Detalles del Título
Detalles del Título

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Título Aseptic processing v.3Libros / Impreso - Libros
Publicación Duluth, MN : Advanstar Communications, ©2010
Descripción Física 93 páginas : ilustraciones ; 28 cm.
Idioma Inglés;
Series Pharmaceutical Technology Resource Guide
Clasificación(es) 615.19
Materia(s) Tecnología farmacéutica; Artículos científicos; Industria farmacéutica;
Nota(s) Incluye referencias bibliográficas
CONTENIDO: Automation. The impact of automation on aseptic processing -- Cleaning & cleaning validation. Equipment-hold time for cleaning validation Setting cleaning validation acceptance limits for topical formulations -- Ruggedness of visible residue limits for cleaning validation -- Cleanroom design & technology. Donning by design: sterile cleanroom gowning evolves to help minimize contamination risk -- Disposables. Disposable components in aseptic processing -- Filtration. Considerations on re-use of sterilizing-grade filters -- Guidelines for selecting normal flow filters -- Integrity testing. Improving the integrity test assurance of multiround housings assessments -- Lyophilization & alternatives. Freeze-drying with closed vials -- Deep freeze: innovations in lyophilization -- Evaluating functional equivalency as a lyophilization-cycle transfer tool -- Risk management. Risk management for aseptic processing -- Compliancerisk management: using a top-down validation approach -- Applying quality by design to sterile manufacturing processes -- Sterilization. Establishing material compatibility, process conditions, and bubble points of filters -- The rotation of disinfectants principle: true or false?.
CodBarras Localización Piso Signatura Estado Categoría
104726Biblioteca Universidad Icesi2615.19/A816/v.3DisponibleCol. General