Cleanrooms and Associated Controlled Environments. Classification of Air Cleanliness by Chemical Concentration (ACC) PDF Download
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Author: Mark Allen Durivage Publisher: Quality Press ISBN: 1951058909 Category : Technology & Engineering Languages : en Pages : 404
Book Description
The purpose of this handbook is to assist individuals for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and provide a reference for the practitioner. The second edition reflects the Body of Knowledge which was updated in 2015. This edition has also incorporated additional information including updated references. The updates reflect the current trends and expectations of the evolving pharmaceutical industry driven by consumer expectations and regulatory oversight. This handbook covers compliance with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, and combination devices, as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients), and packaging and labeling operations.
Author: James T. Walker Publisher: Woodhead Publishing ISBN: 0081025661 Category : Technology & Engineering Languages : en Pages : 594
Book Description
Decontamination in Hospitals and Healthcare, Second Edition, enables users to obtain detailed knowledge of decontamination practices in healthcare settings, including surfaces, devices, clothing and people, with a specific focus on hospitals and dental clinics. - Offers in-depth coverage of all aspects of decontamination in healthcare - Examines the decontamination of surgical equipment and endoscopes - Expanded to include new information on behavioral principles in decontamination, control of microbiological problems, waterborne microorganisms, pseudomonas and the decontamination of laundry
Author: Mark Allen Durivage Publisher: Quality Press ISBN: 1636941516 Category : Technology & Engineering Languages : en Pages : 421
Book Description
The ASQ Certified Pharmaceutical GMP Professional Handbook assists candidates preparing for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and serves as a handy reference guide for practitioners in the field. This handbook covers compliance with good manufacturing practices (GMPs) as regulated and guided by national and international agencies for the pharmaceutical industry.
Author: Kathleen E. McCormick Publisher: Butterworth-Heinemann ISBN: 0323994601 Category : Technology & Engineering Languages : en Pages : 385
Book Description
Quality, second edition, provides comprehensive application of regulatory guidelines and quality concepts and methodologies related to pharmaceutical manufacturing. It is an excellent resource for practitioners, those pursuing pharmaceutical related certifications, and for students trying to learn more about pharmaceutical manufacturing. This book provides the background theory, applied descriptions of the guidelines and concepts, plus questions and problems at the end of the chapters that will help provide practice for the reader to apply the concepts. In this book the authors share their combined 60+ years of extensive practical experience in the industry and in process improvement combined with detailed understanding of the needs of the industry and education system. This book provides real-life examples from industry and guidelines for practical application of tools that can be referenced by operators, engineers, and management.This book is fully revised, updated, and expanded with new content in areas such as QbD, Lean, Six Sigma, basic data analysis, and CAPA tools. - Fully revised, updated, and expanded new edition - Features new topics such as QbD, Lean, Six Sigma, basic data analysis, and CAPA tools - Includes end-of-chapter summaries and end-of-chapter question and/or problems - Provides detailed steps and examples for applying the guidelines and quality tools - Written in an accessible style making the content easy to understand and apply
Author: Zhonglin Xu Publisher: Springer Science & Business Media ISBN: 3642393748 Category : Technology & Engineering Languages : en Pages : 871
Book Description
Fundamentals of Air Cleaning Technology and Its Application in Cleanrooms sets up the theoretical framework for cleanrooms. New ideas and methods are presented, which include the characteristic index of cleanrooms, uniform and non-uniform distribution characteristics, the minimum sampling volume, a new concept of outdoor air conditioning and the fundamentals of leakage-preventing layers. Written by an author who can look back on major scientific achievements and 50 years of experience in this field, this book offers a concise and accessible introduction to the fundamentals of air cleaning technology and its application. The work is intended for researchers, college teachers, graduates, designers, technicians and corporate R&D personnel in the field of HVAC and air cleaning technology. Zhonglin Xu is a senior research fellow at China Academy of Building Research.
Author: Rommel Garcia Publisher: Xlibris Corporation ISBN: 1524589209 Category : Medical Languages : en Pages : 403
Book Description
This book is meant to be a guide to all who want to learn about a highly regulated industry. My approach is to give you, the reader, an example of a fictitious device, and we will take it from a conceptual idea all the way to launch and beyond. My intention is to incorporate the best experiences that I and other contributors have had into this book and convert them into laymans terms for those who are in need. These experiences can and will be indispensable to beginners and professionals alike who are trying their hand in the medical device industry and to those who have not been out of their silo to help see how each of the systems relate to each as a whole. However, it should be noted that the contents of this book should be taken only as information and is not intended to demonstrate how companies can be in compliance. In some instances, there are multiple ways to go through the maze of regulations that are documented and made by agencies because the regulations are pretty much made and designed to be flexible and high level so that companies can adopt their systems, which are solely designed for their purposes. Therefore, this book will try to avoid complicated words and complex technical details of engineering and statistics. This book will strive to be an embodiment of the honest-to-goodness, everyday experiences and issues that folks experience while working in the medical device industry.
Author: Robert B. Heimann Publisher: Walter de Gruyter GmbH & Co KG ISBN: 3110619245 Category : Science Languages : en Pages : 638
Book Description
This book gives an introduction to the highly interdisciplinary field of biomaterials. It concisely summarizes properties, synthesis and modification of materials such as metals, ceramics, polymers or composites. Characterization, in vitro and in vivo testing as well as a selection of various applications are also part of this inevitable guide.
Author: Rajiv Kohli Publisher: Elsevier ISBN: 0128155787 Category : Technology & Engineering Languages : en Pages : 832
Book Description
Developments in Surface Contamination and Cleaning: Applications of Cleaning Techniques, Volume Eleven, part of the Developments in Surface Contamination and Cleaning series, provides a guide to recent advances in the application of cleaning techniques for the removal of surface contamination in various industries, such as aerospace, automotive, biomedical, defense, energy, manufacturing, microelectronics, optics and xerography. The material in this new edition compiles cleaning applications into one easy reference that has been fully updated to incorporate new applications and techniques. Taken as a whole, the series forms a unique reference for professionals and academics working in the area of surface contamination and cleaning. - Presents the latest reviewed technical information on precision cleaning applications as written by established experts in the field - Provides a single source on the applications of innovative precision cleaning techniques for a wide variety of industries - Serves as a guide to the selection of precision cleaning techniques for specific applications
Author: Wayne J Rogers Publisher: Smithers Rapra ISBN: 1909030708 Category : Medical Languages : en Pages : 562
Book Description
The collection of topics in the second volume of this book challenges the reader to think beyond standard methods and question why certain current procedures remain static while technological advances abound in other aspects of sterilisation technology. By small means, better practices may come to pass to help answer some of the residual healthcare sterilisation and nosocomial infection queries: What are some of the current challenges in healthcare sterilisation, and how can they be handled? What are some of the acceptable current non-traditional sterilisation methods, challenging alternatives, and novel modalities? What are some of the packaging, validation and statistical considerations of sterilisation practices? How does design-of-product and packaging interrelate with sterilisation processing? Are the current sterility media and practices optimal for recovery of more modified and more resistant viable organism entities and product? Are there increased sterility and product quality needs with new types of implantables and technological advances within the three dimensional combinations of diagnostics, drug release and challenging medical devices?
Author: British Standards Institute Staff
Author: British Standards Institute Staff
Author: Mark Allen Durivage
Author: James T. Walker
Author: Mark Allen Durivage
Author: Kathleen E. McCormick
Author: Zhonglin Xu
Author: Rommel Garcia
Author: Robert B. Heimann
Author: Rajiv Kohli
Author: Wayne J Rogers