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Author : Russell Madsen
Publisher :
ISBN 13 : 9781942911326
Total Pages : pages
Book Rating : 4.9/5 (113 download)
Download or read book Contamination Control in Healthcare Product Manufacturing written by Russell Madsen and published by . This book was released on 2018-08 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Thomas A. Barber
Publisher : CRC Press
ISBN 13 : 9781574910728
Total Pages : 620 pages
Book Rating : 4.9/5 (17 download)
Download or read book Control of Particulate Matter Contamination in Healthcare Manufacturing written by Thomas A. Barber and published by CRC Press. This book was released on 1999-10-31 with total page 620 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book offers practical applications addressing the specifics of contamination, including particle origination, characterization, identification, and elimination, with a special focus on quality considerations. Written by an industry expert, this material offers a clear and concise understanding of particle populations and their control in stability, efficacy, and predictability in the manufacture of healthcare products. Complete with a full-color insert of micrographs illustrating commonly encountered particulate matter and over eighty figures, tables, and charts. Features
Author : Kevin Williams
Publisher : CRC Press
ISBN 13 : 113553621X
Total Pages : 671 pages
Book Rating : 4.1/5 (355 download)
Download or read book Microbial Contamination Control in Parenteral Manufacturing written by Kevin Williams and published by CRC Press. This book was released on 2004-05-20 with total page 671 pages. Available in PDF, EPUB and Kindle. Book excerpt: This reference surveys emerging trends, concepts, and procedures used in the characterization and control of contaminants; the sterile production of traditional drugs and biologics; the design, construction, and validation of new parenteral facilities; and the monitoring of clean environments-vividly illustrating the routes by which products, proce
Author : Tim Sandle
Publisher : Elsevier
ISBN 13 : 0443216010
Total Pages : 510 pages
Book Rating : 4.4/5 (432 download)
Download or read book Biocontamination Control for Pharmaceuticals and Healthcare written by Tim Sandle and published by Elsevier. This book was released on 2024-01-28 with total page 510 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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. The first edition of the book covered many of the aspects of the strategy, but the new official guidance signals that a roadmap is required to fully comply with its requirements. Completely updated with the newest version of the EU-GPM (EN17141) the new edition expands the coverage of quality risk management and new complete examples to help professionals bridge the gap between regulation and implementation. Biocontamination Control for Pharmaceuticals and Healthcare offers professionals in pharma quality control and related areas guidance on building a complete biocontamination strategy. - Includes the most current regulations - Contains three new chapters, including Application of Quality Risk Management and its Application in Biocontamination Control, Designing an Environmental Monitoring Programme, and Synthesis: An Anatomy of a Contamination Control Strategy - Offers practical guidance on building a complete biocontamination strategy
Author : Kevin Williams
Publisher : CRC Press
ISBN 13 : 9780824753207
Total Pages : 760 pages
Book Rating : 4.7/5 (532 download)
Download or read book Microbial Contamination Control in Parenteral Manufacturing written by Kevin Williams and published by CRC Press. This book was released on 2004-05-20 with total page 760 pages. Available in PDF, EPUB and Kindle. Book excerpt: This reference surveys emerging trends, concepts, and procedures used in the characterization and control of contaminants; the sterile production of traditional drugs and biologics; the design, construction, and validation of new parenteral facilities; and the monitoring of clean environments-vividly illustrating the routes by which products, processes, and manufacturing settings become contaminated through contact with the air, water, raw materials, and the actions of personnel, as well as the current methods necessary to successfully preclude contamination.
