Contamination Control In Practice

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.

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 practices and procedure are in step with current norms. It develops and refines the concept of an integrated micro contamination control. It focuses on the environmental expectations and testing for continued compliance as laid down in: *ISO 14644 Standards for Cleanrooms; *ISO 146 Final Draft International Standards for Biological Monitoring & Control; * MCA Orange Guide December 2002; *USFDA Draft Guidelines for Sterile Drug Products by Aseptic Processing; *WHO Guidelines for Sterile Pharmaceutical Preparations.

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.

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

This Tutorial Text provides a comprehensive introduction to the subject of contamination control, with specific applications to the aerospace industry. The author draws upon his many years as a practicing contamination control engineer, researcher, and teacher. The book examines methods to quantify the cleanliness level required by various contamination-sensitive surfaces and to predict the end-of-life contamination level for those surfaces, and it identifies contamination control techniques required to ensure mission success.

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