Introduction to Contamination Control and Cleanroom Technology PDF Download

Author: Matts Ramstorp
Publisher: John Wiley & Sons
ISBN: 3527613137
Category : Science
Languages : en
Pages : 179

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Book Description
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: Mark Allen Durivage
Publisher: Quality Press
ISBN: 0873899334
Category : Business & Economics
Languages : en
Pages : 386

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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: Matts Ramstorp
Publisher: John Wiley & Sons
ISBN: 3527612610
Category : Science
Languages : en
Pages : 202

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Book Description
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: Barbara Kanegsberg
Publisher: CRC Press
ISBN: 1439828296
Category : Science
Languages : en
Pages : 576

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Book Description
"Nearly all companies which manufacture or fabricate high-value physical objects (components, parts, assemblies) perform critical cleaning at one or more stages. These range from the giants of the semiconductor, aerospace, and biomedical world to a host of small to medium to large companies producing a dizzying array of components"--

Author: Mark Allen Durivage
Publisher: Quality Press
ISBN: 1636941516
Category : Technology & Engineering
Languages : en
Pages : 421

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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: Lucia Clontz
Publisher: CRC Press
ISBN: 1420053493
Category : Medical
Languages : en
Pages : 344

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Book Description
In recent years, the field of pharmaceutical microbiology has experienced numerous technological advances, accompanied by the publication of new and harmonized compendial methods. It is therefore imperative for those who are responsible for monitoring the microbial quality of pharmaceutical/biopharmaceutical products to keep abreast of the latest c

Author: Barbara Kanegsberg
Publisher: CRC Press
ISBN: 1466515945
Category : Science
Languages : en
Pages : 1109

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Book Description
This set consists of two volumes: Cleaning Agents and Systems and Applications, Processes, and Controls. Updated, expanded, re-organized, and rewritten, this two-volume handbook covers cleaning processes, applications, management, safety, and environmental concerns. The editors rigorously examine technical issues, cleaning agent options and systems, chemical and equipment integration, and contamination control, as well as cleanliness standards, analytical testing, process selection, implementation and maintenance, specific application areas, and regulatory issues. A collection of international contributors gives the text a global viewpoint. Color illustrations, video clips, and animation are available online to help readers better understand presented material.

Author: William Whyte
Publisher: John Wiley & Sons
ISBN: 1119965594
Category : Technology & Engineering
Languages : en
Pages : 382

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Book Description
A self-contained and practical book providing step-by-step guidance to the design and construction of cleanrooms, appropriate testing methodologies, and operation for the minimization of contamination... This second edition has been comprehensively revised and includes extensive updates to the two chapters that contain information on cleanroom standards and guidelines. The chapter on risk management has been extensively revised, especially the section on risk assessment. Other new subjects that have been added to the various chapters are those on clean-build, determination of air supply volumes for non-unidirectional airflow cleanrooms, RABS (Restricted Access Barrier Systems), contamination recovery test methods, entry of large items into a cleanroom, glove allergy problems, and how to develop a cleanroom cleaning programme. Used for in-house training and a textbook in colleges, this volume is for cleanroom personnel at all levels. It provides novices with an introduction to the state-of-the-art technology and professionals with an accessible reference to the current practices. It is particularly useful in the semiconductor, pharmaceutical, biotechnology and life sciences industries. William Whyte is an international authority in cleanrooms, with over 45 years experience in research, teaching and consulting in the electronic, healthcare and pharmaceutical industries. He is a member of British and International standards committees writing the International Cleanroom standards, and has received numerous awards for his work in Cleanroom Technology. A comment on the first edition: "...extremely useful and helpful...very well-written, highly organized, easy to understand and follow..." (Environmental Geology, 2003)

Author: Mark J. Jackson
Publisher: Springer Science & Business Media
ISBN: 0387270264
Category : Medical
Languages : en
Pages : 595

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Book Description
Medical devices and surgical tools that contain micro and nanoscale features allow surgeons to perform clinical procedures with greater precision and safety while monitoring physiological and biomechanical parameters more accurately. While surgeons have started to master the use of nanostructured surgical tools in the operating room, this book addresses for the first time the impact and interaction of nanomaterials and nanostructured coatings in a comprehensive manner. Surface Engineered Surgical Tools and Medical Devices presents the latest information and techniques in the emerging field of surface engineered biomedical devices and surgical tools, and analyzes the interaction between nanotechnology, nanomaterials, and tools for surgical applications. Chapters of the book describe developments in coatings for heart valves, stents, hip and knee joints, cardiovascular devices, orthodontic applications, and regenerative materials such as bone substitutes. Chapters are also dedicated to the performance of surgical tools and dental tools and describe how nanostructured surfaces can be created for the purposes of improving cell adhesion between medical devices and the human body.

Author: Kevin Williams
Publisher: CRC Press
ISBN: 113553621X
Category : Medical
Languages : en
Pages : 671

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Book Description
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