Publisher's Synopsis
Biotechnology brings together many fields of expertise including engineering, chemistry, microbiology to mention a few. This paperback book provides a overview of the key themes and requirements of Aseptic processing and sterile manufacturing. It is written in a simple and plain style and provides a practical approach under standing the technologies used within the industry.Chapter 1: FacilitiesChapter 2: Clean UtilitiesChapter 3: Sterile Manufacturing OperationsChapter 4: DepyrogenationChapter 5: Cleaning and DisinfectionChapter 6: Process DevelopmentChapter 7: Physical ProcessesChapter 8: Equipment ValidationChapter 9: Performance QualificationChapter 10: GMP BasicsChapter 11: Data IntegrityGlossary
