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.

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.

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

This book addresses a long felt need in the industry for coherent information on "contamination control, cleanrooms and biosafety" and offers insights, guidance and assistance to ensure that facilities, practices and procedures are in step with current norms. The highlight of the book is its focus on the environmental expectations and testing for continued compliance as laid down in: ISO 14644 Standards for Cleanrooms and Qualification - ISO 14698 Final Draft International Standards for Biological Monitoring and Control The WHO Guidelines for Sterile Pharmaceutical Preparations By explaining the Whys, Hows and Whats, it helps clear myths and misconceptions that abound in the industry, and presents a composite, holistic approach to understanding, analyzing and synthesizing cleanroom systems and practices. Starting from basics the book takes the reader progressively to advanced concepts and techniques that a layman as well as the expert can appreciate and apply the emphasis is centered around real life problems throughout the books. Whether you belong to Aerospace orZoonosis, if contamination Biosafety is your concern, this book is for you.

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

A critical technology in the science of contamination control, environmental monitoring is a technique that provides important data on the quality of a process, processing environment, and final product, which can aid scientists in identifying and eliminating potential sources of contamination in cleanrooms and controlled environments. In response

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.