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Pharmaceutical Water

Pharmaceutical Water
System Design, Operation, and Validation, Second Edition

by William V. Collentro

  • Publisher : CRC Press
  • Release : 2016-04-19
  • Pages : 478
  • ISBN : 142007783X
  • Language : En, Es, Fr & De
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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

Pharmaceutical Water Systems

Pharmaceutical Water Systems
A Book

by Gongchen Zhang

  • Publisher : Academic Press
  • Release : 2019-12-15
  • Pages : 500
  • ISBN : 9780128154397
  • Language : En, Es, Fr & De
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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

Pharmaceutical Water Systems

Pharmaceutical Water Systems
A Book

by Theodore H. Meltzer

  • Publisher : Tall Oaks Pub
  • Release : 1996-01-01
  • Pages : 871
  • ISBN : 9780927188067
  • Language : En, Es, Fr & De
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Ozone Sanitization of Pharmaceutical Water Systems

Ozone Sanitization of Pharmaceutical Water Systems
A Book

by International Society for Pharmaceutical Engineering

  • Publisher : Unknown Publisher
  • Release : 2012
  • Pages : 140
  • ISBN : 9781936379446
  • Language : En, Es, Fr & De
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Validation of Pharmaceutical Processes

Validation of Pharmaceutical Processes
A Book

by James P. Agalloco,Frederick J. Carleton

  • Publisher : CRC Press
  • Release : 2007-09-25
  • Pages : 760
  • ISBN : 9781420019797
  • Language : En, Es, Fr & De
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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

Pharmaceutical Manufacturing Handbook

Pharmaceutical Manufacturing Handbook
Regulations and Quality

by Shayne Cox Gad

  • Publisher : John Wiley & Sons
  • Release : 2008-04-04
  • Pages : 832
  • ISBN : 9780470259825
  • Language : En, Es, Fr & De
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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.

Encyclopedia of Pharmaceutical Technology

Encyclopedia of Pharmaceutical Technology
A Book

by James Swarbrick

  • Publisher : CRC Press
  • Release : 2013-07-01
  • Pages : 1171
  • ISBN : 1439808236
  • Language : En, Es, Fr & De
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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

Practical Pharmaceutical Engineering

Practical Pharmaceutical Engineering
A Book

by Gary Prager

  • Publisher : John Wiley & Sons
  • Release : 2018-11-28
  • Pages : 576
  • ISBN : 1119418844
  • Language : En, Es, Fr & De
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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.

Good Design Practices for GMP Pharmaceutical Facilities, Second Edition

Good Design Practices for GMP Pharmaceutical Facilities, Second Edition
A Book

by Terry Jacobs,Andrew A. Signore

  • Publisher : CRC Press
  • Release : 2016-08-19
  • Pages : 536
  • ISBN : 1482258919
  • Language : En, Es, Fr & De
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This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.

Pharmaceutical Microbiology

Pharmaceutical Microbiology
Essentials for Quality Assurance and Quality Control

by Tim Sandle

  • Publisher : Woodhead Publishing
  • Release : 2015-10-09
  • Pages : 316
  • ISBN : 0081000448
  • Language : En, Es, Fr & De
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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

Pharmaceutical Water

Pharmaceutical Water
System Design, Operation, and Validation

by William V. Collentro

  • Publisher : Unknown Publisher
  • Release : 1998
  • Pages : 682
  • ISBN : 9781003027089
  • Language : En, Es, Fr & De
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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

Pharmaceutical Dosage Forms

Pharmaceutical Dosage Forms
Parenteral Medications, Third Edition. 3 Volume Set

by Sandeep Nema,John D. Ludwig

  • Publisher : CRC Press
  • Release : 2010-08-26
  • Pages : 500
  • ISBN : 1482281783
  • Language : En, Es, Fr & De
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Pharmaceutical Dosage Forms: Parenteral Medications explores the administration of medications through other than the enteral route. First published in 1984 (as two volumes) and then last revised in 1993, this three-volume set presents the plethora of changes in the science and considerable advances in the technology associated with these products

Pharmaceutical Water Systems

Pharmaceutical Water Systems
A Thermal-fluid Analysis of Pipe Dead-legs

by Benjamin L. Austen

  • Publisher : Unknown Publisher
  • Release : 2005
  • Pages : 135
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Pharmaceutical Dosage Forms - Parenteral Medications

Pharmaceutical Dosage Forms - Parenteral Medications
Volume 2: Facility Design, Sterilization and Processing

by Sandeep Nema,John D. Ludwig

  • Publisher : CRC Press
  • Release : 2016-04-19
  • Pages : 406
  • ISBN : 1420086464
  • Language : En, Es, Fr & De
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This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it is recommended for scientists and engineers in the pharmaceutical industry and academia, and will also serve as an excellent reference and training tool for regulatory scientists and quality assurance professionals. First published in 1984 (as two volumes) and then last revised in 1993 (when it grew to three volumes), this latest revision will address the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. The third edition of this book maintains the features that made the last edition so popular but comprises several brand new chapters, revisions to all other chapters, as well as high quality illustrations. Volume two presents: • Chapters on aseptic facility design, environmental monitoring, and cleanroom operations. • A comprehensive chapter on pharmaceutical water systems. • A discussion of quality attributes of sterile dosage forms, including particulate matter, endotoxin, and sterility testing. • A detailed chapter on processing of parenteral drug products (SVPs and LVPs). • Presentations on widely used sterilization technologies – steam, gas / chemical, radiation, filtration and dry heat. • An in-depth chapter on lyophilization.

