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Aprašymas

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: Facilities Chapter 2: Clean Utilities Chapter 3: Sterile Manufacturing Operations Chapter 4: Depyrogenation Chapter 5: Cleaning and Disinfection Chapter 6: Process Development Chapter 7: Physical Processes Chapter 8: Equipment Validation Chapter 9: Performance Qualification Chapter 10: GMP Basics Chapter 11: Data Integrity Glossary