publisher | : CRC Press |
| Release Date | : 2006-01-13 |
| ISBN 10 | : 1420001183 |
| Pages | : 792 pages |
Unique and informative, Water Properties of Food, Pharmaceutical, and Biological Materials is based on lectures and papers given by leading international researchers at the 9th International Symposium of the Properties of Water in Foods (ISOPOW 9) that took place in September 2004. Each chapter presents an authoritative account of the latest research on the physical and chemical properties of water in relation to the stability of food, pharmaceutical, and biological materials. The first part of the text focuses on presentations given by invited speakers, whereas the second part is dedicated to oral presentations and discussions. Topics include the role of water in structural and functional properties, preserving biomolecule functionality in restricted water environments, and micro- and nano- techniques used for assessing water-solid interactions in food and drug development. This book is an invaluable resource that synthesizes cutting-edge information with innovative viewpoints from internationally esteemed researchers who participated in ISOPOW 2004.
| Author | : Maik W. Jornitz |
| Publisher | : CRC Press |
| Release Date | : 2019-06-26 |
| ISBN 10 | : 1351675699 |
| Pages | : 654 pages |
Since sterile filtration and purification steps are becoming more prevalent and critical within medicinal drug manufacturing, the third edition of Filtration and Purification in the Biopharmaceutical Industry greatly expands its focus with extensive new material on the critical role of purification and advances in filtration science and technology. It provides state-of-the-science information on all aspects of bioprocessing including the current methods, processes, technologies and equipment. It also covers industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries. The book is an essential, comprehensive source for all involved in filtration and purification practices, training and compliance. It describes such technologies as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration. Features: Addresses recent biotechnology-related processes and advanced technologies such as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration of medium, buffer and end product Presents detailed updates on the latest FDA and EMA regulatory requirements involving filtration and purification practices, as well as discussions on best practises in filter integrity testing Describes current industry quality standards and validation requirements and provides guidance for compliance, not just from an end-user perspective, but also supplier requirement It discusses the advantages of single-use process technologies and the qualification needs Sterilizing grade filtration qualification and process validation is presented in detail to gain the understanding of the regulatory needs The book has been compilated by highly experienced contributors in the field of pharmaceutical and biopharmaceutical processing. Each specific topic has been thoroughly examined by a subject matter expert.
| Author | : William V. Collentro |
| Publisher | : N.A |
| Release Date | : 1998 |
| ISBN 10 | : 9781003027089 |
| Pages | : 682 pages |
From chemical and biological purity requirements, to system design and its impact on water purity, to the requirements and restrictions imposed by the regulators, this book comprehensively covers the unique water requirements of the pharmaceutical and biotechnology industries. Beginning with a brief overview of the theory and application of the technology, William Collentro clarifies the seemingly overwhelming engineering aspects as he discusses design considerations, operation, maintenance, validation, and regulatory-related topics bases upon personal experience with more than 400 pharmaceutical and related water purification systems. His extensive field experience and the numerous case studies recounted in this book ensure that all relevant aspects of pharmaceutical water technology are thoroughly explained in a clear, concise style.Features
| Author | : James Swarbrick |
| Publisher | : CRC Press |
| Release Date | : 2013-07-01 |
| ISBN 10 | : 1439808236 |
| Pages | : 1171 pages |
Presenting authoritative and engaging articles on all aspects of drug development, dosage, manufacturing, and regulation, this Third Edition enables the pharmaceutical specialist and novice alike to keep abreast of developments in this rapidly evolving and highly competitive field. A dependable reference tool and constant companion for years to com
| Author | : Tim Sandle |
| Publisher | : Woodhead Publishing |
| Release Date | : 2015-10-09 |
| ISBN 10 | : 0081000448 |
| Pages | : 316 pages |
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
| Author | : Gary Prager |
| Publisher | : Wiley |
| Release Date | : 2018-12-18 |
| ISBN 10 | : 0470410329 |
| Pages | : 576 pages |
A practical guide to all key the elements of pharmaceuticals and biotech manufacturing and design Engineers working in the pharmaceutical and biotech industries are routinely called upon to handle operational issues outside of their fields of expertise. Traditionally the competencies required to fulfill those tasks were achieved piecemeal, through years of self-teaching and on-the-job experience—until now. Practical Pharmaceutical Engineering provides readers with the technical information and tools needed to deal with most common engineering issues that can arise in the course of day-to-day operations of pharmaceutical/biotech research and manufacturing. Engineers working in pharma/biotech wear many hats. They are involved in the conception, design, construction, and operation of research facilities and manufacturing plants, as well as the scale-up, manufacturing, packaging, and labeling processes. They have to implement FDA regulations, validation assurance, quality control, and Good Manufacturing Practices (GMP) compliance measures, and to maintain a high level of personal and environmental safety. This book provides readers from a range of engineering specialties with a detailed blueprint and the technical knowledge needed to tackle those critical responsibilities with confidence. At minimum, after reading this book, readers will have the knowledge needed to constructively participate in contractor/user briefings. Provides pharmaceutical industry professionals with an overview of how all the parts fit together and a level of expertise that can take years of on-the-job experience to acquire Addresses topics not covered in university courses but which are crucial to working effectively in the pharma/biotech industry Fills a gap in the literature, providing important information on pharmaceutical operation issues required for meeting regulatory guidelines, plant support design, and project engineering Covers the basics of HVAC systems, water systems, electric systems, reliability, maintainability, and quality assurance, relevant to pharmaceutical engineering Practical Pharmaceutical Engineering is an indispensable “tool of the trade” for chemical engineers, mechanical engineers, and pharmaceutical engineers employed by pharmaceutical and biotech companies, engineering firms, and consulting firms. It also is a must-read for engineering students, pharmacy students, chemistry students, and others considering a career in pharmaceuticals.
