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 ValidationRegulatory RequirementsEU GMP V AnnexValidation and product lifecycleCleanroom QualificationCleanroom EnvironmentCleanroom Zoning and ClassificationTypes of ContaminationCleanroom Classification TableZone ClassificationHVAC Particulate ControlTotal Airflow Volumes & Recovery RatesUnidirectional flowTemperatureRelative Humidity (RH)Control and Spread of SmokeCleaningHVAC System DesignISO Standards for CleanroomsTemperatureAir Handling UnitsFiltrationcourse/ PRE- FiltrationFine / SECONDARY FiltrationCompliance Tests for GMP ZonesClean Room Design ConsiderationsUtility Gases & WaterCLEAN STEAMRO Water, DI water and Water for InjectionWater SystemsHigh Purity Water System DesignWater for InjectionWFI generation, storage and distributionMicrobial LimitsPurified Water SystemsCompressed Air- Generation, storage and distributionIntroductionCompressed Air Design RequirementsDesign Element: Inlet Air filtersDesign RequirementsDesign QualificationDQ EvaluationClean steamFacilities MonitoringGase SystemsArgon GasCARBON DIXOIDEoxygenSteam SterilizationSterilization and DisinfectionParametric ApproachRisk and SterilitySpaulding’s classificationCleaningClean-in-Place (CIP)PIC/S Guidance on LimitsAntimicrobial TechniquesPasteurizationSterilisation ProcessesFDA Categorisation of Established Sterilization ProcessesSteam Sterilizer (Moist Heat) - Development of Sterilization ProcessesThe Sterilizer as EquipmentThe Sterilization ProcessValidation of Steam SterilizersRequalificationIndustry Standards relevant to SterilizationPrinciple of OperationAlternatives to Steam SterilizationEthylene Oxide (EO)Oxidizing and Non Oxidizing DisinfectantsSodium hypochloriteDepyrogenationPyrogensBacterial ToxinPyrogen Assay - Limulus Amoebocyte LysateEndotoxins and DepyrogenationBiological Indicators for Dry HeatControl of MaterialsContamination ConsiderationsStart-up ConditionFailure of DepyrogenationDepyrogenation -Performance Qualification (PQ)Aseptic ProcessingDesign Considerations for Isolator SystemsDefinition of Aseptic ProcessingRegulations and StandardsTechnical Comparison of Terminal Sterilization and Aseptic ProcessingIsolator and Glove AccessIsolator Design RequirementsMaterials of ConstructionIsolator AccessIsolator DecontaminationIsolator Barrier SystemsIsolator InterfacesIsolator DecontaminationFacility Layout for Aseptic ProcessingAir ClassificationsFilling OperationsAseptic Process SimulationSterile Barrier Packaging SystemsMaterial CompatibilityFactors in Design and DevelopmentPerformance of Packaging SystemStability of PackagingLifecycle approach to Sterile Barrier SystemsFactors in Sterile Barrier Validation(c) 2024, Modular MedTech. .