Incluye referencias bibliográficas CONTENIDO: Aseptic processing: a review of current industry practice -- Cleanroom design & technology. Current technology for contained manufacturing -- Cleanroom pressurization methodology -- The LR method in critical areas -- Design criteria and containment evaluation for pharmaceutical containment systems in aseptic dosage form manufacturing facilities -- A novel aseptic connection device: considerations for use in aseptic processing of pharmaceuticals -- The validation of a rapid sterile transfer port (RsTP) system used in barrier filling lines -- Designing transfer carts for class 100 conditions -- Lyophilization & alternatives. A novel freeze pelletization technique for preparing matrix pellets -- Preservation by foam formulation: an alternative to freeze-drying -- Filtration. The economics of modern sterile filtration -- Advances in disposable filtration for biomanufacturing -- The clarification of bioreactor cell cultures for biopharmaceuticals -- Good membrane vibrations: improving protein capture for transgenic drug processing -- Cleaning & cleaning validation. Developing a viable environmental monitoring program for nonsterile pharmaceutical operations -- Aqueous cleaning and solvent substitution in chemical synthesis API manufacturing -- Vapor-phase hydrogen peroxide resistance of environmental isolates -- Design and operational qualification of vapor-phase hydrogen peroxide biological indicator evaluator resistometer (BIER) unit -- Comparing and contrasting barrier isolator decontamination systems -- Implementing total organic carbon analysis for cleaning validation -- Analysis of environmental microbiology data from cleanroom samples -- Microbial testing in support of aseptic processing -- Training for aseptic processing environments -- Design of an aseptic process simulation.