{"product_id":"sterile-processing-of-pharmaceutical-products-9781119802327","title":"Sterile Processing of Pharmaceutical Products","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\u003cp\u003e\u003cb\u003eDescribes the methodologies and best practices of the sterile manufacture of drug products\u003c\/b\u003e \u003c\/p\u003e\u003cp\u003eThoroughly trained personnel and carefully designed, operated, and maintained facilities and equipment are vital for the sterile manufacture of medicinal products using aseptic processing. Professionals in pharmaceutical and biopharmaceutical manufacturing facilities must have a clear understanding of current good manufacturing practice (cGMP) and preapproval inspection (PAI) requirements. \u003c\/p\u003e\u003cp\u003e\u003ci\u003eSterile Processing of Pharmaceutical Products: Engineering Practice, Validation, and Compliance in Regulated Environments \u003c\/i\u003eprovides up-to-date coverage of aseptic processing techniques and sterilization methods. Written by a recognized expert with more than 20 years of industry experience in aseptic manufacturing, this practical resource illustrates a comprehensive approach to sterile manufacturing engineering that can achieve drug manufacturing objectives and goals. Topics include sanitar\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003c\/p\u003e\u003cp\u003ePreface xiii\u003c\/p\u003e \u003cp\u003eAcknowledgments xvii\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Introduction \u003c\/b\u003e\u003cb\u003e1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 Sterilization \u003c\/b\u003e\u003cb\u003e4\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eSteam Sterilization 5\u003c\/p\u003e \u003cp\u003eFlash Sterilization 5\u003c\/p\u003e \u003cp\u003eLow-Temperature Sterilization Technologies 6\u003c\/p\u003e \u003cp\u003eEthylene Oxide Gas Sterilization 6\u003c\/p\u003e \u003cp\u003eHydrogen Peroxide Gas Plasma 7\u003c\/p\u003e \u003cp\u003eDisinfection and Surface Sterilization Using Peracetic Acid 7\u003c\/p\u003e \u003cp\u003eIonizing Radiation 8\u003c\/p\u003e \u003cp\u003eDry-Heat Sterilizers 8\u003c\/p\u003e \u003cp\u003eFiltration 9\u003c\/p\u003e \u003cp\u003eMicrowave 9\u003c\/p\u003e \u003cp\u003eVaporized Hydrogen Peroxide (VHP®) 9\u003c\/p\u003e \u003cp\u003eOzone 9\u003c\/p\u003e \u003cp\u003eFormaldehyde Steam 10\u003c\/p\u003e \u003cp\u003eGaseous Chlorine Dioxide 10\u003c\/p\u003e \u003cp\u003eVaporized Peracetic Acid 10\u003c\/p\u003e \u003cp\u003eInfrared Radiation 10\u003c\/p\u003e \u003cp\u003eSterilization Cycle Verification 11\u003c\/p\u003e \u003cp\u003eMonitoring 11\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Sterile Manufacturing Facilities \u003c\/b\u003e\u003cb\u003e15\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Sanitary Process Piping and Equipment \u003c\/b\u003e\u003cb\u003e17\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eQA Procedures 18\u003c\/p\u003e \u003cp\u003eStandard Operating Procedures – cGMP Installations 19\u003c\/p\u003e \u003cp\u003eHeat Exchangers 19\u003c\/p\u003e \u003cp\u003eSanitary Pumps 20\u003c\/p\u003e \u003cp\u003eSanitary Tanks 20\u003c\/p\u003e \u003cp\u003eInstruments 21\u003c\/p\u003e \u003cp\u003ePressure Transmitter (Various Sources) 21\u003c\/p\u003e \u003cp\u003eTemperature Transmitter (Various Sources) 21\u003c\/p\u003e \u003cp\u003eStandard Operating Procedures – cGMP Installations 25\u003c\/p\u003e \u003cp\u003eSurface Finish 30\u003c\/p\u003e \u003cp\u003eWelding 32\u003c\/p\u003e \u003cp\u003eApplicability 