1st Edition
Sterile Drug Products Formulation, Packaging, Manufacturing and Quality
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
Biography
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.