Author : Nigel Halls
Publisher : CRC Press
ISBN 13 : 1420025805
Total Pages : 198 pages
Book Rating : 4.4/5 (2 download)
Download or read book Microbiological Contamination Control in Pharmaceutical Clean Rooms written by Nigel Halls and published by CRC Press. This book was released on 2016-04-19 with total page 198 pages. Available in PDF, EPUB and Kindle. Book excerpt: Contamination control in pharmaceutical clean rooms has developed from a jumble of science and engineering, knowledge of what has worked well or badly in the past, dependent upon the technology available at the time the clean room was built and subsequent technological developments. Surrounding it all is a blanket of regulations. Taking a multidisc
Author : Luis Jimenez
Publisher : CRC Press
ISBN 13 : 9780367393946
Total Pages : 328 pages
Book Rating : 4.3/5 (939 download)
Download or read book Microbial Contamination Control in the Pharmaceutical Industry written by Luis Jimenez and published by CRC Press. This book was released on 2019-10-17 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: This authoritative reference presents an up-to-date review of the testing methods, emerging technologies, and analytical systems and procedures used to prevent the microbial contamination of pharmaceutical processes, products, and environments. It identifies new tools for sample analysis and evaluation and the impact of these advancements on the continuous supply and manufacturing of pharmaceutical products. With more than 100 tables and 430 current references, the book contains a detailed analysis of microbial contamination recalls for nonsterile and sterile pharmaceutical products, demonstrating the distribution of microorganisms worldwide and the identification by geographical regions.
Author : Matts Ramstorp
Publisher : John Wiley & Sons
ISBN 13 : 3527613137
Total Pages : 179 pages
Book Rating : 4.5/5 (276 download)
Download or read book Introduction to Contamination Control and Cleanroom Technology written by Matts Ramstorp and published by John Wiley & Sons. This book was released on 2008-07-11 with total page 179 pages. Available in PDF, EPUB and Kindle. Book excerpt: Contamination control is being used by more and more industries where the highest level of cleanliness and hygiene is of vital importance. This book covers the basic principles of contamination control and cleanroom technology from a holistic point of view. It deals with cleanliness and hygiene and their effects on the outcome of a process, reflecting the latest results from both scientific and practical points of view. The following topics are covered: contaminants and how they are measured cleanrooms and clean zones cleaning and decontamination cleanroom clothing the impact of people on cleanliness. Intended as an introduction to the area of contamination control, the text is also an excellent source of knowledge for people with both theoretical and practical experience. The Swedish version has been used for a long time within the Nordic countries as a basic training textbook within the pharmaceutical, microelectronics, food and beverage, optics and many other industries.
Author : Denise Bohrer
Publisher : John Wiley & Sons
ISBN 13 : 1118449053
Total Pages : 592 pages
Book Rating : 4.1/5 (184 download)
Download or read book Sources of Contamination in Medicinal Products and Medical Devices written by Denise Bohrer and published by John Wiley & Sons. This book was released on 2012-09-25 with total page 592 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first one-volume guide to sources of contamination in pharmaceuticals and medical devices Most books dealing with contaminants in medicinal products often focus on analytical methods for detecting nonspecific impurities. Key to the work of the pharmaceutical chemist, this unique reference helps identify the sources of contamination in medicinal and pharmaceutical products and medical devices. Divided into three parts, Sources of Contamination in Medicinal Products and Medical Devices covers chemical, microbiological, and physical (particulate matter) contamination, including those originating from sterilization procedures. As compelling as a medical documentary, the book sheds light on how impurities and contaminants can enter the human body transported via a specific product or treatment. Focusing on only those medicinal products and medical devices that may lead to exposure to contaminants harmful to human health, the book offers a comprehensive, systematic look at the entire universe of medical contamination: Chemical contaminants including residual solvents, catalyst residuals, and genotoxic impurities in active pharmaceutical ingredients (APIs) Diagnostic imaging agents (i.e., radiopharmaceuticals and contrast agents) Microbiological and endotoxin contamination involving single and multiple dose products, medical devices, and biofilms Contamination from sterilization procedures, residuals from radiation sterilization, ionizing radiation on packaging materials and medical devices Medicinal gases and volatile anesthetics Biopharmaceuticals including recombinant DNA technology products Extractables and leachables from containers made of glass, plastics, and metal Each section of the book contains information on what contaminants could be expected in a particular product, and how they were generated and reached that product. With up-to-date regulatory guidelines for determining contamination, as well as methods for assessing, quantifying, avoiding and removing contaminants, Sources of Contamination in Medicinal Products and Medical Devices is essential to fully understanding the specific threats that undermine the safety of medicines and medical devices.
