| 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 | : 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 | : 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 | : 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 | : 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 | : 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 | : 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 | : 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 | : International Society for Pharmaceutical Engineering |
| Publisher | : N.A |
| Release Date | : 2012 |
| ISBN 10 | : 9781936379446 |
| Pages | : 140 pages |
| Author | : William M. (Bill) Huitt |
| Publisher | : John Wiley & Sons |
| Release Date | : 2016-09-23 |
| ISBN 10 | : 1119284252 |
| Pages | : 544 pages |
The only comprehensive and authoritative reference guide to the ASME Bioprocessing Piping and Equipment (BPE) standard This is a companion guide to the ASME Bioprocessing Piping and Equipment (BPE) Standard and explains what lies behind many of the requirements and recommendations within that industry standard. Following an introductory narrative to the Standard's early history, industry related codes and standards are explained; the design and engineering aspects cover construction materials, both metallic and nonmetallic; then components, fabrication, assembly and installation of piping systems are explored. Examination, Inspection and Testing then precede the ASME BPE certification process, concluding with a discussion on system design. The author draws on many years' experience and insights from first-hand involvement in the field of industrial piping design, engineering, construction, and management, which includes the bioprocessing industry. The reader will learn why dimensions and tolerances, process instrumentation, and material selection play such an integral part in the manufacture of components and instrumentation. This easy to understand and navigate guide will assist engineers (design, piping, chemical, etc.) who need to understand the basis for much of the Standard’s content, as do the contractors and inspectors who have to meet and validate compliance with the BPE Standard.