33\u003c\/p\u003e \u003cp\u003eProcess\/Procedure 39\u003c\/p\u003e \u003cp\u003eRecords (General) 41\u003c\/p\u003e \u003cp\u003eRecords 44\u003c\/p\u003e \u003cp\u003eAutomatic Orbital Welding 47\u003c\/p\u003e \u003cp\u003eWeld Acceptance Criteria for Automatic Orbital Weld Qualifications 47\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Passivation \u003c\/b\u003e\u003cb\u003e49\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eIn-house Passivation Using Vats 51\u003c\/p\u003e \u003cp\u003eSpot Passivation 53\u003c\/p\u003e \u003cp\u003eAstro Pak UltraPass Gel Passivation 53\u003c\/p\u003e \u003cp\u003eAlternative Process 54\u003c\/p\u003e \u003cp\u003eControl of Passivated Items 57\u003c\/p\u003e \u003cp\u003ePreparing, Testing, and Adjusting Cleaning and Passivation Chemicals (Passivation in Vats) 58\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Chilled Water System \u003c\/b\u003e\u003cb\u003e63\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eProcess Description 65\u003c\/p\u003e \u003cp\u003eCommissioning of HVAC 75\u003c\/p\u003e \u003cp\u003eInstallation Verification – X Ton Chiller System 78\u003c\/p\u003e \u003cp\u003eSystemStartup – X Ton Chiller 81\u003c\/p\u003e \u003cp\u003eFunctional Testing – X Ton Chiller 82\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Clean-In-Place (CIP) Systems \u003c\/b\u003e\u003cb\u003e84\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eLife Cycle Requirements 86\u003c\/p\u003e \u003cp\u003eProduct and Process User Requirements 86\u003c\/p\u003e \u003cp\u003eProcess Quality Requirements 86\u003c\/p\u003e \u003cp\u003eProcess Parameter Requirements 87\u003c\/p\u003e \u003cp\u003eInstallation User Requirements 87\u003c\/p\u003e \u003cp\u003eOperational Requirements 91\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Computerized Automated Systems \u003c\/b\u003e\u003cb\u003e95\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eFunctional Requirement Specification 95\u003c\/p\u003e \u003cp\u003eProcess Automation System 95\u003c\/p\u003e \u003cp\u003eEMS User Requirement Specification 96\u003c\/p\u003e \u003cp\u003eAutomation Overview 96\u003c\/p\u003e \u003cp\u003eSoftware 97\u003c\/p\u003e \u003cp\u003eHardware 97\u003c\/p\u003e \u003cp\u003eSCADA 97\u003c\/p\u003e \u003cp\u003eControl Panels 97\u003c\/p\u003e \u003cp\u003eMain Control Panel 97\u003c\/p\u003e \u003cp\u003eRemote I\/O Panels 98\u003c\/p\u003e \u003cp\u003ePower Distribution Panels 98\u003c\/p\u003e \u003cp\u003eInstrumentation Panels 98\u003c\/p\u003e \u003cp\u003eSystem Functions 98\u003c\/p\u003e \u003cp\u003eSystem Overview 98\u003c\/p\u003e \u003cp\u003eControl Modules 99\u003c\/p\u003e \u003cp\u003eInterfaces 99\u003c\/p\u003e \u003cp\u003eUser Interface (SCADA) 99\u003c\/p\u003e \u003cp\u003ePAS System Overview 99\u003c\/p\u003e \u003cp\u003eGraphical Screen Navigation 99\u003c\/p\u003e \u003cp\u003eClient EMS Area Graphical Screens 99\u003c\/p\u003e \u003cp\u003eGraphical Control Screens 99\u003c\/p\u003e \u003cp\u003eInterfaces to Equipment 101\u003c\/p\u003e \u003cp\u003eInterfaces to Other Systems 101\u003c\/p\u003e \u003cp\u003eEthernet Network 101\u003c\/p\u003e \u003cp\u003eNonfunctional Attributes 101\u003c\/p\u003e \u003cp\u003ePower Failure Recovery 101\u003c\/p\u003e \u003cp\u003ePLC Only Failure 101\u003c\/p\u003e \u003cp\u003eHMI Only Failure 101\u003c\/p\u003e \u003cp\u003eNetwork Only Failure 101\u003c\/p\u003e \u003cp\u003eMaintainability 102\u003c\/p\u003e \u003cp\u003eBackup and Recovery 102\u003c\/p\u003e \u003cp\u003eFunctional