pharmaceutical production facilities pharmaceutical science series

Download Book Pharmaceutical Production Facilities Pharmaceutical Science Series in PDF format. You can Read Online Pharmaceutical Production Facilities Pharmaceutical Science Series here in PDF, EPUB, Mobi or Docx formats.

Pharmaceutical Production Facilities

Author : Cole
ISBN : 0748404384
Genre : Medical
File Size : 78. 70 MB
Format : PDF
Download : 580
Read : 1169

Download Now


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.

Modern Applications Of Plant Biotechnology In Pharmaceutical Sciences

Author : Saurabh Bhatia
ISBN : 9780128024980
Genre : Science
File Size : 76. 30 MB
Format : PDF, ePub
Download : 231
Read : 1186

Download Now


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

Good Design Practices For Gmp Pharmaceutical Facilities

Author : Terry Jacobs
ISBN : 9780824754631
Genre : Medical
File Size : 70. 17 MB
Format : PDF, Kindle
Download : 385
Read : 222

Download Now


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.

Continuous Manufacturing Of Pharmaceuticals

Author : Peter Kleinebudde
ISBN : 9781119001355
Genre : Science
File Size : 54. 69 MB
Format : PDF
Download : 547
Read : 1292

Download Now


A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and raw material use; the accelerated introduction of new drugs; the use of smaller production facilities with lower building and capital costs; the ability to monitor drug quality on a continuous basis; and enhanced process reliability and flexibility. Continuous Manufacturing of Pharmaceuticals prepares professionals to take advantage of that exciting new approach to improving drug manufacturing efficiency. This book covers key aspects of the continuous manufacturing of pharmaceuticals. The first part provides an overview of key chemical engineering principles and the current regulatory environment. The second covers existing technologies for manufacturing both small-molecule-based products and protein/peptide products. The following section is devoted to process analytical tools for continuously operating manufacturing environments. The final two sections treat the integration of several individual parts of processing into fully operating continuous process systems and summarize state-of-art approaches for innovative new manufacturing principles. Brings together the essential know-how for anyone working in drug manufacturing, as well as chemical, food, and pharmaceutical scientists working on continuous processing Covers chemical engineering principles, regulatory aspects, primary and secondary manufacturing, process analytical technology and quality-by-design Contains contributions from researchers in leading pharmaceutical companies, the FDA, and academic institutions Offers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products Timely, comprehensive, and authoritative, Continuous Manufacturing of Pharmaceuticals is an important professional resource for researchers in industry and academe working in the fields of pharmaceuticals development and manufacturing.

Quality

Author : Kate McCormick
ISBN : 075065113X
Genre : Business & Economics
File Size : 21. 69 MB
Format : PDF, Kindle
Download : 736
Read : 416

Download Now


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

How To Validate A Pharmaceutical Process

Author : Steven Ostrove
ISBN : 9780128096536
Genre : Medical
File Size : 28. 53 MB
Format : PDF, Kindle
Download : 558
Read : 246

Download Now


How to Validate a Pharmaceutical Process provides a “how to approach to developing and implementing a sustainable pharmaceutical process validation program. The latest volume in the Expertise in Pharmaceutical Process Technology Series, this book illustrates the methods and reasoning behind processes and protocols. It also addresses practical problems and offers solutions to qualify and validate a pharmaceutical process. Understanding the “why is critical to a successful and defensible process validation, making this book an essential research companion for all practitioners engaged in pharmaceutical process validation. Thoroughly referenced and based on the latest research and literature Illustrates the most common issues related to developing and implementing a sustainable process validation program and provides examples on how to be successful Covers important topics such as the lifecycle approach, quality by design, risk assessment, critical process parameters, US and international regulatory guidelines, and more

Chemical Engineering In The Pharmaceutical Industry

Author : David J. am Ende
ISBN : 9781118088104
Genre : Technology & Engineering
File Size : 62. 73 MB
Format : PDF, ePub
Download : 697
Read : 930

Download Now


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.

Pharmaceutical Manufacturing Handbook

Author : Shayne Cox Gad
ISBN : 0470259809
Genre : Science
File Size : 51. 17 MB
Format : PDF, ePub, Docs
Download : 393
Read : 557

Download Now


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.

Pharmaceutical Production

Author : Bill Bennett
ISBN : 0852954409
Genre : Technology & Engineering
File Size : 85. 16 MB
Format : PDF, ePub, Docs
Download : 982
Read : 625

Download Now


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.

Sterility Sterilisation And Sterility Assurance For Pharmaceuticals

Author : Tim Sandle
ISBN : 9781908818638
Genre : Medical
File Size : 25. 64 MB
Format : PDF, Docs
Download : 845
Read : 824

Download Now


Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. The book outlines and discusses sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging, as well as addressing the cleanroom environments in which products are prepared. Consisting of 18 chapters, the book comprehensively covers sterility, sterilisation and microorganisms; pyrogenicity and bacterial endotoxins; regulatory requirements and good manufacturing practices; and gamma radiation. Later chapters discuss e-beam; dry heat sterilisation; steam sterilisation; sterilisation by gas; vapour sterilisation; and sterile filtration, before final chapters analyse depyrogenation; cleanrooms; aseptic processing; media simulation; biological indicators; sterility testing; auditing; and new sterilisation techniques. Covers the main sterilisation methods of physical removal, physical alteration and inactivation Includes discussion of medical devices, aseptically filled products and terminally sterilised products Describes bacterial, pyrogenic, and endotoxin risks to devices and products

Top Download:

Best Books