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Principles Of Parenteral Solution Validation

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Principles of Parenteral Solution Validation

Principles of Parenteral Solution Validation Book
Author : Igor Gorsky,Harold S. Baseman
Publisher : Academic Press
Release : 2019-04-15
ISBN : 0128094125
Language : En, Es, Fr & De

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Book Description :

Principles of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects involved in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, and regulatory considerations and trends, from process design, to divesting. As part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin, this book incorporates numerous case studies and real-world examples that address timely problems and offer solutions to the daily challenges facing practitioners in this area. Discusses international and domestic regulatory considerations in every section Features callout boxes that contain points-of-interest for each segment of the audience so readers can quickly find their interests and needs Contains important topics, including risk management, the preparation and execution of properly designed studies, scale-up and technology transfer activities, problem-solving, and more

Principles of Parenteral Solution Validation

Principles of Parenteral Solution Validation Book
Author : Igor Gorsky,Harold S. Baseman
Publisher : Academic Press
Release : 2019-11-27
ISBN : 012809446X
Language : En, Es, Fr & De

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Book Description :

Principles of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects involved in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, and regulatory considerations and trends, from process design, to divesting. As part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin, this book incorporates numerous case studies and real-world examples that address timely problems and offer solutions to the daily challenges facing practitioners in this area. Discusses international and domestic regulatory considerations in every section Features callout boxes that contain points-of-interest for each segment of the audience so readers can quickly find their interests and needs Contains important topics, including risk management, the preparation and execution of properly designed studies, scale-up and technology transfer activities, problem-solving, and more

Guideline on General Principles of Process Validation

Guideline on General Principles of Process Validation Book
Author : Anonim
Publisher : Unknown
Release : 1987
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Guideline on General Principles of Process Validation book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

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

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

Parenteral Medications Fourth Edition

Parenteral Medications  Fourth Edition Book
Author : Sandeep Nema,John D. Ludwig
Publisher : CRC Press
Release : 2019-08-08
ISBN : 042957472X
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

Russell Hugo and Ayliffe s Principles and Practice of Disinfection Preservation and Sterilization

Russell  Hugo and Ayliffe s Principles and Practice of Disinfection  Preservation and Sterilization Book
Author : Adam P. Fraise,Jean-Yves Maillard,Syed Sattar
Publisher : John Wiley & Sons
Release : 2013-02-18
ISBN : 1444333259
Language : En, Es, Fr & De

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Book Description :

The new edition of this established and highly respected text is THE definitive reference in its field. It details methods for the elimination or prevention/control of microbial growth, and features: New chapters on bioterrorism and community healthcare New chapters on microbicide regulations in the EU, USA and Canada Latest material on microbial resistance to microbicides Updated material on new and emerging technologies, focusing on special problems in hospitals, dentistry and pharmaceutical practice Practical advice on problems of disinfection and antiseptics in healthcare A systematic review of sterilization methods, with uses and advantages outlined for each Evaluation of disinfectants and their mechanisms of action with respect to current regulations The differences between European and North American regulations are highlighted throughout, making this a truly global work, ideal for worldwide healthcare professionals working in infectious diseases and infection control.

Sterile Product Development

Sterile Product Development Book
Author : Parag Kolhe,Mrinal Shah,Nitin Rathore
Publisher : Springer Science & Business Media
Release : 2013-10-12
ISBN : 1461479789
Language : En, Es, Fr & De

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Book Description :

This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book: • Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines • Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures • Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers This book is a useful resource to scientists and researchers in both industry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development.