Requirement Specification 102\u003c\/p\u003e \u003cp\u003eGLC Environmental Monitoring System 102\u003c\/p\u003e \u003cp\u003eAutomation Overview 103\u003c\/p\u003e \u003cp\u003eSystem Components 104\u003c\/p\u003e \u003cp\u003eSoftware 104\u003c\/p\u003e \u003cp\u003eHardware 104\u003c\/p\u003e \u003cp\u003eControl Panels 104\u003c\/p\u003e \u003cp\u003eGateways 105\u003c\/p\u003e \u003cp\u003eSystem Functions 105\u003c\/p\u003e \u003cp\u003eSystem Overview 105\u003c\/p\u003e \u003cp\u003eControl Modules 105\u003c\/p\u003e \u003cp\u003eInterfaces 105\u003c\/p\u003e \u003cp\u003eUser Interface (SCADA) 105\u003c\/p\u003e \u003cp\u003eGLC EMS Area Graphical Screen 105\u003c\/p\u003e \u003cp\u003eGlobal Logistics Center (GLC) Environmental Monitoring System 105\u003c\/p\u003e \u003cp\u003eInterfaces to Equipment 105\u003c\/p\u003e \u003cp\u003eInterfaces to Other Systems 106\u003c\/p\u003e \u003cp\u003eEthernet Network 106\u003c\/p\u003e \u003cp\u003eWireless Connections 106\u003c\/p\u003e \u003cp\u003eNonfunctional Attributes 106\u003c\/p\u003e \u003cp\u003ePower Failure Recovery 106\u003c\/p\u003e \u003cp\u003ePLC Only Failure 106\u003c\/p\u003e \u003cp\u003eHMI Only Failure 106\u003c\/p\u003e \u003cp\u003eNetwork Only Failure 106\u003c\/p\u003e \u003cp\u003eMaintainability 107\u003c\/p\u003e \u003cp\u003eBackup and Recovery 107\u003c\/p\u003e \u003cp\u003eSoftware Module Design Specification 107\u003c\/p\u003e \u003cp\u003eFunctional Requirement Specification 108\u003c\/p\u003e \u003cp\u003eProcess Automation System 108\u003c\/p\u003e \u003cp\u003eAutomation Overview 109\u003c\/p\u003e \u003cp\u003eSystem Components 109\u003c\/p\u003e \u003cp\u003eSoftware 109\u003c\/p\u003e \u003cp\u003eHardware 110\u003c\/p\u003e \u003cp\u003eControl Panels 110\u003c\/p\u003e \u003cp\u003eSystem Functions 111\u003c\/p\u003e \u003cp\u003eSystem Overview 111\u003c\/p\u003e \u003cp\u003eControl Modules 111\u003c\/p\u003e \u003cp\u003eInterfaces 111\u003c\/p\u003e \u003cp\u003eUser Interface (SCADA) 111\u003c\/p\u003e \u003cp\u003ePAS System Overview Screen 112\u003c\/p\u003e \u003cp\u003eGraphical Screen Navigation 112\u003c\/p\u003e \u003cp\u003eGraphical Control Screens 112\u003c\/p\u003e \u003cp\u003eInterfaces to Equipment 113\u003c\/p\u003e \u003cp\u003eInterfaces to Other Systems 113\u003c\/p\u003e \u003cp\u003eEthernet Network 113\u003c\/p\u003e \u003cp\u003eNonfunctional Attributes 114\u003c\/p\u003e \u003cp\u003ePower Failure Recovery 114\u003c\/p\u003e \u003cp\u003ePLC Only Failure 114\u003c\/p\u003e \u003cp\u003eHMI Only Failure 114\u003c\/p\u003e \u003cp\u003eNetwork Only Failure 114\u003c\/p\u003e \u003cp\u003eMaintainability 114\u003c\/p\u003e \u003cp\u003eBackup and Recovery 114\u003c\/p\u003e \u003cp\u003eSoftware Design Specification 115\u003c\/p\u003e \u003cp\u003eProsoft Configuration 115\u003c\/p\u003e \u003cp\u003eEnabling and Disabling of the Gateway Default Server Interface 115\u003c\/p\u003e \u003cp\u003eTemperature Sensor Settings 116\u003c\/p\u003e \u003cp\u003eHumidity Sensor Settings 116\u003c\/p\u003e \u003cp\u003eSoftware Design Specification 116\u003c\/p\u003e \u003cp\u003eContinuous Logic 116\u003c\/p\u003e \u003cp\u003eModule Classes and Control Modules 116\u003c\/p\u003e \u003cp\u003eVirtual Differential Pressure Alarm Disable 116\u003c\/p\u003e \u003cp\u003eRoom Condition Indication 117\u003c\/p\u003e \u003cp\u003eNavigation Links 117\u003c\/p\u003e \u003cp\u003eAlarm Daily Report 118\u003c\/p\u003e \u003cp\u003eWFI Still Equipment Module Class 118\u003c\/p\u003e \u003cp\u003eWFI Silo Equipment