Quality Assurance of Pharmaceuticals

Quality Assurance of Pharmaceuticals
A Compendium of Guidelines and Related Materials. Good manufacturing practices and inspection

by World Health Organization

  • Publisher : World Health Organization
  • Release : 2007
  • Pages : 409
  • ISBN : 9241547081
  • Language : En, Es, Fr & De
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Quality assurance of pharmaceutical products is a continuing concern of WHO. Despite efforts made around the world to ensure a supply of quality and effective medicines, substandard, spurious and counterfeit products still compromise health care delivery in many countries. To respond to the global need for adequate quality assurance of pharmaceuticals, WHO's Expert Committee on Specifications for Pharmaceutical Preparations has over the years made numerous recommendations to establish standards and guidelines and to promote the effective functioning of national regulatory and control systems and the implementation of internationally agreed standards by trained personnel. Many of the relevant documents endorsed by the Committee are reproduced in this volume providing guidance covering all aspects of good manufacturing practices (GMP). Important texts on inspection are also included. Most of the material has been published separately in the Expert Committee's reports. This compendium brings it together to make it more accessible and of greater practical value to those working in faculties of pharmacy, in medicines regulation and control and in the pharmaceutical industry. This is the second updated edition of the compendium and includes texts published in 2005 and 2006 in the WHO Technical Report Series.

Endotoxin Detection and Control in Pharma, Limulus, and Mammalian Systems

Endotoxin Detection and Control in Pharma, Limulus, and Mammalian Systems
A Book

by Kevin L. Williams

  • Publisher : Springer
  • Release : 2019-07-24
  • Pages : 869
  • ISBN : 3030171485
  • Language : En, Es, Fr & De
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Endotoxin detection and control is a dynamic area of applied science that touches a vast number of complex subjects. The intersection of test activities includes the use of an ancient blood system from an odd “living fossil” (Limulus). It is used to detect remnants of the most primitive and destructive forms of life (prokaryotes) as contaminants of complex modern systems (mammalian and Pharma). Recent challenges in the field include those associated with the application of traditional methods to new types of molecules and manufacturing processes. The advent of “at will” production of biologics in lieu of harvesting animal proteins has revolutionized the treatment of disease. While the fruits of the biotechnology revolution are widely acknowledged, the realization of the differences in the means of production and changes in the manner of control of potential impurities and contaminants in regard to the new versus the old are less widely appreciated. Endotoxin as an ancient, dynamic interface between lifeforms, provides a singular perspective from which to view the parallel development of ancient and modern organisms as well as the progress of man in deciphering the complexity of their interactions in his efforts to overcome disease.

Biocontamination Control for Pharmaceuticals and Healthcare

Biocontamination Control for Pharmaceuticals and Healthcare
A Book

by Tim Sandle

  • Publisher : Academic Press
  • Release : 2018-11-30
  • Pages : 374
  • ISBN : 0128149124
  • Language : En, Es, Fr & De
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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

Good Design Practices for GMP Pharmaceutical Facilities, Second Edition

Good Design Practices for GMP Pharmaceutical Facilities, Second Edition
A Book

by Terry Jacobs,Andrew A. Signore

  • Publisher : CRC Press
  • Release : 2016-08-18
  • Pages : 536
  • ISBN : 1315355027
  • Language : En, Es, Fr & De
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This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.

Parenteral Medications, Fourth Edition

Parenteral Medications, Fourth Edition
A Book

by Sandeep Nema,John D. Ludwig

  • Publisher : CRC Press
  • Release : 2019-07-19
  • Pages : 1125
  • ISBN : 0429576838
  • Language : En, Es, Fr & De
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Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacturing of parenteral dosage forms, effectively balancing theoretical considerations with practical aspects of their development. Previously published as a three-volume set, all volumes have been combined into one comprehensive publication that addresses the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. Key Features: Provides a comprehensive reference work on the formulation and manufacturing of parenteral dosage forms Addresses changes in the science and advances in the technology associated with parenteral medications and routes of administration Includes 13 new chapters and updated chapters throughout Contains the contributors of leading researchers in the field of parenteral medications Uses full color detailed illustrations, enhancing the learning process The fourth edition not only reflects enhanced content in all the chapters but also highlights the rapidly advancing formulation, processing, manufacturing parenteral technology including advanced delivery and cell therapies. The book is divided into seven sectionss: Section 1 - Parenteral Drug Administration and Delivery Devices; Section 2 - Formulation Design and Development; Section 3 - Specialized Drug Delivery Systems; Section 4 - Primary Packaging and Container Closure Integrity; Section 5 - Facility Design and Environmental Control; Section 6 - Sterilization and Pharmaceutical Processing; Section 7 - Quality Testing and Regulatory Requirements

Pharmaceutical Water Systems and the 6D Rule

Pharmaceutical Water Systems and the 6D Rule
A Computational Fluid Dynamics Analysis

by Brian G. Corcoran

  • Publisher : Unknown Publisher
  • Release : 2003
  • Pages : 280
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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