| Author | : Gary Prager |
| Publisher | : John Wiley & Sons |
| Release Date | : 2018-11-28 |
| ISBN 10 | : 1119418844 |
| Pages | : 576 pages |
A practical guide to all key the elements of pharmaceuticals and biotech manufacturing and design Engineers working in the pharmaceutical and biotech industries are routinely called upon to handle operational issues outside of their fields of expertise. Traditionally the competencies required to fulfill those tasks were achieved piecemeal, through years of self-teaching and on-the-job experience—until now. Practical Pharmaceutical Engineering provides readers with the technical information and tools needed to deal with most common engineering issues that can arise in the course of day-to-day operations of pharmaceutical/biotech research and manufacturing. Engineers working in pharma/biotech wear many hats. They are involved in the conception, design, construction, and operation of research facilities and manufacturing plants, as well as the scale-up, manufacturing, packaging, and labeling processes. They have to implement FDA regulations, validation assurance, quality control, and Good Manufacturing Practices (GMP) compliance measures, and to maintain a high level of personal and environmental safety. This book provides readers from a range of engineering specialties with a detailed blueprint and the technical knowledge needed to tackle those critical responsibilities with confidence. At minimum, after reading this book, readers will have the knowledge needed to constructively participate in contractor/user briefings. Provides pharmaceutical industry professionals with an overview of how all the parts fit together and a level of expertise that can take years of on-the-job experience to acquire Addresses topics not covered in university courses but which are crucial to working effectively in the pharma/biotech industry Fills a gap in the literature, providing important information on pharmaceutical operation issues required for meeting regulatory guidelines, plant support design, and project engineering Covers the basics of HVAC systems, water systems, electric systems, reliability, maintainability, and quality assurance, relevant to pharmaceutical engineering Practical Pharmaceutical Engineering is an indispensable “tool of the trade” for chemical engineers, mechanical engineers, and pharmaceutical engineers employed by pharmaceutical and biotech companies, engineering firms, and consulting firms. It also is a must-read for engineering students, pharmacy students, chemistry students, and others considering a career in pharmaceuticals.
| Author | : Arturo Hernandez-Maldonado,Lee Blaney |
| Publisher | : Butterworth-Heinemann |
| Release Date | : 2019-10-19 |
| ISBN 10 | : 012813562X |
| Pages | : 434 pages |
Contaminants of Emerging Concern in Water and Wastewater: Advanced Treatment Processes presents the state-of-the-art in the design and use of adsorbents, membranes, and UV/oxidation processes, along with the challenges that will need to be addressed to close the gap between development and implementation in water/wastewater treatment applications. Chapters cover adsorbent and membrane design and performance, direct comparison of performance data between new (inorganic and metal organic nanoporous materials) and classic adsorbents and membranes, a list of advantages, disadvantages, and challenges related to performance limitations, regenerability, and upscaling. In addition, users will find sections on the identification of potential site and off-site applications that are listed according to adsorbent and membrane types, transformation of CECs in low- and/or medium-pressure UV irradiation processes used for disinfection, the oxidation of CECs by chlorine and ozone, and a comparison of advanced oxidation processes for the treatment of a variety of CECs in water and wastewater. Addresses the advantages/disadvantages of select technologies, including energy resource needs and waste management issues of reverse osmosis, amongst other issues Presents information on the advancements of technology within the realm of Engineered Treatments of CECs Focuses on the inherent science and technology of advanced treatment processes
| Author | : Kevin Williams |
| Publisher | : CRC Press |
| Release Date | : 2004-05-20 |
| ISBN 10 | : 113553621X |
| Pages | : 764 pages |
This reference surveys emerging trends, concepts, and procedures used in the characterization and control of contaminants; the sterile production of traditional drugs and biologics; the design, construction, and validation of new parenteral facilities; and the monitoring of clean environments-vividly illustrating the routes by which products, proce