Principles of Fermentation Technology

Principles of Fermentation Technology Book
Author : Peter F Stanbury,Allan Whitaker,Stephen J Hall
Publisher : Butterworth-Heinemann
Release : 2016-08-31
ISBN : 0444634088
Language : En, Es, Fr & De

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Book Description :

The successful structure of the previous edition of Principles of Fermentation Technology has been retained in this third edition, which covers the key component parts of a fermentation process including growth kinetics, strain isolation and improvement, inocula development, fermentation media, fermenter design and operation, product recovery, and the environmental impact of processes. This accurate and accessible third edition recognizes the increased importance of animal cell culture, the impact of the post-genomics era on applied science and the huge contribution that heterologous protein production now makes to the success of the pharmaceutical industry. This title is ideally suited for both newcomers to the industry and established workers as it provides essential and fundamental information on fermentation in a methodical, logical fashion. Stanbury, Whitaker and Hall have integrated the biological and engineering aspects of fermentation to make the content accessible to members of both disciplines with a focus on the practical application of theory. This text collates all the fermentation fundamentals into one concise reference, making it a valuable resource for fermentation scientists, as well as those studying in the field. Retains its successful structure and covers all components of the fermentation process Integrates the biological and engineering aspects of fermentation to discuss the most recent developments and advancements in the field Written in a style accessible to readers from either a biological or engineering background with each chapter supported by an extensive bibliography

Disinfection and Decontamination

Disinfection and Decontamination Book
Author : Jeanne Moldenhauer
Publisher : CRC Press
Release : 2018-11-20
ISBN : 1351217003
Language : En, Es, Fr & De

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Book Description :

This book describes various methods of decontamination and how the methods work. There is a discussion of the various cleaning and disinfection methods utilized, along with details of how to qualify these methods. It also describes new technologies that may be useful in the battle for decontamination across industries. Finally, this book provides a single resource on how one can address contamination issues for a variety of manufacturing processes and industries.

Pharmaceutical Process Validation Second Edition

Pharmaceutical Process Validation  Second Edition Book
Author : Ira R. Berry,Robert A. Nash
Publisher : CRC Press
Release : 1993-01-29
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Updated to reflect current good manufacturing practice (CGMP) regulations, this text discusses current concepts in validation. New topics covered include: validation of cleaning systems and computer systems; equipment and water systems validation; and lyophilized and aerosol product validation.

Principles of Sterile Product Preparation

Principles of Sterile Product Preparation Book
Author : E. Clyde Buchanan
Publisher : Amer Soc of Health System
Release : 1995
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Principles of Sterile Product Preparation book written by E. Clyde Buchanan, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Process Validation in Manufacturing of Biopharmaceuticals

Process Validation in Manufacturing of Biopharmaceuticals Book
Author : Anurag S. Rathore,Gail Sofer
Publisher : CRC Press
Release : 2012-05-09
ISBN : 1439850941
Language : En, Es, Fr & De

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Book Description :

Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued in

Pharmaceutical Process Validation

Pharmaceutical Process Validation Book
Author : Bernard T. Loftus,Robert A. Nash
Publisher : Marcel Dekker Incorporated
Release : 1984
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Pharmaceutical Process Validation book written by Bernard T. Loftus,Robert A. Nash, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Cumulated Index Medicus

Cumulated Index Medicus Book
Author : Anonim
Publisher : Unknown
Release : 1969
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Cumulated Index Medicus book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Pharmaceutical Dosage Forms

Pharmaceutical Dosage Forms Book
Author : Kenneth E. Avis
Publisher : Routledge
Release : 2018-05-04
ISBN : 135142517X
Language : En, Es, Fr & De

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Book Description :

