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Pharmaceutical Water Systems

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Pharmaceutical Water

Pharmaceutical Water Book
Author : William V. Collentro
Publisher : CRC Press
Release : 2010-12-21
ISBN : 9781420077827
Language : En, Es, Fr & De

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Book Description :

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 water purification systems, the text’s numerous case studies illuminate the best and worst of water system design and operation. The expanded Second Edition also includes new chapters that discuss: passivation and electropolishing rouging ozone systems and accessories USP purified water and water for injection individual component process and instrumentation diagram (P&IDs) with control interface documentation and specification requirements systems installation, start-up, and commissioning

Pharmaceutical Water

Pharmaceutical Water Book
Author : William V. Collentro
Publisher : CRC Press
Release : 2016-04-19
ISBN : 142007783X
Language : En, Es, Fr & De

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Book Description :

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

Validation of Pharmaceutical Processes

Validation of Pharmaceutical Processes Book
Author : James P. Agalloco,Frederick J. Carleton
Publisher : CRC Press
Release : 2007-09-25
ISBN : 1420019791
Language : En, Es, Fr & De

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Book Description :

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 Book
Author : Shayne Cox Gad
Publisher : John Wiley & Sons
Release : 2008-04-04
ISBN : 9780470259825
Language : En, Es, Fr & De

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Book Description :

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.

Quality Assurance of Pharmaceuticals

Quality Assurance of Pharmaceuticals Book
Author : World Health Organization
Publisher : World Health Organization
Release : 2007
ISBN : 9241547081
Language : En, Es, Fr & De

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Book Description :

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.

Encyclopedia of Pharmaceutical Technology

Encyclopedia of Pharmaceutical Technology Book
Author : James Swarbrick
Publisher : CRC Press
Release : 2013-07-01
ISBN : 1439808236
Language : En, Es, Fr & De

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Book Description :

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

Handbook of Validation in Pharmaceutical Processes Fourth Edition

Handbook of Validation in Pharmaceutical Processes  Fourth Edition Book
Author : James Agalloco,Phil DeSantis,Anthony Grilli,Anthony Pavell
Publisher : CRC Press
Release : 2021-10-28
ISBN : 1000436012
Language : En, Es, Fr & De

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Book Description :

Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals. Key Features: Provides an in-depth discussion of recent advances in sterilization Identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions Explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture

Practical Pharmaceutical Engineering

Practical Pharmaceutical Engineering Book
Author : Gary Prager
Publisher : John Wiley & Sons
Release : 2018-11-28
ISBN : 1119418844
Language : En, Es, Fr & De

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Book Description :

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.

Pharmaceutical Dosage Forms

Pharmaceutical Dosage Forms Book
Author : Sandeep Nema,John D. Ludwig
Publisher : CRC Press
Release : 2010-08-26
ISBN : 1482281783
Language : En, Es, Fr & De

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Book Description :

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

Endotoxin Detection and Control in Pharma Limulus and Mammalian Systems

Endotoxin Detection and Control in Pharma  Limulus  and Mammalian Systems Book
Author : Kevin L. Williams
Publisher : Springer
Release : 2019-07-24
ISBN : 3030171485
Language : En, Es, Fr & De

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Book Description :

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.

Pharmaceutical Microbiology

Pharmaceutical Microbiology Book
Author : Tim Sandle
Publisher : Woodhead Publishing
Release : 2015-10-09
ISBN : 0081000448
Language : En, Es, Fr & De

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Book Description :

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 Dosage Forms Parenteral Medications

Pharmaceutical Dosage Forms   Parenteral Medications Book
Author : Sandeep Nema,John D. Ludwig
Publisher : CRC Press
Release : 2016-04-19
ISBN : 1420086464
Language : En, Es, Fr & De

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Book Description :

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.

Biocontamination Control for Pharmaceuticals and Healthcare

Biocontamination Control for Pharmaceuticals and Healthcare Book
Author : Tim Sandle
Publisher : Academic Press
Release : 2018-11-30
ISBN : 0128149124
Language : En, Es, Fr & De

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Book Description :

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

Parenteral Medications Fourth Edition

Parenteral Medications  Fourth Edition Book
Author : Sandeep Nema,John D. Ludwig
Publisher : CRC Press
Release : 2019-07-19
ISBN : 0429576838
Language : En, Es, Fr & De

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Book Description :

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

WHO Expert Committee on Specifications for Pharmaceutical Preparations

WHO Expert Committee on Specifications for Pharmaceutical Preparations Book
Author : WHO Expert Committee on Specifications for Pharmaceutical Preparations,World Health Organization
Publisher : World Health Organization
Release : 2005-11-11
ISBN : 9241209291
Language : En, Es, Fr & De

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Book Description :

This report discusses the monographs on antiretrovirals proposed for inclusion in The International Pharmacopoeia and specifications for radiopharmaceuticals, quality specifications for antituberculosis drugs and the revision of the monograph on artemisinin derivatives, as well as quality control of reference materials, good manufacturing practices, inspection, distribution and trade, and other aspects of quality assurance of pharmaceuticals, and regulatory issues. Several annexes include an amendment togood manufacturing practices: main principles regarding the requirement for the sampling of starting materials, guidelines on good manufacturing practices regarding water for pharmaceutical use, guidelines on the sampling of pharmaceutical products, and draft guidelines for registration of fixed-dose combination medicinal products.

