This reference surveys emerging trends, concepts, and procedures used in the characterization and control of contaminants; the sterile production of traditional drugs and biologics; the design, construction, and validation of new parenteral facilities; and the monitoring of clean environments. Each of the 23 expertly written chapters focuses on a specific phase or aspect of parenteral product manufacture. The book vividly illustrates the routes in which products, processes, and manufacturing settings become contaminated through contact with the air, water, raw materials, and the actions of personnel, as well as the current methods necessary to successfully preclude contamination.

Historical And Emerging Themes In Parenteral Manufacturing Contamination Control. Microbial Contamination Hazard Analysis In Sterile Product Manufacturing. Overview Of Modern Parenteral Processes. The Role Of USP In The Microbiological Assessment Of Parenteral Manufacturing. Sterile Concepts And Bioindicators. Biological Safety Cabinets And Isolators Used In Pharmaceutical Processing. Developing A Process For Aseptic Facility Design And Validation. Pharmaceutical Water Systems: New Orientations In System Design Multimedia Filtration. Airborne Contamination Control. Disinfection Practices In Parenteral Manufacturing. Sterile Filtration. Process Development Of Alternative Sterilization Methods. Terminal Sterilization And Parametric Release. Raw Material Contamination Control. Endotoxin: Worst Case Parenteral Pyrogen. Screening Active Pharmaceutical Ingredients And Excipients For Endotoxin. Viral And Prion Clearance Strategies For Biopharmaceutical Safety. Microbiological Contamination Control In Monoclonal Antibody Production. Statistical Sampling Concepts. Environmental Monitoring. Prevention And Troubleshooting Of Microbial Excursions. Simulation Of Aseptic Manufacture. Standard Methods Of Microbial Identification. Rapid Methods Of Microbial Identification