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Zusatztext "Considering the diversity of topics covered in the book and the diversity of the contributors! the style of writing is surprisingly consistent. Each chapter uses clear! easy-to-understand English? this book should appeal to a wide range of employees within the pharmaceutical and medical device industries! from Chief Executive Officers to managers! quality assurance/regulatory affairs assistants and laboratory staff." -David Pickard! Senior Technical Specialist and Microbiologist! London! UK! in Journal of Medical Device Regulation Informationen zum Autor Stephen P. Denyer, Rosamund M. Baird Klappentext Providing a brief introduction to microbiology for the nonmicrobiologist, this book covers principal aspects of microbiology regarding the preformulation, formulation, manufacturing, and licensure of pharmaceuticals and medical devices. Covering good manufacturing practice in the control of contamination, the text explores monitoring microbiological quality, preserving pharmaceutical formulations, and applying principles of sterilization, including microbiologically specific considerations for biotechnology products and other medical devices. It also provides additional materials on testing package integrity and evaluating contamination risks in clean rooms. Zusammenfassung Covers those principal aspects of microbiology that are relevant to the preformulation, formulation, manufacturing and license application stages involved with the production of pharmaceuticals, while expanding the book's focus to include medical devices. This work provides an introduction to microbiology geared towards the non-microbiologist. Inhaltsverzeichnis Introduction to microbiology. Microbial contamination: spoilage and hazard. Microbial ecology of the production process. The design of controlled environments. Microbiological considerations for biotechnological products. Microbiological considerations in the production of medical devices. Good manufacturing practice in the control of contamination. Dispersion of airborne contaminants and contamination risks in clean rooms. Monitoring microbiological quality: conventional testing methods. Monitoring microbiological quality: application of rapid microbiological methods to pharmaceuticals. Principles of sterilization. Sterilization methods. Assurance of sterility by process validation. Principles of preservation. Antimicrobial preservatives and their properties. Preservative stability and efficacy: formulation influences. Package integrity testing. Official methods of preservative evaluation and testing. Preservative evaluation and testing : the linear regression method. Preservatives, antimicrobial agents and antioxidants: registration and regulatory affairs. Microbial standards for pharmaceuticals. Risk management and microbiological auditing. ...