Good Design Practices for GMP Pharmaceutical Facilities

Good Design Practices for GMP Pharmaceutical Facilities Book
Author : Terry Jacobs,Andrew A. Signore
Publisher : CRC Press
Release : 2016-08-19
ISBN : 1315355027
Language : En, Es, Fr & De

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Book Description :

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.

Microbial Limit and Bioburden Tests

Microbial Limit and Bioburden Tests Book
Author : Lucia Clontz
Publisher : CRC Press
Release : 2008-10-14
ISBN : 9781420053494
Language : En, Es, Fr & De

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Book Description :

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 changes. Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements guides readers through the various microbiological methods listed in the compendia with easy-to-follow diagrams and approaches to validations of such test methodologies. Includes New and Updated Material Now in its second edition, this work is the culmination of research and discussions with technical experts, as well as USP and FDA representatives on various topics of interest to the pharmaceutical microbiologist and those responsible for the microbial quality of products, materials, equipment, and manufacturing facilities. New in this edition is an entire chapter dedicated to the topic of biofilms and their impact on pharmaceutical and biopharmaceutical operations. The subject of rapid methods in microbiology has been expanded and includes a discussion on the validation of alternative microbiological methods and a case study on microbial identification in support of a product contamination investigation. Substantially updated and revised, this book assists readers in understanding the fundamental issues associated with pharmaceutical microbiology and provides them with tools to create effective microbial contamination control and microbial testing programs for the areas under their responsibility.

Handbook of Pharmaceutical Manufacturing Formulations

Handbook of Pharmaceutical Manufacturing Formulations Book
Author : Safaraz K. Niazi
Publisher : CRC Press
Release : 2016-04-19
ISBN : 1420081314
Language : En, Es, Fr & De

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Book Description :

No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing ster

Practical Pharmaceutics

Practical Pharmaceutics Book
Author : Yvonne Bouwman-Boer,V'Iain Fenton-May,Paul Le Brun
Publisher : Springer
Release : 2015-08-24
ISBN : 3319158147
Language : En, Es, Fr & De

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Book Description :

This book contains essential knowledge on the preparation, control, logistics, dispensing and use of medicines. It features chapters written by experienced pharmacists working in hospitals and academia throughout Europe, complete with practical examples as well as information on current EU-legislation. From prescription to production, from usage instructions to procurement and the impact of medicines on the environment, the book provides step-by-step coverage that will help a wide range of readers. It offers product knowledge for all pharmacists working directly with patients and it will enable them to make the appropriate medicine available, to store medicines properly, to adapt medicines if necessary and to dispense medicines with the appropriate information to inform patients and caregivers about product care and how to maintain their quality. This basic knowledge will also be of help to industrial pharmacists to remind and focus them on the application of the medicines manufactured. The basic and practical knowledge on the design, preparation and quality management of medicines can directly be applied by the pharmacists whose main duty is production in community and hospital pharmacies and industries. Undergraduate as well as graduate pharmacy students will find knowledge and backgrounds in a fully coherent way and fully supported with examples.

Handbook of Pharmaceutical Manufacturing Formulations Third Edition

Handbook of Pharmaceutical Manufacturing Formulations  Third Edition Book
Author : Sarfaraz K. Niazi
Publisher : CRC Press
Release : 2019-12-09
ISBN : 1351592238
Language : En, Es, Fr & De

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Book Description :

The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Six, Sterile Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this sixth volume of a six-volume set, compiles data from FDA and EMA new drug applications, patents and patent applications, and other sources of generic and proprietary formulations including author’s own experience, to cover the broad spectrum of cGMP formulations and issues in using these formulations in a commercial setting. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent. Features:  Largest source of authoritative and practical formulations, cGMP compliance guidance and self-audit suggestions  Differs from other publications on formulation science in that it focuses on readily scalable commercial formulations that can be adopted for cGMP manufacturing  Tackles common difficulties in formulating drugs and presents details on stability testing, bioequivalence testing, and full compliance with drug product safety elements  Written by a well-recognized authority on drug and dosage form development including biological drugs and alternative medicines