This book integrates the fundamentals of facility design for clean rooms, adjacent zones and clean utilities. There is extensive resources available that address these topics, however, they are often taken in isolation with a focus on one particular subject. This publication by Modular MedTech pulls the core knowledge across facility design, HVAC, cleanroom classification and clean utilities into one consolidated title. The book is presented in large 7.5inches x 9 inches with colour illustrations included where necessary. After reading this book the reader should be confident in understanding how requirements for facilities are defined and how requirements are assessed through design qualification and verified in qualification and validation. Introduction to Commissioning, Qualification And Validation Regulatory Requirements EU GMP V Annex Validation and product lifecycle Cleanroom Qualification Cleanroom Environment Cleanroom Zoning and Classification Types of Contamination Cleanroom Classification Table Zone Classification HVAC Particulate Control Total Airflow Volumes & Recovery Rates Unidirectional flow Temperature Relative Humidity (RH) Control and Spread of Smoke Cleaning HVAC System Design ISO Standards for Cleanrooms Temperature Air Handling Units Filtration course/ PRE- Filtration Fine / SECONDARY Filtration Compliance Tests for GMP Zones Clean Room Design Considerations Utility Gases & Water CLEAN STEAM RO Water, DI water and Water for Injection Water Systems High Purity Water System Design Water for Injection WFI generation, storage and distribution Microbial Limits Purified Water Systems Compressed Air- Generation, storage and distribution Introduction Compressed Air Design Requirements Design Element: Inlet Air filters Design Requirements Design Qualification DQ Evaluation Clean steam Facilities Monitoring Gase Systems Argon Gas CARBON DIXOIDE oxygen Steam Sterilization Sterilization and Disinfection Parametric Approach Risk and Sterility Spaulding’s classification Cleaning Clean-in-Place (CIP) PIC/S Guidance on Limits Antimicrobial Techniques Pasteurization Sterilisation Processes FDA Categorisation of Established Sterilization Processes Steam Sterilizer (Moist Heat) - Development of Sterilization Processes The Sterilizer as Equipment The Sterilization Process Validation of Steam Sterilizers Requalification Industry Standards relevant to Sterilization Principle of Operation Alternatives to Steam Sterilization Ethylene Oxide (EO) Oxidizing and Non Oxidizing Disinfectants Sodium hypochlorite Depyrogenation Pyrogens Bacterial Toxin Pyrogen Assay - Limulus Amoebocyte Lysate Endotoxins and Depyrogenation Biological Indicators for Dry Heat Control of Materials Contamination Considerations Start-up Condition Failure of Depyrogenation Depyrogenation -Performance Qualification (PQ) Aseptic Processing Design Considerations for Isolator Systems Definition of Aseptic Processing Regulations and Standards Technical Comparison of Terminal Sterilization and Aseptic Processing Isolator and Glove Access Isolator Design Requirements Materials of Construction Isolator Access Isolator Decontamination Isolator Barrier Systems Isolator Interfaces Isolator Decontamination Facility Layout for Aseptic Processing Air Classifications Filling Operations Aseptic Process Simulation Sterile Barrier Packaging Systems Material Compatibility Factors in Design and Development Performance of Packaging System Stability of Packaging Lifecycle approach to Sterile Barrier Systems Factors in Sterile Barrier Validation (c) 2024, Modular MedTech