Module Class 126\u003c\/p\u003e \u003cp\u003eEM_SILO 126\u003c\/p\u003e \u003cp\u003eWFI Primary Loop Equipment Module Class 143\u003c\/p\u003e \u003cp\u003eEM_PRIM_LOOP 143\u003c\/p\u003e \u003cp\u003eWFI Supply Header Equipment Module Class 155\u003c\/p\u003e \u003cp\u003eEM_HEADER 155\u003c\/p\u003e \u003cp\u003eElectrical – Controls Equipment Specifications 162\u003c\/p\u003e \u003cp\u003eDocumentation 165\u003c\/p\u003e \u003cp\u003eDrives\/Motors 165\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 Personal Protective Equipment (PPE) and Process Flow \u003c\/b\u003e\u003cb\u003e170\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 Sterile Aseptic Processing \u003c\/b\u003e\u003cb\u003e172\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 Integrated Facility Design \u003c\/b\u003e\u003cb\u003e174\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eCase Study 178\u003c\/p\u003e \u003cp\u003eIssue 178\u003c\/p\u003e \u003cp\u003eRoot Cause 178\u003c\/p\u003e \u003cp\u003eCorrective Action 179\u003c\/p\u003e \u003cp\u003ePreventive Actions 179\u003c\/p\u003e \u003cp\u003e\u003cb\u003e12 Barriers and Isolators \u003c\/b\u003e\u003cb\u003e180\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eIsolator Design Considerations 181\u003c\/p\u003e \u003cp\u003e\u003cb\u003e13 Guidelines for Statistical Procedure \u003c\/b\u003e\u003cb\u003e183\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eProcess Capability Analysis 184\u003c\/p\u003e \u003cp\u003eLong-term Studies 186\u003c\/p\u003e \u003cp\u003eAcceptance Sampling 187\u003c\/p\u003e \u003cp\u003eAttribute and Variable Sampling Plans 187\u003c\/p\u003e \u003cp\u003eVariable Sampling Plans – ANSI Z1.9 188\u003c\/p\u003e \u003cp\u003eNormality 188\u003c\/p\u003e \u003cp\u003eTransformation of Non-normal Data (Normalization) 190\u003c\/p\u003e \u003cp\u003eProtocol Sampling 190\u003c\/p\u003e \u003cp\u003eFailure Mode and Effect Analysis (FMEA) 191\u003c\/p\u003e \u003cp\u003eCalculating or Recalculating Control Limits 193\u003c\/p\u003e \u003cp\u003e\u003cb\u003e14 Calibration \u003c\/b\u003e\u003cb\u003e194\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eContingency Plan\/Disaster Recovery 204\u003c\/p\u003e \u003cp\u003e\u003cb\u003e15 Cleaning Validation \u003c\/b\u003e\u003cb\u003e205\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eNew Products and Product Changes 208\u003c\/p\u003e \u003cp\u003eCleaning Processes and Changes 208\u003c\/p\u003e \u003cp\u003eRisk Assessment\/Matrix Approach 209\u003c\/p\u003e \u003cp\u003eMatrix Development 209\u003c\/p\u003e \u003cp\u003eCleaning Processes (Manual and Automated) 210\u003c\/p\u003e \u003cp\u003eCPP\/CQA 210\u003c\/p\u003e \u003cp\u003eCleaning Validation Life Cycle – Cleaning Method Development 211\u003c\/p\u003e \u003cp\u003eStrategy for Process Controls 211\u003c\/p\u003e \u003cp\u003eWorst-Case Identification – Product\/Component 211\u003c\/p\u003e \u003cp\u003eEquipment 212\u003c\/p\u003e \u003cp\u003eValidation Tests\/Inspections – Visual Inspection 212\u003c\/p\u003e \u003cp\u003eChemical Testing 212\u003c\/p\u003e \u003cp\u003eMicrobiological Testing 213\u003c\/p\u003e \u003cp\u003eEndotoxin Testing 213\u003c\/p\u003e \u003cp\u003eSampling Methods 213\u003c\/p\u003e \u003cp\u003eDirect Swab Sampling 214\u003c\/p\u003e \u003cp\u003eRinse Sampling 214\u003c\/p\u003e \u003cp\u003eCoupon Testing 214\u003c\/p\u003e \u003cp\u003eSampling Sites 214\u003c\/p\u003e \u003cp\u003eAcceptance Criteria 214\u003c\/p\u003e \u003cp\u003eResidual Levels 214\u003c\/p\u003e \u003cp\u003eEndotoxin Levels 215\u003c\/p\u003e \u003cp\u003eMicrobiological Levels 215\u003c\/p\u003e \u003cp\u003eCleaning Agents\/Sanitizer Validation Studies 215\u003c\/p\u003e \u003cp\u003eHold Time Development 216\u003c\/p\u003e \u003cp\u003eDirty Hold Time 216\u003c\/p\u003e \u003cp\u003eClean Hold Time 217\u003c\/p\u003e \u003cp\u003eAdditional Hold Times\/Cleaning Frequencies 217\u003c\/p\u003e \u003cp\u003eContinuous Process Verification 217\u003c\/p\u003e \u003cp\u003eFailure Investigations 217\u003c\/p\u003e \u003cp\u003e\u003cb\u003e16 Validation of Filling Equipment \u003c\/b\u003e\u003cb\u003e218\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eTechnical References 223\u003c\/p\u003e \u003cp\u003e\u003cb\u003e17 Manufacturing Process Validation \u003c\/b\u003e\u003cb\u003e224\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eStage 2 – Process Qualification 229\u003c\/p\u003e \u003cp\u003e\u003cb\u003eAppendix A Installation Test Plans \u003c\/b\u003e\u003cb\u003e232\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003eAppendix B Operational Tests Plans \u003c\/b\u003e\u003cb\u003e235\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003eAppendix C WFI Turbulence Flow Requirements \u003c\/b\u003e\u003cb\u003e238\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003eAppendix D Water For Injection (WFI) – Design Requirements \u003c\/b\u003e\u003cb\u003e239\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eProcess Description 240\u003c\/p\u003e \u003cp\u003eSpecifications 241\u003c\/p\u003e \u003cp\u003eLife Cycle Requirements 241\u003c\/p\u003e \u003cp\u003eProduct and Process User Requirements 241\u003c\/p\u003e \u003cp\u003eProduct Description 241\u003c\/p\u003e \u003cp\u003eOperating Ranges 243\u003c\/p\u003e \u003cp\u003eMaterial of Construction 244\u003c\/p\u003e \u003cp\u003eMetallics 244\u003c\/p\u003e \u003cp\u003ePlastics 244\u003c\/p\u003e \u003cp\u003eElastomers 244\u003c\/p\u003e \u003cp\u003eGlass 244\u003c\/p\u003e \u003cp\u003eWelding Requirements 245\u003c\/p\u003e \u003cp\u003eConstruction Requirements 246\u003c\/p\u003e \u003cp\u003eLubrication Requirements 247\u003c\/p\u003e \u003cp\u003eElectrical Requirements 247\u003c\/p\u003e \u003cp\u003eSafety Requirements 247\u003c\/p\u003e \u003cp\u003eOperational Requirements 248\u003c\/p\u003e \u003cp\u003eProcess Constraints and Limitations 248\u003c\/p\u003e \u003cp\u003eProcess Control System 248\u003c\/p\u003e \u003cp\u003eOperator Interface 249\u003c\/p\u003e \u003cp\u003ePower Loss and Recovery 250\u003c\/p\u003e \u003cp\u003eCleaning and Sanitizing 250\u003c\/p\u003e \u003cp\u003eMaintenance Requirements 250\u003c\/p\u003e \u003cp\u003eTraining and Documentation Requirements 250\u003c\/p\u003e \u003cp\u003e\u003cb\u003eAppendix E Solution Transfer System (STS) – Design Requirements \u003c\/b\u003e\u003cb\u003e252\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eSystem Description 253\u003c\/p\u003e \u003cp\u003eBulk Powder Handling System 255\u003c\/p\u003e \u003cp\u003eGlossary 259\u003c\/p\u003e \u003cp\u003eNomenclature 261\u003c\/p\u003e \u003cp\u003eReferences 263\u003c\/p\u003e \u003cp\u003eFurther Reading 267\u003c\/p\u003e \u003cp\u003eIndex 335\u003c\/p\u003e","brand":"John Wiley \u0026 Sons Inc","offers":[{"title":"Default Title","offer_id":49407157469527,"sku":"9781119802327","price":119.65,"currency_code":"GBP","in_stock":false}],"url":"https:\/\/bookcurl.com\/products\/sterile-processing-of-pharmaceutical-products-9781119802327","provider":"Book Curl","version":"1.0","type":"link"}