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 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.
Contents: Basics of contamination control; Environment specification; Elements of cleanroom design engineering; Air filters; Laminar airflow; qualification; Human interface in controlled environments; Cleaning cleanrooms; Sterilisation; Good disinfection practice.
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