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 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
