Williams K.L. (ed.) Microbial Contamination Control in Parenteral Manufacturing

New York: Marcel Dekker. – 2004. −. 670 p. (Drugs and the Pharmaceutical Sciences. Volume 140) Parenteral drugs require sterility in every case; there is no gray area in that regard. What, then, is the relevance of contamination control in parenteral manufacturing? Contamination control occurs at a multitude of sites along the series of processes that lead invariably to the final result that is a sterile product. Part I, Chapters 1–5, lays a foundation, both historical and modern, for microbiology, parenteral therapeutics production, and sterile concepts. Part II, Chapters 6–10, begins with description of the equipment commonly used to isolate product from the outside environment, including operators: biological safety cabinets and isolators. Part III, Chapters 11–17, begins with detailing the manifold choices available and the means of assuring the correct use of sterilizing-grade filters, including integrity, pressure, and chemical compatibility testing, to name a few. Part IV describes the important functions of sampling (numerical assessment) and gauging (making quality judgments) the microbiological state of critical environments, in-process materials, and final product.Concepts and Foundations of Parenteral Manufacturing Contamination Control.
Historical and Emerging Themes in Parenteral Manufacturing Contamination Control.
Microbial Contamination Hazard Analysis in Sterile Product Manufacturing.
Overview of Modern Parenteral Poducts and Processes.
The Role of USP in the Microbiological Assessment of Parenteral Manufacturing.
Sterility and Bioindicators.
Control of Contaminants Via Facilities And Utilities.
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.
Airborne Contamination Control.
Disinfection Practices in Parenteral Manufacturing.
Manufacturing Process Control of Contaminants.
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.
Sampling, Monitoring, and Identifying Contaminants.
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.