Sterile processing of pharmaceutical products : engineering practice, validation, and compliance in regulated environments / / Sam A. Hout

• Autore: Hout Sam A.
• Pubblicazione: Hoboken, NJ : , : John Wiley & Sons, Inc., , 2022
• Descrizione fisica: 1 online resource (371 pages)
• Disciplina: 338.476151
• Soggetto topico: Pharmaceutical industry
• Nota di contenuto: Cover -- Title Page -- Copyright -- Contents -- Preface -- Acknowledgments -- Chapter 1 Introduction -- Chapter 2 Sterilization -- Steam Sterilization -- Flash Sterilization -- Low‐Temperature Sterilization Technologies -- Ethylene Oxide Gas Sterilization -- Hydrogen Peroxide Gas Plasma -- Disinfection and Surface Sterilization Using Peracetic Acid -- Ionizing Radiation -- Dry‐Heat Sterilizers -- Filtration -- Microwave -- Vaporized Hydrogen Peroxide (VHP®) -- Ozone -- Formaldehyde Steam -- Gaseous Chlorine Dioxide -- Vaporized Peracetic Acid -- Infrared Radiation -- Sterilization Cycle Verification -- Monitoring -- Chapter 3 Sterile Manufacturing Facilities -- Chapter 4 Sanitary Process Piping and Equipment -- QA Procedures -- Standard Operating Procedures - cGMP Installations -- Heat Exchangers -- Sanitary Pumps -- Sanitary Tanks -- Instruments -- Pressure Transmitter (Various Sources) -- Temperature Transmitter (Various Sources) -- Standard Operating Procedures - cGMP Installations -- Surface Finish -- Welding -- Applicability -- Process/Procedure -- Records (General) -- Records -- Automatic Orbital Welding -- Weld Acceptance Criteria for Automatic Orbital Weld Qualifications -- Chapter 5 Passivation -- In‐house Passivation Using Vats -- Spot Passivation -- Astro Pak UltraPass Gel Passivation -- Alternative Process -- Control of Passivated Items -- Preparing, Testing, and Adjusting Cleaning and Passivation Chemicals (Passivation in Vats) -- Chapter 6 Chilled Water System -- Process Description -- Commissioning of HVAC -- Installation Verification - X Ton Chiller System -- System Startup - X Ton Chiller -- Functional Testing - X Ton Chiller -- Chapter 7 Clean‐In‐Place (CIP) Systems -- Life Cycle Requirements -- Product and Process User Requirements -- Process Quality Requirements -- Process Parameter Requirements. ; Installation User Requirements -- Operational Requirements -- Chapter 8 Computerized Automated Systems -- Functional Requirement Specification -- Process Automation System -- EMS User Requirement Specification -- Automation Overview -- Software -- Hardware -- SCADA -- Control Panels -- Main Control Panel -- Remote I/O Panels -- Power Distribution Panels -- Instrumentation Panels -- System Functions -- System Overview -- Control Modules -- Interfaces -- User Interface (SCADA) -- PAS System Overview -- Graphical Screen Navigation -- Client EMS Area Graphical Screens -- Graphical Control Screens -- Interfaces to Equipment -- Interfaces to Other Systems -- Ethernet Network -- Nonfunctional Attributes -- Power Failure Recovery -- PLC Only Failure -- HMI Only Failure -- Network Only Failure -- Maintainability -- Backup and Recovery -- Functional Requirement Specification -- GLC Environmental Monitoring System -- Automation Overview -- System Components -- Software -- Hardware -- Control Panels -- Gateways -- System Functions -- System Overview -- Control Modules -- Interfaces -- User Interface (SCADA) -- GLC EMS Area Graphical Screen -- Global Logistics Center (GLC) Environmental Monitoring System -- Interfaces to Equipment -- Interfaces to Other Systems -- Ethernet Network -- Wireless Connections -- Nonfunctional Attributes -- Power Failure Recovery -- PLC Only Failure -- HMI Only Failure -- Network Only Failure -- Maintainability -- Backup and Recovery -- Software Module Design Specification -- Functional Requirement Specification -- Process Automation System -- Automation Overview -- System Components -- Software -- Hardware -- Control Panels -- System Functions -- System Overview -- Control Modules -- Interfaces -- User Interface (SCADA) -- PAS System Overview Screen -- Graphical Screen