{"product_id":"facilities-utilities-cleanroom-qualification-ben-oshea-9798321090954","title":"Facilities, Utilities \u0026 Cleanroom Qualification for Pharmaceuticals and Biologics","description":"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.\u003cbr\u003eAfter 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.\u003cbr\u003eIntroduction to Commissioning, Qualification And Validation\u003cbr\u003eRegulatory Requirements\u003cbr\u003eEU GMP V Annex\u003cbr\u003eValidation and product lifecycle\u003cbr\u003eCleanroom Qualification\u003cbr\u003eCleanroom Environment\u003cbr\u003eCleanroom Zoning and Classification\u003cbr\u003eTypes of Contamination\u003cbr\u003eCleanroom Classification Table\u003cbr\u003eZone Classification\u003cbr\u003eHVAC Particulate Control\u003cbr\u003eTotal Airflow Volumes \u0026amp; Recovery Rates\u003cbr\u003eUnidirectional flow\u003cbr\u003eTemperature\u003cbr\u003eRelative Humidity (RH)\u003cbr\u003eControl and Spread of Smoke\u003cbr\u003eCleaning\u003cbr\u003eHVAC System Design\u003cbr\u003eISO Standards for Cleanrooms\u003cbr\u003eTemperature\u003cbr\u003eAir Handling Units\u003cbr\u003eFiltration\u003cbr\u003ecourse\/ PRE- Filtration\u003cbr\u003eFine \/ SECONDARY Filtration\u003cbr\u003eCompliance Tests for GMP Zones\u003cbr\u003eClean Room Design Considerations\u003cbr\u003eUtility Gases \u0026amp; Water\u003cbr\u003eCLEAN STEAM\u003cbr\u003eRO Water, DI water and Water for Injection\u003cbr\u003eWater Systems\u003cbr\u003eHigh Purity Water System Design\u003cbr\u003eWater for Injection\u003cbr\u003eWFI generation, storage and distribution\u003cbr\u003eMicrobial Limits\u003cbr\u003ePurified Water Systems\u003cbr\u003eCompressed Air- Generation, storage and distribution\u003cbr\u003eIntroduction\u003cbr\u003eCompressed Air Design Requirements\u003cbr\u003eDesign Element: Inlet Air filters\u003cbr\u003eDesign Requirements\u003cbr\u003eDesign Qualification\u003cbr\u003eDQ Evaluation\u003cbr\u003eClean steam\u003cbr\u003eFacilities Monitoring\u003cbr\u003eGase Systems\u003cbr\u003eArgon Gas\u003cbr\u003eCARBON DIXOIDE\u003cbr\u003eoxygen\u003cbr\u003eSteam Sterilization\u003cbr\u003eSterilization and Disinfection\u003cbr\u003eParametric Approach\u003cbr\u003eRisk and Sterility\u003cbr\u003eSpaulding's classification\u003cbr\u003eCleaning\u003cbr\u003eClean-in-Place (CIP)\u003cbr\u003ePIC\/S Guidance on Limits\u003cbr\u003eAntimicrobial Techniques\u003cbr\u003ePasteurization\u003cbr\u003eSterilisation Processes\u003cbr\u003eFDA Categorisation of Established Sterilization Processes\u003cbr\u003eSteam Sterilizer (Moist Heat) - Development of Sterilization Processes\u003cbr\u003eThe Sterilizer as Equipment\u003cbr\u003eThe Sterilization Process\u003cbr\u003eValidation of Steam Sterilizers\u003cbr\u003eRequalification\u003cbr\u003eIndustry Standards relevant to Sterilization\u003cbr\u003ePrinciple of Operation\u003cbr\u003eAlternatives to Steam Sterilization\u003cbr\u003eEthylene Oxide (EO)\u003cbr\u003eOxidizing and Non Oxidizing Disinfectants\u003cbr\u003eSodium hypochlorite\u003cbr\u003eDepyrogenation\u003cbr\u003ePyrogens\u003cbr\u003eBacterial Toxin\u003cbr\u003ePyrogen Assay - Limulus Amoebocyte Lysate\u003cbr\u003eEndotoxins and Depyrogenation\u003cbr\u003eBiological Indicators for Dry Heat\u003cbr\u003eControl of Materials\u003cbr\u003eContamination Considerations\u003cbr\u003eStart-up Condition\u003cbr\u003eFailure of Depyrogenation\u003cbr\u003eDepyrogenation -Performance Qualification (PQ)\u003cbr\u003eAseptic Processing\u003cbr\u003eDesign Considerations for Isolator Systems\u003cbr\u003eDefinition of Aseptic Processing\u003cbr\u003eRegulations and Standards\u003cbr\u003eTechnical Comparison of Terminal Sterilization and Aseptic Processing\u003cbr\u003eIsolator and Glove Access\u003cbr\u003eIsolator Design Requirements\u003cbr\u003eMaterials of Construction\u003cbr\u003eIsolator Access\u003cbr\u003eIsolator Decontamination\u003cbr\u003eIsolator Barrier Systems\u003cbr\u003eIsolator Interfaces\u003cbr\u003eIsolator Decontamination\u003cbr\u003eFacility Layout for Aseptic Processing\u003cbr\u003eAir Classifications\u003cbr\u003eFilling Operations\u003cbr\u003eAseptic Process Simulation\u003cbr\u003eSterile Barrier Packaging Systems\u003cbr\u003eMaterial Compatibility\u003cbr\u003eFactors in Design and Development\u003cbr\u003ePerformance of Packaging System\u003cbr\u003eStability of Packaging\u003cbr\u003eLifecycle approach to Sterile Barrier Systems\u003cbr\u003eFactors in Sterile Barrier Validation\u003cbr\u003e(c) 2024, Modular MedTech\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Ben O'Shea\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9798321090954\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e Independently Published\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 04\/29\/2024\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 120\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Paperback\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 0.48lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 9.25h x 7.50w x 0.25d","brand":"Ben O'Shea","offers":[{"title":"Paperback","offer_id":46199268868351,"sku":"9798321090954","price":27.99,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_6b4097df-5fea-4721-84a2-cf7dc4010e11.jpg?v=1727925556","url":"https:\/\/www.whiterainbookhouse.com\/products\/facilities-utilities-cleanroom-qualification-ben-oshea-9798321090954","provider":"WR Book House","version":"1.0","type":"link"}