Author : David Roesti
Publisher : John Wiley & Sons
ISBN 13 : 1119356075
Total Pages : 594 pages
Book Rating : 4.1/5 (193 download)
Download or read book Pharmaceutical Microbiological Quality Assurance and Control written by David Roesti and published by John Wiley & Sons. This book was released on 2020-01-02 with total page 594 pages. Available in PDF, EPUB and Kindle. Book excerpt: Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks
Download or read book Contamination Control in High-technology Manufacturing written by and published by . This book was released on 2009 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Matts Ramstorp
Publisher : Wiley-VCH
ISBN 13 :
Total Pages : 216 pages
Book Rating : 4.3/5 (91 download)
Download or read book Contamination Control in Practice written by Matts Ramstorp and published by Wiley-VCH. This book was released on 2003 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: Contamination control has received great interest and found increasing use within several industrial branches including microelectronics, pharmaceuticals, food and beverages using various concepts of contamination control in their production, purification or packaging process. The book supplies a holistic view of contamination control, presenting the different types of contaminants in a summarized form. The focus is on how to protect products and processes from external contamination and also on different ways to take care of and control contaminants generated in the process. The aim is to eliminate them from a product or a process flow (e.g. through filtration), or to render them harmless (e.g. through sterilisation by moist heat). Product purity or the cleanliness of process flows are often complex matters and hard to define in easily understood terms. This book covers a variety of different techniques used in order to achieve and maintain certain overall cleanliness levels for both microbiological or inanimate particle contaminants. It supplies basic knowledge including validation aspects for industrial branches working with increased demands of cleanliness, for instance water purification, steam, pressurized gases and different flows in a process together with finished products.
Author : Alvin Lieberman
Publisher : Springer Science & Business Media
ISBN 13 : 1468465120
Total Pages : 419 pages
Book Rating : 4.4/5 (684 download)
Download or read book Contamination Control and Cleanrooms written by Alvin Lieberman and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 419 pages. Available in PDF, EPUB and Kindle. Book excerpt: Contamination control standards and techniques for all phases of the production of high-technology products are spelled out in this applications-orientated guide. Practical cleaning methods for products and process fluids are accompanied by tips on selecting operations based on economy and efficiency. Explanations of contaminant measurement devices cover operation, error sources and remedial methods. Engineers will find vital data on contaminant sources, as well as coverage of operations and procedures that aggravate contaminant effects.
Author : J. Luciano
Publisher : Springer Science & Business Media
ISBN 13 : 1461341337
Total Pages : 485 pages
Book Rating : 4.4/5 (613 download)
Download or read book Air Contamination Control in Hospitals written by J. Luciano and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 485 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a well conceived and executed volume detailing in close to encyclopedic proportions the question of control of air borne contamination in hospital environments. Many different ap plication areas are described and well documented. Alternative solutions are presented in historical perspective with the neces sary scientific background to provide the uninitiated an oppor tunity to learn not only how to solve a particular problem but more critically why one solution is preferable to another. Every clinician concerned for his patients' welfare must consider the quality of the environment within the hospital--for only there is it potentially controllable Airborne dissemination of nosocomial infections are considered generally rare today. This may be the result of improved intrahospital environmental control or better infection control techniques. If one considers airborne contaminatiqn, real or potential, as undesirable within certain areas of a hospital then proper environmental control must be included in the framework of the physical and functional struc ture. Often it is difficult to specify which controls are needed for a specific application. Frequently this is a problem of in adequate knowledge of the application area and not the availability of technology. Too often, in the rush to provide a solution the newest and most sophisticated equipment is chosen, installed, and found to be more than is required for the task. To avoid these types of errors it is necessary to provide a series of alternative solutions for each problem.