Navigation -- Graphical Control Screens -- Interfaces to Equipment. ; Interfaces to Other Systems -- Ethernet Network -- Nonfunctional Attributes -- Power Failure Recovery -- PLC Only Failure -- HMI Only Failure -- Network Only Failure -- Maintainability -- Backup and Recovery -- Software Design Specification -- Prosoft Configuration -- Enabling and Disabling of the Gateway Default Server Interface -- Temperature Sensor Settings -- Humidity Sensor Settings -- Software Design Specification -- Continuous Logic -- Module Classes and Control Modules -- Virtual Differential Pressure Alarm Disable -- Room Condition Indication -- Navigation Links -- Alarm Daily Report -- WFI Still Equipment Module Class -- WFI Silo Equipment Module Class -- EM& -- uscore -- SILO -- WFI Primary Loop Equipment Module Class -- EM& -- uscore -- PRIM& -- uscore -- LOOP -- WFI Supply Header Equipment Module Class -- EM& -- uscore -- HEADER -- Electrical - Controls Equipment Specifications -- Documentation -- Drives/Motors -- Chapter 9 Personal Protective Equipment (PPE) and Process Flow -- Chapter 10 Sterile Aseptic Processing -- Chapter 11 Integrated Facility Design -- Case Study -- Issue -- Root Cause -- Corrective Action -- Preventive Actions -- Chapter 12 Barriers and Isolators -- Isolator Design Considerations -- Chapter 13 Guidelines for Statistical Procedure -- Process Capability Analysis -- Long‐term Studies -- Acceptance Sampling -- Attribute and Variable Sampling Plans -- Variable Sampling Plans - ANSI Z1.9 -- Normality -- Transformation of Non‐normal Data (Normalization) -- Protocol Sampling -- Failure Mode and Effect Analysis (FMEA) -- Calculating or Recalculating Control Limits -- Chapter 14 Calibration -- Contingency Plan/Disaster Recovery -- Chapter 15 Cleaning Validation -- New Products and Product Changes -- Cleaning Processes and Changes -- Risk Assessment/Matrix Approach -- Matrix Development. ; Cleaning Processes (Manual and Automated) -- CPP/CQA -- Cleaning Validation Life Cycle - Cleaning Method Development -- Strategy for Process Controls -- Worst‐Case Identification - Product/Component -- Equipment -- Validation Tests/Inspections - Visual Inspection -- Chemical Testing -- Microbiological Testing -- Endotoxin Testing -- Sampling Methods -- Direct Swab Sampling -- Rinse Sampling -- Coupon Testing -- Sampling Sites -- Acceptance Criteria -- Residual Levels -- Endotoxin Levels -- Microbiological Levels -- Cleaning Agents/Sanitizer Validation Studies -- Hold Time Development -- Dirty Hold Time -- Clean Hold Time -- Additional Hold Times/Cleaning Frequencies -- Continuous Process Verification -- Failure Investigations -- Chapter 16 Validation of Filling Equipment -- Chapter 17 Manufacturing Process Validation -- Stage 2 - Process Qualification -- Appendix A Installation Test Plans -- Appendix B Operational Tests Plans -- Appendix C WFI Turbulence Flow Requirements -- Appendix D Water For Injection (WFI) - Design Requirements -- Process Description -- Specifications -- Life Cycle Requirements -- Product and Process User Requirements -- Product Description -- Operating Ranges -- Material of Construction -- Metallics -- Plastics -- Elastomers -- Glass -- Welding Requirements -- Construction Requirements -- Lubrication Requirements -- Electrical Requirements -- Safety Requirements -- Operational Requirements -- Process Constraints and Limitations -- Process Control System -- Operator Interface -- Power Loss and Recovery -- Cleaning and Sanitizing -- Maintenance Requirements -- Training and Documentation Requirements -- Appendix E Solution Transfer System (STS) - Design Requirements -- System Description -- Bulk Powder Handling System -- Glossary -- Nomenclature -- References -- Further Reading -- Index -- EULA.
• Titolo autorizzato: Sterile processing of pharmaceutical products
• ISBN: 1-119-80234-2; 1-119-80235-0; 1-119-80233-4
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Lingua di pubblicazione: Inglese
• Record Nr.: 9910830350803321
• Lo trovi qui: Univ. Federico II