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Informationen zum Autor Michael J. Akers Ph.D. is Senior Director of Pharmaceutical Research and Development at Baxter and leads the Baxter Lyophilization Center of Excellence in Bloomington, Indiana. Dr. Akers received his B.A. degree from Wabash College and Ph.D. degree in Pharmaceutics from the University of Iowa College of Pharmacy, and has previously been employed at Searle Laboratories, Alcon Laboratories, University of Tennessee, and Eli Lilly and Company. Dr. Akers is active in the Parenteral Drug Association and is a Fellow of the American Association of Pharmaceutical Scientists. He is editor-in-chief of Pharmaceutical Development and Technology , and author or editor of six books, including Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Packaging Integrity Testing , Third Edition , 2002. Klappentext Supplying the latest research on the formulation, manufacture, quality control, and regulation of pharmaceuticals, biopharmaceuticals, and related products, this reference contains up-to-the-minute chapters on contamination control, facilities management, inspection, distribution, GMP, sterility and stability testing, and aseptic environments. Zusammenfassung Supplying the latest research on the formulation, manufacture, quality control, and regulation of pharmaceuticals, biopharmaceuticals, and related products, this reference contains up-to-the-minute chapters on contamination control, facilities management, inspection, distribution, GMP, sterility and stability testing, and aseptic environments. Inhaltsverzeichnis Introduction, scope, and history of sterile products Characteristics of sterile dosage forms Types of sterile dosage forms Sterile product packaging systems Overview of product development Formulation components (solvents and solutes) Sterile products packaging chemistry Formulation and stability of solutions Dispersed systems Formulation of freeze-dried powders Overcoming formulation problems and some case studies Overview of sterile product manufacturing Contamination control Sterile manufacturing facilities Water and air quality in sterile manufacturing facilities Personnel requirements for sterile manufacturing Sterilization methods in sterile product manufacturing Sterile filtration Sterile product filling, stoppering, and sealing Freeze-dry (lyophilization) processing Aseptic processing Inspection, labeling, and secondary packaging Barrier and other advanced technologies in aseptic processing Stability, storage, and distribution of sterile drug products Good manufacturing practice Quality assurance and control Microorganisms and sterility testing Pyrogens and pyrogen/endotoxin testing Particles and particulate matter testing Sterile product-package integrity testing Administration of injectable drug products Clinical hazards of injectable drug administration Biopharmaceutical considerations with injectable drug delivery ...
