Sterile Drug Products

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.

Introduction, scope, and history of sterile productsCharacteristics of sterile dosage formsTypes of sterile dosage formsSterile product packaging systemsOverview of product developmentFormulation components (solvents and solutes)Sterile products packaging chemistryFormulation and stability of solutionsDispersed systemsFormulation of freeze-dried powdersOvercoming formulation problems and some case studiesOverview of sterile product manufacturingContamination controlSterile manufacturing facilitiesWater and air quality in sterile manufacturing facilitiesPersonnel requirements for sterile manufacturingSterilization methods in sterile product manufacturingSterile filtrationSterile product filling, stoppering, and sealingFreeze-dry (lyophilization) processingAseptic processingInspection, labeling, and secondary packagingBarrier and other advanced technologies in aseptic processingStability, storage, and distribution of sterile drug productsGood manufacturing practiceQuality assurance and controlMicroorganisms and sterility testingPyrogens and pyrogen/endotoxin testingParticles and particulate matter testingSterile product-package integrity testingAdministration of injectable drug productsClinical hazards of injectable drug administrationBiopharmaceutical considerations with injectable drug delivery