The Biologics and Biotechnology Handbook for Engineers

This book provides a wide ranging overview of key themes and technologies used in Biotechnology. It is written from an engineers perspective and focuses on understanding the key subject areas including facility requirements, clean utilities, equipment validation, aseptic processes, Chapter 1: FacilitiesIntroduction Contamination Control Material Flow Material Transfer Disinfection and Cleaning Agents GMP Zoning Environmental Grade A (Aseptic) Environmental Grade B Environmental Grade C Environmental Grade D Chapter 2: Clean UtilitiesCompressed Air Water Systems Water for Injection Clean SteamHVAC Chapter 3: Sterile Manufacturing OperationsUnit Operations Raw materials Upstream Processing Filling Operations Container Closure Integrity Isolator Barrier SystemsDecontamination Agents Containment Steam Sterilisers Chapter 4: DepyrogenationWhat is Depyrogenation? Pyrogens Endotoxins and Depyrogenation Biological Indicators for Dry HeatControl of Materials In-Process Controls Cooling Failure of Depyrogenation Chapter 5: Cleaning and DisinfectionCleaning ValidationPICS/s Guidance on limit Test Methods Cleaning Process Design Piping Utilities Chapter 6: Process DevelopmentVial Washers Depyrogenation Tunnels Isolators Chapter 7: Physical ProcessesFluid Flow Classification of Fluids Mixing Vessel Geometry Heat Transfer Chapter 8: Equipment ValidationDepyrogenation Tunnels (Equipment Validation) Isolators (Equipment Validation) Steam Sterilisers (Equipment Qualification) Chapter 9: Performance QualificationDepyrogenation Isolators Steam SterilisersChapter 10: Data IntegrityThe Lifecycle of Data System Categorisation Chapter 11: Test Method Validation Basics Chapter 12: Ethylene Oxide SterilisationSterilisation and Parametric Release Sterilisation Conditions Packaging Systems Pure ethylene oxide sterilizers Ethylene Oxide Sterilisation Cycles Biological indicator (BI) placement Chapter 13: Single Use TechnologyIntroduction Extractables and Leachables BiocompatibilityChapter:14 Extractables and LeachablesIntroductionExtractables Explained Leachables Explained