pharmaceutical production facilities pharmaceutical science series

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Pharmaceutical Production Facilities

Author : Cole
ISBN : 0748404384
Genre : Medical
File Size : 69. 69 MB
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Pharmaceutical Production Facilities: Design and Applications considers the concepts and constraints that have to be considered in the design of small, medium and large scale production plants. The layout, along with the flow of materials and personnel through facilities are considered with reference to ensuring compliance with current good manufacturing practice. The book explains how clean rooms have developed, and how recent regulations affect their design. The latest concepts for reducing contamination levels from the operator and the product are discussed. It assess current changes in standards and quality control and makes suggestions for the "ideal production environment" to enable standards to be validated to current standards.

Good Design Practices For Gmp Pharmaceutical Facilities

Author : Terry Jacobs
ISBN : 9780849398537
Genre : Medical
File Size : 27. 63 MB
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A convenient single-source reference for anyone involved in the planning, construction, validation, and maintenance of modern pharmaceutical facilities, this guide assists project managers as they develop, diagram, and implement pharmaceutical production facility projects-demonstrating how advances in technology and external regulation can impact the production and efficacy of a pharmaceutical facility and the products it produces.

Good Design Practices For Gmp Pharmaceutical Facilities Second Edition

Author : Terry Jacobs
ISBN : 9781482258912
Genre : Medical
File Size : 64. 82 MB
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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.

Modern Applications Of Plant Biotechnology In Pharmaceutical Sciences

Author : Saurabh Bhatia
ISBN : 9780128024980
Genre : Science
File Size : 54. 59 MB
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Modern Applications of Plant Biotechnology in Pharmaceutical Sciences explores advanced techniques in plant biotechnology, their applications to pharmaceutical sciences, and how these methods can lead to more effective, safe, and affordable drugs. The book covers modern approaches in a practical, step-by-step manner, and includes illustrations, examples, and case studies to enhance understanding. Key topics include plant-made pharmaceuticals, classical and non-classical techniques for secondary metabolite production in plant cell culture and their relevance to pharmaceutical science, edible vaccines, novel delivery systems for plant-based products, international industry regulatory guidelines, and more. Readers will find the book to be a comprehensive and valuable resource for the study of modern plant biotechnology approaches and their pharmaceutical applications. Builds upon the basic concepts of cell and plant tissue culture and recombinant DNA technology to better illustrate the modern and potential applications of plant biotechnology to the pharmaceutical sciences Provides detailed yet practical coverage of complex techniques, such as micropropogation, gene transfer, and biosynthesis Examines critical issues of international importance and offers real-life examples and potential solutions

Pharmaceutical Manufacturing Handbook

Author : Shayne Cox Gad
ISBN : 0470259809
Genre : Science
File Size : 60. 17 MB
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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.

Continuous Manufacturing Of Pharmaceuticals

Author : Peter Kleinebudde
ISBN : 9781119001324
Genre : Science
File Size : 63. 81 MB
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10.7.3 State of Control

Chemical Engineering In The Pharmaceutical Industry

Author : David J. am Ende
ISBN : 9781118088104
Genre : Technology & Engineering
File Size : 28. 95 MB
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This book deals with various unique elements in the drug development process within chemical engineering science and pharmaceutical R&D. The book is intended to be used as a professional reference and potentially as a text book reference in pharmaceutical engineering and pharmaceutical sciences. Many of the experimental methods related to pharmaceutical process development are learned on the job. This book is intended to provide many of those important concepts that R&D Engineers and manufacturing Engineers should know and be familiar if they are going to be successful in the Pharmaceutical Industry. These include basic analytics for quantitation of reaction components– often skipped in ChE Reaction Engineering and kinetics books. In addition Chemical Engineering in the Pharmaceutical Industry introduces contemporary methods of data analysis for kinetic modeling and extends these concepts into Quality by Design strategies for regulatory filings. For the current professionals, in-silico process modeling tools that streamline experimental screening approaches is also new and presented here. Continuous flow processing, although mainstream for ChE, is unique in this context given the range of scales and the complex economics associated with transforming existing batch-plant capacity. The book will be split into four distinct yet related parts. These parts will address the fundamentals of analytical techniques for engineers, thermodynamic modeling, and finally provides an appendix with common engineering tools and examples of their applications.

Advanced Aseptic Processing Technology

Author : James Agalloco
ISBN : 9781439825440
Genre : Medical
File Size : 80. 25 MB
Format : PDF
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The preparation of sterile products using aseptic processing is considered perhaps the most critical process in the pharmaceutical industry and has witnessed continual improvement over the last half century. New approaches that have transformed classical aseptic production methods are appearing almost daily. This book reviews emerging technologies for aseptic processing that will markedly reduce the level of contamination risk for sterile products and includes coverage on: The use of isolator and barrier concepts for aseptic processing and assembly. The application of robotics as an alternative to gowned personnel. The increasing reliance on automation to minimize or eliminate operator intervention. The design, operational, monitoring and compliance changes necessary for success with advanced aseptic processing. Advanced Aseptic Processing Technology is an essential reference for anyone working with sterile products, and is recommended for individuals in manufacturing,, compliance, regulatory affairs, microbiology, environmental monitoring, sterility testing, sterilization, validation, engineering, development, facility and equipment design, component and equipment suppliers, automation, and robotics.

Quality

Author : Kate McCormick
ISBN : 075065113X
Genre : Business & Economics
File Size : 31. 3 MB
Format : PDF, Docs
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The Pharmaceutical Engineering Series is a comprehensive reference for the pharmaceutical professional covering all aspects from quality, documentation and validation through manufacturing processes to facility design and management. In 'Quality', Dr Kate McCormick provides the reader with comprehensive coverage of this vital subject, including the quality life cycle, management and cost of quality, GMP, auditing and inspections. This book with the others in the series will become a unique source of reference and educational material for the readership. Case studies and examples make the book of direct practical relevance to the professional in the pharmaceutical industry Find the answers you are looking for quickly and easily with clear indexing and referencing Reference to international standards and practice mean this book will be useful wherever you are working

Pharmaceutical Production

Author : Bill Bennett
ISBN : 0852954409
Genre : Technology & Engineering
File Size : 23. 24 MB
Format : PDF
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Most of the significant developments of medicines have occurred in the last 70 years, and by a process of trial and error many plants and other substances have been used by man to produce certain pharmalogical effects.

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