Completely updated and enlarged to three volumes (originally published as two volumes), the Second Edition of Pharmaceutical Dosage Forms: Parenteral Medications examines every important aspect of sterile drug products. This volume (3) offers comprehensive coverage of medical devices, quality assurance and regulatory issues.;This in-depth reference and text: discusses regulatory requirements in record-keeping based on the US Food and Drug Administration's (FDA) Current Good Manufacturing Practices; places special emphasis on methods of detecting, counting and sizing particles; offers new perspectives on contemporary validation concepts and how they affect the validation process; explains current FDA enforcement activities, the voluntary compliance policy, select court cases, and how these relate to parenterals; provides recent materials on the use of audits as a means of verifying the efficacy of manufacturing control systems; highlights new US regulations for medical devices; and examines quality assurance, including new information on biological control tests for medical device materials.;With the contributions of leading experts, volume 3 of Pharmaceutical Dosage Forms: Parenteral Medications is intended as a day-to-day reference for pharmacists, medical device manufacturers, quality control and regulatory personnel, chemists and drug patent and litigation attorneys, as well as a text for upper-level undergraduate, graduate and continuing-education students in the pharmaceutical sciences.

Separations Technology

Separations Technology Book
Author : Wayne P. Olson
Publisher : CRC Press
Release : 2020-02-03
ISBN : 1000725049
Language : En, Es, Fr & De

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Book Description :

Authored by a team of respected scientists and technologists, this book covers many pharmaceutical and biotechnology separations methods currently in use. Practical applications and descriptions are offered for air elutriation, microporous filtration, ultrafiltration, phase partitioning, crystallization, and chromatographic technologies such as adsorption, affinity, chelate, ion-exchange, size-exclusion, template, hydrophobic interaction, biotransformations, and chiral separations. Containing hundreds of references and a complete index, this book is designed for research and development scientists, process optimization engineers, and quality control laboratory scientists as well as quality assurance professionals and others needing to understand current separation techniques.

Pharmaceutical Manufacturing Handbook

Pharmaceutical Manufacturing Handbook Book
Author : Shayne Cox Gad
Publisher : John Wiley & Sons
Release : 2008-03-21
ISBN : 0470259809
Language : En, Es, Fr & De

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Book Description :

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.

Cleanroom Microbiology for the Non Microbiologist

Cleanroom Microbiology for the Non Microbiologist Book
Author : David M. Carlberg
Publisher : CRC Press
Release : 1995-04-30
ISBN : 9780935184730
Language : En, Es, Fr & De

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Book Description :

Written for the professional who has an immediate need for the information but has little or no training in the subject, Cleanroom Microbiology for the Non-Microbiologist introduces principles of microbiology. It explains the consequences of microbiological contamination, what contamination is all about, how microorganisms grow, and how they can be controlled. The book introduces the vocabulary of microbiology and the types, sources, control, and elimination of organisms encountered in the manufacture of sterile products. Beginning with a discussion of the various types of organisms, the text then covers applications for bacterial detection, avoidance of contamination, cleanroom design considerations, and validation of disinfection methods. This book is especially relevant for supervisors and managers who need a sound understanding of contamination control and is particularly effective for use in training. It also is an excellent resource for validation engineers, quality assurance and non-microbiologist quality-control staff, maintenance personnel, and process development staff.

Development and Manufacture of Protein Pharmaceuticals

Development and Manufacture of Protein Pharmaceuticals Book
Author : Steve L. Nail,Michael J. Akers
Publisher : Springer Science & Business Media
Release : 2012-12-06
ISBN : 1461505496
Language : En, Es, Fr & De

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Book Description :

In this era of biotechnology there have been many books covering the fundamentals of recombinant DNA technology and protein chemistry. However, not many sources are available for the pharmaceutical develop ment scientist and other personnel responsible for the commercialization of the finished dosage forms of these new biopharmaceuticals and other products from biotechnology. This text will help to fill this gap. Once active biopharmaceutical molecules are candidates for clinical trial investigation and subsequent commercialization, a number of other activities must take place while research and development on these molecules continues. The active ingredient itself must be formulated into a finished dosage form that can be conveniently used by health care professionals and patients. Properties of the biopharmaceutical molecule must be clearly understood so that the appropriate finished product formulation can be developed. Finished product formulation development includes not only the chemical formulation, but also the packaging system, the manufacturing process, and appropriate control strategies to assure such good manufacturing practice attributes as safety, identity, strength, purity, and quality.