Author : Samuel H Yalkowsky
Publisher :
ISBN 13 : 9781420055351
Total Pages : 320 pages
Book Rating : 4.0/5 (553 download)
Download or read book Active Pharmaceutical Ingredients, Second Edition written by Samuel H Yalkowsky and published by . This book was released on 2009-12-23 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: Equivalence testing has grown significantly in importance over the last two decades, especially as its relevance to a variety of applications has become understood. Yet published work on the general methodology remains scattered in specialists' journals, and for the most part, it focuses on the relatively narrow topic of bioequivalence assessment. With a far broader perspective, Testing Statistical Hypotheses of Equivalence provides the first comprehensive treatment of statistical equivalence testing. The author addresses a spectrum of...
Author : Roger W. Welker
Publisher : John Wiley & Sons
ISBN 13 : 0471414522
Total Pages : 534 pages
Book Rating : 4.4/5 (714 download)
Download or read book Contamination and ESD Control in High-Technology Manufacturing written by Roger W. Welker and published by John Wiley & Sons. This book was released on 2006-09-18 with total page 534 pages. Available in PDF, EPUB and Kindle. Book excerpt: A practical "how to" guide that effectively deals with the control of both contamination and ESD This book offers effective strategies and techniques for contamination and electrostatic discharge (ESD) control that can be implemented in a wide range of high-technology industries, including semiconductor, disk drive, aerospace, pharmaceutical, medical device, automobile, and food production manufacturing. The authors set forth a new and innovative methodology that can manage both contamination and ESD, often considered to be mutually exclusive challenges requiring distinct strategies. Beginning with two general chapters on the fundamentals of contamination and ESD control, the book presents a logical progression of topics that collectively build the necessary skills and knowledge: Analysis methods for solving contamination and ESD problems Building the contamination and ESD control environment, including design and construction of cleanrooms and ESD protected environments Cleaning processes and the equipment needed to support these processes Tooling design and certification Continuous monitoring Consumable supplies and packaging materials Controlling contamination and ESD originating from people Management of cleanrooms and ESD protected workplace environments Contamination and ESD Control in High-Technology Manufacturing conveys a practical, working knowledge of contamination and ESD control strategies and techniques, and it is filled with case studies that illustrate key principles and the benefits of contamination and ESD control. Moreover, its straightforward style makes the material, which integrates many disciplines of engineering and science, clear and accessible. Written by three leading industry experts, this book is an essential guide for engineers and designers across the many industries where contamination and ESD control is a concern.
Author : Carrillo-Cedillo, Eugenia Gabriela
Publisher : IGI Global
ISBN 13 : 1799896153
Total Pages : 298 pages
Book Rating : 4.7/5 (998 download)
Download or read book Quality Control Applications in the Pharmaceutical and Medical Device Manufacturing Industry written by Carrillo-Cedillo, Eugenia Gabriela and published by IGI Global. This book was released on 2022-03-18 with total page 298 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality control in pharmaceutical products and medical devices is vital for users as failing to comply with national and international regulations can lead to accidents that could easily be avoided. For this reason, manufacturing a quality medical product will support patient safety. Microbiologists working in both the pharmaceutical and medical device industries face considerable challenges in keeping abreast of the myriad microbiological references available to them and the continuously evolving regulatory requirements. Quality Control Applications in the Pharmaceutical and Medical Device Manufacturing Industry presents the importance of quality control in pharmaceutical products and medical devices, which must have very high-quality standards to not cause problems to the health of patients. It reinforces and updates the knowledge of analytical, instrumental, and biological methods to demonstrate the correct quality control and good manufacturing practice for pharmaceutical products and medical devices. Covering topics such as pharmaceutical nano systems, machine learning, and software validation, this book is an essential resource for managers, engineers, supervisors, pharmacists, chemists, academicians, and researchers.
